CN101947234A - Preparation method for preparation containing glucosamine and application thereof - Google Patents
Preparation method for preparation containing glucosamine and application thereof Download PDFInfo
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Abstract
The invention discloses a preparation method for preparation containing glucosamine and an application thereof. The preparation is characterized in that the major component is one or the combination of more of the glucosamine, glucosamine hydrochloride, glucosamine sulfate sodium chloride double salt or potassium chloride double salt, and chondroitin sulfate. The preparation method is simple, convenient and time-saving to operate and is easy for large industrialized production.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, mainly be specifically related to contain the preparation method and the application thereof of glucosamine formulations.
Background technology
Glycosaminoglycan is a kind of natural saccharide that derives from chitin; be the Main Ingredients and Appearance in the cartilage matrix; by changing its side-chain structure; easilier in articular cartilage combine with water; the maintenance articular cavity lubricates the effect with compensator or trimmer pressure; impaired chondrocyte is had the certain protection effect, can synthetic use, existing commonly used have glucosamine, glucosamine hydrochloride, glucosamine sulfate sodium chloride double salt or potassium chloride double salt etc.Glucosamine is one of least unit of forming poly-glucosamine, and it and alduronic acid have been formed poly-glucosamine, comprise chondroitin sulfate, keratan sulfate, dermatan sulfate and hyaluronic acid.
Anti-inflammatory drug only can improve the symptom of osteoarthritis, and also may command symptom development of glycosaminoglycan helps the reparation of cartilage.Preparation at U.S.'s glycosaminoglycan and chondroitin sulfate has been added in the food, has very high safe reliability.Oral such medicine can reach therapeutic purposes, the patient of, pulmonary disease poor with blood circulation diseases, hepatic and renal function, diabetes for some, has safety equally, for the preparation of taking metallic elements such as adding magnesium, zinc, selenium, should note producing behind these electrolytic etching of metal to cardiovascular inhibitory action.Oral dose reached 1500mg and can reach therapeutic effect every day, patient for fat or long-term oral diuretics also wants boost to 2000～2500mg, just can reach therapeutic effect after confirming in the experiment to take for 4～6 weeks, therefore should adhere to taking at least 1 month.Side reaction after taking for a long time is less, and is also gentle.
The cartilage protection effect of glycosaminoglycan and chondroitin sulfate also is embodied in and can improves synovial membrane and produce hyaluronic ability, and normal hyaluronic acid level can reduce the regression of cartilage surface in the articular cavity, alleviates the symptom of osteoarthritis.When this class Chondroprotective agents applies to the chondrocyte of In vitro culture; synthetic and the gathering of proteoglycan all raises; the activity of collagenase reduces; glycosaminoglycan and chondroitin sulfate are the synthetic base substances of proteoglycan, and sulfate group is to keep the stable critical network structure of cartilage cell epimatrix simultaneously.In animal model, glycosaminoglycan also has antiphlogistic potential, although the activity influence to Cycloxygenase in the inflammatory reaction or proteolytic enzyme is little, owing to increased the synthetic of proteoglycan, but brought into play the effect and the tytosis epimatrix of stabilizing cell membrane, play antiphlogistic effect indirectly, this is with NSAID s class mechanism of drug action difference, but this two classes drug combination can play synergism, reduce NSAID s class amount of drug, alleviate side reaction; Chondroitin sulfate also may have certain anti-inflammatory property, play a role at the aspects such as tropism, phagocyte and activity of lysozyme that suppress inflammatory mediator, but the antiinflammatory ability is low than medicines such as indometacin, ibuprofen.Safety and effectiveness that a lot of experiment confirm glycosaminoglycan and chondroitin sulfate are also arranged clinically, Rovati is in a randomized, double-blind experiment, the patient of 252 routine knee joint osseous arthritiies, part is not taken glycosaminoglycan (each 500mg, every day 3 times) and contrast take placebo treatment 4 time-of-weeks, patient's gonalgia of 55%, swelling, limitation of activity symptom obviously alleviate, and matched group only is 38%.Eichelt etc. are in one group of patient, intramuscular injection CSSO3 400mg, 2 times weekly, administration group (55%) has the significance meaning with placebo group (33%) difference on relief of symptoms when treating for 6 weeks, Buesi finds in the research of observing chondroitin sulfate extract for treating osteoarthritis: each oral 800mg, every day 2 times, after taking 6 months continuously, patient's symptom of 43% is obviously improved, only have 3% to improve and take placebo group, and can significant prolongation suffer from the limb travel time, symptom alleviate also be continue (part is not being taken back 1,3, reach 15% in 6 months, 24% and 37%).Unite and take these two kinds of medicines (glycosaminoglycan 1500mg/d, chondroitin sulfate 1200mg/d) and can reach the obvious treatment effect equally.In with the comparative study of NSAID s class medicine, find to reach and take pain relieving and the antiphlogistic effects of ibuprofen during 1 week taking cartilage protection class medicine 2 Zhou Houke; as if ibuprofen 2 all backs symptoms are stable taking; and continue to take the trend that symptom behind the chondroitin sulfate still has further improvement; final therapeutic effect is: the ibuprofen group reaches 52%; chondroitin sulfate group 48%; but the incidence rate ibuprofen group of side reaction is 35%, and the chondroitin sulfate group only is 6%.Therefore NSAID s class agents alleviate symptom is rapider, though and cartilage protection class medicine is low slightly on therapeutic effect, the onset gentleness, it is less to take the back side reaction for a long time.
Glycosaminoglycan and chondroitin sulfate are as the important composition in the articular cartilage substrate; the characteristic that in external and body, all has the protection articular cartilage in the experiment; also can alleviate the symptom of osteoarthritis in the clinical practice; diverse ways is provided for the Drug therapy of osteoarthritis, the improvement of dosage form and the safety of dosage also need be furtherd investigate.
Summary of the invention
The objective of the invention is to disclose the preparation that a class contains the glucosamine composition, its Main Ingredients and Appearance may be one or more the combination wherein of glucosamine, glucosamine hydrochloride, glucosamine sulfate sodium chloride double salt or potassium chloride double salt, chondroitin sulfate.And in actual preparation process, may add some human bodies necessary trace element as calcium, magnesium, ferrum, germanium, bismuth, selenium etc.Purpose is stabilization formulations, heightens the effect of a treatment simultaneously.
Above-mentioned said trace element should add in the mode that can be used safely in human body known to now, the organic or inorganic salt of various elements preferably, add as: the calcium constituent form with calcium salt, calcium salt can be one or more the combination in calcium gluconate, calcium hydrogen phosphate, calcium lactate, calcium chloride, Citric acid calcium, calcium sulfate, calcium acetate, calcium amino acid chelate, the threonic acid calcium; Magnesium elements adds with the form of magnesium salt, and magnesium salt can be one or more the combination in magnesium sulfate or the magnesium chloride; Ferrum element adds with the form of divalent iron salt, and divalent iron salt can be that ferrous sulfate, Fructus Vitis viniferae acid are ferrous, one or more the combination in the ferrous fumarate, ferrous lactate, ferrous succinate; Sodium selenite etc.
Above-mentionedly contain that mass ratio is 1000: 1～100 in the preparation of glucosamine and trace element, dosage form can be that solid preparation (its kind comprises: conventional tablet, effervescent tablet, granule, capsule etc.) also can be an injection class preparation.Wherein need to add some alkaline solvents be diethanolamine to D-glucosamine injection class preparation, triethanolamine or ethylenediamine etc. as alkaline conditioner to adapt to injection pH.
The above-mentioned production method that contains the glucosamine lyophilized formulations, its feature includes but are not limited to the following aspects: the hydrochloric acid solution that Main Ingredients and Appearance 0.05～0.8g is dissolved in 0.04mol/L is an amount of, stirs it is dissolved fully; Excipient 0～2g adds above-mentioned solution, is stirred to dissolving fully, adds water to capacity; The alkalescence solvent can directly add above-mentioned solution, also can be mixed with injection separately and be used.The active carbon of adding 0.1% stirs 15～30min, takes off charcoal, through the extremely clarification of 0.45um, 0.22um filtering with microporous membrane; According to 1～10ml part dress, carry out lyophilization.Freezing dry process comprises: pre-freeze process 2～10 hours; The sublimation drying process was with 0.5～2 ℃ of/hour heating rate drying 20～72 hours; Heat preservation and dryness process 3～8 hours.
The above-mentioned production method that contains aminoglucose injection, its feature includes but are not limited to the following aspects: the hydrochloric acid solution that Main Ingredients and Appearance 0.05～0.8g is dissolved in 0.04mol/L is an amount of, stirs it is dissolved fully; Can add in trace element, antioxidant, the alkaline solvent one or more dissolvings fully, add the injection water to capacity, alkalescence also can be mixed with injection separately and be used; The active carbon of adding 0.1% stirs 15～30min, takes off charcoal, through the extremely clarification of 0.45um, 0.22um filtering with microporous membrane; Adorn brown ampoule according to 1～10ml part.
Specific embodiments
Embodiment 1: glucosamine hydrochloride capsule (specification: glucosamine hydrochloride 0.24g)
Glucosamine hydrochloride 240g
Magnesium chloride 100g
Microcrystalline Cellulose 50g
5%PVP
K30(70% ethanol) is an amount of
Magnesium stearate 5g
Make 1000
Preparation process: each supplementary material is crossed 80 mesh sieves pulverize, get glucosamine hydrochloride, magnesium chloride and the microcrystalline Cellulose mix homogeneously of recipe quantity, add 5%PVP
K30(70% ethanol) system soft material, 20 orders are granulated, 40～50 ℃ of dryings, 16 order granulate add magnesium stearate and above-mentioned granule mixing, No. 1 capsule of fill.
Embodiment 2: compound glucosamine sulfate chewable tablet (specification: glucosamine sulfate sodium chloride double salt 0,314g/ chondroitin sulfate 0.2g)
Glucosamine sulfate sodium chloride double salt 314g
Chondroitin sulfate (in pure product) 200g
Calcium lactate 300g
Lactose 200g
Aspartame 15g
Malic acid 10g
2%HPMC (60% alcoholic solution) is an amount of
Orange flavor essence 10g
Magnesium stearate 10g
Make 1000 amounts
Preparation process: each supplementary material is crossed 80 mesh sieves pulverize; get glucosamine sulfate sodium chloride double salt, chondroitin sulfate, calcium lactate, lactose, aspartame and the malic acid mix homogeneously of recipe quantity; add 2%HPMC (60% alcoholic solution) system soft material; 16 orders are granulated; 40～50 ℃ of dryings; 12 order granulate add magnesium stearate and above-mentioned granule mixing, the compacting special-shaped tablets.
Embodiment 3: glucosamine sulfate lyophilizing (glucosamine sulfate sodium chloride double salt 0.5025g)
Glucosamine sulfate sodium chloride double salt 502.5g
Lidocaine hydrochloride 10g
Diethanolamine 20g
Mannitol 100g
Hydrochloric acid is an amount of
Add injection water 3000ml
Make 1000 bottles
Process for preparation: get 80% water yield and be mixed with the 0.04mol/L hydrochloric acid solution, add the stirring of glucosamine sulfate sodium chloride double salt it is dissolved fully; Add recipe quantity lidocaine hydrochloride, mannitol and diethanolamine, be stirred to dissolving fully, add water to capacity.The active carbon of adding 0.05% stirs 15～30min, takes off charcoal, through the extremely clarification of 0.45um, 0.22um filtering with microporous membrane; According to 3ml part dress, carry out lyophilization.Freezing dry process comprises: pre-freeze process 2～10 hours; The sublimation drying process was with 0.5～2 ℃ of/hour heating rate drying 20～72 hours; Heat preservation and dryness process 3～8 hours.
Embodiment 4: glucosamine sulfate injection (glucosamine sulfate sodium chloride double salt 0.5025g)
Glucosamine sulfate sodium chloride double salt 502.5g
Lidocaine hydrochloride 10g
Hydrochloric acid is an amount of
Add injection water 2000ml
Make 1000
Process for preparation: get 80% water yield and be mixed with the 0.04mol/L hydrochloric acid solution, add the stirring of glucosamine sulfate sodium chloride double salt it is dissolved fully; Add the recipe quantity lidocaine hydrochloride and be stirred to dissolving fully, add water to capacity.The active carbon of adding 0.05% stirs 15～30min, takes off charcoal, through the extremely clarification of 0.45um, 0.22um filtering with microporous membrane; According to the 2ml embedding.
Other prepares alkaline conditioner, and is as follows:
Diethanolamine 24g
Add injection water 1000ml
Make 1000
Or:
Triethanolamine 20g
Add injection water 1000ml
Make 1000
Or:
Anhydrous ethylenediamine 20g
Add injection water 1000ml
Make 1000
Process for preparation: the alkaline conditioner that takes by weighing above-mentioned recipe quantity adds water to capacity, stirs, and adds 0.05% active carbon, stirs 15～30min, takes off charcoal, through the extremely clarification of 0.45um, 0.22um filtering with microporous membrane; According to the 1ml embedding, 15 parts of clocks of 121 ℃ of sterilizations.
Stability test:
The graceful institute of materia medica of Weir, sample source Nanjing
Sample lot number 070901,070902,070903
Reference substance source and the 100588-200501 of lot number Nat'l Pharmaceutical ﹠ Biological Products Control Institute
The investigation project is with reference to " new drug (chemical drugs) research guideline ", " medicine registration management way " and " Chinese pharmacopoeia 2005 editions, the study on the stability project of determining this product is appearance character, acid-base value, related substance, content.
The range estimation of investigation method appearance character.
Acid-base value is according to " 2010 editions two appendix VI H of Chinese Pharmacopoeia item is measured down.
The related substance high performance liquid chromatography (" 2010 editions two appendix V D of Chinese pharmacopoeia)
The assay high performance liquid chromatography (" 2010 editions two appendix V D of Chinese Pharmacopoeia)
Accelerated test: this product (lot number 070901,070902,070903) is pressed the environment of commercially available back in relative humidity 75% ± 5%, places in 40 ℃ ± 2 ℃ calorstats, part not in the 1st, 2,3,6 the end of month pick test, investigate the stability of this product.The results are shown in following table:
Injection glucosamine sulfate accelerated test result
Long-term investigation: with this product (lot number 070901,070902,070903) by the environment of commercially available back in relative humidity 60% ± 10% (filling the hermetic container of saturated sodium nitrite solution), place in 25 ℃ ± 2 ℃ calorstats, part not in the 3rd, 6,9,12,18,24 the end of month pick test, investigate the stability of this product, the results are shown in following table:
The injection glucosamine sulfate result of the test that keeps sample for a long time
Claims (12)
1. contain the preparation method and the application thereof of glucosamine formulations, it is characterized in that Main Ingredients and Appearance is one or more the combination wherein of glucosamine, glucosamine hydrochloride, glucosamine sulfate sodium chloride double salt or potassium chloride double salt, chondroitin sulfate.
2. according to the preparation that contains glucosamine in the claim 1, it is characterized in that the necessary trace element of main component and some human bodies as: calcium, magnesium, ferrum, germanium, bismuth, selenic mass ratio are 1000: 1～100.
3. add with the form of calcium salt according to calcium constituent in the claim 2, calcium salt can be one or more the combination in calcium gluconate, calcium hydrogen phosphate, calcium lactate, calcium chloride, Citric acid calcium, calcium sulfate, calcium acetate, calcium amino acid chelate, the threonic acid calcium.
4. add with the form of magnesium salt according to magnesium elements in the claim 2, magnesium salt can be one or more the combination in magnesium sulfate or the magnesium chloride.
5. add with the form of divalent iron salt according to ferrum element in the claim 2, divalent iron salt can be that ferrous sulfate, Fructus Vitis viniferae acid are ferrous, one or more the combination in the ferrous fumarate, ferrous lactate, ferrous succinate.
6. add with the form that is used for human body safety now according to germanium, bismuth, selenium element in the claim 2, as: sodium selenite etc.
7. according to the solid preparation that contains glucosamine described in claim 1 or 2, its kind comprises: conventional tablet, effervescent tablet, chewable tablet, granule, capsule etc.
8. according to containing glucosamine injection class preparation described in claim 1 or 2, it is characterized in that described antioxidant is one or more the mixing in sodium sulfite, sodium pyrosulfite, the ascorbic acid, addition 0.01%～0.5%.
9. inject the class preparation according to the glucosamine that contains described in claim 1 or 2, it is characterized in that described alkaline solvent is a diethanolamine, triethanolamine or ethylenediamine etc.
10. according to containing glucosamine injection class preparation described in claim 1 or 2, it is characterized in that described lyophilization excipient is one or more the mixing in mannitol, dextran, sodium chloride, calcium chloride, lactose, the glucose.
11. the production method that contains the glucosamine lyophilized formulations according to claim 1 and 2, its feature includes but are not limited to the following aspects:
(1). the hydrochloric acid solution that main component 0.05～0.8g is dissolved in 0.04mol/L is an amount of, stirs it is dissolved fully;
(2). excipient 0～2g adds above-mentioned solution, is stirred to dissolving fully, adds water to capacity; The alkalescence solvent can directly add above-mentioned solution, also can be mixed with injection separately and be used.
(3). the active carbon of adding 0.1%, stir 15～30min, take off charcoal, through the extremely clarification of 0.45um, 0.22um filtering with microporous membrane;
(4). according to 1～10ml packing, carry out lyophilization.
(5). freezing dry process comprises: pre-freeze process 2～10 hours; The sublimation drying process was with 0.5～2 ℃ of/hour heating rate drying 20～72 hours; Heat preservation and dryness process 3～8 hours.
12. the production method that contains aminoglucose injection according to claim 1, its feature includes but are not limited to the following aspects:
(1). the hydrochloric acid solution that main component 0.05～0.8g is dissolved in 0.04mol/L is an amount of, stirs it is dissolved fully; (2). can add in trace element, antioxidant, the alkaline solvent one or more dissolvings fully, add the injection water to capacity, alkalescence also can be mixed with injection separately and be used;
(3). the active carbon of adding 0.1%, stir 15～30min, take off charcoal, through the extremely clarification of 0.45um, 0.22um filtering with microporous membrane;
(4). according to the brown ampoule of 1～10ml packing.
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102961389A (en) * | 2012-11-27 | 2013-03-13 | 任金山 | Composition containing glucosamine as well as preparation method and detection method thereof |
| CN104666264A (en) * | 2015-02-12 | 2015-06-03 | 浙江诚意药业股份有限公司 | Chitosamine hydrochloride chewable tablet and preparation method thereof |
| CN105193760A (en) * | 2015-10-08 | 2015-12-30 | 北京康力基生物科技有限公司 | High-content glucosamine sulfate tablet and preparation method |
| CN105982911A (en) * | 2015-01-29 | 2016-10-05 | 上海建华精细生物制品有限公司 | Preparation method of high-viscoelasticity injection composed of glucosamine and sodium hyaluronate |
| CN106474077A (en) * | 2015-11-30 | 2017-03-08 | 湖南恒生制药股份有限公司 | The preparation method of injection chondroitin sulfate |
| CN107048412A (en) * | 2017-04-26 | 2017-08-18 | 北京盛美诺生物技术有限公司 | A kind of masticatory pattern product containing typeⅡ Collagen |
| CN108034962A (en) * | 2017-12-14 | 2018-05-15 | 浙江蓝极膜技术有限公司 | A kind of device that aminoglucose sulfate is prepared using membrane technology |
| CN108740305A (en) * | 2018-05-10 | 2018-11-06 | 青岛农业大学 | Special calcium tablet of Diseases of Cow and preparation method thereof |
| CN110680808A (en) * | 2019-11-08 | 2020-01-14 | 山东润德生物科技有限公司 | Amino sugar chewable tablet and preparation method thereof |
| CN114748417A (en) * | 2022-05-26 | 2022-07-15 | 山东润德生物科技有限公司 | Oral glucosamine preparation and preparation method and application thereof |
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| CN101036691A (en) * | 2007-04-11 | 2007-09-19 | 张金桦 | Health-caring product for improving bone density and immunity |
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Patent Citations (2)
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| CN101036691A (en) * | 2007-04-11 | 2007-09-19 | 张金桦 | Health-caring product for improving bone density and immunity |
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Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102961389B (en) * | 2012-11-27 | 2014-07-16 | 任金山 | Composition containing glucosamine as well as preparation method and detection method thereof |
| CN102961389A (en) * | 2012-11-27 | 2013-03-13 | 任金山 | Composition containing glucosamine as well as preparation method and detection method thereof |
| CN105982911A (en) * | 2015-01-29 | 2016-10-05 | 上海建华精细生物制品有限公司 | Preparation method of high-viscoelasticity injection composed of glucosamine and sodium hyaluronate |
| CN104666264B (en) * | 2015-02-12 | 2018-05-15 | 浙江诚意药业股份有限公司 | A kind of aminoglucose hydrochloride chewable tablets and preparation method thereof |
| CN104666264A (en) * | 2015-02-12 | 2015-06-03 | 浙江诚意药业股份有限公司 | Chitosamine hydrochloride chewable tablet and preparation method thereof |
| CN105193760A (en) * | 2015-10-08 | 2015-12-30 | 北京康力基生物科技有限公司 | High-content glucosamine sulfate tablet and preparation method |
| CN106474077A (en) * | 2015-11-30 | 2017-03-08 | 湖南恒生制药股份有限公司 | The preparation method of injection chondroitin sulfate |
| CN107048412A (en) * | 2017-04-26 | 2017-08-18 | 北京盛美诺生物技术有限公司 | A kind of masticatory pattern product containing typeⅡ Collagen |
| CN108034962A (en) * | 2017-12-14 | 2018-05-15 | 浙江蓝极膜技术有限公司 | A kind of device that aminoglucose sulfate is prepared using membrane technology |
| CN108740305A (en) * | 2018-05-10 | 2018-11-06 | 青岛农业大学 | Special calcium tablet of Diseases of Cow and preparation method thereof |
| CN110680808A (en) * | 2019-11-08 | 2020-01-14 | 山东润德生物科技有限公司 | Amino sugar chewable tablet and preparation method thereof |
| CN110680808B (en) * | 2019-11-08 | 2021-04-13 | 山东润德生物科技有限公司 | Amino sugar chewable tablet and preparation method thereof |
| CN114748417A (en) * | 2022-05-26 | 2022-07-15 | 山东润德生物科技有限公司 | Oral glucosamine preparation and preparation method and application thereof |
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Application publication date: 20110119 |