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Limit detection method of bear gall powder extract in phlegm-heat clearing injection and fingerprint spectrum thereof

A detection method and injection technology, applied in measuring devices, instruments, scientific instruments, etc., can solve problems such as increased content of injections, achieve stable results, good separation effect, and good reproducibility

Active Publication Date: 2020-06-12
SHANGHAI KAIBAO PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] In the current standard, since ursodeoxycholic acid is the main medicinal ingredient and characteristic ingredient, it is controlled as a content measurement item, and only the upper limit of chenodeoxycholic acid content in bear bile powder is controlled
However, there is no report on the clinical effectiveness of the two components of 3α-hydroxy-7-oxo-5β-cholanic acid and 7α-hydroxy-3-oxo-5β-cholanic acid. increase, so it needs to be restricted together with chenodeoxycholic acid

Method used

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  • Limit detection method of bear gall powder extract in phlegm-heat clearing injection and fingerprint spectrum thereof
  • Limit detection method of bear gall powder extract in phlegm-heat clearing injection and fingerprint spectrum thereof
  • Limit detection method of bear gall powder extract in phlegm-heat clearing injection and fingerprint spectrum thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] A limited detection method of bear bile powder extract in Tanreqing injection is provided, characterized in that, the bear bile powder extract includes ursodeoxycholic acid, chenodeoxycholic acid, 3α-hydroxyl-7-oxycholic acid Dai-5β-cholanic acid and 7α-hydroxyl-3-oxo-5β-cholanic acid; the limited detection method is HPLC-DAD method, and the steps include:

[0040] S1. Preparation of reference substance solution: take ursodeoxycholic acid reference substance, chenodeoxycholic acid reference substance, 3α-hydroxy-7-oxo-5β-cholanic acid reference substance and 7α-hydroxy-3-oxo- An appropriate amount of 5β-cholic acid reference substance was precisely weighed, dissolved in methanol and diluted to contain 4.0 mg of ursodeoxycholic acid, 0.6 mg of chenodeoxycholic acid, 3α-hydroxy-7-oxo-5β- A mixed standard solution of 0.02 mg of cholanic acid and 0.06 mg of 7α-hydroxy-3-oxo-5β-cholanic acid was used as a reference solution;

[0041] S2. Prepare the test solution: provide d...

Embodiment 2

[0060] Take ursodeoxycholic acid reference substance, 3α-hydroxy-7-oxo-5β-cholanic acid reference substance, chenodeoxycholic acid reference substance and 7α-hydroxy-3-oxo-5β-cholanic acid reference substance Appropriate amount, accurately weighed, dissolved in methanol and diluted to contain 8.0mg of ursodeoxycholic acid, 0.04mg of 3α-hydroxy-7-oxo-5β-cholic acid, 1.2mg of chenodeoxycholic acid and 7α -Hydroxy-3-oxo-5β-cholanic acid 0.12 mg mixed solution, shake well, as mixed reference solution. Precisely draw and mix reference substance solutions 1, 2, 5, 10, 15mL into 20mL measuring bottles respectively to prepare a series of standard solutions, take the reference substance concentration (mg / mL) as the abscissa X, and the peak area as the ordinate Y, draw Standard curve, and calculate the regression equation. The results showed that the peak area of ​​ursodeoxycholic acid had a good linear relationship with the concentration of the reference substance in the range of 0.36...

Embodiment 3

[0085] Investigation of column temperature: Take the test solution and measure it at the column temperature of 25°C, 30°C, 35°C, and 40°C respectively. As a result, the change of column temperature has no adverse effect on the separation and peak shape of the common peaks.

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Abstract

The invention relates to a limit detection method for a bear gall powder extract in a phlegm-heat clearing injection. The bear gall powder extract comprises ursodeoxycholic acid, chenodeoxycholic acid, 3 [alpha]-hydroxyl-7-oxo-5[beta]-cholanic acid and 7 [alpha]-hydroxyl-3-oxo-5[beta]-cholanic acid. The limit detection method is an HPLC-DAD method and comprises the following steps: S1, preparing areference substance solution; S2, preparing a test solution; and S3, performing limit detection. The invention also relates to a fingerprint spectrum obtained by adopting the limit detection method,the fingerprint spectrum has four characteristic peaks in total, and each peak takes an ursodeoxycholic acid peak as a reference peak. According to the limit detection method disclosed by the invention, limit detection is carried out on the bear gall powder extract by calculating the peak area of a test sample and the peak area of a reference substance through adoption of an external standard method; by calculating the similarity between the fingerprint spectrum of the test sample and the reference fingerprint spectrum, the product quality is accurately, efficiently and comprehensively monitored, and meanwhile, the authenticity of the product is identified.

Description

technical field [0001] The invention relates to the technical field of drug analysis and detection, in particular to a method for limited detection of bear bile powder extract in Tanreqing injection and its fingerprint. Background technique [0002] The main components of bear bile powder in Tanreqing injection include ursodeoxycholic acid, 3α-hydroxy-7-oxo-5β-cholanic acid, chenodeoxycholic acid, 7α-hydroxy-3-oxo-5β - Cholanic acid. The main ingredients in the raw materials of Tanreqing Injection, bear bile powder and decoction pieces, are tauroursodeoxycholic acid and taurourchenodeoxycholic acid. During the preparation of Tanreqing Injection, two cattle The hydrolysis of sulfodeoxycholic acid, in the extract of bear bile powder, mainly ursodeoxycholic acid and chenodeoxycholic acid, also produced a small amount of 3α-hydroxy-7-oxo-5β-cholic acid, 7α-Hydroxy-3-oxo-5β-cholanic acid. [0003] In the current standard, since ursodeoxycholic acid is the main medicinal ingred...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/86G01N30/06
CPCG01N30/88G01N30/8679G01N30/8686G01N30/06G01N2030/884G01N2030/047Y02A50/30
Inventor 季申李雯婷胡青苗水张小利
Owner SHANGHAI KAIBAO PHARMA
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