Quality control method and construction method of Tibetan red yeast rice

A technology of quality control method and construction method, which is applied in the field of detection of active ingredients of saffron red yeast rice, to achieve the effects of improving detection efficiency, good repeatability, and good durability

Pending Publication Date: 2021-11-12
西藏月王药诊生态藏药科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are certain differences between Tibetan red yeast rice and traditional Chinese medicine red yeast rice in terms of "bacterial strains, fermentation substrates, and production environments". At present, there are few reports on the quality standards of Tibetan red yeast rice. Due to differences in aspects such as production environment and production environment, it is necessary to study the composition and quality control of saffron red yeast rice, establish standards that reflect the characteristics of saffron red yeast rice, and avoid homogenization

Method used

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  • Quality control method and construction method of Tibetan red yeast rice
  • Quality control method and construction method of Tibetan red yeast rice
  • Quality control method and construction method of Tibetan red yeast rice

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] Embodiment 1 Saffron monascus sample quality control construction method

[0090] Test equipment: KQ-300DE CNC ultrasonic cleaner (power 300W, adjustable frequency, Kunshan Ultrasonic Instrument Co., Ltd.); Milli-Q ultrapure water instrument (Millipore Corporation, USA); electric heating constant temperature blast drying oven (Shanghai New Miao Medical Instrument Manufacturing Co., Ltd.); Alcohol meter; BT25S electronic analytical balance (Beijing Sartorius Instrument System Co., Ltd.); R-210 rotary thin film transevaporator (Swiss BUCHI company); LC-20ATXR Shimadzu liquid chromatography Instrument (Shimadzu Instruments, Japan); ABsicex TOF5600+ mass spectrometer (Aibo Caisi Instrument Company, USA); Disposable sterile syringe (with needle) Shengguang Medical Products Co., Ltd.; Disposable 0.22, 0.45 μm filter membrane Guangzhou City Rui Science Instrument Co., Ltd.; YMC C18 chromatographic column (YMC Technology, Japan);

[0091] Mass spectrometry conditions: electros...

Embodiment 2

[0114] Example 2 Investigation on the Methodology of HPLC Fingerprint of Red Koji Sample

[0115] precision test : according to the quality control construction condition of embodiment 1, accurately draw respectively lovastatin (lactone) reference substance solution (0.1054mg / ml) and lovastatin (acid formula) reference substance solution (0.1243mg / ml) 10 μ L, inject A liquid chromatograph was used for determination, and each reference substance solution was repeatedly injected 6 times, and the peak area was recorded. The precision test results are shown in Table 2.

[0116] Table 2 Precision test results

[0117]

[0118] The results showed that the peak area RSDs of lovastatin (lactone) and lovastatin (acid form) measured above were 0.93% and 0.19%, respectively, both less than 2.0%, indicating that the precision of the system was good.

[0119] repeatability test : get about 0.5g of samples of different batches of red yeast rice, accurately weigh 6 parts, put in a s...

Embodiment 3

[0154] Example 3 HPLC fingerprint analysis of saffron red koji decoction pieces

[0155] The detection condition is the same as that in Example 1. Get 14 batches of saffron red koji decoction samples, and get 2 samples for each batch of samples. The chromatographic peaks whose retention time is greater than 1000 in the chromatographic data of 28 samples are automatically integrated in 2 to 38 minutes. The chromatogram of a sample with batch number 20080201 was used as a reference chromatogram, the median generation method was used, and the time width was selected as 0.1min. The chromatographic data of 28 samples were imported into the similarity evaluation system of traditional Chinese medicine chromatographic fingerprints (2012 version), and 6 samples were selected by comparison. Common characteristic component peaks are used as marker peaks for multi-point calibration, and full-spectrum peak matching is performed to obtain peak matching fingerprints ( Figure 5, R: control f...

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Abstract

The invention discloses a quality control method and a construction method of Tibetan red yeast rice. The effective components of the Tibetan red yeast rice comprise a nucleoside compound, a monascus pigment compound, lovastatin, citrinin and a moracoline compound. The quality control method comprises the step of detecting effective components of the Tibetan red yeast rice by adopting a UHPLC (Ultra High Performance Liquid Chromatography) method. According to the quality control method of the Tibetan red yeast rice, the conditions of the liquid chromatography are explored according to the component characteristics of the Tibetan red yeast rice, 21 effective components in the Tibetan red yeast rice can be identified and detected at a time, the detection efficiency is greatly improved, the chemical components and the quality characteristics of the Tibetan red yeast rice are comprehensively reflected, the Tibetan red yeast rice can be effectively distinguished from existing traditional Chinese medicine red yeast rice, and homogenization is avoided.

Description

technical field [0001] The invention relates to the technical field of detection of effective components of saffron red yeast rice, in particular to a quality control method and a construction method of saffron red yeast rice. Background technique [0002] Red yeast rice is a commonly used lipid-lowering drug, which is fermented by Monascus bacterium. There are two kinds of red yeast rice drugs in clinical use, namely Chinese medicine "red yeast rice" and Tibetan medicine "Tibetan red yeast rice". The traditional Chinese medicine "red yeast rice" is fermented with japonica rice as the substrate and inoculated with the fungus Monascus purpureus Went (CGMCC, No.0272 strain) of Aspergillus family. It is also commonly known as "red yeast rice". Its patent medicines Xuezhikang Capsules and Zhibituo Capsules; Tibetan medicine "Tibetan Red Yeast" (formerly known as: Highland Barley Red Yeast), based on the species of highland barley (Hordeum vulgare var.nudum Hook.f.), a special cro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8809
Inventor 胡学民
Owner 西藏月王药诊生态藏药科技有限公司
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