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Quality control method of Shuganjieyu capsule

A quality control method, a technique for soothing the liver and relieving depression, applied in the field of medicine, can solve the problems of ineffective separation of effective active ingredients, long detection time, complicated operation, etc., and achieve objective and accurate quality control, good quality, and good peak separation Effect

Active Publication Date: 2014-01-22
SICHUAN JISHENGTANG PHARMLS
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, there are a lot of reports on the detection methods of the fingerprints of Acanthopanax or Hypericum perforatum. However, we know through experiments that the detection conditions of the HPLC fingerprints of Acanthopanax or Hypericum perforatum in the prior art cannot be used for Shugan Jieyu Capsules The determination of fingerprints has the disadvantages of being unable to effectively separate the effective active ingredients in Acanthopanax and Hypericum perforatum, long detection time, low efficiency, and complicated operation.

Method used

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  • Quality control method of Shuganjieyu capsule
  • Quality control method of Shuganjieyu capsule
  • Quality control method of Shuganjieyu capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Embodiment 1. The determination of Hypericum perforatum fingerprint spectrum

[0069] 1. Reagents: Acetonitrile (HPLC, Sigma aldrich Company Inc. USA), formic acid was of analytical grade (Sigma aldrich Company Inc. USA), purified water was made by Milli-Q pure water system (Millipore Bedford, MA, USA).

[0070] 2. Instrument: Agilent Infinity 1290 (CA, USA) is used in conjunction with Finnigan LTQ Ion Trap Mass Spectrometer (San Jose, CA, USA), and the software is Agilent Chemstation and Xcalibur respectively.

[0071] 3. Sample preparation of Hypericum perforatum extract: Take Hypericum perforatum extract (prepared according to Example 5) and weigh 0.22g, place it in a 25ml measuring bottle, add 50%CH 3 OH solution, ultrasonic 30min, dissolved, add 50% CH 3 OH was fixed to the mark, and filtered to obtain the Hypericum perforatum extract sample solution;

[0072] 4. Chromatographic conditions: The chromatographic column is filled with octadecylsilane bonded silica g...

Embodiment 2

[0090] The mensuration of embodiment Er Acanthopanax fingerprint spectrum

[0091] 1. Reagents and instruments are the same as in Example 1 in this experiment

[0092] 2. Sample preparation of Acanthopanax senticosus extract: Take Acanthopanax senticosus extract (prepared according to Example 6) and weigh 0.20g, put it in a 25ml measuring bottle, add 50%CH 3 OH solution, ultrasonic 30min, dissolved, add 50% CH 3 OH was constant to the mark, and filtered to obtain the sample solution of Acanthopanax senticosus extract;

[0093] 3. Chromatographic conditions: The chromatographic column is filled with octadecylsilane bonded silica gel; gradient elution is adopted, mobile phase A is formic acid aqueous solution, mobile phase B is acetonitrile, and the gradient elution procedure is:

[0094] During 0-3min, the mobile phase A is 95% 0.1% formic acid aqueous solution, and the mobile phase B is 5% acetonitrile;

[0095] During 10min, mobile phase A was 90% 0.1% formic acid aqueous ...

Embodiment 3

[0109] Example three Shuganjieyu capsules quality control detection

[0110] 1. Sample: Shugan Jieyu Capsule reference substance, provided by Chengdu Kanghong Pharmaceutical Group Co., Ltd., batch number: 110902.

[0111] 2. Reagents: acetonitrile (HPLC, Sigma aldrich Company Inc. USA), formic acid of analytical grade (Sigma aldrich Company Inc. USA), purified water made by Milli-Q pure water system (Millipore Bedford, MA, USA), ammonium acetate (Guangdong Guanghua Chemical Factory Co., Ltd., China).

[0112] 3. Instrument: Agilent Infinity 1290 (CA, USA) is used in conjunction with Finnigan LTQ Ion Trap Mass Spectrometer (San Jose, CA, USA), and the software is Agilent Chemstation and Xcalibur respectively.

[0113] 4. Preparation of Shuganjieyu Capsule Reference Substance Solution: Take 0.25 g of the contents of the Reference Substance capsule in a 25ml measuring bottle, add 50% CH 3 OH about 20ml, ultrasonic for 30min, add 50%CH 3 OH to the mark, shake well, take an appr...

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Abstract

The invention discloses a quality control method of a Shuganjieyu capsule, which can measure a Shuganjieyu capsule fingerprint atlas through a high efficiency liquid chromatography method and can effectively monitor the medicine quality. The method comprises the steps of firstly establishing a Shuganjieyu capsule contrast fingerprint spectrogram, measuring a product fingerprint atlas to be detected of the Shuganjieyu capsule, finally comparing the product fingerprint atlas to be detected of the Shuganjieyu capsule with the comparison fingerprint atlas of the Shugan jieyu capsule, recognizing the quantity of the same absorption peak, and determining whether the product quality is qualified. The method provided by the invention has the advantages that information of main chemical components in the fingerprint atlas is compared, so that the quality control of a medicine is preformed from the substance group entirety of the medicine and a macroscopical angle, and the medicine quality of the Shuganjieyu capsule is reasonably reflected.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a quality control method for Shugan Jieyu capsules. Background technique [0002] Depression is a common mental illness, mainly manifested as low mood, loss of interest, pessimism, slow thinking, self-blame, poor diet and sleep, worry or feeling of multiple discomforts in the body, and even suicidal thoughts and behaviors in severe cases. With the development of modern society and economy, the pressure of people's life and work increases, and the incidence of depression increases year by year. At present, depression has rapidly become the second most important disease that causes a serious burden on human beings among the global diseases. The pain caused to patients and their families and the loss to society are unmatched by other diseases. Therefore, the social demand for drugs for the treatment of depression is huge. Compared with Western medicine using specific target drug therapy, C...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/86
Inventor 柯潇邬智刚朱文漓
Owner SICHUAN JISHENGTANG PHARMLS
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