Quality control method of radix bupleuri scorzoneraefolii injection

Abstract

The invention discloses a quality control method of radix bupleuri scorzoneraefolii injection. The quality control method of the radix bupleuri scorzoneraefolii injection comprises the steps of: establishing a comparative fingerprint of the radix bupleuri scorzoneraefolii injection through a gas chromatographic method, measuring fingerprints of detection samples of various radix bupleuri injections, calculating the similarity of the detection samples, inspecting the peak area ratio of a target peak to a reference peak, and checking whether the detection samples accord with requirements or not.According to the quality control method of the radix bupleuri scorzoneraefolii injection in the invention, the fingerprint of the radix bupleuri scorzoneraefolii injection is established; the qualityof the radix bupleuri scorzoneraefolii injection is controlled through the fingerprint and content measurement; the quality control method has the advantages of being good in repeatability, high in stability and the like; the quality of the radix bupleuri scorzoneraefolii injection can be effectively monitored; and the stability and the security of clinical application of the radix bupleuri scorzoneraefolii injection can be improved.

Description

technical field

[0001] The invention belongs to a quality control method of traditional Chinese medicine injection, in particular to a quality control method of Nanchaihu injection. Background technique

[0002] Bupleurum Injection has the effect of clearing heat and relieving exterior, and is used to treat fevers such as colds, influenza and malaria. It has a wide range of clinical applications. It is the first Chinese medicine injection developed in my country, and it is a commonly used Chinese patent medicine for clearing away heat and relieving exterior syndrome. At present, the Bupleurum bupleurum circulating in the market mainly includes northern bupleurum, southern bupleurum and bamboo-leaf bupleurum. Due to different varieties, their main components and contents are quite different. Therefore, the prepared injections cannot be evaluated by uniform testing methods.

[0003] At present, the Bupleurum quality standard in the 2015 edition of the Chinese Veterinary Pharm...

Examples

experiment example 1

[0037] 1. Establishment of Control Fingerprint of Nanchaihu Injection

[0038] 1. Selection of detection method: Nanbupleurum injection mainly contains volatile components, so GC-FID method is used to establish fingerprints;

[0039] 2. Chromatographic column screening: SH-Rtx-5 (30m×0.32mm×0.25μm); Agilent HP-5 (30m×0.32mm×0.25μm) two chromatographic columns were investigated, the results showed that SH-Rtx- 5 capillary column (stationary phase is 5% diphenyl-95% dimethylpolysiloxane) has the best separation effect and is more suitable for the detection of fingerprint of Nanbupleurum injection.

[0040] 3. Chromatographic conditions, preparation of reference solution and test solution:

[0041]A capillary column with 5% diphenyl-95% dimethyl polysiloxane (SH-Rtx-5) as the stationary phase (column length 30m, inner diameter 0.32mm, film thickness 0.25μm), the column temperature is programmed Heating, the initial temperature is 35°C, keep for 2min, raise the temperature at 1°...

technical field

[0001] The invention belongs to a quality control method of traditional Chinese medicine injection, in particular to a quality control method of Nanchaihu injection. Background technique

[0002] Bupleurum Injection has the effect of clearing heat and relieving exterior, and is used to treat fevers such as colds, influenza and malaria. It has a wide range of clinical applications. It is the first Chinese medicine injection developed in my country, and it is a commonly used Chinese patent medicine for clearing away heat and relieving exterior syndrome. At present, the Bupleurum bupleurum circulating in the market mainly includes northern bupleurum, southern bupleurum and bamboo-leaf bupleurum. Due to different varieties, their main components and contents are quite different. Therefore, the prepared injections cannot be evaluated by uniform testing methods.

[0003] At present, the Bupleurum quality standard in the 2015 edition of the Chinese Veterinary Pharm...

Examples

experiment example 1

[0037] 1. Establishment of Control Fingerprint of Nanchaihu Injection

[0038] 1. Selection of detection method: Nanbupleurum injection mainly contains volatile components, so GC-FID method is used to establish fingerprints;

[0039] 2. Chromatographic column screening: SH-Rtx-5 (30m×0.32mm×0.25μm); Agilent HP-5 (30m×0.32mm×0.25μm) two chromatographic columns were investigated, the results showed that SH-Rtx- 5 capillary column (stationary phase is 5% diphenyl-95% dimethylpolysiloxane) has the best separation effect and is more suitable for the detection of fingerprint of Nanbupleurum injection.

[0040] 3. Chromatographic conditions, preparation of reference solution and test solution:

[0041]A capillary column with 5% diphenyl-95% dimethyl polysiloxane (SH-Rtx-5) as the stationary phase (column length 30m, inner diameter 0.32mm, film thickness 0.25μm), the column temperature is programmed Heating, the initial temperature is 35°C, keep for 2min, raise the temperature at 1°...

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