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Miglinide calcium composition tablet and preparation method thereof

A technology of mitiglinide calcium and its composition, which is applied in the field of pharmaceutical preparations, can solve problems such as unstable storage at room temperature, low solubility in water, and slow dissolution of tablets, and achieve accurate dosage, short production cycle, and fast disintegration speed Effect

Active Publication Date: 2016-08-31
NANHAI PHARMA CHONGQING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the mitiglinide calcium raw material has problems such as unstable storage at room temperature, light density, low solubility in water, and poor powder fluidity, which makes its preparation process more difficult, and the tablet is prone to problems such as slow dissolution and low dissolution rate.

Method used

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  • Miglinide calcium composition tablet and preparation method thereof
  • Miglinide calcium composition tablet and preparation method thereof
  • Miglinide calcium composition tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] The preparation of embodiment 1 mitiglinide calcium composition tablet

[0067] Prepare three batches of pilot test samples according to the above-mentioned determined prescription process, summarized as follows:

[0068] Feeding and output (5mg) of the sample in table 2

[0069] Batch number, date of trial production, main drug dosage, theoretical output and output.

[0070]

[0071] Table 3 Sample Testing Standards

[0072]

[0073] Reference substance information:

[0074] Lot No. 13-SSR-75-1; Quantity 98%; Source Toronto Research Chemicals Inc.

[0075] Table 4 Sample Test Results

[0076]

[0077] It can be seen from the above that all indicators of the samples prepared by this prescription process all meet the requirements, so the process is feasible.

Embodiment 2

[0078] Embodiment 2: Preparation of mitiglinide calcium composition tablet

[0079] Produce 1000 pieces of mitiglinide calcium tablets (specification 5mg), and the core contains the following raw materials in parts by weight: mitiglinide calcium 5g, lactose 30g, pregelatinized starch 7.5g, microcrystalline cellulose 30g, hydroxypropyl cellulose 1.5g, 4.5g silicon dioxide, 0.5g magnesium stearate, appropriate amount of povidone K30.

[0080] Pass mitiglinide calcium through a 100-mesh sieve, pass lactose, pregelatinized starch, microcrystalline cellulose, hydroxypropyl cellulose, and silicon dioxide through a 80-mesh sieve respectively; Calcium glinide, lactose, pregelatinized starch, microcrystalline cellulose, hydroxypropyl cellulose, and silicon dioxide are evenly mixed to obtain the first mixture; add 5% povidone k30 aqueous solution to the first mixture to make soft material, passed through a 24-mesh sieve for granulation, dried the obtained granules at 60°C until the wat...

Embodiment 3

[0081] The preparation of embodiment 3 mitiglinide calcium composition tablet

[0082] Production of 1000 mitiglinide calcium tablets (specification 10mg) tablet cores contains the following raw materials in parts by weight: mitiglinide calcium 10g, lactose 60g, pregelatinized starch 15g, microcrystalline cellulose 55g, hydroxypropyl cellulose 3g, Silicon dioxide 9g, magnesium stearate 1g, appropriate amount of povidone K30.

[0083] Pass mitiglinide calcium through a 100-mesh sieve, pass lactose, pregelatinized starch, microcrystalline cellulose, hydroxypropyl cellulose, and silicon dioxide through a 80-mesh sieve respectively; Calcium linide, lactose, pregelatinized starch, microcrystalline cellulose, hydroxypropyl cellulose, and silicon dioxide are uniformly mixed to obtain the first mixture; 5% povidone k30 aqueous solution is added to the first mixture to make a soft material , pass through a 24-mesh sieve for granulation, dry the prepared granules at 60°C until the wate...

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Abstract

The invention provides a mitiglinide calcium composition tablet and a preparation method thereof. The weight ratio of the composition components is: 7-12 parts of mitiglinide calcium, 40-70 parts of lactose, and 5-5 parts of pregelatinized starch 20 parts, 25-60 parts of microcrystalline cellulose, 1-5 parts of hydroxypropyl cellulose, 5-12 parts of silicon dioxide, 0.1-3 parts of magnesium stearate, appropriate amount of povidone K30. The composition tablet of mitiglinide calcium provided by the present invention has components with readily available synthetic raw materials and low cost. The preparation method is simple, and the prepared tablet has the characteristics of fast disintegration speed, high dissolution rate, good stability, accurate dosage, convenient taking, and portability. The process of the invention is simple, easy to control, short production cycle, and low production cost. Suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a mitiglinide calcium composition tablet for treating diseases of diabetic patients and a preparation method thereof. Background technique [0002] With the improvement of people's living standards, more and more people suffer from diabetes. Diabetes is a comprehensive metabolic disease characterized by chronic hyperglycemia, which is a chronic or lifelong disease. Diabetes, together with cardiovascular and cerebrovascular diseases and cancer, is one of the three major diseases that seriously threaten human health due to its high incidence, disability and mortality. Diabetes is mainly caused by defects in insulin secretion and / or insulin action. Long-term high blood sugar in diabetic patients can cause damage to various target organs such as the heart, brain, and kidney, and is especially an important risk factor for cardiovascular diseases. Cont...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4035A61K47/38A61P5/50A61P3/10
Inventor 邹世红陈向尚光华孙川聂国祥唐万鹏唐金春聂凯
Owner NANHAI PHARMA CHONGQING
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