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Improved production process of Shengmai injection

A technology for Shengmai injection and production process, applied in the field of Shengmai injection and production process of Shengmai injection, can solve problems such as side effects of Shengmai injection and affect the therapeutic effect, and achieve the safety and reduction of drug use. Pain response, the effect of eliminating vascular irritation and toxicity

Active Publication Date: 2011-02-16
HEHUANG PHARMA SHANGHAI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The object of the present invention is to provide an improved production process of Shengmai Injection. The improved production process of Shengmai Injection should solve the problem that the Shengmai Injection obtained by the existing production process has side effects and affects the therapeutic effect. technical issues

Method used

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  • Improved production process of Shengmai injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Shengmai Injection was originally published in Volume 15 of the Ministry of Health Drug Standards for Traditional Chinese Medicine Preparations (WS 3 -B-2865-98) Shengmai injection prescription and process:

[0021] [Recipe] Red Ginseng 100g; Ophiopogon japonicus 312g; Schisandra 156g

[0022] [Production process] For the above three flavors, take red ginseng coarse grains (or thin slices), add ethanol to reflux extraction 5 times, each time for 2 hours, combine the extracts, filter, refrigerate the filtrate, recover ethanol, add NaOH to adjust the pH to 6.5, and steam to No alcohol smell, refrigerate, filter, and the filtrate is used for liquid preparation; take coarse powder of schisandra chinensis, soak in cold water, collect the distillate by steam distillation, and use it for liquid preparation; decoct the dregs of the medicine twice, combine the decoction, and filter , the filtrate is concentrated to a thick paste, add ethanol until the alcohol content reaches 85...

Embodiment 2

[0026] Example 2 Improved production process of Shengmai Injection

[0027] [Recipe] Red Ginseng 100g; Ophiopogon japonicus 312g; Schisandra 156g

[0028][Method] For the above three flavors, take red ginseng coarse grains (or thin slices), add ethanol to reflux extraction 5 times, each time for 2 hours, combine the extracts, filter, refrigerate the filtrate, recover ethanol, add NaOH to adjust the pH to 6.5, and steam to No alcohol smell, refrigerate, filter, and the filtrate is used for liquid preparation; take the coarse powder of Schisandra chinensis, soak in cold water, collect the distillate of Schisandra chinensis by steam distillation, and use it for liquid preparation; add water to decoct the dregs twice, combine the decoction, filter After filtering, the filtrate is concentrated to a thick paste, adding ethanol until the alcohol content reaches 85%, refrigerating, filtering, adjusting the pH to 6.5-7 with 35% sodium hydroxide solution in the filtrate, refrigerating, ...

Embodiment 3

[0029] The assay method of malic acid in the Shengmai Injection produced by the improved production process of embodiment 3 and its medicinal materials and intermediates

[0030] 1. Instruments, reagents and samples

[0031] 1.1 Instrument

[0032] High performance liquid chromatography: Agilent 1100; autosampler: G1322A; column thermostat: G1316A; detector: DAD G1315B; ultrasonic cleaner: SK7200LH, Shanghai Kedao Ultrasonic Instrument Co., Ltd.

[0033] 1.2 Reagents and reagents

[0034] Citric acid reference substance: National Institute for the Control of Pharmaceutical and Biological Products; batch number: 111679-200401; for content determination.

[0035] L-malic acid reference substance: SIGMA Company; batch number: 01011AE; for content determination.

[0036] Methanol is chromatographically pure, water is double distilled water, and other reagents are analytically pure.

[0037] The medicinal material of Schisandra was provided by the material warehouse and sample ...

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Abstract

The patent refers to the field of 'pharmaceutical preparations'. The invention relates to an improved production process of a Shengmai injection. The Shengmai injection comprises red ginseng, radix ophiopogonis and schisandra chinensis. The production process comprises the steps of extracting the red ginseng, extracting the schisandra chinensis and extracting the radix ophiopogonis. The step of extracting the red ginseng comprises the following flows of: pulverizing the red ginseng; adding alcohol for extracting; and filtering. The step of extracting the schisandra chinensis comprises the following flows of: pulverizing the schisandra chinensis and distilling; extracting the radix ophiopogonis with water and then settling with alcohol; then adding water for regulating; and adding a proper quantity of active carbon for filtering. The step of extracting the radix ophiopogonis comprises the following flows of: extracting the radix ophiopogonis with water, and settling with alcohol; then uniformly mixing the extracting solutions of the red ginseng, the radix ophiopogonis and the schisandra chinensis and filtering; regulating the pH, and filtering; after the filter solution is subjected to fine filtering, heating; adding a proper quantity of Twain-80; and filtering, encapsulating and sterilizing to obtain the Shengmai injection. In the production process, the contents of citric acid and malic acid in a finished Shengmai injection product are both not higher than 0.1 percent, therefore, the blood vessel irritation and the toxic reaction of the Shengmai injection are reduced, and the pain reaction in the treatment of patients is reduced.

Description

technical field [0001] The invention relates to the field of traditional Chinese medicine, in particular to Shengmai injection, in particular to an improved production process of Shengmai injection. Background technique [0002] The traditional Chinese medicine Shengmai Injection is derived from the ancient prescription "Shengmaisan", which is a national essential medicine and a national protected variety of traditional Chinese medicine, and is an essential Chinese patent medicine for emergencies in traditional Chinese medicine. The production standard number of the enterprise is WS3B-2865-98. The protected variety number of traditional Chinese medicine is ZYB20720050746. [0003] The active ingredients of Shengmai Injection are composed of red ginseng, Ophiopogon japonicus, and Schisandra chinensis, which have the functions of nourishing qi and nourishing yin, and restoring the pulse. The pharmacological effects of Shengmai Injection are mainly to dilate coronary vessels,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61P9/02A61P9/06A61P31/14A61K36/8968A61P39/06A61P9/10A61P9/04
Inventor 郭安胡春湘岳镭陈忠樑
Owner HEHUANG PHARMA SHANGHAI
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