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Compound tablet of pioglitazone hydrochloride, glimepiride and preparation method thereof

A technology of pioglitazone hydrochloride and glimepiride, which is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, pill delivery, etc., can solve the problem of unsatisfactory dissolution of glimepiride and glimepiride Stability impact, poor dissolution of glimepiride and other issues, to achieve the effect of improving product stability, improving solubility, and being suitable for industrial production

Inactive Publication Date: 2010-08-18
SHANDONG XINHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] But, there is following problem in the compound preparation that present glimepiride and pioglitazone hydrochloride form: (1) promptly the dissolution rate of glimepiride is not ideal enough, that is to say, dissolution rate is lower than single square glimepiride tablet; 2) Poor stability, related substances (mainly glimepiride impurities) easily exceed the standard within the validity period
The patent (WO2005041962) applied by Japan's Takeda Pharmaceutical Co., Ltd. describes that the product adopts a double-layer tableting process, and solves the problem of poor dissolution of glimepiride by adding Tween 80 and wine spraying granulation process in the formula, but due to the Glimepiride is sensitive to heat and easily decomposes under high temperature conditions. The above-mentioned granulation and drying process will have a greater impact on the stability of glimepiride, and the preparation process of this method is complicated, the cycle is too long, and the yield is low. Industrialization is difficult

Method used

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  • Compound tablet of pioglitazone hydrochloride, glimepiride and preparation method thereof
  • Compound tablet of pioglitazone hydrochloride, glimepiride and preparation method thereof
  • Compound tablet of pioglitazone hydrochloride, glimepiride and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Based on 1000 pieces

[0030] Glimepiride and Sodium Lauryl Sulfate Mixed Powder 4.0g

[0031] Pioglitazone Hydrochloride 33.0g

[0032] Mannitol 280g

[0033] Croscarmellose Sodium 5.5g

[0034] Magnesium Stearate 5.5g

[0035] Preparation:

[0036] Step 1: Mix glimepiride and sodium lauryl sulfate at a ratio of 1:1 and pulverize through 200 mesh, and set aside.

[0037] The second step: Weigh the mixed powder of glimepiride and sodium lauryl sulfate prepared in the first step in the mixer, and add the formula amount of pioglitazone hydrochloride, mannitol, croscarmepiride sodium, lauryl sulfate Sodium sulfate and magnesium stearate are mixed evenly, and the granule content is measured, and the direct tableting method is adopted to obtain the product.

Embodiment 2

[0039] Based on 1000 pieces

[0040] Glimepiride and Mannitol Mixed Powder 8.0g

[0041] Pioglitazone Hydrochloride 33.0g

[0042] Mannitol 125g

[0043] Sodium carboxymethyl starch 10.0g

[0044] Sodium Lauryl Sulfate 8.0g

[0045] Magnesium stearate 0.5g

[0046] Preparation:

[0047] Step 1: Glimepiride and mannitol are mixed and pulverized at a ratio of 1:1 to pass through 200 mesh, and set aside.

[0048]The second step: Weigh the mixed powder of glimepiride and mannitol prepared in the first step in the mixer, and add the formula amount of pioglitazone hydrochloride, mannitol, sodium carboxymethyl starch, sodium lauryl sulfate and stearic acid Magnesium, after mixing evenly, measure the particle content, and adopt the direct compression method to obtain the product.

Embodiment 3

[0050] Based on 1000 pieces

[0051] Glimepiride and Sodium Lauryl Sulfate Mixed Powder 8.0g

[0052] Pioglitazone Hydrochloride 33.0g

[0053] Mannitol 70g

[0054] Crystal Cellulose PH102 75g

[0055] Lactose 80g

[0056] Sodium carboxymethyl starch 10.0g

[0057] Magnesium Stearate 5.5g

[0058] Preparation:

[0059] Step 1: Mix glimepiride and sodium lauryl sulfate at a ratio of 1:1 and pulverize through 200 mesh, and set aside.

[0060] The second step: Weigh the mixed powder of glimepiride and mannitol prepared in the first step in the mixer, and add the formula amount of pioglitazone hydrochloride, mannitol, sodium carboxymethyl starch, crystal cellulose, lactose, dodecane Sodium hydroxysulfate and magnesium stearate, mix evenly, measure the granule content, and adopt the direct compression method to get final product.

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Abstract

The invention relates to a compound tablet of pioglitazone hydrochloride, glimepiride and a preparation method thereof. The compound tablet contains sodium dodecyl sulfate and auxiliary with poor hygroscopicity, wherein the weight ratio of glimepiride to pioglitazone hydrochloride is 1-4:33; the content of sodium dodecyl sulfate by weight percent is 0.1-5%, and the content of the auxiliary with poor hygroscopicity by weight percent is 20-95%. The preparation method comprises the steps: the raw material of glimepiride, pioglitazone hydrochloride and the auxiliary with poor hygroscopicit are mixed into smashed mixing powder, the mixing powder, the raw material of pioglitazone hydrochloride, filler, disintegrant and lubricator are evenly mixed, and the mixture is subject to tabletting. The compound tablet solves the problems of imperfect dissolution of glimepiride, inferior stability and large industrialization difficulty of glimepiride. The preparation method according to the invention has the advantages of simple process, easy operation and better suitability for industrial production.

Description

technical field [0001] The invention relates to a compound tablet of pioglitazone hydrochloride and glimepiride and a preparation method thereof, belonging to the technical field of medicines. Background technique [0002] Diabetes mellitus is a heterogeneous syndrome of primary carbohydrate metabolism disorders caused by multiple etiologies. There is often absolute or relative insulin deficiency and / or insulin resistance. Hyperglycemia from all etiologies is an essential feature of this syndrome. Diabetes is divided into type I diabetes and type II diabetes. The prevalence of insulin-dependent diabetics (IDDM, type I) is 0.07-3.4 / 1000 in all countries in the world. The prevalence rate of non-insulin-dependent diabetic patients (IDDM, type II) is 2-4% in developed countries, accounting for more than 90% of the total number of diabetic patients, and about 5-10% among people over 40 years old. In 2000, the number of patients with type 2 diabetes worldwide was 150 million. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K31/4015A61P3/10A61K9/20A61K47/20
Inventor 陈延祥鲁凤莉张红贞张春华
Owner SHANDONG XINHUA PHARMA CO LTD
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