Mesosulide capsules and preparation method thereof

A technology of Mesosol capsule and Sosulide, which is applied in the directions of capsule delivery, pharmaceutical formulations, and medical preparations of inactive ingredients, etc., to achieve the effects of improving solubility, high dissolution rate and good curative effect.

Inactive Publication Date: 2018-11-02
WUHAN OPTICS VALLEY HUMANWELL BIO PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, the current research on mesosulide preparations still needs to be strengthened

Method used

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  • Mesosulide capsules and preparation method thereof
  • Mesosulide capsules and preparation method thereof
  • Mesosulide capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Embodiment 1: Prescription research of Mesosulide Capsules

[0040] Since the main drug mesosulide is almost insoluble in water and the amount of the main drug is relatively large, the difficulty in the prescription process is to improve the dissolution rate of this product. In this example, the prescription of Mesosulide Capsules with a specification of 50 mg / capsules was studied. Specifically, due to the poor water solubility and fluidity of the raw material Mesosulide, it was considered to add water-soluble excipients and disintegration. The dissolution agent was used to promote dissolution, and 9 prescriptions were designed, as shown in Table 1.

[0041] Table 1 Different formulation designs

[0042]

[0043]

[0044] Note: In the preparation of adhesives, hypromellose needs to be prepared with purified water to make 4% hypromellose aqueous solution (g / g), and povidone K30 needs to be added with purified water to make 8% polyvinyl alcohol. Vitone K30 aqueous...

Embodiment 2

[0063] Embodiment 2: Prescription process optimization of Mesosulide Capsules

[0064] In this study, according to the dosage form requirements of the Chinese Pharmacopoeia 2010 edition, referring to the "Basic Technical Guidelines for the Research of Chemical Pharmaceutical Preparations" promulgated by CDE, combined with the characteristics of capsules, and taking the dissolution rate as the investigation index, the excipients used in the prescription of this product were investigated. Type and dosage were further screened.

[0065] (1) Screening of fillers

[0066] Adjust the ratio and dosage of lactose and microcrystalline cellulose, and investigate the effects of different ratios and dosages of diluents (in this article, "filler" and "diluent" can be used interchangeably) on the capsule formability and dissolution rate. and the result is as follows:

[0067] In this study, the combination of lactose and microcrystalline cellulose was used as the diluent. The prescription...

Embodiment 3

[0099] Embodiment 3: investigation on the particle size of mesosulide crude drug

[0100] Follow the steps below to investigate the impact of the particle size of the bulk drug on Mesosulide Capsules, specifically as follows:

[0101] Based on the prescription 21 in Example 2, the preparation process of the present invention is further optimized in order to further improve the dissolution rate of the mesosulide capsules of the present invention.

[0102] Specifically, according to prescription 21, two groups (group A and group B) of mesosulide capsules were prepared respectively, the method for preparing group A mesosulide capsules was as follows, the preparation method of group B mesosulide capsules was the same as that of A group The difference in the preparation method of the mesosulide capsule is that the main drug mesosulide is mixed with the auxiliary material filler without micronization treatment.

[0103] The preparation method of group A mesosulide capsules is as fo...

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Abstract

The invention provides a Meisuoshuli capsule and a preparation method thereof. The Meisuoshuli capsule comprises Meisuoshuli and pharmaceutically acceptable auxiliary materials. The Meisuoshuli capsule has the advantages of high dissolution rate, stable quality, simple operation, convenience, fastness, and suitableness for industrial production.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to mesosulide capsules and a preparation method thereof. Background technique [0002] Mesosulide is a Class 1.1 new chemical drug jointly developed by Humanwell Pharmaceutical Group and the Academy of Military Medical Sciences. Mesosulide is a non-steroidal anti-inflammatory drug (NSAID for short). Prostaglandins (PGE1, PGE2) and thromboxane A2 (TXA2), that is, reduce the synthesis of prostaglandins, thromboxanes and other inflammatory mediators, so it has good antipyretic, analgesic, anti-inflammatory, detumescence and other effects. The raw material of mesosulide is insoluble in water, and no suitable preparation of mesosulide has been reported yet. Therefore, it is of great significance to develop mesosulide preparations with good curative effect, high bioavailability and few side effects. [0003] However, the current research on mesosulide preparations still needs to be strengthened...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/18A61K47/26A61K47/38A61K47/32
Inventor 王学海李莉娥许勇廖娟娟黄怡黄璐涂荣华杨仲文乐洋江曦朱垒余艳平刘荃王伟田华肖强范昭泽杨菁张毅
Owner WUHAN OPTICS VALLEY HUMANWELL BIO PHARMA
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