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Method for detection and quality control of medicine composition

A quality control method and detection method technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as unreasonable wavelength selection, large baseline fluctuations, and no preliminary investigation on the durability of analysis methods.

Active Publication Date: 2014-10-01
SICHUAN JISHENGTANG PHARMLS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] 3) The baseline fluctuates greatly, the wavelength selection is unreasonable, and the background interference is serious, see literature [2,4,6,8-9,13-17];
[0011] 4) The durability of various analytical methods has not been preliminarily investigated, see literature [1-17]

Method used

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  • Method for detection and quality control of medicine composition
  • Method for detection and quality control of medicine composition
  • Method for detection and quality control of medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0092] Embodiment 1 literature method (Fan Zhifeng, the content of hyperin, rutin and hypericin in different parts of Hypericum perforatum in Xinjiang and the influence of extraction process on them, Xinjiang Traditional Chinese Medicine, 2005,23,4:4-6 ) Determination of Hyperin and Rutin in Shugan Jieyu Capsules

[0093] 1. Sample

[0094] Shuganjieyu capsules (batch number: 111118) were provided by Chengdu Kanghong Pharmaceutical Group Co., Ltd.; hyperoside reference substance (111521-201004) was purchased from China Institute for the Control of Pharmaceutical and Biological Products; rutin reference substance (100080-200707) Purchased from China Institute for the Control of Pharmaceutical and Biological Products;

[0095] 2. Instruments and reagents

[0096] Agilent infinity1100 liquid chromatography (Agilent, USA); BS110S electronic balance (Sartorius, Germany); column Agilent Eclipse Plus C18, 5um, 250*4.6mm; acetonitrile (HPLC grade, Honeywell, LOT: AH015-4A); citric a...

Embodiment 2

[0101] Content detection of hyperin and rutin in the embodiment two Shuganjieyu capsules

[0102] 1. Sample

[0103] With embodiment one;

[0104] 2. Instruments and reagents

[0105] Agilent infinity1100 liquid chromatograph (Agilent, USA); Chromatographic column Agilent Eclipse Plus C18, 5um, 250*4.6mm; Methanol (HPLC, Honeywell, LOT: DF578); Acetonitrile (HPLC, Honeywell, LOT: AH015-4A); Absolute ethanol (Kelon, LOT: 20111105); formic acid (sigma-aldrich, LOT: BCBB7667); ultrapure water made by Milli-Q pure water system (Millipore Bedford, MA, USA)

[0106] 3. Detection method

[0107] Preparation of the test solution: Take 0.2495 g of the content of Shugan Jieyu Capsules in a 50ml volumetric flask, add 50% ethanol to the mark, shake well, extract with ultrasound for 30 minutes, and filter with a 0.45 μm membrane to obtain the product.

[0108] High performance liquid chromatography detection conditions: high performance liquid chromatography detection conditions: mobil...

Embodiment 3

[0112] Content Detection of Hyperin and Rutin in Sanshugan Jieyu Capsules

[0113] 1. Drugs

[0114] With embodiment one;

[0115] 2. Instruments and reagents

[0116] Agilent infinity1100 liquid chromatograph (Agilent, USA); Chromatographic column Agilent Eclipse Plus C18, 5um, 250*4.6mm; Methanol (HPLC, Honeywell, LOT: DF578); Acetonitrile (HPLC, Honeywell, LOT: AH015-4A); Absolute ethanol (Kelon, LOT: 20111105); NaH 2 PO 4 .2H 2 O (Hua Da, LOT: 20101113); H 3 PO 4 (AR, Comeo, LOT: 20100906); Ultrapure water was made by Milli-Q pure water system (Millipore Bedford, MA, USA)

[0117] 3. Detection method

[0118] Preparation of the test solution: Take 0.2495 g of the content of Shugan Jieyu Capsules in a 50ml volumetric flask, add 50% ethanol to the mark, shake well, extract with ultrasound for 30 minutes, and filter with a 0.45 μm membrane to obtain the product.

[0119] High performance liquid chromatography detection conditions: mobile phase A: 50mM NaH 2 PO 4 Aq...

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Abstract

The invention discloses a method for detection and quality control of a medicine composition. The medicine composition is a composition containing hypericum perforatum, the content of hyperoside, the content of rutin and the content of lilac glycosides are detected through liquid chromatography, and the adopted liquid chromatography determination conditions are characterized in that octadecylsilane chemically bonded silica serves as filler of a chromatographic column, a mobile phase A is a NaH2PO4 buffer solution, a mobile phase B is a mixed solution of acetonitrile and methyl alcohol, and gradient elution is adopted. The method has the advantages of being quick, efficient, stable, accurate and the like, and quality control over the medicine composition can be quickly and effectively conducted.

Description

technical field [0001] The invention relates to the quality control of medicines, in particular to a method for detection and quality control of pharmaceutical compositions. Background technique [0002] Depression has quickly become the second most important disease that has caused a serious burden on human beings in the world. 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, Chinese medicine uses active substance groups, which can act on multiple targets and present pleiotropic effects, and adjustment is its main mechanism of action, showing the uniqueness of traditional medicine. Shugan Jieyu Capsule is the first Chinese patent medicine approved by SFDA for the treatment of depression in China. It is composed of Hypericum perforatum and Acanthopanax acanthus. The main eff...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/60
Inventor 柯潇邬智刚乔怀耀
Owner SICHUAN JISHENGTANG PHARMLS
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