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A kind of detection method of pharmaceutical composition

A detection method and composition technology, applied in measurement devices, instruments, scientific instruments, etc., can solve problems such as unreasonable wavelength selection, background interference, and large baseline fluctuations.

Active Publication Date: 2016-01-20
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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  • A kind of detection method of pharmaceutical composition
  • A kind of detection method of pharmaceutical composition
  • A kind of detection method of pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] Example 1 Literature method (Fan Zhifeng, The content of hyperoside, rutin and hypericin in different parts of Hypericum perforatum in Xinjiang and the effect of extraction process on them, Xinjiang Traditional Chinese Medicine, 2005,23,4:4-6 ) Determination of hyperoside and rutin in Shugan Jieyu capsules

[0090] 1. Sample

[0091] Shugan Jieyu 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;

[0092] 2. Instruments and reagents

[0093] Agilentinfinity1100 liquid chromatograph (Agilent, USA); BS110S electronic balance (Sartorius, Germany); Column AgilentEclipsePlusC18, 5um, 250*4.6mm; Acetonitrile (HPLC grade, Honeywell, LOT: AH015-4A); Citric acid (pharmace...

Embodiment 2

[0098] Example 2 Detection of hyperoside and rutin in Shugan Jieyu capsules

[0099] 1. Sample

[0100] Same as Example One;

[0101] 2. Instruments and reagents

[0102] Agilentinfinity1100 liquid chromatograph (Agilent, USA); column AgilentEclipsePlusC18, 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); ultra-pure water made by Milli-Q pure water system (MilliporeBedford, MA, USA)

[0103] 3. Detection method

[0104] Preparation of test solution: Take 0.2495g of the contents of Shugan Jieyu Capsules in a 50ml volumetric flask, add 50% ethanol to the mark, shake well, extract with ultrasound for 30min, filter with 0.45μm membrane, and get it.

[0105] High performance liquid chromatography detection conditions: high performance liquid chromatography detection conditions: mobile phase A: 1% formic acid water, mobile phase B: 20% methanol + 80% aceto...

Embodiment 3

[0109] Example The content detection of hyperoside and rutin in Sanshugan Jieyu capsules

[0110] 1. Medicine

[0111] Same as Example One;

[0112] 2. Instruments and reagents

[0113] Agilentinfinity1100 liquid chromatograph (Agilent, USA); column AgilentEclipsePlusC18, 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 (China University, LOT: 20101113); H 3 PO 4 (AR, Comeo, LOT: 20100906); Ultra-pure water is made by Milli-Q pure water system (MilliporeBedford, MA, USA)

[0114] 3. Detection method

[0115] Preparation of test solution: Take 0.2495g of the contents of Shugan Jieyu Capsules in a 50ml volumetric flask, add 50% ethanol to the mark, shake well, extract with ultrasound for 30min, filter with 0.45μm membrane, and get it.

[0116] HPLC detection conditions: mobile phase A: 50mMNaH 2 PO 4 Aqueous solution, H 3 PO 4 Adjust pH to 4.0; mobile phase B: acetonitrile; mo...

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PUM

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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 the detection and quality control of a medicine composition. Background technique [0002] Depression has quickly become the second most important disease in the global disease that poses a serious burden to humans. The suffering caused to patients and their families and the loss to society are unmatched by other diseases. Therefore, the society's demand for drugs for the treatment of depression is huge. Compared with Western medicine using specific target drugs for treatment, Chinese medicine uses active substance groups that 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 consists of two Chinese medicines: Hypericum perforatum and Acanthopana...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/60
Inventor 柯潇邬智刚乔怀耀
Owner SICHUAN JISHENGTANG PHARMLS
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