CN1768758A - Soft capsule of medicinal composition and its preparation method - Google Patents
Soft capsule of medicinal composition and its preparation method Download PDFInfo
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- CN1768758A CN1768758A CN 200510117563 CN200510117563A CN1768758A CN 1768758 A CN1768758 A CN 1768758A CN 200510117563 CN200510117563 CN 200510117563 CN 200510117563 A CN200510117563 A CN 200510117563A CN 1768758 A CN1768758 A CN 1768758A
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Abstract
The invention provides a medicinal composition soft capsule and its preparing process, wherein the capsule is prepared from glucosamine and content comprising mixture of diluent, auxiliary solvent, solubilizing agent, suspension auxiliary agent, and surface active agent.
Description
Technical field
The present invention relates to a kind of medicinal composition soft capsule preparation and preparation method thereof, the active component of said composition soft capsule is a glucosamine salt.
Background technology
Glucosamine is the essential material of a kind of physiology, almost is distributed in human body institute in a organized way, participates in structure tissue and cell membrane, is the synthetic intermediate material of proteoglycan macromole, and content is the highest in the cartilage.Glucosamine is an important monosaccharide of higher mammal protein chain, and tumor cell is had lethal effect preferably, and very little to human normal cell's toxicity.
(osteoarthritis OA) is a kind of degenerative disease to osteoarthritis, mainly shows as articular cartilage Developmental and Metabolic Disorder and ossa articularia structural failure, causes afunction when serious.How only present medicine relief of symptoms, and to causing the pathological process of OA, promptly the dysbolismus effect of articular cartilage is more little.Glucosamine is the base substance of synthetic glycosaminoglycans of articular cartilage and HA skeleton, and glycosaminoglycans and HA are again the essential materials that forms Dan Baijutang in the joint.Glucosamine can pass through blood synovial membrane barrier, is dispersed in the chondrocyte, and is absorbed by chondrocyte.In a large amount of clinical trials, glucosamine treatment OA has obtained curative effect preferably, and toxic and side effects is less.Further studies show that in recent years, glucosamine are the main components that constitutes chondrocyte, and connective tissue is had the effect of reparation, treatment and anti-inflammatory analgesic, can prevent and treat the various diseases that cartilaginous tissue is degenerated and caused.
The glucosamine acid hydrolysis can generate glucosamine salt, primary raw material for synthetic anticarcinogen NSC-178248, also being treatment joint disease medicine and antibiotic synergist, is again one of main component of sweetening agent, antioxidant and bacillus bifidus culture medium, and purposes is very extensive.Glucosamine salt is soluble in water, diluted acid and dilute alkaline soln, is slightly soluble in methanol, ethanol, and certain moisture is arranged, and mobile poor, operation easier is bigger when doing solid orally ingestible, and content uniformity is bigger.
Summary of the invention
The present invention is intended to improve the loading amount accuracy of its active component glucosamine salt solid orally ingestible of a kind of medicinal composition soft capsule; overcome solid preparation and draw operating difficulties due to moist; improve curative effect; reduce dust from flying simultaneously with the healthy and environment of protection operator, having proposed active component is the soft capsule of glucosamine salt.
Another object of the present invention provides a kind of preparation method of medicinal composition soft capsule.
A kind of medicinal composition soft capsule of the present invention can prepare by the various appropriate method of soft capsule preparation, and its preferred for preparation method is as follows: with a plurality of mixed the content in glucosamine salt and diluent, cosolvent, solubilizing agent, suspending agent, the surfactant; Get gelatin, purified water, sorbitol and/or glycerol, opacifier routinely the abundant mixing of ratio get glue, make the adhesive tape of suitable depth; Adopt die pressing to prepare soft capsule, soft capsule cleans soft capsule, drying through solidifying by cooling in wind, drying with appropriate solvent, promptly gets product.
Described a kind of medicinal composition soft capsule preparation is characterized in that containing glucosamine salt and other soft capsule preparation acceptable carriers of can be used for human body.
Described a kind of medicinal composition soft capsule preparation is characterized in that the salt of glucosamine can be glucosamine hydrochloride or glucosamine sulphate.
Described a kind of medicinal composition soft capsule, wherein said carrier comprise a plurality of in diluent, cosolvent, solubilizing agent, suspending agent, the surfactant.
Described a kind of medicinal composition soft capsule, wherein said diluent comprise Polyethylene Glycol, soybean oil, safflower oil, hydrogenated palm oil, olive oil, Oleum Vitis viniferae, Semen Maydis oil or the Oleum Cocois of PEG400 or PEG600 liquid state, preferred PEG400 or olive oil; The addition 10%--60% of diluent.
Described a kind of medicinal composition soft capsule, wherein said cosolvent comprise the lower aliphatic alcohols of C3-C8 or its mixture, hydroxypropyl, preferred hydroxypropyl; The addition of cosolvent is 1%--20%.
Described a kind of medicinal composition soft capsule, wherein said solubilizing agent comprises lactic acid, acetic acid, oleic acid, malic acid, tartaric acid, citric acid, linoleic acid, maleic acid, oxalic acid, benzenesulfonic acid, linolenic acid, citric acid, preferred lactic acid; The addition of solubilizing agent is 1%--20%.
Described a kind of medicinal composition soft capsule, wherein said suspending agent comprises the solid-state Polyethylene Glycol of PEG4000, PEG6000, aerosil, liquid paraffin, sucrose ester, lanoline, lecithin, Cera Flava, glyceryl monostearate, C8-C22 high fatty alcohol or its mixture, preferred aerosil; The suspending agent addition is 1%--30%.
Described a kind of medicinal composition soft capsule, wherein said surfactant comprise sorbester p17, sorbester p18, Tween 80, polysorbate60, sodium lauryl sulphate, neutral liquid ester, preferred neutral liquid ester; The addition of surfactant is 1%～20%.
Described a kind of medicinal composition soft capsule, the content of wherein said glucosamine salt are 10%～60%.
The preparation method of described a kind of medicinal composition soft capsule, with a plurality of mixed the content in glucosamine salt and diluent, cosolvent, solubilizing agent, suspending agent, the surfactant, with gelatin, purified water, sorbitol and/or glycerol, opacifier is the capsule material, adopt die pressing to prepare soft capsule, soft capsule is through solidifying by cooling in wind, drying, wash, do eventually, promptly with appropriate solvent.
The specific embodiment:
A kind of medicinal composition soft capsule of the present invention can prepare by the various appropriate method of soft capsule preparation, preferably makes by being prepared as follows method:
The preparation of content: get glucosamine salt, diluent (the Polyethylene Glycol that comprises PEG400 or PEG600 liquid state, soybean oil, safflower oil, hydrogenated palm oil, olive oil, Oleum Vitis viniferae, Semen Maydis oil or Oleum Cocois, preferred PEG400 or olive oil), cosolvent (lower aliphatic alcohols or its mixture that comprise C3-C8, hydroxypropyl, preferred hydroxypropyl), solubilizing agent (comprises lactic acid, acetic acid, oleic acid, malic acid, tartaric acid, citric acid, linoleic acid, maleic acid, oxalic acid, benzenesulfonic acid, linolenic acid, preferred lactic acid), suspending agent (comprises PEG4000, the Polyethylene Glycol that PEG6000 is solid-state, aerosil, liquid paraffin, sucrose ester, lanoline, lecithin, Cera Flava, glyceryl monostearate, C8-C22 high fatty alcohol or its mixture, preferred aerosil), surfactant (comprises sorbester p17, sorbester p18, Tween 80, polysorbate60, sodium lauryl sulphate, neutral liquid ester, preferred neutral liquid ester) a plurality of mixed content that gets in, standby.
Soft capsule molding preparation: get gelatin, purified water, sorbitol and/or glycerol, the abundant mixing of opacifier gets glue, it is standby to regulate the adhesive tape that is compressed to suitable depth by press; Adopt die pressing to prepare soft capsule,, clean soft capsule, drying with appropriate solvent, promptly through solidifying by cooling in wind, drying.
Beneficial effect of the present invention is embodied in following aspect:
1, dispersion of medicine, stripping is more complete, and dissolution rate is stable; In human body, absorb steadily, improved bioavailability, stable curative effect.
2, loading amount is accurately more easy to control, and active constituent content is even, and dosage is accurate, and blood drug level is more stable, stable curative effect, and side effect is less.
3, since the preparation characteristic (with soft capsule shell sealing, secluding air, shading packing content thing) of soft capsule determine its can overcome glucosamine salt solid orally ingestible draw moist due to poor stability, effectively keep the stable of medicine, improved safety, the effectiveness of medicine.
4, reduce flying upward of dust in the production process, protected the healthy and environment of operator.
Enumerate several embodiment and be used to further specify the present invention, but the present invention does not mean and only is confined to following examples.
The soft capsule of following examples preparations, all be with gelatin, sorbitol and/or glycerol, water, opacifier routinely ratio be the capsule material.
Appearance character, disintegration, the content of investigating soft capsule by influence factor's test respectively wait the feasibility that further specifies soft capsule preparation method of the present invention.
Embodiment 1)
PEG400 220g
Glucosamine hydrochloride 240g
Neutral liquid ester 10g
Aerosil 30g
Granulate 1000
The soft capsule content that adopts above prescription to make adopts die pressing to prepare soft capsule, and through study of pharmacy influence factor test, it is as follows to investigate the result:
| The investigation factor | Appearance character | Disintegration (min) | Content (%) |
| 0 day | Oval soft capsule | 15 | 98.3 |
| | Oval soft capsule | 13 | 98.1 |
| | Oval soft capsule | 14 | 99.0 |
| | Oval soft capsule | 15 | 98.7 |
Conclusion: investigate through high temperature, high humidity, high light condition effect factor, this product visual examination no change, disintegration time and content are all stable, show that this preparation method is feasible.
Embodiment 2)
PEG600 250g
Glucosamine hydrochloride 260g
Lactic acid 10g
Hydroxypropyl 30g
Granulate 1000
The soft capsule content that adopts above prescription to make adopts die pressing to prepare soft capsule, and through study of pharmacy influence factor test, it is as follows to investigate the result:
| The investigation factor | Appearance character | Disintegration (min) | Content (%) |
| 0 day | Oval soft capsule | 16 | 98.9 |
| |
Oval soft capsule | 14 | 99.0 |
| |
Oval soft capsule | 13 | 98.4 |
| |
Oval soft capsule | 15 | 98.2 |
Conclusion: investigate through high temperature, high humidity, high light condition effect factor, this product visual examination no change, disintegration time and content are all stable, show that this preparation method is feasible.
Embodiment 3)
PEG400 240g
Glucosamine sulphate 260g
PEG4000 20g
Aerosil 30g
Granulate 1000
Adopt above prescription to make soft capsule content, adopt die pressing to prepare soft capsule, through study of pharmacy influence factor test, it is as follows to investigate the result:
| The investigation factor | Appearance character | Disintegration (min) | Content (%) |
| 0 day | Oval soft capsule | 14 | 98.4 |
| | Oval soft capsule | 16 | 98.6 |
| | Oval soft capsule | 15 | 98.3 |
| | Oval soft capsule | 14 | 98.6 |
Conclusion: investigate through high temperature, high humidity, high light condition effect factor, this product visual examination no change, disintegration time and content are all stable, show that this preparation method is feasible.
Embodiment 4)
Semen Maydis oil 280g
Glucosamine hydrochloride 290g
Cera Flava 30g
Granulate 1000
Adopt above prescription to make soft capsule content, adopt die pressing to prepare soft capsule, through study of pharmacy influence factor test, it is as follows to investigate the result:
| The investigation factor | Appearance character | Disintegration (min) | Content (%) |
| 0 day | Oval soft capsule | 15 | 98.0 |
| | Oval soft capsule | 15 | 98.7 |
| | Oval soft capsule | 16 | 98.3 |
| | Oval soft capsule | 15 | 98.4 |
Conclusion: investigate through high temperature, high humidity, high light condition effect factor, this product visual examination no change, disintegration time and content are all stable, show that this preparation method is feasible.
Embodiment 5)
Olive oil 280g
Glucosamine hydrochloride 290g
Aerosil 20g
Lecithin 10g
Granulate 1000
Adopt above prescription to make soft capsule content, adopt die pressing to prepare soft capsule, through study of pharmacy influence factor test, it is as follows to investigate the result:
| The investigation factor | Appearance character | Disintegration (min) | Content (%) |
| 0 day | Oval soft capsule | 15 | 98.9 |
| | Oval soft capsule | 16 | 98.2 |
| | Oval soft capsule | 14 | 98.6 |
| High light 10 days | Oval soft capsule | 15 | 99.1 |
Conclusion: investigate through high temperature, high humidity, high light condition effect factor, this product visual examination no change, disintegration time and content are all stable, show that this preparation method is feasible.
Embodiment 6)
Compare with external stripping characteristics according to 5 batches of (numbering corresponding) glucosamine salt soft capsules of embodiment of the invention method preparation and existing preparation glucosamine hydrochloride hard capsule (capsule founds in the Portugal), select 0.05kgL for use with reference to national standard with embodiment number
-1Hydrochloric acid solution (the 0.1molL of SDS
-1) as dissolution medium, dissolving-out method adopts the oar method to operate, and the results are shown in following table and accompanying drawing:
| Sample time (min) | 5 | 10 | 15 | 20 | 30 | 40 | 50 | 60 |
| Capsule founds in the Portugal | 5.12 | 26.87 | 46.79 | 55.14 | 62.32 | 70.18 | 75.98 | 81.83 |
| Glucosamine hydrochloride soft capsule 1 | 0 | 28.38 | 56.95 | 69.49 | 79.99 | 86.43 | 90.01 | 92.72 |
| Glucosamine hydrochloride soft capsule 2 | 0 | 27.85 | 57.72 | 71.46 | 81.86 | 87.78 | 89.87 | 93.43 |
| Glucosamine sulphate soft capsule 3 | 0 | 28.02 | 57.19 | 72.43 | 80.58 | 86.97 | 89.93 | 93.18 |
| Glucosamine hydrochloride soft capsule 4 | 0 | 22.74 | 51.07 | 66.79 | 75.95 | 83.91 | 86.19 | 88.73 |
| Glucosamine hydrochloride soft capsule 5 | 0 | 23.16 | 53.23 | 65.82 | 77.79 | 81.81 | 87.08 | 89.96 |
Conclusion: the stripping situation of glucosamine salt soft capsule is better than hard capsule, and stripping is more complete, and dissolution rate is stable.
Claims (10)
1. a medicinal composition soft capsule preparation is characterized in that containing glucosamine salt and other soft capsule preparation acceptable carriers of can be used for human body.
2. the described a kind of medicinal composition soft capsule preparation of claim 1 is characterized in that glucosamine salt can be glucosamine hydrochloride or glucosamine sulphate.
3. the described a kind of medicinal composition soft capsule of claim 1-2, wherein said carrier comprise a plurality of in diluent, cosolvent, solubilizing agent, suspending agent, the surfactant.
4. the described a kind of medicinal composition soft capsule of claim 1-3, wherein said diluent comprises Polyethylene Glycol, soybean oil, safflower oil, hydrogenated palm oil, olive oil, Oleum Vitis viniferae, Semen Maydis oil or the Oleum Cocois of PEG400 or PEG600 liquid state; The addition 10%--60% of diluent.
5. the described a kind of medicinal composition soft capsule of claim 1-3, wherein said cosolvent comprise the lower aliphatic alcohols of C3-C8 or its mixture, hydroxypropyl; The addition of cosolvent is 1%--20%.
6. the described a kind of medicinal composition soft capsule of claim 1-3, wherein said solubilizing agent comprises lactic acid, acetic acid, oleic acid, malic acid, tartaric acid, citric acid, linoleic acid, maleic acid, benzenesulfonic acid, oxalic acid, linolenic acid, citric acid; The addition of solubilizing agent is 1%--20%.
7. the described a kind of medicinal composition soft capsule of claim 1-3, wherein said suspending agent comprises the solid-state Polyethylene Glycol of PEG4000, PEG6000, aerosil, liquid paraffin, sucrose ester, lanoline, lecithin, Cera Flava, glyceryl monostearate, C8-C22 high fatty alcohol or its mixture; The suspending agent addition is 1%--30%.
8. the described a kind of medicinal composition soft capsule of claim 1-3, wherein said surfactant comprises sorbester p17, sorbester p18, Tween 80, polysorbate60, sodium lauryl sulphate, neutral liquid ester; The addition of surfactant is 1%～20%.
9. aforesaid right requires each described a kind of medicinal composition soft capsule, and the content of wherein said glucosamine salt is 10%～60%.
10. the preparation method of each described a kind of medicinal composition soft capsule of claim 1-9, it is characterized in that a plurality of mixed the content in glucosamine salt and diluent, cosolvent, solubilizing agent, suspending agent, the surfactant, with gelatin, purified water, sorbitol and/or glycerol, opacifier is the capsule material, adopt die pressing to prepare soft capsule, soft capsule is through solidifying by cooling in wind, drying, wash, do eventually, promptly with appropriate solvent.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510117563 CN1768758A (en) | 2005-11-08 | 2005-11-08 | Soft capsule of medicinal composition and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510117563 CN1768758A (en) | 2005-11-08 | 2005-11-08 | Soft capsule of medicinal composition and its preparation method |
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| CN1768758A true CN1768758A (en) | 2006-05-10 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102948732A (en) * | 2011-08-22 | 2013-03-06 | 重庆市生物技术研究所有限责任公司 | Healthcare food for increasing bone mineral density and improving osteoporosis |
| CN115590864A (en) * | 2022-10-08 | 2023-01-13 | 山东润德生物科技有限公司（Cn） | Process for preparing high-stability glucosamine sulfate by fermentation method |
-
2005
- 2005-11-08 CN CN 200510117563 patent/CN1768758A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102948732A (en) * | 2011-08-22 | 2013-03-06 | 重庆市生物技术研究所有限责任公司 | Healthcare food for increasing bone mineral density and improving osteoporosis |
| CN115590864A (en) * | 2022-10-08 | 2023-01-13 | 山东润德生物科技有限公司（Cn） | Process for preparing high-stability glucosamine sulfate by fermentation method |
| CN115590864B (en) * | 2022-10-08 | 2023-09-12 | 山东润德生物科技有限公司 | Process for preparing high-stability glucosamine sulfate by fermentation method |
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