CN1292740C - Ginseng and Chinese angelica root dripping pill and its preparing method - Google Patents
Ginseng and Chinese angelica root dripping pill and its preparing method Download PDFInfo
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Abstract
The present invention relates to a medicine composition used for the treatment of the deficiency of both qi and blood, sallow complexion, heart palpitation, breath shortness, poor appetite, lassitude and other disorders, which has the functions of qi and blood supplement and invigoration. The present invention has the purposes for complementing the deficiency of existing oral medicine preparations used for the treatment of the disorders and providing a ginseng-angelica dripping pill which is an oral preparation having high bioavailability, quick medicine release, rapid effect, high medicine content, convenient pill taking, low price, no pollution during production and convenient carrying. The ginseng-angelica dripping pill of the present invention is prepared from the raw materials of ginseng, angelica and other Chinese medicines, and a medicinal carrier serving as a matrix.
Description
Technical field
The present invention relates to a kind of benefiting vital QI and blood effect that has, be used for deficiency of both QI and blood, the pharmaceutical composition of treatment for diseases such as shallow complexion, shortness of breath and palpitation, lack of appetite asthenia is a kind of drug composition oral preparation that feedstock production forms with the extract that contains 2 flavor active ingredient of Chinese herbs such as Leptoradix Ginseng Rubra, Radix Angelicae Sinensis particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The ginseng and Chinese angelica root granule that the preparation method that provides among-the B-3127-98 is prepared from, it is a kind of benefiting vital QI and blood effect that has, be used for deficiency of both QI and blood, the oral granular formulation of treatment for diseases such as shallow complexion, shortness of breath and palpitation, lack of appetite asthenia, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Below be drug standard WS
3Prescription that provides among-the B-3127-98 and technology and brief description:
Prescription: Leptoradix Ginseng Rubra 100g, Radix Angelicae Sinensis 350g
Method for making: above two flavors, Leptoradix Ginseng Rubra is measured warm macerating five times, each 8 hours for 4 times with 60% ethanol, merge warm macerating liquid, filter, filtrate is condensed into fluid extract, add 2 times of amounts of ethanol, stir evenly, leave standstill, get supernatant, residue adds 3 times of amounts of 60% ethanol, stirs evenly, leave standstill, get supernatant, merge with above-mentioned supernatant, reclaim ethanol, being concentrated into relative density is the thick paste of 1.2～1.25 (80 ℃).Radix Angelicae Sinensis extracts volatile oil, aqueous solution after distillation device is in addition collected, medicinal residues decoct with water three times, and 4 hours for the first time, 3 hours for the second time, 2 hours for the third time, collecting decoction filters, and filtrate is condensed into fluid extract, under Radix Ginseng Rubra face technology item, be processed into the thick paste that relative density is 1.2～1.25 (80 ℃) from " adding ethanol " in accordance with the law.With above-mentioned two kinds of thick pastes and glucose 900g mixing, make granule, drying adds volatile oil, mixing, promptly.
Function cures mainly: benefiting vital QI and blood.Be used for deficiency of both QI and blood, shallow complexion, shortness of breath and palpitation, lack of appetite asthenia.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.The medicament contg of granule is also lower, takes inconvenience.
In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Summary of the invention
Purpose of the present invention, be to replenish the existing deficiency of both QI and blood that is used for, the deficiency of the oral drug preparation of treatment for diseases such as shallow complexion, shortness of breath and palpitation, lack of appetite asthenia, a kind of bioavailability height is provided, and has quick release, fast produce effects, the medicament contg height, taking convenience, cheap, and free of contamination aborning oral formulations ginseng and Chinese angelica root dripping pill.Ginseng and Chinese angelica root dripping pill involved in the present invention is a raw material with 2 flavor Chinese medicines such as Leptoradix Ginseng Rubra, Radix Angelicae Sinensis, after extraction obtains containing the extract of above 2 flavor Chinese medicine active pharmaceutical ingredients, is prepared from the pharmaceutically suitable carrier as substrate again.Be prepared by the following technical solutions, can obtain ginseng and Chinese angelica root dripping pill involved in the present invention:
[preparation method]
1. raw material: the extract thick paste or the dry powder that contain Leptoradix Ginseng Rubra, Radix Angelicae Sinensis active pharmaceutical ingredient;
2. substrate: Polyethylene Glycol
(2000～20000), one or more the mixture in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, fused solution and/or the emulsion and/or the suspension that will contain drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
[appendix: a kind of Leptoradix Ginseng Rubra, Radix Angelicae Sinensis active pharmaceutical ingredient preparation method of extract of containing] is unit with g or kg, according to the weight portion meter, gets 2 parts of Leptoradix Ginseng Rubra, 7 parts of Radix Angelicae Sinensis, more than two flavors, Leptoradix Ginseng Rubra is measured warm macerating 5 times with 4 times of 60% ethanol, each 8 hours, merge warm macerating liquid, filter, filtrate is condensed into fluid extract, adds 2 times of amounts of ethanol, stir evenly, leave standstill, get supernatant, residue adds 3 times of amounts of 60% ethanol, stir evenly, leave standstill, get supernatant, merge with above-mentioned supernatant, reclaim ethanol, under 80 ℃ of conditions, be concentrated into relative density and be 1.2～1.25 thick paste; Radix Angelicae Sinensis extracts volatile oil, and the aqueous solution after distillation device is in addition collected, and medicinal residues decoct with water three times, the 1st time 4 hours, the 2nd time 3 hours, the 3rd time 2 hours, collecting decoction filtered, filtrate is condensed into fluid extract, with reference to previous process, is condensed into relative density and is 1.2～1.25 thick paste under 80 ℃ of conditions; Above-mentioned two kinds of thick pastes are mixed and set aside to below 60 ℃, add volatile oil, mixing promptly get the extract thick paste, or makes drying under (0.1MPa), low temperature (60 ℃) condition that reduces pressure, and is ground into dry powder, promptly gets extract dry powder.
What provide above is a kind of preparation method of common drug extract, under the same or analogous prerequisite of main active pharmaceutical ingredient of extract, is not limited to this a kind of method.
Beneficial effect
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The ginseng and Chinese angelica root granule that the preparation method that provides among-the B-3127-98 is prepared from, it is a kind of benefiting vital QI and blood effect that has, be used for deficiency of both QI and blood, the oral granular formulation of treatment for diseases such as shallow complexion, shortness of breath and palpitation, lack of appetite asthenia, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.The medicament contg of granule is also lower, takes inconvenience.
In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Shenerwuwei dripping pill involved in the present invention is compared with the Shenerwuwei essence has following beneficial effect:
1. ginseng and Chinese angelica root dripping pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains Leptoradix Ginseng Rubra, Radix Angelicae Sinensis active pharmaceutical ingredient; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; and substrate is hydrophilic; medicine had wetting action; can make medicine molten microgranule or the solution of loosing into rapidly; thereby make the dissolving of medicine and absorb quickening; thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
2. ginseng and Chinese angelica root dripping pill involved in the present invention, contact promptly with saliva and to dissolve rapidly, and absorb by oral mucosa, not only rapid-action, and the influence of not taken food, promptly all can containing take after meal ante cibum, can not produce any residual harmful substance at gastric yet, thereby make that patient's medication is safer, also have medication convenience, characteristic of accurate simultaneously.
3. ginseng and Chinese angelica root dripping pill involved in the present invention mixes the extract that contains active constituents of medicine mutually with molten matrix, splashes in the not miscible condensed fluid and makes.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
4. production technology, the equipment of preparation drop pill are simple, easy to operate, the automaticity height, and labor intensity is low, the production efficiency height.Workshop does not have dust simultaneously, helps labor protection and environmental protection yet.
5. the production cost of preparation drop pill is usually with about 50% of other oral formulations of kind, and compares with oral liquid, and the dosage of drop pill is accurate, thereby makes the patient take metering control easily.
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of ginseng and Chinese angelica root dripping pill of the present invention.
First group: the test of single-matrix
1. the preparation of drug extract: it is standby to make the extract dry powder that contains Leptoradix Ginseng Rubra, Radix Angelicae Sinensis active pharmaceutical ingredient earlier according to [appendix: a kind of Leptoradix Ginseng Rubra, Radix Angelicae Sinensis active pharmaceutical ingredient preparation method of extract of containing];
2. substrate: Polyethylene Glycol
(2000,4000,6000,8000,10000,20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the ginseng and Chinese angelica root dripping pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared ginseng and Chinese angelica root dripping pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared ginseng and Chinese angelica root dripping pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared ginseng and Chinese angelica root dripping pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. the preparation of drug extract: it is standby to make the extract dry powder that contains Leptoradix Ginseng Rubra, Radix Angelicae Sinensis active pharmaceutical ingredient earlier according to [appendix: a kind of Leptoradix Ginseng Rubra, Radix Angelicae Sinensis active pharmaceutical ingredient preparation method of extract of containing];
2. substrate:
2.1 Polyethylene Glycol---English name Macrogol,
2.2 polyoxyethylene stearate 40 esters---English name Polyoxyl (40) Stearate,
Molecular formula is with C
17H
35COO (CH
2CH
2O)
nH represents that n is about 40,
2.3 poloxamer---English name Poloxamer, polyoxyethylene poly-oxygen propylene aether,
Molecular formula HO (C
2H
4O)
a(C
3H
6O)
b(C
2H
4O)
cH,
The sodium salt of the starch carboxymethyl ester that 2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch generates with the monoxone effect under alkali condition,
2.5 betacyclodextrin---English name Betacyclodextrin, molecular formula C
6H
10O
5, this product is that ring dextrin glucosyl transferase acts on 7 glucoses that starch generates with α-1, the bonded cyclic oligosaccharide of 4-glycosidic bond;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the ginseng and Chinese angelica root dripping pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared ginseng and Chinese angelica root dripping pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 4.
Test 5: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared ginseng and Chinese angelica root dripping pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 5.
Test 6: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared ginseng and Chinese angelica root dripping pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 6.
Test 7: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared ginseng and Chinese angelica root dripping pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 7.
Test 8: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared ginseng and Chinese angelica root dripping pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 8.
Test 9: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared ginseng and Chinese angelica root dripping pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 9.
Test 10: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained ginseng and Chinese angelica root dripping pill when 1: 1 proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 1 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained ginseng and Chinese angelica root dripping pill when 1: 3 proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 3 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained ginseng and Chinese angelica root dripping pill when 1: 9 proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 9 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 12.
The group practices of table 1 drug extract and single-matrix
(drug extract: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | 50.0 | 62 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 75 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 8000 | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 73 | ＜30 | ＞10 | ++ |
| Betacyclodextrin | 50.0 | 69 | ＜30 | ＞10 | + |
| Poloxamer | 50.0 | 75 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium | 50.0 | 73 | ＜30 | ＞10 | + |
| Sodium lauryl sulphate | 50.0 | 68 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 55 | ＞30 | ＞10 | ++ |
| Sodium stearate | 50.0 | 55 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 50.0 | 57 | ＞30 | ＞10 | + |
| Lac | 50.0 | 56 | ＞30 | ＞10 | + |
The group practices of table 2 drug extract and single-matrix
(drug extract: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | 25.0 | 81 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 90 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 25.0 | 82 | ＜30 | ＞10 | ++ |
| Poloxamer | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 81 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 78 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 79 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 73 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 73 | ＞30 | ＞10 | +++ |
The group practices of table 3 drug extract and single-matrix
(drug extract: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | 10.0 | 83 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 93 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 10.0 | 88 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 80 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 82 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 82 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 78 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 79 | ＞30 | ＞10 | +++ |
The group practices of table 4 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 50 | 84 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 82 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 79 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 72 | ＜30 | ＞10 | + |
The group practices of table 5 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 25 | 88 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 89 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1:1 | 25 | 86 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 82 | ＜30 | ＞10 | ++ |
The group practices of table 6 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 10 | 88 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 86 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 83 | ＜30 | ＞10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 80 | ＜30 | ＞10 | +++ |
The group practices of table 7 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 50 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 86 | ＜30 | ＜10 | ++ |
The group practices of table 8 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 25 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 9 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 10 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 92 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 89 | ＜30 | ＜10 | +++ |
The group practices of table 10 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 50 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 87 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 84 | ＜30 | ＞10 | +++ |
The group practices of table 11 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 25 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 87 | ＜30 | ＜10 | +++ |
The group practices of table 12 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
1. can be seen by the result in the table: when the ratio of drug extract and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of drug extract and substrate is 1: 3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of drug extract and substrate is 1: 9, the rounding rate, the ball method of double differences is different and index such as hardness improves not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.
Claims (2)
1. a ginseng and Chinese angelica root dripping pill with Leptoradix Ginseng Rubra, when being classified as raw material, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) according to the weight portion meter, get 2 parts of Leptoradix Ginseng Rubra, 7 parts of Radix Angelicae Sinensis, more than two the flavor, Leptoradix Ginseng Rubra is measured warm macerating 5 times for 4 times with 60% ethanol, and each 8 hours, merge warm macerating liquid, filter, filtrate is condensed into fluid extract, adds 2 times of amounts of ethanol, stirs evenly, leave standstill, get supernatant, residue adds 3 times of amounts of 60% ethanol, stir evenly, leave standstill, get supernatant, merge with above-mentioned supernatant, reclaim ethanol, under 80 ℃ of conditions, be concentrated into relative density and be 1.2～1.25 thick paste; Radix Angelicae Sinensis extracts volatile oil, and the aqueous solution after distillation device is in addition collected, and medicinal residues decoct with water three times, the 1st time 4 hours, the 2nd time 3 hours, the 3rd time 2 hours, collecting decoction filtered, filtrate is condensed into fluid extract, with reference to previous process, is condensed into relative density and is 1.2～1.25 thick paste under 80 ℃ of conditions; Above-mentioned two kinds of thick pastes are mixed and set aside to below 60 ℃, add volatile oil, mixing promptly gets the extract thick paste, or makes drying being decompressed under 0.1MPa, 60 ℃ of cryogenic conditions, is ground into dry powder, promptly gets the extract that contains Leptoradix Ginseng Rubra and Radix Angelicae Sinensis effective ingredient, and is standby;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium, by weight, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10, describedly contains the extract of Leptoradix Ginseng Rubra and Radix Angelicae Sinensis effective ingredient and the ratio of substrate is 1: 3;
(3) according to aforementioned proportion, accurately take by weighing drug extract and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
(4) temperature control system of adjustment drop pill machine makes the water dropper temperature heating of drop pill machine and remains on 50 ℃～90 ℃, and the temperature cooling of condensing agent also remains on 40 ℃～-5 ℃;
(5) temperature for the treatment of dropping-pill machine head and condensing agent is stable respectively when reaching described state, will contain fused solution and/or the emulsion and/or the suspension of described extract and substrate, places in the water dropper jar of drop pill machine, splashes in the condensing agent and shrinks molding promptly.
2. ginseng and Chinese angelica root dripping pill according to claim 1 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100089073A CN1292740C (en) | 2005-02-24 | 2005-02-24 | Ginseng and Chinese angelica root dripping pill and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100089073A CN1292740C (en) | 2005-02-24 | 2005-02-24 | Ginseng and Chinese angelica root dripping pill and its preparing method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
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| CN1292740C true CN1292740C (en) | 2007-01-03 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1436527A (en) * | 2002-02-07 | 2003-08-20 | 王志刚 | Glimepiride dripping pills |
| CN1546027A (en) * | 2003-12-02 | 2004-11-17 | 北京正大绿洲医药科技有限公司 | Dripping pills for treating allergic disease and its preparation process |
| CN1546141A (en) * | 2003-12-12 | 2004-11-17 | 北京科信必成医药科技发展有限公司 | Blumea oil dripping pills and its preparation process |
-
2005
- 2005-02-24 CN CNB2005100089073A patent/CN1292740C/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1436527A (en) * | 2002-02-07 | 2003-08-20 | 王志刚 | Glimepiride dripping pills |
| CN1546027A (en) * | 2003-12-02 | 2004-11-17 | 北京正大绿洲医药科技有限公司 | Dripping pills for treating allergic disease and its preparation process |
| CN1546141A (en) * | 2003-12-12 | 2004-11-17 | 北京科信必成医药科技发展有限公司 | Blumea oil dripping pills and its preparation process |
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|---|---|
| CN1682832A (en) | 2005-10-19 |
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