Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

High purified tanshinone óÄA sodium sulfonate, fabricating method, and preparation

A technology of tanshinone and sodium sulfonate, which is applied in the field of medicine, and can solve problems such as the increase in the amount of related substances in preparations and the tendency to produce precipitation

Inactive Publication Date: 2007-02-21
JILIN SIHUAN PHARM CO LTD
View PDF0 Cites 10 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] During the research and production process of Tanshinone IIA Sodium Sulfonate Injection Small Water Injection, the inventors found that there were two serious technical problems, namely (1) after one month under the accelerated test conditions at 40°C, the relevant The amount of the substance rises rapidly (measured according to the method of standard -0923), (2) the injection is prone to precipitation after being placed under the accelerated test conditions of 40°C for one month
[0006] Although the present inventor has carried out comprehensive and in-depth research from methods such as the prescription of preparation, technology, still do not solve these two problems

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] (1) The raw material is low-purity sodium tanshinone IIA sulfonate (batch number Y041120), purchased from Shanghai No. 1 Biochemical Pharmaceutical Co., Ltd., measured according to standard-0923, the content is 96.3%, and the total amount of related substances is less than 8%. The amount of impurities is less than 4% [but greater than 6% and 3% respectively, with 4% and 3% as the control], and the rest of the items meet the requirements. After passing the inspection, use the high-performance liquid chromatography of the present invention to measure content and related substances, and the content is 93.8%. The total amount of related substances is 13.42%, and the amount of individual impurities is 6.11%.

[0069] (2) To 1000ml of ethanol at 56°C, add 200g of lower purity sodium tanshinone IIA sulfonate (batch number Y041120) powder;

[0070] (3) Stir while adding to dissolve the powder to obtain a nearly saturated clear solution;

[0071] (4) 50ml of chloroform added i...

Embodiment 2

[0076] (1) raw material is the high-purity sodium tanshinone IIA sulfonate (batch number Y050415) that above-mentioned embodiment 1 makes, measure by standard-0923, content is 98.6%, related substance total amount is less than 7%, and the amount of single impurity is less than 4% % [but greater than 6% and 3% respectively, with 4%, 3.5%, and 3% for comparison], and the rest of the items meet the requirements. After passing the inspection, use the high performance liquid chromatography of the present invention to measure content and related substances, the content is 97.4%, the total amount of related substances is 7.73%, and the amount of a single impurity is 2.97%.

[0077] (2) In 1000ml of ethanol at 59°C, 200g of lower-purity sodium tanshinone IIA sulfonate (batch number Y050415) powder was added;

[0078] (3) Stir while adding to dissolve the powder to obtain a nearly saturated clear solution;

[0079] (4) 50ml of chloroform added in a ratio of 5% by volume, stirred evenl...

Embodiment 3

[0084] (1) The raw material is low-purity sodium tanshinone IIA sulfonate (batch number Y050212), self-made, and the self-made method is: according to the prior art, extracting tanshinone IIA (HPLC method) with a purity of 81% from Salvia miltiorrhiza, then using concentrated sulfuric acid Sulfonation reaction was carried out to obtain sodium tanshinone IIA sulfonate (batch number Y050212). Measured according to the standard -0923, the content is 93.3%, the total amount of related substances is less than 12%, the amount of a single impurity is less than 6% [but greater than 10% and 5% respectively, and 5% and 6% are compared], and the rest of the items meet the regulations. After passing the inspection. The content and related substances are measured by the high-performance liquid chromatography of the present invention, and the content is 92.6%, the total amount of related substances is 13.66%, and the amount of a single impurity is 6.03%.

[0085] (2) In 1000ml of ethanol a...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

This invention relates to a method for preparing high-purity sodium tanshionone IIA sulfonate, and preparations containing the compound. Determined by HPLC, the content of sodium tanshionone IIA sulfonate is higher than 96%, the total content of the related materials is lower than 10%, and the content of individual impurities is lower than 4.0%. The injection of high-purity sodium tanshionone IIA sulfonate can avoid the problems of flotation and precipitation of components. Besides, the compounds can also be manufactured into large-volume infusion and freeze-dried powder injection.

Description

【Technical field】 [0001] The invention belongs to the technical field of medicine, relates to a sodium tanshinone IIA sulfonate, in particular to a high-purity sodium tanshinone IIA sulfonate, a preparation method of the sodium tanshinone IIA sulfonate, and the use of the sodium tanshinone IIA sulfonate prepared preparations. 【Background technique】 [0002] Salvia miltiorrhiza (RADIX ET RHIZOMA SALVIAE MILTIORRHIZAE), as an important Chinese herbal medicine, has been included in many editions of "Chinese Pharmacopoeia". Salvia miltiorrhiza is the dry root and rhizome of Salvia miltiorrhiza Bge. Excavated in spring and autumn, removed from sediment, and dried. Salvia Miltiorrhiza is bitter in nature, slightly cold; GUIXIN, Liver Meridian. It has the functions of dispelling blood stasis and relieving pain, promoting blood circulation and promoting menstrual flow, clearing away heart-fire and relieving restlessness. For irregular menstruation, amenorrhea dysmenorrhea, accum...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): C07D307/77A61K31/343A61K9/08A61K9/19A61K9/00A61P9/10A61P3/06A61P7/02A61P43/00G01N30/02G01N33/15
Inventor 张玉梅晏四平
Owner JILIN SIHUAN PHARM CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com