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Near-infrared quality detection system for ginkgo leaf purification process of Yinshen meridian-dredging capsule

A purification process, near-infrared technology, applied in measurement devices, instruments, scientific instruments, etc., can solve the problems of low production automation, lack of on-line detection and control of key quality control parameters for process quality control, and difficulty in overcoming internal quality control. achieve good performance

Inactive Publication Date: 2020-04-17
TIANSHENG PHARMA GROUP
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Problems solved by technology

[0002] At present, there is a lack of unified and scientific quality control standards for most traditional Chinese medicine preparations. For example, in the whole process of traditional Chinese medicine extraction, separation, concentration, drying, preparation, and sterilization, each step of the pharmaceutical unit basically relies on manual control and offline testing. , the lack of objective process quality control and online detection and control of key quality control parameters, the low degree of production automation, resulting in difficult to overcome technical blind spots in internal quality control, making it difficult to achieve stable and uniform product quality between batches. Therefore, the research The innovative application of fast and effective on-line inspection technology for the complex material and quality control system in the production process of traditional Chinese medicine tablets, the integrated application of key technologies for quality control in the production process, and the construction of a scientific and reliable quality control technology system for the whole process of Chinese medicine tablet production will provide a great guarantee for the quality of traditional Chinese medicine tablets. Provide technical support for the stability and controllability of medicines, ensure the safety and effectiveness of medicines, improve the technical level and technical content of the Chinese medicine industry as a whole, and promote the modernization process of Chinese medicines

Method used

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Embodiment

[0023] The invention provides a near-infrared quality detection system for the ginkgo leaf purification process of Yinshen Tongluo Capsules, comprising the following devices,

[0024] Fourier transform near-infrared spectrometer collects the near-infrared transmission spectrum of the eluent sample. Air is used as a blank background with a resolution of 8cm-1. The 2mm quartz cuvette is used as a sample pool. Each sample spectrum is scanned 32 times to collect full-spectrum information , scan each sample three times, and obtain the average spectrum through software processing;

[0025] High-performance liquid chromatography, used for chromatographic analysis of reagents, wherein the chromatographic column is an XBridge Shield RP18 chromatographic column; the mobile phase is methanol-0.4% phosphoric acid solution; the detection wavelength is 360nm; the flow rate is 1mL / min, and the injection volume is 10μL;

[0026] Analytical balance, weighing each reagent;

[0027] Electronic ...

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Abstract

The invention discloses a near-infrared quality detection system for a ginkgo leaf purification process of a Yinshen capsule for dredging collaterals. Device comprising the following, the Fourier transform near-infrared spectrometer is used for collecting a near-infrared transmission spectrum of an eluent sample, taking air as a blank background, taking a quartz cuvette with the resolution of 8cm<-1 > and 2mm as a sample pool, scanning each sample spectrum for 32 times, collecting full-spectrum information, scanning each sample for three times, and obtaining an average spectrum through software processing; the high performance liquid chromatograph is used for carrying out chromatographic analysis on the reagent, and a chromatographic column is an XBridge Shield RP18 chromatographic column; wherein a mobile phase is a methanol-0. 4% phosphoric acid solution; the detection wavelength is 360 nm; wherein the flow rate is 1mL / min, and the sample size is 10mu L; the high-speed centrifuge isused for centrifuging the reagent to be centrifuged; and evaporating and concentrating the test solution by using a rotary evaporator. A ginkgo leaf macroporous resin purification process is taken asa research object, offline feasibility research before establishment of an online detection method is mainly carried out, and a research system is explored and preliminarily established.

Description

technical field [0001] The invention relates to the technical field of on-line monitoring of drug production, in particular to a near-infrared quality detection system for the purification process of ginkgo leaves of Yinshen Tongluo capsule. Background technique [0002] At present, there is a lack of unified and scientific quality control standards for most traditional Chinese medicine preparations. For example, in the whole process of traditional Chinese medicine extraction, separation, concentration, drying, preparation, and sterilization, each step of the pharmaceutical unit basically relies on manual control and offline testing. , the lack of objective process quality control and online detection and control of key quality control parameters, the low degree of production automation, resulting in difficult to overcome technical blind spots in internal quality control, making it difficult to achieve stable and uniform product quality between batches. Therefore, the researc...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/74
CPCG01N30/74G01N30/88G01N2030/743G01N2030/884
Inventor 刘爽谈宗华王晓吴统选刘彦张聪
Owner TIANSHENG PHARMA GROUP
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