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A kind of metformin hydrochloride sustained-release preparation and preparation method thereof

A technology of metformin hydrochloride and sustained-release preparations, which is applied in the direction of pharmaceutical formulas, medical preparations with no active ingredients, and medical preparations containing active ingredients, etc. It can solve the problems of large differences in filling volume, long filling time, and large equipment loss. , to achieve high particle size uniformity, improve accuracy, and reduce toxic and side effects

Active Publication Date: 2021-07-20
HEBEI IDEAL & HIGHTECH PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When preparing capsule sustained-release preparations, metformin hydrochloride is generally mixed with various excipients to make pellets, and then coated. In the process of filling capsules, the prepared pellets need to have good fluidity and uniform particle size, otherwise it will cause capsules During the filling process, the filling volume varies greatly, the filling time is long, the requirements for equipment are high, or the equipment loss is large, etc.

Method used

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  • A kind of metformin hydrochloride sustained-release preparation and preparation method thereof
  • A kind of metformin hydrochloride sustained-release preparation and preparation method thereof
  • A kind of metformin hydrochloride sustained-release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] A sustained-release preparation of metformin hydrochloride, comprising active ingredients and auxiliary materials, wherein:

[0051] Active ingredients include:

[0052] Metformin hydrochloride 250 parts by weight,

[0053] Excipients include:

[0054]

[0055]

[0056] Among them, the blank core is a low-substituted hydroxypropyl cellulose core, the particle size of the blank core is 35-40 mesh, and the particle size of talcum powder is 900-1200 mesh; the slow-release agent I is Eudragit NE30D, carboxymethyl A mixture of sodium starch glycolate and calcium hydrogen phosphate dihydrate, wherein the mass ratio of Eudragit NE30D, sodium carboxymethyl starch and calcium hydrogen phosphate dihydrate is 10:1:2; sustained release agent II is Eudragit A mixture of NE30D and L30D-55, wherein the mass ratio of Eudragit NE30D and L30D-55 is 6:1.

[0057] A method for preparing the above-mentioned metformin hydrochloride sustained-release preparation, comprising the steps...

Embodiment 2

[0065] A sustained-release preparation of metformin hydrochloride, comprising active ingredients and auxiliary materials, wherein:

[0066] Active ingredients include:

[0067] Metformin hydrochloride 300 parts by weight,

[0068] Excipients include:

[0069]

[0070] Among them, the blank core is a low-substituted hydroxypropyl cellulose core, the particle size of the blank core is 35-40 mesh, and the particle size of talcum powder is 900-1200 mesh; the slow-release agent I is preferably Eudragit NE30D, carboxymethyl A mixture of sodium starch glycolate and calcium hydrogen phosphate dihydrate, wherein the mass ratio of Eudragit NE30D, sodium carboxymethyl starch and calcium hydrogen phosphate dihydrate is 10:3:4; slow-release agent II is preferably Eudragit A mixture of NE30D and L30D-55, wherein the mass ratio of Eudragit NE30D and L30D-55 is 8:1; the binder is preferably hydroxypropyl methylcellulose.

[0071] A method for preparing the above-mentioned metformin hydr...

Embodiment 3

[0079] A sustained-release preparation of metformin hydrochloride, comprising active ingredients and auxiliary materials, wherein:

[0080] Active ingredients include:

[0081] 275 parts by weight of metformin hydrochloride,

[0082] Excipients include:

[0083]

[0084] Among them, the blank core is a low-substituted hydroxypropyl cellulose core, the particle size of the blank core is 35-40 mesh, and the particle size of talcum powder is 900-1200 mesh; the slow-release agent I is preferably Eudragit NE30D, carboxymethyl A mixture of sodium starch glycolate and calcium hydrogen phosphate dihydrate, wherein the mass ratio of Eudragit NE30D, sodium carboxymethyl starch and calcium hydrogen phosphate dihydrate is 10:2:3; slow-release agent II is preferably Eudragit A mixture of NE30D and L30D-55, wherein the mass ratio of Eudragit NE30D and L30D-55 is 7:1; the binder is preferably hydroxypropyl methylcellulose.

[0085] A method for preparing the above-mentioned metformin h...

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Abstract

The invention discloses a metformin hydrochloride slow-release preparation and a preparation method thereof, which belong to the technical field of diabetes pharmacy and include active ingredients and auxiliary materials, the active ingredients include 250-300 parts by weight of metformin hydrochloride, and the auxiliary materials include 75-90 parts by weight of blank pills Core, 120-150 parts by weight of talcum powder, 70-85 parts by weight of sustained-release agent I, 70-85 parts by weight of sustained-release agent II, 15-30 parts by weight of hydroxypropyl methylcellulose, 1-3 Ethyl maltol in parts by weight, Span-85 in 5-10 parts by weight. The metformin hydrochloride sustained-release preparation of the present invention has an ideal hypoglycemic effect, and can achieve a sustained and stable hypoglycemic effect in the body; the prepared metformin hydrochloride pellets have good fluidity and high particle size uniformity, which improves the accuracy of the filling amount when filling capsules The metformin hydrochloride sustained-release preparation also has the advantages of strong stability and good sustained-release effect.

Description

technical field [0001] The invention relates to metformin hydrochloride, in particular to a sustained-release preparation of metformin hydrochloride, belonging to the technical field of diabetes pharmacy. Background technique [0002] Diabetes is caused by genetic factors, immune dysfunction, microbial infection and its toxins, free radical toxins, mental factors and other pathogenic factors acting on the body to cause hypofunction of pancreatic islets and insulin resistance. and electrolytes and a series of metabolic disorder syndromes. Clinically, hyperglycemia is the main feature. In typical cases, symptoms such as polyuria, polydipsia, polyphagia, and weight loss can occur, namely "three excesses and one deficiency". Once diabetes (blood sugar) is not well controlled, it will cause complications and lead to Diabetes, eyes, feet and other parts of the failure of the disease, and can not be cured; diabetes has become a common and frequently-occurring disease in my country ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/62A61K9/58A61K9/56A61K31/155A61K47/32A61K47/36A61P3/10
CPCA61K9/0002A61K9/1617A61K9/5026A61K9/5036A61K9/5084A61K31/155A61P3/10
Inventor 白巧红郭超孙建强韩盼盼权颖梁健军张晓宁谢承艳卢利英孙云杰
Owner HEBEI IDEAL & HIGHTECH PHARMA
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