CN1686521A - Psoriasis drip pill and its preparation method - Google Patents
Psoriasis drip pill and its preparation method Download PDFInfo
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- CN1686521A CN1686521A CN 200510056856 CN200510056856A CN1686521A CN 1686521 A CN1686521 A CN 1686521A CN 200510056856 CN200510056856 CN 200510056856 CN 200510056856 A CN200510056856 A CN 200510056856A CN 1686521 A CN1686521 A CN 1686521A
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Abstract
A Chinese medicine in the form of dripping pill for treating psoriasis is prepared from China root, chinaroot greenbrier, rhizome and medicinal carrier.
Description
Technical field
The present invention relates to a kind of Detoxication of dispeling the wind that has, be used for the treatment of the pharmaceutical composition of diseases such as psoriasis, particularly with contain the Chinese medicine Rhizoma Smilacis Glabrae, Rhizoma Smilacis Chinensis extraction of active ingredients thing is a kind of drug composition oral preparation that feedstock production forms.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The silver bits electuary that the preparation method that provides among-the B-2003-95 is prepared from, be a kind of Detoxication of dispeling the wind that has, be used for the treatment of the oral granular formulation of diseases such as psoriasis, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of this type of disease.Below be drug standard WS
3Prescription that provides among-the B-2003-95 and technology and brief description:
Prescription: Rhizoma Smilacis Glabrae 600g, Rhizoma Smilacis Chinensis 600g
Method for making: above two flavors decoct with water 3h for the first time, each 2h of second and third time three times, collecting decoction filters, and it is 1.20 that filtrate is concentrated into relative density, add ethanol to containing the alcohol amount, leave standstill, filter for 55-60%, reclaim ethanol, be condensed into the clear paste that relative density is 1.24-1.26,0.8 part of its clear paste, 3 parts of cane sugar powders, 1 part in dextrin, mixing, make granule, drying, promptly.
Function cures mainly: the detoxifcation of dispeling the wind.Be used for psoriasis.
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.Granule also has medicament contg also lower, takes deficiencies such as 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 is to replenish the existing deficiency that is used for the treatment of psoriatic oral drug preparation, and a kind of bioavailability height is provided, and has a quick release, produce effects fast, medicament contg height, taking convenience, cheap, and free of contamination aborning psoriasis drip pill.Psoriasis drip pill involved in the present invention, with contain the Chinese medicine Rhizoma Smilacis Glabrae, Rhizoma Smilacis Chinensis extraction of active ingredients thing is a raw material, be prepared from pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain psoriasis drip pill involved in the present invention:
[preparation method]
1. the preparation of drug extract: with g or kg is unit, according to the weight portion meter, fetch earth 1 part in Poria, 1 part of Rhizoma Smilacis Chinensis, more than 2 flavors, decoct with water 3 times, the 1st time 3 hours, 2nd, 3 times each 2 hours, collecting decoction filtered, it is 1.2～1.3 that filtrate is concentrated into relative density, adding ethanol is 55～60% to containing the alcohol amount, leaves standstill, and filters, reclaim ethanol, at 0.1Mpa, be condensed into relative density under 60 ℃ of following conditions and be 1.2～1.3 thick paste, or thick paste is continued to make under the same conditions drying, be ground into dry powder, promptly;
2. substrate: Polyethylene Glycol
(1000～20000), 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.
Beneficial effect
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The silver bits electuary that the preparation method that provides among-the B-2003-95 is prepared from, be a kind of Detoxication of dispeling the wind that has, be used for the treatment of the oral granular formulation of diseases such as psoriasis, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of this type of 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.Granule also has medicament contg also lower, takes deficiencies such as 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.
Psoriasis drip pill involved in the present invention is compared with silver bits electuary has following beneficial effect:
1. psoriasis drip pill involved in the present invention; utilize surfactant to be substrate; the extract of pharmaceutically active ingredient is made solid dispersion in containing Rhizoma Smilacis Glabrae, Rhizoma Smilacis Chinensis 2 flavors, makes medicine be molecule, colloid or microcrystalline state and is scattered in the substrate, and the total surface area of medicine increases; and substrate is hydrophilic; medicine is had wetting action, can make that medicine is rapidly molten to loose into microgranule or solution, thereby make the dissolving of medicine and absorb and accelerate; thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
2. psoriasis drip 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. psoriasis drip 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 psoriasis drip pill of the present invention:
First group: the test of single-matrix
1. raw material: it is standby to make drug extract dry powder earlier according to preparation method 1;
2. substrate: Polyethylene Glycol
(1000,2000,4000,6000,8000,10000,20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac etc.;
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 psoriasis drip pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared psoriasis drip pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
1000, 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, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared psoriasis drip pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
1000, 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, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared psoriasis drip pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, 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, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. raw material: it is standby to make drug extract dry powder earlier according to preparation method 1;
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 psoriasis drip pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared psoriasis drip 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, 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 experimental results and see Table 4.
Test 5: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared psoriasis drip 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, 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 experimental results and see Table 5.
Test 6: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared psoriasis drip 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, 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 experimental results and see Table 6.
Test 7: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared psoriasis drip 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, 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 experimental results and see Table 7.
Test 8: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared psoriasis drip 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, 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 experimental results and see Table 8.
Test 9: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared psoriasis drip 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, 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 experimental results and see Table 9.
Test 10: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained psoriasis drip 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, 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 experimental results and see Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained psoriasis drip 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, 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 experimental results and see Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained psoriasis drip 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, 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 experimental results and see 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 1000 | ????50.0 | ????58 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 2000 | ????50.0 | ????63 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????50.0 | ????75 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 6000 | ????50.0 | ????74 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 8000 | ????50.0 | ????76 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 10000 | ????50.0 | ????78 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 20000 | ????50.0 | ????77 | ????＜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 | ????57 | ????＞30 | ????＞10 | ++ |
| Sodium stearate | ????50.0 | ????55 | ????＞30 | ????＞10 | ++ |
| Glycerin gelatine | ????50.0 | ????57 | ????＞30 | ????＞10 | + |
| Lac | ????50.0 | ????59 | ????＞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 1000 | ????25.0 | ????65 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 2000 | ????25.0 | ????83 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????25.0 | ????87 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????25.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????25.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????25.0 | ????91 | ????＜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 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????25.0 | ????87 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????25.0 | ????84 | ????＜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 | ????75 | ????＞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 1000 | ????10.0 | ????67 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 2000 | ????10.0 | ????84 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????10.0 | ????85 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????10.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????10.0 | ????91 | ????＜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 | ????90 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????84 | ????＜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 | ????81 | ????＞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 | ????81 | ????＜30 | ????＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????50 | ????82 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????50 | ????83 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????50 | ????74 | ????＜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 | ????85 | ????＜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 | ????87 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????86 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????85 | ????＜30 | ????＞10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????10 | ????82 | ????＜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 | ????92 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????50 | ????87 | ????＜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 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????25 | ????92 | ????＜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 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????10 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????10 | ????91 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????10 | ????90 | ????＜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 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????50 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????50 | ????87 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????50 | ????88 | ????＜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 | ????93 | ????＜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 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????10 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????10 | ????91 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????10 | ????90 | ????＜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 (5)
1. one kind is used for the treatment of psoriatic pharmaceutical composition psoriasis drip pill, is raw material with the extract that contains Rhizoma Smilacis Glabrae, Rhizoma Smilacis Chinensis 2 flavor active ingredient of Chinese herbs, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 the preparation of drug extract: with g or kg is unit, according to the weight portion meter, fetch earth 1 part in Poria, 1 part of Rhizoma Smilacis Chinensis, more than 2 flavors, decoct with water 3 times, the 1st time 3 hours, 2nd, 3 times each 2 hours, collecting decoction filtered, it is 1.2～1.3 that filtrate is concentrated into relative density, adding ethanol is 55～60% to containing the alcohol amount, leaves standstill, and filters, reclaim ethanol, at 0.1Mpa, be condensed into relative density under 60 ℃ of following conditions and be 1.2～1.3 thick paste, or thick paste is continued to make under the same conditions drying, be ground into dry powder, promptly;
1.2 substrate: Polyethylene Glycol
(1000～20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, above-mentioned pharmaceutically suitable carrier one or more mixture wherein;
1.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
2. psoriasis drip pill as claimed in claim 1 is characterized in that: described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or Polyethylene Glycol and poloxamer or Polyethylene Glycol and carboxymethyl starch sodium or Polyethylene Glycol and betacyclodextrin; With g or kg is unit, and by weight, its mixed proportion is polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10.
3. any psoriasis drip pill as claimed in claim 1 or 2 is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
4. the preparation method of a psoriasis drip pill is characterized in that being made of following process:
4.1 the preparation of drug extract: with g or kg is unit, according to the weight portion meter, 1 part in the Poria that fetches earth, 1 part of Rhizoma Smilacis Chinensis, more than two the flavor, decoct with water 3h for the first time, each 2h of second and third time three times, collecting decoction filters, and it is 1.20 that filtrate is concentrated into relative density, add ethanol to containing the alcohol amount, leave standstill, filter for 55-60%, reclaim ethanol,, be condensed into the thick paste that relative density is 1.24-1.26 under 60 ℃ the condition at 0.1Mpa, or thick paste continued through the low-temperature reduced-pressure drying, pulverize, promptly get dry powder;
4.2 substrate: Polyethylene Glycol
(1000～20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, above-mentioned pharmaceutically suitable carrier one or more mixture wherein;
4.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4.4, accurately take by weighing drug extract and substrate according to the given ratio of prescription, 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;
4.5 adjust the temperature control system of 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 ℃;
4.6 when treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches 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, shrink molding promptly.
5. as the preparation method of psoriasis drip pill as described in the claim 4, it is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510056856 CN1686521A (en) | 2005-03-28 | 2005-03-28 | Psoriasis drip pill and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510056856 CN1686521A (en) | 2005-03-28 | 2005-03-28 | Psoriasis drip pill and its preparation method |
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|---|---|
| CN1686521A true CN1686521A (en) | 2005-10-26 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101648936B (en) * | 2009-09-17 | 2012-08-15 | 荣昌制药(淄博)有限公司 | Chemical composition separation method of traditional Chinese medicine smilax composition and clinical application thereof |
| CN103239653A (en) * | 2012-02-13 | 2013-08-14 | 陕西兴邦药业有限公司 | Traditional Chinese medicine composition for psoriasis and preparation method thereof |
-
2005
- 2005-03-28 CN CN 200510056856 patent/CN1686521A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101648936B (en) * | 2009-09-17 | 2012-08-15 | 荣昌制药(淄博)有限公司 | Chemical composition separation method of traditional Chinese medicine smilax composition and clinical application thereof |
| CN103239653A (en) * | 2012-02-13 | 2013-08-14 | 陕西兴邦药业有限公司 | Traditional Chinese medicine composition for psoriasis and preparation method thereof |
| CN103239653B (en) * | 2012-02-13 | 2014-11-12 | 陕西兴邦药业有限公司 | Traditional Chinese medicine composition for psoriasis and preparation method thereof |
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