Potassium dehydroandrogrpholide succinate injection and preparation method thereof

Abstract

The invention discloses a potassium dehydroandrogrpholide succinate injection which contains the following components in 2,000ml of injection: 40.0g of potassium dehydroandrogrpholide succinate, 7.6g of sodium hydrogen carbonate, 7.0g of sodium dihydrogen phosphate anhydrous, 2.8g of disodium hydrogen phosphate, 2.8g of Beta-mercaptoethanol, 2.0g of medicinal carbon and the balance of injection water. A preparation method comprises the following steps of: after dissolving the sodium hydrogen carbonate by using the injection water with 50-60 DEG C, adding the potassium dehydroandrogrpholide succinate, stirring until the potassium dehydroandrogrpholide succinate is dissolved completely; and sequentially adding buffer solutions of the sodium dihydrogen phosphate anhydrous and the disodium hydrogen phosphate and the Beta-mercaptoethanol, uniformly stirring for constant volume, adding the active carbon for absorption, decarburizing and filtering, nitrogenizing and encapsulating after detecting that the semi-finished product is qualified, wherein the filling quality of the injection is 2ml. The preparation method is characterized in that: 1, a hollow fiber ultrafiltration device is used for replacing the original active carbon absorbed filtering system during the production; and 2, the quality of the semi-finished product of the potassium dehydroandrogrpholide succinate injection is controlled by using a high performance liquid chromatography.

Description

Technical field: [0001] The invention relates to an injection and a production method thereof, in particular to a formula of Chuanhuning injection and a preparation method thereof, belonging to the field of biomedicine. Background technique: [0002] Chuanhuning injection is a sterilized aqueous solution made of Chuanhuning raw material plus sodium bicarbonate and other auxiliary materials. Its anti-inflammatory effect is the strongest among the thirteen kinds of andrographolide injections. The virus inactivation test proved that it has a strong inactivation effect on adenovirus (ADV) type 3, influenza virus type A, and type A respiratory syncytial virus (RSY); Streptococcus type 2, Escherichia coli, and Streptococcus pneumoniae have inhibitory effects on various pathogenic bacteria, and are widely used in the treatment of viral pneumonia, viral acute upper respiratory infection, dysentery, Japanese encephalitis, pulmonary heart disease, and asthma attacks It is known as a...

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Problems solved by technology

[0003] The initial raw material of Chuanhuning injection is the extract of traditional Chinese medicinal materials with extremely complex chemical composition. In addition, its molecular structure has bridge-shaped conjugated double chains and α, β unsaturated lactone bonds. It has high chemical activity and is prone to hydrolysis and oxidation. reaction, and finally cause the solution to become darker in color, lower in content, and unstable in quality

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