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Quality Control Method of Shenrong Yijing Tablets

A quality control method, the technology of Shenrong Yijing Tablets, applied in the field of medicine, can solve the problems of white blood cell and hemoglobin reduction, and achieve the effect of safe and effective medicine, controllable quality and good quality

Inactive Publication Date: 2019-03-29
中国人民解放军第一五九医院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Interferon and ribavirin are commonly used in the clinical treatment of hepatitis C and hepatitis B, but they often cause side effects such as decreased white blood cells and hemoglobin in patients

Method used

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  • Quality Control Method of Shenrong Yijing Tablets
  • Quality Control Method of Shenrong Yijing Tablets
  • Quality Control Method of Shenrong Yijing Tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1, the identification of Radix Astragali

[0036] Take 3g of Shenrong Yijing Tablets, remove the coating according to the conventional method, grind it into powder, add 20ml of methanol to the powder, heat and reflux for 1h, filter, evaporate the filtrate to dryness, add 30ml of water to dissolve the residue, and then saturate it with n-butanol water The solution was extracted twice, 20ml each time, the n-butanol extract was combined, and the n-butanol extract was washed twice with water, 20ml each time, the water was discarded, the washed n-butanol solution was evaporated to dryness, and the residue was added methanol 0.5 ml dissolved, as the test solution.

[0037]Take astragaloside IV, add methanol to make a reference substance solution containing 1mg per 1ml.

[0038] Methanol was used as a negative control solution.

[0039] According to the thin-layer chromatography test, draw 2 μl of each of the above three solutions, and place them on the same silic...

Embodiment 2

[0041] Embodiment 2, the identification of ginseng

[0042] Take 5g of Shenrong Yijing Tablets, remove the coating according to the conventional method, grind it into powder, put it in a stoppered Erlenmeyer flask, add 50ml of methanol, heat and reflux for 2h, let it cool, filter, measure 25ml of the filtrate and evaporate to dryness, Add 30ml of water to the residue to dissolve, transfer to a separatory funnel, shake and extract with chloroform twice, 30ml each time, discard the chloroform, then shake and extract with n-butanol water-saturated solution 5 times, 20ml each time , combined n-butanol extract, washed twice with ammonia test solution, 30ml each time, and then washed with n-butanol water saturated solution 30ml, took n-butanol solution and evaporated to dryness, the residue was dissolved in 1ml methanol, as the test solution .

[0043] Take ginsenoside Rg1 and Re and add methanol to make a mixed reference solution containing 2 mg per 1 ml.

[0044] Methanol was us...

Embodiment 3

[0047] Embodiment 3, ginsenoside Rg 1 and ginsenoside Re content determination

[0048] (1) Method of content determination

[0049] Ginseng is the main medicinal taste in Shenrong Yijing Tablets. This method adopts high performance liquid phase method to treat ginseng with ginsenoside Rg 1 and ginsenoside Re as indicators for content determination.

[0050] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; acetonitrile was used as mobile phase A, water was used as mobile phase B, and gradient elution was performed; column temperature was 40°C; flow rate was 1.0ml / min, the detection wavelength is 203nm, and the number of theoretical plates is ≥6000 based on the peak of ginsenoside Rg1.

[0051] The elution gradient is:

[0052]

[0053]

[0054] Preparation of reference solution: Accurately weigh 0.2 mg ginsenoside Rg 1 Reference substance, ginsenoside Re reference substance, add 1ml of methanol, shake wel...

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Abstract

The invention discloses a quality control method of a ginseng antler essence reinforcing tablet. The method comprises the following steps: identifying astragalus membranaceus and ginseng in medicines through a thin layer chromatography; and detecting the contents of main active components, namely ginsenoside Rg1(C42H72O14) and ginsenoside Re(C48H82O18), in the medicine, through a high performance liquid chromatography. The method is high in specificity and high in reproducibility; and the drug quality can be controlled, and thus the requirements on safe, effective and quality-controllable drugs can be truly met.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a quality control method for Shenrong Yijing Tablets. Background technique [0002] In recent years, the morbidity and mortality of malignant tumors in my country have continued to increase. According to the epidemiological research report of the National Cancer Center: In the next 20 years, the incidence and mortality of malignant tumors in my country will continue to rise. If effective measures are not taken, the number of cancer cases and deaths in my country will rise to 4 million and 3 million in 2020, and to 5 million and 3.5 million in 2030. Surgery, radiotherapy and chemotherapy are common methods for clinical treatment of malignant tumors. However, radiotherapy and chemotherapy often cause serious side effects during treatment, resulting in symptoms such as leukopenia and hemoglobin decrease. It is also reported that the incidence of hepatitis C and hepa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06G01N30/74G01N30/90
CPCG01N30/06G01N30/74G01N30/90
Inventor 吕宏迪王海伟王自勤段国方张正臣李文俊
Owner 中国人民解放军第一五九医院
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