High-purity beraprost sodium crystal form as well as preparation method and application thereof
By beating in an aprotic solvent, a high-purity sodium crystal polymorph of bean prostaglandin sodium crystal was successfully prepared, which solved the problems of low purity and poor uniformity of bean prostaglandin sodium amorphous substances in the prior art, and achieved efficient API quality control and preparation production.
CN119638658APending Publication Date: 2025-03-18CHANGZHOU BOHIV PHARM TECH CO LTD
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Patent Information
- Application Number
- CN202411820140.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-11
- Publication Date
- 2025-03-18
AI Technical Summary
Technical Problem
In the existing preparation method for sodium betaprostaglandin, the obtained amorphous substance has low purity, is difficult to transfer, and has poor uniformity, making it difficult to meet the purity and uniformity requirements of the drug management organization.
Method used
High-purity sodium betaprostaglandin crystal polymorphs were prepared by beating the amorphous powder in an aprotic solvent such as acetonitrile, using specific stirring steps and conditions.
Benefits of technology
It achieves high purity of sodium beprostaglandin (HPLC purity is more than 99.5%), uniformity and easy transferability, meets the quality requirements of drug management institutions, and improves the feasibility of API quality control and preparation production.
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Abstract
The invention provides a preparation method of a polymorphic form of beraprost sodium as shown in a formula (I) and the obtained polymorphic form. The method provided by the invention comprises the following steps: adding a solvent into a beraprost sodium amorphous foamed solid shown as a formula (I); and stirring the obtained system to obtain the white beraprost sodium polymorph shown in the formula (I), wherein the solvent is an aprotic solvent. The beraprost sodium crystal solid disclosed by the invention is easy to transfer, good in uniformity and high in purity, and particularly, the HPLC (High Performance Liquid Chromatography) purity is remarkably improved, so that production management and quality control of beraprost sodium API are facilitated. # imgabs0 #
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