Anti-inflammatory tablet HPLC fingerprint construction method
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A technology of fingerprint spectrum and construction method, which is applied in the quality control of anti-inflammatory tablets and the field of high-performance liquid phase fingerprint spectrum, and achieves the effects of good absorption value, good peak shape and easy identification.
Active Publication Date: 2016-08-31
吉林修正药业新药开发有限公司 +1
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Before the present invention, there is no report on the method of establishing fingerprints with the contained chemical components of Xiaoyan Tablets as indicators
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Embodiment 1
[0033] Embodiment 1 of the present invention: detection of fingerprints of different batches of Xiaoyan Tablets
[0036] 1.2 Purified water (Wahaha), acetonitrile (chromatographically pure), and other reagents are analytically pure. Chlorogenic acid, teretin B, baicalin, baicalin, baicalein, wogonin reference substances (lot numbers 110753-200413, 110741-200506, 110715-201016, 111528-200606, 111595-200905, 111514-200403, China Institute for Food and Drug Control). Anti-inflammatory tablets (batch numbers: 150301, 150302, 150303, 150304, 150305, 150601, 150801, 150802, 150803, 150804, 150805, revised Pharmaceutical Group Co., Ltd.).
[0037] 2 Determinatio...
Embodiment 2
[0050] Example 2: Determination and data analysis of fingerprints of 11 batches of Xiaoyan Tablets
[0051] 11 batches of anti-inflammatory tablets were taken and tested according to the conditions of Example 1 to obtain the HPLC spectra of 11 batches of samples. Figure 3.
[0052] Through the comparison of 11 batches of PHLC chromatograms, the similarity evaluation is carried out to determine its characteristic common peaks: import the chromatograms of 11 batches of Xiaoyan Tablets into the "Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System" 2004A Edition (National Pharmacopoeia Commission), and use the common peaks mode, set the time window width to 0.1min, and generated standard fingerprints by the average method, and determined 27 common peaks. The similarities of the 11 batches of Xiaoyan Tablets are all greater than 0.9, as shown in Table 3. The relative retention times of the 27 common peaks are basically the same, but there are large difference...
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Abstract
An anti-inflammatory tablet HPLC fingerprint construction method comprises the following steps: 1, preparing a test solution: grinding an anti-inflammatory tablet, weighing the ground tablet, placing the ground tablet in an extractor, adding petroleum ether, carrying out hot reflux extraction, removing the petroleum ether, adding methanol, carrying out ultrasonic treatment, supplementing methanol, and filtering the obtained solution; 2, preparing a reference solution: taking a chlorogenic acid reference substance, an aesculetin reference substance, a scutelloside reference substance, a linarin reference substance, a baicalein reference substance and a wogonin reference substance; and 3, determining: respectively taking the reference solution and the test solution, respectively injecting the reference solution and the test solution to a liquid chromatograph, recording the chromatogram in 120min, and processing the chromatogram through using fingerprint software to obtain the fingerprint of the anti-inflammatory tablet. The method has the advantages of establishing the common mode of the HPLC characteristic fingerprint of the anti-inflammatory tablet, calibration of 27 common peaks, effective characterization of the quality of the anti-inflammatory tablet, overcoming of unicity and one-sidedness of original quality control methods, and high application values.
Description
technical field [0001] The invention belongs to the field of medicine, and in particular relates to the establishment of high performance liquid phase fingerprints of Xiaoyan Tablets by using high performance liquid chromatography for quality control of Xiaoyan Tablets. Background technique [0002] Fingerprint of traditional Chinese medicine refers to the spectrum of common peaks that can mark the group characteristics of various components in the traditional Chinese medicine and its preparations, which are obtained after proper processing of Chinese medicinal materials and detected by certain analytical methods and instruments. Through the formulation and comparison of the relative retention time and content or ratio of the overall characteristic peaks of the fingerprint, the quality of Chinese medicinal materials and Chinese medicinal products can be effectively controlled to ensure the relative stability of product quality. At present, the most commonly used detection me...
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