Detection method of pharmaceutical preparation for curing stomach pain caused by qi stagnation

A technology for pharmaceutical preparations and detection methods, applied in the detection field of pharmaceutical preparations, can solve the problems of control, lack of a method for measuring limonene content of Qi-stagnation Weitong Granules, unfavorable quality of Qi-stagnation Weitong Granules, etc. Stability, fast detection method effect

Inactive Publication Date: 2015-09-09
辽宁华润本溪三药有限公司 +1
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] For this reason, what the present invention aims to solve is the technical problem that there is no limonene content determination method in Qizhiweitong granules in the prior art, which is not cond

Method used

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  • Detection method of pharmaceutical preparation for curing stomach pain caused by qi stagnation
  • Detection method of pharmaceutical preparation for curing stomach pain caused by qi stagnation
  • Detection method of pharmaceutical preparation for curing stomach pain caused by qi stagnation

Examples

Experimental program
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Effect test

experiment example

[0084] 1. Instruments and reagents

[0085] 1.1 Instrument

[0086] Shimadzu 10A high performance liquid chromatograph (Shimadzu Corporation, Japan);

[0087] ACCULAB ALC-11C.4 electronic balance (German Sartorius Group);

[0088] SHZ-DⅢ type circulating water vacuum pump (Gongyi Yuhua Instrument Co., Ltd.);

[0089] Welch Ultimate LP-C18 chromatographic column (4.6mm×250mm, 5μm) (U.S. Yuexu Company), made by three-position bonding process (three silicon-hydroxyl bonds combined with a bonding phase C18);

[0090] Ultrapure water treatment device (Milli-Q, Millipore Corporation, USA);

[0091] HS6150 Ultrasonic Cleaner (Tianjin Hengao Technology Development Co., Ltd.);

[0092] HHS type electronic constant temperature water bath (Shanghai Boxun Industrial Co., Ltd. Medical Equipment Factory).

[0093] 1.2 Test drug

[0094] Sugar-free qi stagnation stomach pain granules (Liaoning China Resources Benxi Three Medicines Co., Ltd., batch numbers are 20141112, 20141111, 20140304, 20140914, 2014091...

Embodiment 1

[0172] Example 1 Preparation of sugar-free granules

[0173] [Prescription] 36 parts by weight of Bupleurum, 20 parts by weight of licorice, 40 parts by weight of Cyperus rotundus, 40 parts by weight of Corydalis, 48 ​​parts by weight of white peony, and 40 parts by weight of Fructus Aurantii.

[0174] [Preparation method] (1) Take selected parts by weight of Citrus aurantium and Cyperus rotundus, extract to obtain extract A and volatile oil A; add β-cyclodextrin and water to the volatile oil A, and clathrate for 0.5 to 4 hours to obtain Inclusion compound A;

[0175] (2) Take selected parts by weight of Bupleurum, Licorice, Corydalis and Radix Paeoniae Alba, add water and extract twice, the first extraction is 0.5 to 4 hours, the second extraction is 0.5 to 3 hours, and the extracts obtained from the two extractions are combined , Get extract B;

[0176] (3) Combine the above extraction solution A and extraction solution B, concentrate to a thick paste with a relative density of 1...

Embodiment 2

[0177] Example 2 Determination of Limonene by Chemical Bonded Phase Chromatography

[0178] In this embodiment, the chemical bonding phase chromatography method for determining the content of limonene includes the following steps:

[0179] (1) Take 2.5g of the drug preparation to be tested, add 50mL of 100% methanol, weigh, ultrasonic for 30min, let cool, weigh again, make up the lost weight with methanol, shake well, filter, and take the filtrate as the test product Solution

[0180] (2) Take an appropriate amount of limonene reference substance and add 100% methanol to make a solution containing 0.1 μL of limonene per 1 mL of methanol as the reference substance solution;

[0181] (3) Chromatographic conditions: 250×4.6mm, 5μm Welch Ultimate LP-C18 as the chromatographic column, with three silyl hydroxyl bonds and one C18 bonded octadecylsilane bonded silica as the stationary phase, Use acetonitrile:water=70:30 as mobile phase, time: 30min, column temperature: 10-30℃, detection wa...

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Abstract

The invention relates to a detection method of a pharmaceutical preparation for curing stomach pain caused by qi stagnation. The detection method comprises the following cinene content measuring steps: (1) taking 2.0-3.0g of pharmaceutical preparation to be detected, adding 10-100mL of 30%-100% methanol, weighing, carrying out ultrasonic or heating reflux for 10-60min, cooling, weighing again, supplementing the lost weight by using 30%-100% methanol, shaking uniformly, and filtering, thereby obtaining filtrate which is taken as a sample solution; (2) taking a cinene reference substance, adding methanol to prepare a solution in which every 1mL of methanol contains 0.05-0.15 micro-liter of cinene, wherein the solution is taken as a reference substance solution; (3) implementing chromatographic conditions, wherein C18 is taken as a chromatographic column, a chemically bonded phase is taken as a fixed phase, a mixed solution with the volume ratio of acetonitrile to water being (60-80) to (40-20) is taken as a mobile phase, the time is 20-40min, the column temperature is 10-30 DEG C, the detection wavelength is 210nm, and the flow rate is 0.5-1.5mL/min; and (4) respectively precisely sucking 6-10 micro-liter of sample solution and 6-10 micro-liter of reference substance solution, and measuring by injecting the solutions into high performance liquid chromatograph. The detection method is rapid and comprehensive, is strong in pertinence, is beneficial to effective control on quality of the pharmaceutical preparation and also is beneficial to improving the use safety and stability.

Description

Technical field [0001] The invention belongs to the field of detection of traditional Chinese medicine preparations, and specifically relates to a detection method of a pharmaceutical preparation for treating qi stagnation and stomachache. Background technique [0002] Qizhiweitong Granules are composed of the raw materials Bupleurum, licorice, Cyperus rotundus, Corydalis, Radix Paeoniae Rubra, and Citrus aurantium. It has the functions of soothing the liver, regulating qi, and relieving stomach pain. It is clinically used for stagnation of liver qi, chest irritation, fullness, and epigastric Treatment of pain and other diseases. "Chinese Pharmacopoeia 2010 Edition" controls the quality of Qizhiweitong Granules by qualitative identification of paeoniflorin by TLC and HPLC quantitative determination of paeoniflorin. [0003] Citrus aurantium, originally published in "Lei Gong Pao Zhu Lun", is the dry and immature fruit of the Rutaceae plant Citrus aurantium L. and its cultivated va...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/90
Inventor 孟宪生何晓霞潘英韩凌张跃飞常馨包永睿王帅马鹏岗
Owner 辽宁华润本溪三药有限公司
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