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Dampness-resolving and toxin-vanquishing composition quality control method based on near infrared spectroscopy

A quality control method, near-infrared spectroscopy technology, applied in the direction of measuring devices, material analysis through optical means, instruments, etc., can solve the problems of complicated preparation process, fixed sampling timing, and low quality monitoring requirements, so as to improve stability And reliability, high accuracy, fast results

Pending Publication Date: 2021-02-05
GUANGDONG YIFANG PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, most of the research on Huashibaidu formula focuses on pharmacology and curative effect, and there is no research on its quality standard.
Moreover, the existing production is limited to a small area, there is no large-scale industrial production, and the requirements for quality control are relatively low
[0003] On the other hand, for the production of traditional Chinese medicine compound preparations, changes in different raw material bases and various process parameters during the production process can lead to unstable final product quality
Conventional detection methods such as HPLC, due to the complicated sample preparation process, long measurement cycle, and low analysis efficiency, cannot achieve real-time monitoring of the production process and cannot quickly and accurately determine whether the quality of the entire batch of products is qualified.
In addition, the existing detection method is limited by the influence of the measurement time, and its sampling timing is often fixed; for example, in the mixing process, sampling is carried out after a specific time of mixing or after the end of mixing
This sampling method basically does not consider the advance and lag of the end point of the process caused by factors such as differences in the quality of raw materials and fluctuations in working conditions, which is likely to cause problems such as instability in the extraction quality of different batches and a decrease in the utilization rate of medicinal materials.
[0004] Therefore, the existing assay method cannot solve the quality control problem of the key process link in the production process of Huashibaidu granules; and the existing assay method requires many instruments and a long detection period, and cannot quickly evaluate the Huashibaidu composition The quality situation in the production process cannot effectively achieve good quality control in the production process of the Huashibaidu composition

Method used

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  • Dampness-resolving and toxin-vanquishing composition quality control method based on near infrared spectroscopy
  • Dampness-resolving and toxin-vanquishing composition quality control method based on near infrared spectroscopy
  • Dampness-resolving and toxin-vanquishing composition quality control method based on near infrared spectroscopy

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preparation example Construction

[0075] The preparation method of the dehumidification and detoxification composition comprises: first mixing, extraction, secondary mixing and molding of various raw materials to obtain the finished dehumidification and detoxification composition.

[0076] Specifically, when the dosage form of the Huashibaidu composition is granules, various raw materials are mixed for the first time, decocted and extracted, concentrated to obtain a clear paste, and the clear paste and auxiliary materials are mixed for a second time, and dried to obtain The Huashibaidu composition extract is mixed for the third time with the Huashibaidu composition extract and auxiliary materials, and then granulated to obtain a finished product.

[0077] When the dosage form of the Huashibaidu composition is a tablet / capsule, the various raw materials are mixed for the first time, decocted and extracted, concentrated to obtain a clear cream, and the clear cream and auxiliary materials are mixed for a second ti...

Embodiment 1

[0134] This example provides a quality control method for Huashibaidu granules based on near-infrared spectroscopy.

[0135] Among them, the preparation method of Huashibaidu Granules is as follows: take 150g of ephedra, 250g of patchouli, 375g of raw gypsum, 225g of fried bitter almonds, 225g of French pinellia, 250g of magnolia officinalis, 375g of bran-fried atractylodes, 250g of fried grass nuts, and Poria cocos. 375g, 250g astragalus, 250g red peony, 250g Tinglizi, 125g rhubarb, 75g licorice, the above fourteen flavors, raw gypsum and boil for 30 minutes, add the other eleven flavors except patchouli and rhubarb, add 8 times the water After decocting for 50 minutes, add patchouli and rhubarb, decoct for another 10 minutes, filter, and concentrate the filtrate to an appropriate amount; add 8 times the amount of water to decoct the dregs of the medicine for 1 hour, filter, and concentrate the filtrate to an appropriate amount. Combine the liquid medicines and concentrate th...

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Abstract

The invention discloses a dampness-resolving and toxin-vanquishing composition quality control method based on near infrared spectroscopy, which comprises the following steps: acquiring a dampness-resolving and toxin-vanquishing composition sample to be detected, collecting the near infrared spectrum of the dampness-resolving and toxin-vanquishing composition sample, and determining the total content of ephedrine hydrochloride and pseudoephedrine hydrochloride in the dampness-resolving and toxin-vanquishing composition to be detected by using a pre-established ephedrine determination model, and judging whether the quality of the dampness-resolving and toxin-vanquishing composition is qualified or not according to the determination result. The establishment method of the ephedrine determination model comprises the following steps: acquiring a sample, determining the total content of actual ephedrine hydrochloride and pseudoephedrine hydrochloride in the sample, collecting near infraredspectrum data of the sample, and establishing an ephedrine determination model according to the two types of data. The determination method provided by the invention is short in period, high in speedand high in accuracy, can realize on-line monitoring, is beneficial to controlling the whole process of the dampness-resolving and toxin-vanquishing composition, and is beneficial to improving the stability and reliability of product quality.

Description

technical field [0001] The invention relates to the technical field of quality control of traditional Chinese medicines, in particular to a method for quality control of a Huashibaidu composition based on near-infrared spectroscopy. Background technique [0002] Huashibaidu recipe consists of ephedra, patchouli, raw gypsum, fried bitter almonds, French pinellia, magnolia officinalis, bran fried herb, fried grass nuts, poria cocos, astragalus, red peony root, Tinglizi, rhubarb and licorice 14 flavors Composed of traditional Chinese medicine, it has the effects of detoxification and dampness, clearing heat and relieving asthma. It is used for closed lung syndrome caused by internal stagnation of heat and exogenous cold and dampness. , can improve fever, cough, fatigue and other symptoms, and effectively promote lung imaging changes and absorption of lung lesions. At present, most of the researches on Huashibaidu formula focus on pharmacology and curative effect, but there is ...

Claims

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Application Information

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IPC IPC(8): G01N21/359
CPCG01N21/359
Inventor 魏梅程学仁鲁云干丽张志鹏罗文汇陈江平刘丽萍梁志毅张正邓李红钟霞梁丽金王寿富陈丹燕潘玲李定发
Owner GUANGDONG YIFANG PHARMA
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