CN103860508A - Metformin hydrochloride sustained release tablet and preparation method thereof - Google Patents
Metformin hydrochloride sustained release tablet and preparation method thereof Download PDFInfo
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- CN103860508A CN103860508A CN201410077037.4A CN201410077037A CN103860508A CN 103860508 A CN103860508 A CN 103860508A CN 201410077037 A CN201410077037 A CN 201410077037A CN 103860508 A CN103860508 A CN 103860508A
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- release tablet
- carboxymethyl cellulose
- cellulose sodium
- sustained release
- metformin hydrochloride
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Abstract
The invention discloses a metformin hydrochloride sustained release tablet. The metformin hydrochloride sustained release tablet comprises the following components in percentage by weight: 50%-60% of metformin hydrochloride sustained release tablets, 10%-20% of low-viscosity carboxymethyl cellulose sodium and 38%-45% of high-viscosity carboxymethyl cellulose sodium. By adopting the combination of carboxymethyl cellulose sodium with different viscosities, good release effect is achieved, and tabletting is easy at the same time. The invention further discloses a preparation method of the metformin hydrochloride sustained release tablet, which is simple in process and low in cost.
Description
Technical field
The present invention relates to field of medicaments, refer to especially a kind of diabecron sustained-release tablet, the invention still further relates to a kind of preparation method of diabecron sustained-release tablet.
Background technology
Metformin hydrochloride is biguanides oral hypoglycemic.There is multiple mechanism of action, comprise that delay glucose absorbed by gastrointestinal, increase the utilization of periphery glucose by improving the sensitivity of insulin, and suppress liver, the excessive gluconeogenesis of kidney, do not reduce ND's blood sugar level.
The blood drug level of diabecron sustained-release preparation has that blood drug level is steady, orally once improved the compliance that patient uses every day, and tool is of great significance clinically.
Metformin hydrochloride is a kind of very easily water-soluble medicine, in conventional hypromellose or carbomer, polyoxyethylene, its process need that forms gel has the regular hour, and within this period of time, Fast Stripping release of principal agent, cannot reach good release profiles.
On the other hand, in patent CN101912075, announce at home after making label with polyoxyethylene and principal agent and used coating membrane coating, also need to make controlled release tablet, complex process in the mode of the two sides of tablet punching.In most of pharmaceutical factories production equipment at home, be difficult to existing industrialization.
In patent CN200580010132.1, announced with polyoxyethylene and xanthan gum be slow-release material, need to first adopt solvent granulation forming section, then prepare mixture, then mix with the granule forming section after oven dry, finally be pressed into tablet, production process is many, and production cost is high.
In above method, preparation process operation is many, and production cost is high, and this product belongs to common drug, Market competition, and production cost has important meaning very.
Summary of the invention
One of object of the present invention is to propose a kind of diabecron sustained-release tablet, reaches good releasing effect.
Another object of the present invention has been to propose a kind of preparation method of diabecron sustained-release tablet, and technique is simple, production cost is low, is suitable for propagation and employment.
Technical scheme of the present invention is achieved in that a kind of diabecron sustained-release tablet, comprises each component of following weight portion:
Diabecron sustained-release tablet 50-60%,
Low viscosity Carboxymethyl cellulose sodium 10-20%,
High viscosity Carboxymethyl cellulose sodium 38-45%.
Further, the viscosity of described low viscosity Carboxymethyl cellulose sodium is less than 4000m.pa.s.
Further, the viscosity of described high viscosity Carboxymethyl cellulose sodium is greater than 9000m.pa.s.
The preparation method of diabecron sustained-release tablet a: direct compression after diabecron sustained-release tablet, low viscosity Carboxymethyl cellulose sodium are mixed homogeneously with high viscosity Carboxymethyl cellulose sodium, to obtain final product.
Beneficial effect of the present invention is: described diabecron sustained-release tablet of the present invention, by diabecron sustained-release tablet is mixed with the Carboxymethyl cellulose sodium of two kinds of different viscosities scopes, sodium carboxymethyl cellulose very easily dissolves in water, after dissolving, form full-bodied gel layer and stop the further infiltration of moisture content and gel can form protective layer, make the release of principal agent slow, through a large amount of experimental results show that, adopt the combination of different viscosities sodium carboxymethyl cellulose, reach beyond thought releasing effect, and sodium carboxymethyl cellulose compressibility is good, directly pressed powder, the final production technology of simplifying, reduce production costs.
The preparation method technique of described diabecron sustained-release tablet of the present invention and simple, simple to operate, is suitable for propagation and employment.
Accompanying drawing explanation
In order to be illustrated more clearly in the embodiment of the present invention or technical scheme of the prior art, to the accompanying drawing of required use in embodiment or description of the Prior Art be briefly described below, apparently, accompanying drawing in the following describes is only some embodiments of the present invention, for those of ordinary skills, do not paying under the prerequisite of creative work, can also obtain according to these accompanying drawings other accompanying drawing.
Fig. 1 is the present invention's (finished product 2) and the comparison of commercially available sample release curve;
The specific embodiment
Below in conjunction with the accompanying drawing in the embodiment of the present invention, the technical scheme in the embodiment of the present invention is clearly and completely described, obviously, described embodiment is only the present invention's part embodiment, rather than whole embodiment.Based on the embodiment in the present invention, those of ordinary skills, not making the every other embodiment obtaining under creative work prerequisite, belong to the scope of protection of the invention.
Embodiment 1
| Supplementary material | (unit g) for consumption |
| Diabecron sustained-release tablet | 50.0 |
| Low-viscosity sodium carboxymethyl cellulose (3000m.pa.s) | 5.0 |
| High-viscosity sodium carboxymethyl cellulose (10000m.pa.s) | 45.0 |
After raw material is mixed homogeneously with sodium carboxymethyl cellulose, direct compression, the heavy scope 0.95～1.05g of sheet, gets product 1.
| Supplementary material | (unit g) for consumption |
| Diabecron sustained-release tablet | 45.0 |
| Low-viscosity sodium carboxymethyl cellulose (3500m.pa.s) | 14.0 |
| High-viscosity sodium carboxymethyl cellulose (9500m.pa.s) | 41.0 |
After raw material is mixed homogeneously with sodium carboxymethyl cellulose, direct compression, the heavy scope 1.05～1.15 of sheet, gets product 2.
Inventor detects obtaining finished product, specific as follows
1, adopt the drug release determination method of pharmacopeia to detect the most full-bodied K100M replacement sodium carboxymethyl cellulose tabletting in the present invention and hypromellose, result the present invention meets standards of pharmacopoeia, and all in standard intermediate value, the very good and K100M of release is prominent to be released obviously, does not meet quality standard:
| Sample time | Finished product 1 | K100M | Standards of pharmacopoeia |
| 1h | 30.3 | 44.8 | 20～40% |
| 3h | 55.4 | 70.7 | 45～65% |
| 10h | 95.7 | 96.4 | Be greater than 80% |
2, the present invention (finished product 2) and the comparison of commercially available sample release curve, similar factors is 89, and both release in vitro are consistent, and result is as shown in Figure 1.
The foregoing is only preferred embodiment of the present invention, in order to limit the present invention, within the spirit and principles in the present invention not all, any modification of doing, be equal to replacement, improvement etc., within all should being included in protection scope of the present invention.
Claims (4)
1. a diabecron sustained-release tablet, is characterized in that, comprises each component of following weight portion:
Diabecron sustained-release tablet 50-60%,
Low viscosity Carboxymethyl cellulose sodium 10-20%,
High viscosity Carboxymethyl cellulose sodium 38-45%.
2. diabecron sustained-release tablet described in claim 1, is characterized in that: the viscosity of described low viscosity Carboxymethyl cellulose sodium is less than 4000m.pa.s.
3. diabecron sustained-release tablet described in claim 1, is characterized in that: the viscosity of described high viscosity Carboxymethyl cellulose sodium is greater than 9000m.pa.s.
4. as the preparation method of diabecron sustained-release tablet as described in arbitrary in claim 1-3, it is characterized in that: direct compression after diabecron sustained-release tablet, low viscosity Carboxymethyl cellulose sodium are mixed homogeneously with high viscosity Carboxymethyl cellulose sodium, to obtain final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410077037.4A CN103860508B (en) | 2014-03-04 | 2014-03-04 | A kind of diabecron sustained-release tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410077037.4A CN103860508B (en) | 2014-03-04 | 2014-03-04 | A kind of diabecron sustained-release tablet and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN103860508A true CN103860508A (en) | 2014-06-18 |
| CN103860508B CN103860508B (en) | 2016-01-27 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110693845A (en) * | 2019-12-01 | 2020-01-17 | 仁和堂药业有限公司 | Preparation process of metformin hydrochloride sustained-release tablet |
| CN110787143A (en) * | 2019-12-01 | 2020-02-14 | 仁和堂药业有限公司 | Metformin hydrochloride tablet and application thereof |
| CN110801443A (en) * | 2019-12-03 | 2020-02-18 | 仁和堂药业有限公司 | Metformin hydrochloride sustained-release preparation and quality detection method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1415288A (en) * | 2002-10-22 | 2003-05-07 | 南京长澳医药科技有限公司 | Metformin hydrochloride slowly released tablet and its preparation method |
-
2014
- 2014-03-04 CN CN201410077037.4A patent/CN103860508B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1415288A (en) * | 2002-10-22 | 2003-05-07 | 南京长澳医药科技有限公司 | Metformin hydrochloride slowly released tablet and its preparation method |
Non-Patent Citations (2)
| Title |
|---|
| 刘雅敏等: "《药物制剂常用辅料》", 31 January 1994, 天津科技翻译出版公司, article "羧甲基纤维素钠", pages: 276-278 * |
| 杨亚鹏: "辅料对水易溶性药物缓释制剂体外释放影响的研究", 《中国优秀硕士学位论文全文数据库 医药卫生科技辑》, 15 September 2012 (2012-09-15), pages 56 - 62 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110693845A (en) * | 2019-12-01 | 2020-01-17 | 仁和堂药业有限公司 | Preparation process of metformin hydrochloride sustained-release tablet |
| CN110787143A (en) * | 2019-12-01 | 2020-02-14 | 仁和堂药业有限公司 | Metformin hydrochloride tablet and application thereof |
| CN110801443A (en) * | 2019-12-03 | 2020-02-18 | 仁和堂药业有限公司 | Metformin hydrochloride sustained-release preparation and quality detection method thereof |
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| Publication number | Publication date |
|---|---|
| CN103860508B (en) | 2016-01-27 |
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Address after: 519000 unit 1301, floor 13, zone a plant, No. 1 Gangle Road, Tangjiawan Town, high tech Zone, Zhuhai, Guangdong Patentee after: ZHUHAI SKYPHARM TECH Co.,Ltd. Address before: 519000 unit 512, 5th floor, main building, No. 10, Keji 1st Road, Gangwan Avenue, Tangjiawan Town, Zhuhai City, Guangdong Province Patentee before: ZHUHAI SKYPHARM TECH Co.,Ltd. |
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