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Method for evaluating batch quality consistency of Xuesaitong dropping pills based on near infrared spectrum technology

A technology of near-infrared spectroscopy and dripping pills, which is applied in the direction of measuring devices, material analysis through optical means, instruments, etc., to achieve the effects of green environmental protection cost, good application prospects, and easy operation

Inactive Publication Date: 2020-03-17
朗天药业(湖北)有限公司
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  • Claims
  • Application Information

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Problems solved by technology

In recent years, with the development of chemometrics technology, near-infrared spectroscopy has been widely used in the field of traditional Chinese medicine, and has been studied in the identification of raw material sources of traditional Chinese medicine, content determination, adulteration of traditional Chinese medicine and pharmaceutical process monitoring, etc., but so far There is no public report on the establishment of a method for rapid evaluation of the quality consistency of different batches of Xuesaitong dripping pills using near-infrared spectroscopy

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  • Method for evaluating batch quality consistency of Xuesaitong dropping pills based on near infrared spectrum technology
  • Method for evaluating batch quality consistency of Xuesaitong dropping pills based on near infrared spectrum technology
  • Method for evaluating batch quality consistency of Xuesaitong dropping pills based on near infrared spectrum technology

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Embodiment 1

[0037] 1. Collection of samples

[0038] Select 14 batches of normal batches of Xuesaitong dropping pill samples, and the number of each batch of sample dropping pills is at least 100. In addition, normal batch samples need to meet the following conditions, namely: the total saponin content of notoginseng per drop pill is about 10 mg; all dissolve within 30 minutes; the shape is round and uniform in color; the weight difference limit is ±15%.

[0039] 2. Optimization of near-infrared spectrum acquisition conditions

[0040] Randomly select a sample in the wavenumber range of 10000 ~ 4000cm -1 Next, optimize the three parameter conditions of the number of scans, resolution and optimization gain, according to 3 × 3 random combinations, a total of 27 combinations, the specific information is shown in Table 1. Each combination of conditions was scanned 6 times. According to the calculation of the relative standard deviation of the absorbance at each wave number, a trend chart was ...

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Abstract

The invention discloses a method for evaluating batch quality consistency of Xuesaitong dropping pills based on a near infrared spectrum technology. The method comprises the following steps: selectingdifferent batches of Xuesaitong dropping pills from the same manufacturer as samples, randomly extracting one sample from the samples to optimize near infrared spectrum acquisition conditions, and performing spectrum acquisition on the samples according to the optimized acquisition conditions; selecting an appropriate spectral band for modeling, and preprocessing the spectrum; and then analyzingand synthesizing the spectral data by using a multivariable analysis tool, establishing a quality consistency test model of a Xueshuitong dropping pill sample, setting control limits for the quality of different batches of samples, evaluating the quality of a to-be-detected sample by using the established evaluation model and the calculated control limits, determining a sample exceeding the control limits as an abnormal sample, and otherwise, evaluating the good sample quality consistency. With the disclosed method, the quality control level in the product process can be improved; the qualitystability and controllability of the product are guaranteed; and the method has the wide application value.

Description

technical field [0001] The invention relates to a method for evaluating the quality consistency of Xuesaitong dripping pill samples, in particular to a method based on near-infrared spectroscopy combined with related chemometrics technology, which can easily, quickly, scientifically and accurately evaluate the quality consistency of different batches of dropping pill samples. The evaluation method belongs to the technical field of traditional Chinese medicine detection and quality control. Background technique [0002] Xuesaitong dripping pills are obtained by changing the dosage form of Xuesaitong Tablets recorded in the 17th volume of standard traditional Chinese medicine preparations issued by the Ministry of Traditional Chinese Medicine. It has the characteristics of fast dissolution rate, high bioavailability, good curative effect, less toxic and side effects, easy storage and carrying, and simple preparation. Its main functions include promoting blood circulation and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/359
CPCG01N21/359
Inventor 黎翩李文龙蔡翔候一哲陈景丽程祖武李英
Owner 朗天药业(湖北)有限公司
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