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Multi-component process dynamic quality control testing method for injection containing marsdenia tenocissima

A technology for controlling detection and customs clearance can be applied in the field of research methodology of traditional Chinese medicine preparations, which can solve the problems of neglect in the production process.

Inactive Publication Date: 2013-08-14
JIANGSU PROVINCE INST OF TRADITIONAL CHINESE MEDICINE
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  • Abstract
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  • Application Information

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Problems solved by technology

In addition, quality control is only for the final product, and the production process is ignored

Method used

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  • Multi-component process dynamic quality control testing method for injection containing marsdenia tenocissima
  • Multi-component process dynamic quality control testing method for injection containing marsdenia tenocissima
  • Multi-component process dynamic quality control testing method for injection containing marsdenia tenocissima

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Experimental program
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Embodiment

[0028] figure 2 It is a multi-component process dynamic quality control method containing Tongguanteng injection, and its specific steps are:

[0029] 1. Extraction of Tongguanteng medicinal materials

[0030] Different batches of dried Tongguan rattan medicinal materials were crushed with a pulverizer, passed through a 40-mesh sieve, and 100g of the powder was precisely weighed, and 8 times the amount of water was added, and decocted in a round-bottomed flask for 2 hours / time, decocted twice, and Filter through gauze, combine the filtrates, concentrate in a rotary evaporator at 70°C to a concentration of 1g crude drug / ml, and store at -4°C for future use.

[0031] 2. Preparation of intermediates in the process of preparing Tongguanteng injection (hereinafter referred to as intermediates)

[0032] Add ethanol to the medicinal material extract to make the alcohol content reach 75%, fully stir, let it stand, and filter; add distilled water to dissolve the precipitate, add eth...

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Abstract

The invention belongs to the field of methodology for studying traditional Chinese medicine preparations, and relates to a multi-component process dynamic quality control testing method for an injection containing marsdenia tenocissima. The method is specifically used for testing and controlling a marsdenia tenocissima herb, an intermediate applied to the process of preparing the injection containing marsdenia tenocissima, and phenolic acid, steroidal saponins and saccharides in the finished injection containing marsdenia tenocissima. When the content sum of the phenolic acid, the steroidal saponins and the saccharides is more than the content of total solids by 50 percent to 95 percent, the content ratio of the phenolic acid to the steroidal saponins to the saccharides is (1 percent-95 percent):(1 percent-95 percent): (1 percent-95 percent); and when the total content of the phenolic acid and the steroidal saponins is not less than 0 percent to 85 percent, the quality of the injection containing marsdenia tenocissima is best. The method overcomes the problem that in a traditional quality control method, only maker components of a finished product are taken into consideration, but the influence of other links of a preparing technological process to product quality is ignored, and the method can effectively improve the quality controllability of traditional Chinese medicine preparations and reduce the content difference of preparation components from batch to batch.

Description

technical field [0001] The invention relates to a multi-component process dynamic quality control detection method for Tongguanteng injection, which belongs to the field of research methodology of traditional Chinese medicine preparations. Background technique [0002] The quality control of traditional Chinese medicine preparations has always been an important issue on the road of international development of traditional Chinese medicine. The complex characteristics of traditional Chinese medicine ingredients have brought a stalemate in the preparation of stable and controllable traditional Chinese medicine preparations, and it is also a key issue that makes it difficult for traditional Chinese medicine preparations to be recognized internationally. The current quality of traditional Chinese medicine / Chinese medicine preparations depends on the detection of one or several components to judge the quality of the method can no longer meet the requirements of the international ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 贾晓斌封亮张明华顾俊菲
Owner JIANGSU PROVINCE INST OF TRADITIONAL CHINESE MEDICINE
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