Mitiglinide calcium formulation and its detection method

A technology of mitiglinide calcium and its composition, which is applied in the field of preparations containing mitiglinide calcium and its quality control, which can solve the problems of large differences in loading, poor fluidity, and difficult operation, and reduce moisture absorption , Enhanced stability, increased fluidity

Inactive Publication Date: 2009-11-18
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Miglinide calcium has the problem of instability, and it will degrade when left at room temperature for a certain period of time. At the same time, mitiglinide calcium also has a certain degree of hygroscopicity and poor fluidity. It is difficult to operate when making preparations. When filling capsules, Large differences in loading capacity affect product quality and shelf life

Method used

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  • Mitiglinide calcium formulation and its detection method
  • Mitiglinide calcium formulation and its detection method
  • Mitiglinide calcium formulation and its detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0101] Preparation of tablets:

[0102] Miglinide Calcium 5g (in C 38 h 48 CaN 2 o 6 2H 2 O meter)

[0103] Lactose 160g

[0104] Mannitol 10g

[0105] Microcrystalline Cellulose 20g

[0106] Sodium carboxymethyl starch 10g

[0107] Sodium Lauryl Sulfate 1g

[0108] 5% starch slurry appropriate amount

[0109]

[0110] Makes 1000 pieces

[0111] The preparation method is:

[0112] The mitiglinide calcium is crushed through a 100-mesh sieve for later use, and the lactose, microcrystalline cellulose, mannitol, sodium carboxymethyl starch, and sodium lauryl sulfate are respectively passed through a 100-mesh sieve for later use.

[0113]Mix the above raw and auxiliary materials evenly, use 5% starch slurry to make soft material, and granulate with 24 mesh nylon mesh. Large granules need to be sieved and granulated to make them uniform granules; sieved with a 30-mesh sieve for granulation, and then pressed into tablets.

Embodiment 2

[0115] Preparation of capsules:

[0116] Miglinide Calcium 2.5g (in C 38 h 48 CaN 2 o 6 2H 2 O meter)

[0117] Lactose 80g

[0118] Mannitol 5g

[0119] Microcrystalline Cellulose 10g

[0120] Sodium carboxymethyl starch 5g

[0121] Sodium Lauryl Sulfate 0.5g

[0122] 5% starch slurry appropriate amount

[0123]

[0124] Makes 1000 capsules

[0125] The preparation method is:

[0126] The mitiglinide calcium is crushed through a 100-mesh sieve for later use, and the lactose, microcrystalline cellulose, mannitol, sodium carboxymethyl starch, and sodium lauryl sulfate are respectively passed through a 100-mesh sieve for later use.

[0127] Mix the above raw and auxiliary materials evenly, use 5% starch slurry to make soft material, and granulate with 24 mesh nylon mesh. Large granules need to be sieved and granulated to make them uniform granules; sieved with a 30-mesh sieve for granulation and packed into capsules.

Embodiment 3

[0129] Preparation of tablets:

[0130] Miglinide Calcium 10g (in C 38 h 48 CaN 2 o 6 2H 2 O meter)

[0131] Lactose 320g

[0132] Mannitol 20g

[0133] Microcrystalline Cellulose 40g

[0134] Sodium carboxymethyl starch 20g

[0135] Sodium Lauryl Sulfate 2g

[0136] 5% starch slurry appropriate amount

[0137]

[0138] Makes 1000 pieces

[0139] The preparation method is:

[0140] The mitiglinide calcium is crushed through a 100-mesh sieve for later use, and the lactose, microcrystalline cellulose, mannitol, sodium carboxymethyl starch, and sodium lauryl sulfate are respectively passed through a 100-mesh sieve for later use.

[0141] Mix the above raw and auxiliary materials evenly, use 5% starch slurry to make soft material, and granulate with 24 mesh nylon mesh. Large granules need to be sieved and granulated to make them uniform granules; sieved with a 30-mesh sieve for granulation, and then pressed into tablets.

[0142] ...

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Abstract

The invention relates to a new formulation of mitiglinide calcium and its quality control method. The pharmaceutical composition of the invention is granulated by mixing mitiglinide calcium with lactose, mannitol, microcrystalline cellulose and sodium carboxymethyl starch Finally, the hygroscopicity is greatly reduced, the fluidity is increased, the dissolution is rapid, and the stability of the product is enhanced.

Description

Technical field: [0001] The invention relates to an antidiabetic drug preparation, in particular to a preparation containing mitiglinide calcium and a quality control method thereof. Background technique: [0002] Diabetes is a common and frequently-occurring disease, and the number of its patients is increasing rapidly with the improvement of people's living standards, population aging, changes in lifestyle, and advances in diagnostic techniques. According to the relevant data of WHO, the prevalence rate, disability rate, mortality rate and degree of harm of diabetes rank the third among non-communicable diseases, and it has become the third serious threat to human health after cardiovascular and cerebrovascular diseases and tumors. three diseases, [0003] At present, oral hypoglycemic agents clinically used for the treatment of type II diabetes are mainly sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, and meglitaides. Among them, insulin-secret...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/404A61K9/20A61K9/48A61K9/08A61K47/38A61P3/10
Inventor 严洁
Owner TIANJIN HANKANG PHARMA BIOTECH
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