Potassium dehydroandrographolide succinate injection and preparation method

Abstract

The invention relates to potassium dehydroandrographolide succinate injection and a preparation method, in particular to a pharmaceutical composition which comprises potassium dehydroandrographolide succinate, alkali metal salt and water for injection. The preparation method of the pharmaceutical composition comprises steps as follows: auxiliary materials such as the alkali metal salt and the like are dissolved in an appropriate amount of the water for injection, the potassium dehydroandrographolide succinate is added to the solution and stirred to be dissolved, about 0.1%-0.5% of activated carbon is added to the solution and stirred for absorption for 30 minutes, and filtration is performed to remove carbon; the water for injection is refilled to a full dose, a pH value of the solution is checked, and if necessary, an acidifying or alkalizing agent is used for adjusting the pH value of the solution to be in the range from 6.5 to 8.0; 0.4 mu m and 0.22 mu m millipore filtering films are used for filtering a liquid medicine, the liquid medicine is split and filled in glass bottles, then sealed and autoclaved at the temperature of 115 DEG C for 30 minutes, and the potassium dehydroandrographolide succinate injection is obtained. The prepared potassium dehydroandrographolide succinate injection has a good pharmaceutical property.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a medicament for treating viral pneumonia and viral upper respiratory tract infection, in particular to a Chuanhuning preparation, in particular to a stable Chuanhuning injection and the preparation of the injection method. Background technique [0002] Chuanhuning, chemical name: 14-dehydroxyl 11,12-didehydroandrographolide-3,19-disuccinic acid half ester monopotassium salt, English name: Potassium Dehydroandrograpolide Succinate; molecular formula: C28H35KO10, molecular weight: 570.68, its molecular formula Following formula I (it also can be referred to as formula I compound in the present invention): [0003] [0004] The existing clinically used Chuanhuning preparations include freeze-dried powder injections, small-volume water injections and large-volume infusions. Due to the stability of Chuanhuning, there are usually problems, so the classic powder injections are still...

AI Technical Summary

Problems solved by technology

It is believed that there are bridge-shaped conjugated structures, α and β-unsaturated lactone bonds in the molecular structure of Chuanhuning drug, and its aqueous solution is prone to hydrolysis, resulting in darker color and lower content of the product

Common chemical stability is manifested by the increase of impurities and / or the decrease of content, such as Fu Chunmei et al. Research, Journal of Pharmaceutical Analysis, 2005, 25(2): 157) reported: "Injection stability investigation found that the peak area of ​​related substances increased significantly, and the content decreased, and the content of many commercially available products was only the labeled amount after half a year About 80%, and the increase of related substances does not match the decrease of content, indicating that the inspection of related substances did not fully reflect the decomposition products of the sample...It is recommended that the production unit improve the production process of injection or make powder injection to improve its stability

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