Method for detecting quality of medicinal water extracts of Qipi oral liquid based on HPLC (High Performance Liquid Chromatography) fingerprint spectrum

Abstract

The invention provides a method for detecting quality of medicinal water extracts of Qipi oral liquid based on an HPLC (High Performance Liquid Chromatography) fingerprint spectrum. The method comprises the following steps of: preparing a comparison product solution and a tested sample solution; performing HPLC measurement; establishing a standard fingerprint spectrum; and detecting the sample. According to the method, a freezing technology and quality of the medicinal water extracts of the Qipi oral liquid can be effectively represented, energy source is saved and labor hour is reduced; the method is beneficial to monitoring the quality of products; and the method has the advantages of simple method, excellent stability, high precision, excellent repeatability, and the like.

Description

technical field

[0001] The invention relates to a quality detection method of the Qipi oral liquid medicinal material water extract, in particular to a quality detection method of the Qipi oral liquid medicinal material water extract based on HPLC fingerprints. Background technique

[0002] Qipi Oral Liquid is four types of new drugs (traditional Chinese medicine) produced by Jilin Yimintang Pharmaceutical Co., Ltd., mainly composed of ginseng, fried Atractylodes macrocephala, Poria cocos, licorice, tangerine peel, yam, fried lotus seeds, fried hawthorn, fried Liushenqu, fried Maigan Composed of Bud and Alisma raw materials, according to preclinical pharmacology and toxicology studies, it has the effect of invigorating the spleen and stomach, and is mainly used to treat spleen and stomach weakness, indigestion, abdominal distension and sugar caused by spleen deficiency.

[0003] According to the analysis of prescriptions based on TCM theory and experience, the spleen deficie...

Examples

Embodiment 1

[0025] Example 1 Preparation of Frozen Qipi Oral Liquid Medicinal Material Water Extract

[0026] Weigh 10g of tangerine peel, 20g of Atractylodes macrocephala (stir-fry), 20g of poria cocos, 10g of licorice, 20g of Chinese yam, 20g of lotus seeds (stir-fry), 10g of hawthorn (stir-fry), 16g of Liushenqu (stir-fry), 10g of malt (stir-fry) and Alisma 10g. Combine the dregs and aqueous solution of tangerine peel and Atractylodes atractylodes distillation with Poria cocos, licorice, yam, lotus seeds, hawthorn, Liushenqu, malt and Alisma, add 6 or 5 times the amount of water to decoct twice, the first time for 2 hours, the second time The second time is 1 hour, filter, combine the filtrates, concentrate to a relative density of 1.12-1.20 (85°C), and place it at -20°C for 48 hours (until the solution is completely frozen and placed for more than 24 hours).

[0027] The process of distilling and extracting tangerine peel and Atractylodes macrocephala is as follows: adding 4 times the...

Embodiment 2

[0028] Example 2 Construction of HPLC Fingerprint of Qipi Oral Liquid Medicinal Material Water Extract Liquid Freezing Liquid

[0029] 1. Instruments and reagents

[0030] 1.1 Instrument: Shimadzu LC-2010AHT high performance liquid chromatography (quaternary pump, online degasser, column thermostat (column temperature 28°C), automatic sampler, UVD detector); BS210S electronic balance; chromatographic column: Agilent ZORBAX SB-C 18 (5μm, 4.6×250mm).

[0031] 1.2 Reagent: hesperidin reference substance (purchased from China National Institute of Pharmaceutical and Biological Products). The reagents used for liquid chromatography analysis are chromatographically pure, the rest of the reagents are analytically pure, and the water is ultrapure water.

[0032] 2. High performance liquid chromatography

[0033] 2.1 Preparation of reference substance solution: Accurately weigh an appropriate amount of hesperidin reference substance, accurately weigh it, and add methanol to make a ...

Embodiment 3

[0037] Example 3 Construction of HPLC Standard Fingerprint of Qipi Oral Liquid Medicinal Material Water Extract Freezing Liquid

[0038] Get 8 batches of Qipi Oral Liquid Medicinal Material Water Extract Freezing Liquid, detect by the conditions of Example 1, obtain the HPLC collection of illustrative plates of 8 batches of samples, as figure 2 shown. Through the comparison of 8 batches of HPLC chromatograms, the similarity evaluation system of the HPLC chromatograms was evaluated using the software "Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System" recommended by the Chinese Pharmacopoeia Commission, and the common characteristic peaks were determined to obtain the standard fingerprint of Qipi Oral Liquid.

[0039] In the standard fingerprint spectrum, the fingerprint spectrum of Qipi oral liquid medicinal material water extract frozen solution contains 6 common characteristic peaks, and the reference peak is hesperidin (peak No. 6).

[0040] The re...

technical field

[0001] The invention relates to a quality detection method of the Qipi oral liquid medicinal material water extract, in particular to a quality detection method of the Qipi oral liquid medicinal material water extract based on HPLC fingerprints. Background technique

[0002] Qipi Oral Liquid is four types of new drugs (traditional Chinese medicine) produced by Jilin Yimintang Pharmaceutical Co., Ltd., mainly composed of ginseng, fried Atractylodes macrocephala, Poria cocos, licorice, tangerine peel, yam, fried lotus seeds, fried hawthorn, fried Liushenqu, fried Maigan Composed of Bud and Alisma raw materials, according to preclinical pharmacology and toxicology studies, it has the effect of invigorating the spleen and stomach, and is mainly used to treat spleen and stomach weakness, indigestion, abdominal distension and sugar caused by spleen deficiency.

[0003] According to the analysis of prescriptions based on TCM theory and experience, the spleen deficie...

Examples

Embodiment 1

[0025] Example 1 Preparation of Frozen Qipi Oral Liquid Medicinal Material Water Extract

[0026] Weigh 10g of tangerine peel, 20g of Atractylodes macrocephala (stir-fry), 20g of poria cocos, 10g of licorice, 20g of Chinese yam, 20g of lotus seeds (stir-fry), 10g of hawthorn (stir-fry), 16g of Liushenqu (stir-fry), 10g of malt (stir-fry) and Alisma 10g. Combine the dregs and aqueous solution of tangerine peel and Atractylodes atractylodes distillation with Poria cocos, licorice, yam, lotus seeds, hawthorn, Liushenqu, malt and Alisma, add 6 or 5 times the amount of water to decoct twice, the first time for 2 hours, the second time The second time is 1 hour, filter, combine the filtrates, concentrate to a relative density of 1.12-1.20 (85°C), and place it at -20°C for 48 hours (until the solution is completely frozen and placed for more than 24 hours).

[0027] The process of distilling and extracting tangerine peel and Atractylodes macrocephala is as follows: adding 4 times the...

Embodiment 2

[0028] Example 2 Construction of HPLC Fingerprint of Qipi Oral Liquid Medicinal Material Water Extract Liquid Freezing Liquid

[0029] 1. Instruments and reagents

[0030] 1.1 Instrument: Shimadzu LC-2010AHT high performance liquid chromatography (quaternary pump, online degasser, column thermostat (column temperature 28°C), automatic sampler, UVD detector); BS210S electronic balance; chromatographic column: Agilent ZORBAX SB-C 18 (5μm, 4.6×250mm).

[0031] 1.2 Reagent: hesperidin reference substance (purchased from China National Institute of Pharmaceutical and Biological Products). The reagents used for liquid chromatography analysis are chromatographically pure, the rest of the reagents are analytically pure, and the water is ultrapure water.

[0032] 2. High performance liquid chromatography

[0033] 2.1 Preparation of reference substance solution: Accurately weigh an appropriate amount of hesperidin reference substance, accurately weigh it, and add methanol to make a ...

Embodiment 3

[0037] Example 3 Construction of HPLC Standard Fingerprint of Qipi Oral Liquid Medicinal Material Water Extract Freezing Liquid

[0038] Get 8 batches of Qipi Oral Liquid Medicinal Material Water Extract Freezing Liquid, detect by the conditions of Example 1, obtain the HPLC collection of illustrative plates of 8 batches of samples, as figure 2 shown. Through the comparison of 8 batches of HPLC chromatograms, the similarity evaluation system of the HPLC chromatograms was evaluated using the software "Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System" recommended by the Chinese Pharmacopoeia Commission, and the common characteristic peaks were determined to obtain the standard fingerprint of Qipi Oral Liquid.

[0039] In the standard fingerprint spectrum, the fingerprint spectrum of Qipi oral liquid medicinal material water extract frozen solution contains 6 common characteristic peaks, and the reference peak is hesperidin (peak No. 6).

[0040] The re...

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