CN101496790A - Acarbose chewable tablet - Google Patents
Acarbose chewable tablet Download PDFInfo
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- CN101496790A CN101496790A CNA2009100963145A CN200910096314A CN101496790A CN 101496790 A CN101496790 A CN 101496790A CN A2009100963145 A CNA2009100963145 A CN A2009100963145A CN 200910096314 A CN200910096314 A CN 200910096314A CN 101496790 A CN101496790 A CN 101496790A
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- acarbose
- chewable tablet
- tablet
- chewing tablet
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Abstract
The invention relates to a chewing tablet taking acarbose as an active component. The acarbose is taken as the medical active component, and the acarbose is mixed with a pharmaceutically acceptable auxiliary material to form the drug composition. The acarbose has the defect of easy hardening due to absorption of moisture, but the novel compound auxiliary material, namely Avicel CL611 is used in the chewing tablet, so that the chewing tablet has the advantages of simple process, direct tabletting, time conservation and labor conservation, and can also overcome the defect of easy absorption of moisture existing in the common chewing tablet.
Description
Technical field
The present invention relates to a kind of is the oral formulations of active ingredient with the acarbose, belongs to medical technical field.
Background technology
The onset diabetes rate is still increasing year by year.Chinese then become the severely afflicated area of morbidity, the diabetics number is only second to India, occupies the second place of the world.According to the data that The World Health Organization (WHO) provides, developed country's diabetes prevalence then is about 3% up to 5%～10% in China, the most conservative measuring and calculating, and the annual increase of Chinese diabetics one million people just has 2,700 people's New Developments every day; To the year two thousand thirty, whole world diabetics number will be doubled than 2000.
The analyst points out that in following a period of time, it is steady relatively that the type 1 diabetes sickness rate will keep, but type 2 diabetes mellitus patient number then can steady-state growth.At US and European, type 2 diabetes mellitus patient number accounts for 90% of all diabetics numbers at present, then almost reaches 100% in the Asia.
A part of patient is based on insulin resistant in the type ii diabetes, and how fat patient is, and because of insulin resistant, insulin sensitivity descends, and insulin increases compensating its insulin resistant in the blood, but patient's hyperglycemia relatively, insulin secretion is relative deficiency still; Another part patient is based on defect of insulin secretion.
Acarbose (Acarbose), chemical name: O-4, the two deoxidation-4-[[(1S of 6-, 4R, 5S, 6S) 4,5,6-trihydroxy-3-(methylol)-2-cyclohexenyl-1-amino]-a-D-glucopyranosyl (1 → 4)-O-a-D-glucopyranosyl-(1 → 4)-D-Glucopyranose..Acarbose is succeeded in developing by Bayer A.G and is gone on the market in Germany in nineteen ninety.1994 is a kind of novel oral antidiabetic drug in China's list marketing, and it is a kind of biosynthetic false tetrose.Animal test results shows: this product is active inhibited to the a-glucosidase of small bowel cell brush border, thereby caused the degraded of polysaccharide, oligosaccharide or disaccharidase in the intestinal, make the degradation of glucose of self-carbon water compound and be absorbed into blood speed and slow down, reduced the rising of post-prandial glycemia, the average blood sugar value is descended.
Acarbose uses at present clinically is tablet and capsule, and the instructions of taking of conventional tablet is taken for chewing with former mouthfuls of foods before the meal or in eating.Can know that according to this instructions of taking chewable tablet is more suitable.
Since its special physical property, the easy moisture absorption of acarbose, and hardening after the moisture absorption has a strong impact on mouthfeel and drug effect.The former powder of acarbose is mobile poor, and does not possess cohesive and compressibility, so there is following difficulty in preparation: one is to use traditional wet granulation technology to lump; The 2nd, if adopt traditional dry method direct compression technology, need add dry binder again, as PVP, dextrin etc., but the just easy moisture absorption of binding agent commonly used itself, also easily moisture absorption hardening in storage process; Three are to use the easy mouthfeel of words chewable tablet of more multiple adjuvant poor, and grittiness is arranged.Therefore be necessary to screen that supplementary product kind is few, consumption is few, efficacy stability, acarbose preparation that mouthfeel is good, to improve patient's compliance.
Summary of the invention
The objective of the invention is to overcome the difficulty and the defectives such as the easy moisture absorption of prepared chewable tablet, mouthfeel difference that in preparation process, exist in the prior art.
The invention discloses a kind of Acarbose chewable tablet, by weight percentage, composed of the following components:
Acarbose: 1-40%
Avicel?CL611：10-99％
Correctives: 0-60%
Lubricant: 0-10%
Wherein said Avicel CL611, it is to carry out the composite auxiliary material made after the Special Mixed by microcrystalline Cellulose and sodium carboxymethyl cellulose, for west drugmaker uses maximum anti-precipitation pharmaceutic adjuvants, be used for suspensoid more, can form uniform suspendible medicinal liquid as adding Avicel CL611 with 3% ratio, it is opaque gluey attitude, and period of storage that can corresponding prolongation product.Avicel CL611 is used for Acarbose chewable tablet abrupt good effect, even adjuvant is only used one kind of Avicel CL611, also have good fluidity, directly compressible, characteristics that hygroscopicity is low, cause does not add other adjuvants such as insoluble lubricant, mouthfeel is good, no grittiness, and technology simple, save time, laborsaving.
In addition, have better taste, can add a certain amount of correctives: as sorbitol, mannitol, saccharin sodium, cyclamate, aspartame (Radix Asparagi sweet peptide), Sucralose, talin and acesulfame-K etc. in order to make preparation.Because xylitol is pleasantly sweet, diabetics is edible also, and mouthfeel is good, and no grittiness also can be worked as filler, so preferred xylitol.
For the ease of tabletting, also can add a certain amount of lubricant: as magnesium stearate, stearic acid, calcium stearate, zinc stearate, hydrogenated vegetable oil, Glyceryl Behenate sodium lauryl sulphate, Stepanol MG, Polyethylene Glycol, Pulvis Talci, micropowder silica gel, but because of lubricant water insoluble, influence mouthfeel, therefore add less, hydrogenated vegetable oil has auxiliary moisture-proof role as far as possible.Preferred hydrogenated vegetable oil.
By the Acarbose chewable tablet of prescription preparation disclosed by the invention, through the pharmacy check, each index conformance with standard, and its hygroscopicity has bigger improvement than conventional tablet.
Specific embodiment
Come acarbose preparation of the present invention done further specifying by following example, but be not limited in following example.
Embodiment 1
Prescription:
The supplementary material that takes by weighing above-mentioned recipe quantity is crossed 80 mesh sieves respectively, mixing, and tabletting, both.
Embodiment 2
Prescription:
The supplementary material that takes by weighing above-mentioned recipe quantity is crossed 80 mesh sieves respectively, mixing, and tabletting, both.
Embodiment 3
Prescription:
The supplementary material that takes by weighing above-mentioned recipe quantity is crossed 80 mesh sieves respectively, mixing, and tabletting, both.
Embodiment 4: the contrast test of chewable tablet of the present invention and commercially available ordinary tablet
Acarbose chewable tablet and ordinary tablet (Zhongmei Huadong Pharmaceutical Co., Ltd. Hangzhou makes, lot number 080601) according to the foregoing description preparation are pressed preparation conventional sense method, contrast, and the results are shown in following table:
Experimental data shows that Acarbose chewable tablet has greatly improved on moisture absorption weightening finish and mouthfeel than acarbose ordinary tablet, makes it more can meet patient's needs.
Claims (5)
1, a kind of Acarbose chewable tablet, by weight percentage, composed of the following components:
Acarbose: 1-40%
Avicel?CL611：10-99％
Correctives: 0-60%
Lubricant: 0-10%
2, Acarbose chewable tablet as claimed in claim 1 is characterized in that, described correctives is one or more the mixture in xylitol, sorbitol, mannitol, saccharin sodium, cyclamate or the aspartame.
3, Acarbose chewable tablet as claimed in claim 1 or 2 is characterized in that, described correctives is an xylitol.
4, Acarbose chewable tablet as claimed in claim 1, it is characterized in that described lubricant is one or more the mixture in magnesium stearate, stearic acid, calcium stearate, zinc stearate, hydrogenated vegetable oil, Glyceryl Behenate, sodium lauryl sulphate, Stepanol MG, Polyethylene Glycol, Pulvis Talci or the micropowder silica gel.
As claim 1 or 4 described Acarbose chewable tablets, it is characterized in that 5, described lubricant is a hydrogenated vegetable oil.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910096314A CN101496790B (en) | 2009-02-19 | 2009-02-19 | Acarbose chewable tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910096314A CN101496790B (en) | 2009-02-19 | 2009-02-19 | Acarbose chewable tablet |
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| Publication Number | Publication Date |
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| CN101496790A true CN101496790A (en) | 2009-08-05 |
| CN101496790B CN101496790B (en) | 2012-08-29 |
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| CN200910096314A Active CN101496790B (en) | 2009-02-19 | 2009-02-19 | Acarbose chewable tablet |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103505441A (en) * | 2012-06-29 | 2014-01-15 | 北京韩美药品有限公司 | Oral solid preparation containing biguanides and acarbose and preparation method thereof |
| CN104013590A (en) * | 2014-05-09 | 2014-09-03 | 万特制药(海南)有限公司 | Acarbose-containing medicinal composition and preparation method thereof |
| CN105326785A (en) * | 2015-10-09 | 2016-02-17 | 北京万全德众医药生物技术有限公司 | Acarbose oral solution |
| CN105831380A (en) * | 2016-04-20 | 2016-08-10 | 贺灿炎 | Candies capable of treating diabetes mellitus and preparation method of candies |
| CN110051639A (en) * | 2019-03-15 | 2019-07-26 | 河北嘉迈医药科技有限公司 | A kind of fater disintegration type nicergoline tablets and preparation method thereof |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1235587C (en) * | 2002-12-12 | 2006-01-11 | 复旦大学 | 9-nitrocamptothecin solid dispersant and preparation method |
| CN1296050C (en) * | 2003-12-10 | 2007-01-24 | 浙江海正药业股份有限公司 | Acarbose enteric coated tablets and its prepn. method |
| CN100464754C (en) * | 2007-03-12 | 2009-03-04 | 杭州中美华东制药有限公司 | Acarbose medicine composition and its prepn |
| CN101336904B (en) * | 2008-08-08 | 2010-12-29 | 杭州华东医药集团生物工程研究所有限公司 | Acarbose chewable tablets and preparation method thereof |
-
2009
- 2009-02-19 CN CN200910096314A patent/CN101496790B/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103505441A (en) * | 2012-06-29 | 2014-01-15 | 北京韩美药品有限公司 | Oral solid preparation containing biguanides and acarbose and preparation method thereof |
| CN104013590A (en) * | 2014-05-09 | 2014-09-03 | 万特制药(海南)有限公司 | Acarbose-containing medicinal composition and preparation method thereof |
| CN105326785A (en) * | 2015-10-09 | 2016-02-17 | 北京万全德众医药生物技术有限公司 | Acarbose oral solution |
| CN105831380A (en) * | 2016-04-20 | 2016-08-10 | 贺灿炎 | Candies capable of treating diabetes mellitus and preparation method of candies |
| CN110051639A (en) * | 2019-03-15 | 2019-07-26 | 河北嘉迈医药科技有限公司 | A kind of fater disintegration type nicergoline tablets and preparation method thereof |
| CN110051639B (en) * | 2019-03-15 | 2021-08-31 | 河北嘉迈医药科技有限公司 | Rapidly disintegrating nicergoline tablet and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101496790B (en) | 2012-08-29 |
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Owner name: NEW DRUG RESEARCH INSTITUTE CO., LTD. OF HANGZHOU Free format text: FORMER NAME: BIOENGINEERING INST. CO., LTD., HANGZHOU EAST-CHINA MEDICINE GROUP |
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Address after: 310012 West Lake international science and technology building, 391 Wen two road, Zhejiang, Hangzhou C901 Patentee after: HANGZHOU HUADONG MEDICINE GROUP NEW MEDICINE RESEARCH INSTITUTE CO., LTD. Address before: 310012 West Lake international science and technology building, 391 Wen two road, Zhejiang, Hangzhou C901 Patentee before: Hangzhou Huadong Medicine Group Biological Engineering Research Institute Co., Ltd. |
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Effective date of registration: 20160519 Address after: 310012 West Lake international science and technology building, 391 Wen two road, Zhejiang, Hangzhou C901 Patentee after: HANGZHOU HUADONG MEDICINE GROUP NEW MEDICINE RESEARCH INSTITUTE CO., LTD. Patentee after: Zhongmei Huadong Pharmaceutical Co., Ltd., Hangzhou Address before: 310012 West Lake international science and technology building, 391 Wen two road, Zhejiang, Hangzhou C901 Patentee before: HANGZHOU HUADONG MEDICINE GROUP NEW MEDICINE RESEARCH INSTITUTE CO., LTD. |