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Quality control method of fructus xanthil dripping pills for treating rhinitis
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A detection method, the technology of cocklebur, applied in measuring devices, medical formulas, medical preparations containing active ingredients, etc., can solve the problems of inaccurate and reliable quality control of cocklebur rhinitis dripping pills, etc.
Active Publication Date: 2011-07-20
四川字库山制药有限公司
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Problems solved by technology
However, since drug quality issues are closely related to human health, the requirements for drug quality control are getting higher and higher, and safety and efficacy are equally important; The control method is not accurate and reliable enough for the quality control of cocklebur rhinitis dripping pills, does not meet the needs of modern medicine development, and needs to be further improved
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Embodiment 1
[0109] This example is: using the method of the present invention to treat 10 batches of Xanthium rhinitis dripping pills (batch numbers: 041201, 041202, 041203, 041204, 041205, 041206, 041207, 041208, 041209, 041210, all by Sichuan Hebang Sunshine Pharmaceutical Co., Ltd. Provided by the company) to determine the content of baicalin, the specific method is as follows:
[0110] Chromatographic conditions and system suitability test: use octadecylsilane bonded silica gel as filler; methanol-water-phosphoric acid (47:53:0.2, volume ratio) solution as mobile phase, flow rate 1ml / min; detection wavelength is 280nm ; Column temperature: 40℃. The number of theoretical plates is not less than 2500 based on the peak of baicalin.
[0111] Preparation of reference solution: accurately weigh an appropriate amount of baicalin reference substance, add 50% methanol to make a solution containing about 45μg of baicalin per 1ml, and get it.
[0112] Preparation of test solution: Take 0.4-0.6g of Xa...
Embodiment 2
[0117] This example is: using the method of the present invention to treat 10 batches of Xanthium rhinitis dripping pills (batch numbers: 041201, 041202, 041203, 041204, 041205, 041206, 041207, 041208, 041209, 041210, all by Sichuan Hebang Sunshine Pharmaceutical Co., Ltd. Provided by the company) for TLC identification, the specific method is as follows:
[0118] (1) TLC identification of Scutellaria baicalensis Georgi and Angelica dahurica:
[0119] A. Preparation of test solution:
[0120] Take 5g of Xanthium rhinitis dripping pills, add 20ml of diluted hydrochloric acid with a concentration of 10% by mass, heat and reflux for 1 hour, let cool, filter, and extract the filtrate twice with ether, 20ml each time, and the aqueous solution for later use. Combine Ether extract, wash with water until it is neutral, evaporate to dryness, add 1ml of ethanol to the residue to dissolve, as the test solution I;
[0121] In addition, take 5g of negative samples lacking Scutellaria baicalensis ...
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Abstract
The invention discloses a quality control method of fructus xanthil dripping pills for treating rhinitis. In the method, a high performance liquid chromatography is used to measure the the content of scutelloside, and octadecyl silane bonded silica gel is used as a filling agent; a methanol-water-phosphoric acid solution in volume ratio of 47:53:0.2 is used as a mobile phase at the rate of 1ml / min; the wave length for testing is 280 nm; the column temperature is 40 DEG C; a reference substance solution and a test sample solution are respectively and precisely absorbed and injected into a liquid chromatograph for the measurement; and the calculation is carried out according to the measurement result to obtain the content of the scutelloside in the fructus xanthil dripping pills for treating rhinitis. The quality control method provides a method for measuring the content of the scutelloside in the fructus xanthil dripping pills for treating rhinitis, so that the quality control on the fructus xanthil dripping pills for treating rhinitis is more accurate and efficient, thereby providing convenience for ensuring the clinical efficacy. The method for measuring the content has the advantages of simple operation and accurate result as well as high precision, repetitiveness, stability and the like.
Description
Technical field [0001] The invention belongs to the technical field of quality control of pharmaceutical preparations, and particularly relates to a detection method of Xanthium rhinitis dripping pills. Background technique [0002] Xanthium rhinitis dripping pill is a new dosage form modified from Xanthium rhinitis capsule. Xanthium rhinitis capsules are included in the fourteenth volume of traditional Chinese medicine prescriptions of the Ministry of Health. It has the effects of dispelling wind, clearing lung heat, clearing the nose and orifices, and relieving headache; it is used for wind-heat nasal diseases, including acute and Chronic rhinitis, sinusitis, allergic rhinitis, etc. [0003] Xanthium rhinitis capsules are based on Xanthium chinensis extract powder 180g, gypsum extract powder 1.76g, Angelica dahurica extract powder 62.1g, borneol 30g, Xinyi flower volatile oil 4ml, menthol 15g, Xinyi flower extract powder 72.2g, Scutellaria baicalensis A capsule preparation made...
Claims
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