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A fast-dissolving mitiglinide calcium preparation and its preparation and detection method

A mitiglinide calcium preparation technology, which is applied in the field of fast-dissolving mitiglinide calcium preparations and its preparation and testing, can solve the problems of affecting patient confidence, high failure rate, weight gain, etc., and avoid granulation time And the stirring speed is too low, it is not easy to produce dust, and the effect of uniform properties

Active Publication Date: 2019-03-15
YICHANG HEC CHANGJIANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, in addition to the high failure rate of the first treatment of sulfonylureas, about 10% of patients do not respond to subsequent treatments, and their main adverse reactions are hypoglycemia and severe weight gain; although biguanides were introduced in the 1950s It has not been used in the treatment of diabetes, but the obvious gastrointestinal side effects limit its application in some patients; the main adverse reactions of α-glucosidase inhibitors also appear in gastrointestinal side effects; thiazolidinediones have been used in recent years However, concerns about edema and heart failure have seriously affected patients' confidence in this class of drugs

Method used

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  • A fast-dissolving mitiglinide calcium preparation and its preparation and detection method
  • A fast-dissolving mitiglinide calcium preparation and its preparation and detection method
  • A fast-dissolving mitiglinide calcium preparation and its preparation and detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1 A fast-dissolving mitiglinide calcium tablet

[0032] 5 parts of mitiglinide calcium; 40 parts of lactose; 30 parts of microcrystalline cellulose; 20 parts of starch; 55 parts of hypromellose E; 5 parts of carboxymethyl starch; 0.1 part of magnesium stearate.

[0033] The particle size of the mitiglinide calcium bulk drug D(0.5)≤10 μm, D(0.9)≤40 μm.

[0034] Prepare the method for the described mitiglinide calcium preparation of right, described method comprises the following steps:

[0035] 1) Miglinide calcium and lactose were mixed for 10 minutes to obtain material 1;

[0036] 2) Material 1 was put into a wet mixing granulator together with lactose, microcrystalline cellulose, starch, and 30% sodium carboxymethyl starch, and mixed at a stirring speed of 120 rpm / min for 8 minutes to obtain material 2;

[0037] 3) Prepare hypromellose E3 or E5 into an aqueous solution with a concentration of 1%-10%, add material 2 to it, and granulate to obtain material 3. ...

Embodiment 2

[0042] Example 2 A fast-dissolving mitiglinide calcium capsule

[0043] A mitiglinide calcium preparation, characterized in that the preparation comprises the following components in parts by weight:

[0044] 5 parts of mitiglinide calcium; 30 parts of lactose; 20 parts of microcrystalline cellulose; 30 parts of starch; 1.5 parts of sodium carboxymethyl starch; 32 parts of hypromellose E; 4 parts of sodium carboxymethyl starch; 0.1 part of magnesium stearate.

[0045] The particle size of the mitiglinide calcium bulk drug D(0.5)≤10 μm, D(0.9)≤40 μm.

[0046] Prepare the method for the described mitiglinide calcium preparation of right, described method comprises the following steps:

[0047] 1) mitiglinide calcium and lactose were mixed for 5 minutes to obtain material 1;

[0048] 2) Material 1 was put into a wet mixing granulator together with lactose, microcrystalline cellulose, starch, and 40% sodium carboxymethyl starch, and mixed at a stirring speed of 100 rpm / min for ...

Embodiment 3

[0054] Embodiment 3, different granularity mitiglinide calcium crude drug preparation mitiglinide calcium tablet dissolution rate influence

[0055] Adopt the method of the present invention, other raw material proportioning and method are consistent, compare the impact of different raw material particle sizes on the dissolution rate of mitiglinide calcium tablets, the specific results are shown in Table 1 (slurry method, 50rpm, 900ml, n=6).

[0056] Table 1 Effect of different particle sizes of mitiglinide calcium raw materials on the dissolution rate of mitiglinide calcium tablets

[0057]

[0058] As can be seen from Table 1, the particle size of the mitiglinide calcium raw material has a significant impact on the dissolution rate of the mitiglinide calcium tablet. The dissolution rate of mitiglinide calcium tablets can reach more than 90% in 10 minutes.

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Abstract

The invention relates to the field of medicinal preparations, and relates to a rapid-dissolution mitiglinide preparation, and a preparation method and a detection method thereof. The prescription of the preparation comprises 4-6 parts of a mitiglinide raw medicine, 25-45 parts of lactose, 15-35 parts of microcrystalline cellulose, 15-35 parts of starch, 1.5-5.5 parts of hydroxypropyl methylcellulose E3 or hydroxypropyl methylcellulose E5, 3-10 parts of sodium carboxymethyl starch and 0.05-0.3 parts of magnesium stearate. The rapid-dissolution mitiglinide preparation has the advantages of easy obtaining of auxiliary materials, low cost, simple preparation method, fast in vitro digestion, realization of the 10min dissolution rate of various dissolution media reaching 90% or above, and stable quality.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a fast-dissolving mitiglinide calcium preparation and a preparation and detection method thereof. Background technique [0002] In recent years, it has been found that the impairment of insulin secretion in the early phase is an important factor in the development of type 2 diabetes. Therefore, drugs that can restore the early secretion of postprandial insulin and reduce postprandial blood sugar have become effective drugs for the treatment of type 2 diabetes. At present, oral drugs clinically used to treat type 2 diabetes mainly include sulfonylureas (SU), biguanides, α-glucosidase inhibitors, thiazolidinedione (TZD) and glinides, etc. Among them, in addition to the high failure rate of the first treatment of sulfonylureas, about 10% of patients do not respond to subsequent treatments, and their main adverse reactions are hypoglycemia and severe weight gain; although b...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/48A61K31/4035A61K47/38A61K47/36A61K47/26A61P3/10G01N30/02
CPCA61K9/2018A61K9/2054A61K9/2059A61K9/4858A61K9/4866A61K31/4035G01N30/02G01N2030/027
Inventor 鲁科明吴春华周威
Owner YICHANG HEC CHANGJIANG PHARMA CO LTD
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