CN100479861C - Intensified additive for chondroitin sulfate capsule formulation and tablet and preparation method thereof - Google Patents
Intensified additive for chondroitin sulfate capsule formulation and tablet and preparation method thereof Download PDFInfo
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- CN100479861C CN100479861C CNB2005100556846A CN200510055684A CN100479861C CN 100479861 C CN100479861 C CN 100479861C CN B2005100556846 A CNB2005100556846 A CN B2005100556846A CN 200510055684 A CN200510055684 A CN 200510055684A CN 100479861 C CN100479861 C CN 100479861C
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- sodium alginate
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Abstract
The reinforcing additive for chondroitin sulfate capsule and tablet is prepared with glucosamine hydrochloride 0.5-3 weight portions and sodium alginate 1-8 weight portions. Clinical observation proves the effect of the additive in raising the curative effect of chondroitin sulfate.
Description
Technical field
The present invention relates to a kind of pharmaceutic adjuvant and preparation method thereof, relate in particular to intensified additive of Ossonate Capsules and tablet and preparation method thereof, belong to drug world.
Background technology
Chondroitin sulfate is the important composition of soft tissue of joint, is the main medicine that treatment degenerative joint sexually transmitted disease (STD) commonly used clinically becomes, and common dosage forms mainly contains two kinds in capsule and tablet.In the production of these two kinds of dosage forms,, guarantee that simple grain preparation medicine amount accurately need add conventional adjuvant such as CaSO for principal agent is uniformly dispersed
4, dispersants such as starch or dextrin, filler, above-mentioned these adjuvants only play and chondroitin sulfate are uniformly dispersed and effect such as preparations shaping, can not play the effect of strengthening and improving for the curative effect of chondroitin sulfate.
Summary of the invention
Technical problem to be solved by this invention is to overcome the deficiencies in the prior art, and a kind of intensified additive is provided, and replaces above-mentioned pharmaceutic adjuvant commonly used with it, not only can be used to produce capsule and tablet equally, can also strengthen the curative effect of chondroitin sulfate.
Technical problem to be solved by this invention realizes by following technological approaches:
A kind of intensified additive that improves chondroitin sulfate preparation curative effect, mainly make by the raw material of following weight parts:
1～8 part of 0.5～3 part of glucosamine hydrochloride and sodium alginate.
Be preferably:
Glucosamine hydrochloride 0.5～2 weight portion, sodium alginate 3～7 weight portions.
More preferably:
Glucosamine hydrochloride 1 weight portion, sodium alginate 5 weight portions.
The N-acetylglucosamine composition that is contained in the intensified additive of the present invention, animal experiment and clinical research data show can suppress the arthritis that granuloma causes, the pain of energy ameliorate osteoarthritis is so can strengthen the therapeutic effect of chondroitin sulfate.Another composition sodium alginate has cholesterol reducing, and the effect of blood sugar lowering and whole intestinal can suppress heavy metals such as cadmium, strontium, lead again and absorb in vivo, can also dredging vascellum, blood viscosity lowering, vessel softening, strengthen the blood circulation of patient part, help medicine and arrive affected area.In addition, it is good thickening that sodium alginate has superior physical property, and film property and high stability play the effect that keeps N-acetylamino acid glucose stability in the present invention.When intensified additive of the present invention is used to prepare the chondroitin sulfate preparation, can be with reference to the addition and the principal agent chondroitin sulfate material mixing of conventional adjuvant, encapsulated or tabletting.
The used raw material of the present invention all can be bought from market and obtain, and specification is a pharmaceutical grade.
Another technical problem to be solved by this invention provides a kind of method for preparing above-mentioned intensified additive.
A kind of method for preparing intensified additive, step is as follows:
1, glucosamine hydrochloride is sloughed hydrochloric acid and N-acetylation and handled, fully react after-filtration and get crystallization, add pure water crystallization is dissolved, after resin anion (R.A.) post decontamination, fine straining, vacuum concentration, oven drying at low temperature get N-acetylamino acid glucose elaboration.
2, sodium alginate is added H
2O
2In, warm, stir and make dissolving, add 95% ethanol again, make to produce precipitation centrifugal filtration, the sodium alginate of must degrading.
3, mixed: with above-mentioned N-acetylglucosamine raw material and degraded sodium alginate raw material, behind abundant mixing on the mixed powder machine, the oven drying at low temperature crushing screening is standby.
4, final mixed: the water-retaining agent that takes a morsel adds above-mentioned raw materials one by one with the method for doubly grinding to be mixed in the powder, mixing gradually, and packing is promptly.
Further describe beneficial effect of the present invention by the following examples, it should be understood that these embodiment only are used for the purpose of illustration, never limit the scope of the invention.
The specific embodiment
[embodiment 1]
1, gets 1kg pharmaceutical grade glucosamine hydrochloride, add in the mixed liquid of 1200ml diethylamine and 20000ml dehydrated alcohol, fully the reaction after-filtration adds the 100ml acetic anhydride, stirring at normal temperature 1h again, get the about 0.9kg of N-acetylglucosamine crude product, with this crude product 9000ml dissolved in purified water, slowly by resin anion (R.A.) post decontamination, behind the eluent vacuum concentration, in oven dry below 60 ℃, get N-acetylglucosamine elaboration 0.85kg.
2, get 5kg food stage sodium alginate, add 50, the dense H of 000ml
2O
2In, be warming up to 60 ℃, stir 2h, make sodium alginate complete molten after, stop heating, continue to stir, add 150 from the top, 000ml95% ethanol makes to produce precipitation, centrifugal filtration dries as far as possible, the sodium alginate of must the degrading product 4kg that wets.
3, get the wet product 4kg of degraded sodium alginate and N-acetylglucosamine elaboration 0.85kg, abundant mixing on mixed powder machine, 100 mesh sieves were pulverized in 60 ℃ of oven dry down.
4, get the 6g sodium hexameta phosphate, mix powder with last step 4.85kg one by one by the method for doubly grinding and mix evenly, packing promptly gets product of the present invention.
[embodiment 2]
1, gets 0.5kg pharmaceutical grade glucosamine hydrochloride, add in the mixed liquid of 600ml diethylamine and 10000ml dehydrated alcohol, fully the reaction after-filtration adds the 50ml acetic anhydride, stirring at normal temperature 1h again, get the about 0.45kg of N-acetylglucosamine crude product, with this crude product 4500ml dissolved in purified water, slowly by resin anion (R.A.) post decontamination, behind the eluent vacuum concentration, in oven dry below 60 ℃, get N-acetylglucosamine elaboration 0.425kg.
2, get 1kg food stage sodium alginate, add 10, the dense H of 000ml
2O
2In, be warming up to 60 ℃, stir 2h, make sodium alginate complete molten after, stop heating, continue to stir, add 30 from the top, 000ml95% ethanol makes to produce precipitation, centrifugal filtration dries as far as possible, the sodium alginate of must the degrading product 0.8kg that wets.
3, get the wet product 0.8kg of degraded sodium alginate and N-acetylglucosamine elaboration 0.425kg, abundant mixing on mixed powder machine, 100 mesh sieves were pulverized in 60 ℃ of oven dry down.
4, get the 0.8g sodium hexameta phosphate, mix powder with last step 1.225kg one by one by the method for doubly grinding and mix evenly, packing promptly gets product of the present invention.
[embodiment 3]
1, gets 2kkg pharmaceutical grade glucosamine hydrochloride, add in the mixed liquid of 2400ml diethylamine and 40000ml dehydrated alcohol, fully the reaction after-filtration adds the 200ml acetic anhydride, stirring at normal temperature 1h again, get the about 1.8kg of N-acetylglucosamine crude product, with this crude product 18000ml dissolved in purified water, slowly by resin anion (R.A.) post decontamination, behind the eluent vacuum concentration, in oven dry below 60 ℃, get N-acetylglucosamine elaboration 1.7kg.
2, get 8kg food stage sodium alginate, add 80, the dense H of 000ml
2O
2In, be warming up to 60 ℃, stir 2h, make sodium alginate complete molten after, stop heating, continue to stir, add 240 from the top, 000ml95% ethanol makes to produce precipitation, centrifugal filtration dries as far as possible, the sodium alginate of must the degrading product 6.2kg that wets.
3, get the wet product 6.2kg of degraded sodium alginate and N-acetylglucosamine elaboration 1.7kg, abundant mixing on mixed powder machine, 100 mesh sieves were pulverized in 60 ℃ of oven dry down.
4, get the 8g sodium hexameta phosphate, mix powder with last step 7.9kg one by one by the method for doubly grinding and mix evenly, packing promptly gets product of the present invention.
[embodiment 4] preparation chondroitin sulfate tablet
Get the product 250g of embodiment 1 preparation, wet granulation after the 50-60 ℃ of drying, is sneaked into chondroitin sulfate powder 240g and the 10g magnesium stearate of crossing 100 mesh sieves, fully behind the mixing, tabletting makes 2000, the 0.25g/ sheet altogether, every sulfur acid chrondroitin 0.12g, the 15min disintegrate meets the pharmacopeia regulation.
[test example] clinical observation on the therapeutic effect test
One, physical data
Accept 42 routine patients altogether for medical treatment, wherein male 26 examples, women 16 examples; 42 years old mean age; Wherein arthralgia patient 18 examples, arthritic's 16 examples, omoplate arthralgia patient 8 examples are divided into two groups at random, i.e. test group and matched group, every group 21 example;
Two, Therapeutic Method
Test group adopts the prepared chondroitin sulfate tablet in treatment of the embodiment of the invention, and warm water is oral, and 5 slices/time, 3 times/day; Positive controls patient takes the Kang Deling sheet, the 0.25g/ sheet, and warm water is oral, and 5 slices/time, 3 times/day; Observed the other medicines of stopping using during the treatment altogether 10 days.
Three, result of the test
| Pain relief onset time | The pain relief persistent period | Drug withdrawal is pain bounce-back number two days later | |
| Test group | Average 2.2 hours | Average 8 hours | 2 people |
| Positive controls | Average 4.5 hours | Average 6 hours | 10 people |
Result of the test shows that the curative effect that the prepared chondroitin sulfate tablet of additive of the present invention is used for the treatment of arthralgia will obviously be better than the positive control medicine, illustrates that additive of the present invention can strengthen the curative effect of chondroitin sulfate really.
Claims (4)
1, the intensified additive of a kind of Ossonate Capsules and tablet is mainly made by the raw material of following weight parts: 1～8 part of 0.5～3 part of glucosamine hydrochloride and sodium alginate; It prepares according to following steps:
1), glucosamine hydrochloride sloughed hydrochloric acid and N-acetylation handle, fully react after-filtration and get crystallization, add pure water crystallization dissolved, after resin anion (R.A.) post decontamination, fine straining, vacuum concentration, oven drying at low temperature, N-acetylamino acid glucose elaboration;
2), sodium alginate is added H
2O
2In, warm, stir and make dissolving, add 95% ethanol again, make to produce precipitation centrifugal filtration, the sodium alginate of must degrading is standby;
3), with above-mentioned N-acetylglucosamine raw material and degraded sodium alginate raw material, behind abundant mixing on the mixed powder machine, the oven drying at low temperature crushing screening is standby;
4), the water-retaining agent that takes a morsel adds above-mentioned raw materials one by one with the method for doubly grinding and mixes in the powder, mixing, packing promptly.
2, according to the described intensified additive of claim 1, it is characterized in that the weight portion of each raw material is: glucosamine hydrochloride 0.5～2 weight portion, sodium alginate 3～7 weight portions.
3, according to the described intensified additive of claim 2, it is characterized in that the weight portion of each raw material is: glucosamine hydrochloride 1 weight portion, sodium alginate 5 weight portions.
4, the purposes of the described arbitrary intensified additive of claim 1～3 in preparation Ossonate Capsules or tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100556846A CN100479861C (en) | 2005-03-23 | 2005-03-23 | Intensified additive for chondroitin sulfate capsule formulation and tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100556846A CN100479861C (en) | 2005-03-23 | 2005-03-23 | Intensified additive for chondroitin sulfate capsule formulation and tablet and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1836730A CN1836730A (en) | 2006-09-27 |
| CN100479861C true CN100479861C (en) | 2009-04-22 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005100556846A Expired - Fee Related CN100479861C (en) | 2005-03-23 | 2005-03-23 | Intensified additive for chondroitin sulfate capsule formulation and tablet and preparation method thereof |
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Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102492001A (en) * | 2011-12-15 | 2012-06-13 | 石狮市华宝海洋生物化工有限公司 | Method for preparing N-acetyl-D-(+)-glucosamine |
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Assignee: Anhui Chen-Bright Bioengineering Co., Ltd. Assignor: Wang Shanke Contract fulfillment period: 2009.8.28 to 2019.8.27 Contract record no.: 2009340000298 Denomination of invention: Intensified additive for chondroitin sulfate capsule formulation and tablet and its preparation method Granted publication date: 20090422 License type: Exclusive license Record date: 20090909 |
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Free format text: EXCLUSIVE LICENSE; TIME LIMIT OF IMPLEMENTING CONTACT: 2009.8.28 TO 2019.8.27; CHANGE OF CONTRACT Name of requester: ANHUI KEBAO BIOLOGY ENGINEERING CO., LTD. Effective date: 20090909 |
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Granted publication date: 20090422 Termination date: 20210323 |
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| CF01 | Termination of patent right due to non-payment of annual fee |