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Chinese Pharmaceutical Journal ; (24): 298-304, 2020.
Article in Chinese | WPRIM | ID: wpr-857775


OBJECTIVE: To establish a method combining triterpenoids fingerprint with chemometric analysis based on reference drug, and determine 89 batches of samples to evaluate the quality of Ganoderma preparations. METHODS: The samples were extracted by ultrasonic with methanol, chromatography was performed on Agilent TC C18(2) column (4.6 mm×250 mm, 5 μm) with gradient elution with acetonitrile and 0.02% phosphoric acid aqueous solution. The detection wavelength was set at 254 nm. Principal component analysis and HCA heatmap were used for data analysis. RESULTS: The chromatographic fingerprint has 56 characteristic peaks. By comparing the samples with the reference drug, it was found that Ganoderma preparations were produced using Ganoderma lucidum by almost all manufacturers. Principal component analysis, HCA heatmap analysis and similarity analysis divided the samples into three categories. The first type had characteristic peaks and peak areas which were consistent with the reference drug, and the quality was better. The second type had characteristic peaks which consistent with the reference drug, but the peak areas were smaller and the quality was medium. And the third type was different from the reference drug, which was the problem sample. The strong characteristic peaks for classification of different samples were peak 26, peak 31, peak 24, peak 32 and peak 18. CONCLUSION: The method is comprehensive, accurate and specific, and it can be used for comprehensive quality evaluation of triterpenoids in Ganoderma preparations.

Chinese Pharmaceutical Journal ; (24): 1438-1441, 2019.
Article in Chinese | WPRIM | ID: wpr-857927


OBJECTIVE: To apply reference drug in the fingerprint study of Niuhuang qingwei pills, and perform primary evaluation of the quality grade of the samples. METHODS: Ultra performance liquid chromatography (UPLC) separation was performed on an AQUITY UPLC BEH C18 column with gradient elution using acetonitrile (containing 0.5% formic acid)-0.5% formic acid at a flow rate of 0.2 mL•min-1. The injection volume was 2 μL and the column temperature was maintained at 40 ℃. The detection wavelength was set at 254 nm. By comparing with reference substances and the reference herbal materials, characteristic peaks and their ascriptions were investigated. Using Niuhuang qingwei pills reference drug as the accompanying physical control, the similarities of the fingerprints of 49 batches of samples from 18 manufacturers were calculated, and the quality grades were evaluated. RESULTS: The similarities of all samples fell within the range of 0.76-0.98. The similarities of 49 samples were above 0.75 and met the second-grade limit. The similarity of 24 samples were above 0.90 and met the first-grade limit. CONCLUSION: The method is simple, accurate and rapid. It can be used for the quality control and grade evaluation of Niuhuang qingwei pills, which provides reference for the quality grade research of Chinese patent medicines.

Article in Chinese | WPRIM | ID: wpr-771514


To achieve a comprehensive understanding of heavy metals and harmful elements residues in Niuhuang Qingwei Pills,49 samples from 18 manufactures were collected from 31 provinces in China.Risk assessment and control preparations were applied innovatively in evaluation of exogenous pollution in traditional Chinese Medicine.Determination methods for Pb,Cd,As,Hg and Cu were established by inductively coupled plasma mass spectrometry(ICP-MS).Based on the procedures including hazard identification,hazard characterization,exposure assessment and risk characterization,risk assessment was performed and residual limits for Pb,Cd,As,Hg and Cu in the drug were formulated.The results showed that the hazardous quotients(HQ) of the elements were decreased in the following order:Pb>As>Cu>Hg>Cd,and the total hazardous index(HI) of heavy metals and harmful elements in Niuhuang Qingwei Pills was above 1,implying health risk of the drug.Under the proposed limits,5 elements in the control preparation as well as Cd and Cu in the samples were within the limits range,but the excess rates of Pb,As and Hg in the samples were 12%,12% and 14%,respectively.For the first time,basic steps for risk assessment of Chinese patent medicine were established,which provided model and reference for risk assessment and limit formulation of other drugs.

China , Drug Contamination , Drugs, Chinese Herbal , Reference Standards , Metals, Heavy , Risk Assessment
Article in Chinese | WPRIM | ID: wpr-851549


Objective To identify whole ingredients in Niuhuang Qingwei Pills (NQP) and give primary grade evaluation of NQP. Methods Firstly, microscopic characteristics specified by the statutory standard of NQP were summarized. Then new microscopic identification methods were established for Sennae Folium and Gypsum Fibrosum while new thin layer chromatography (TLC) identification methods were established for Bovis Calculus Artifactus, Borneolum Syntheticum, and Rhei Radix et Rhizoma. In addition, microscopic identification method for Menthae Haplocalycis Herba was improved. In this way, whole-ingredient identification of 17 materials were realized. NQP reference drug was developed and applied as accompanying control in whole-ingredient identification and primary grade evaluation of the samples. Results According to the results of 48 samples from 18 manufactures by primary grade evaluation, 10, 37, and 1 samples were classified as superior, qualified, and unqualified, respectively. Conclusion The proposed methods are accurate, simple, and objective, which offers a more comprehensive approach for quality control of NQP. And the methods provide research strategy and experimental basis for further work on establishment of grade standard.

Article in Chinese | WPRIM | ID: wpr-811763


@#This study was to evaluate quality consistency of domestic generic and reference preparations. Content and related substances of domestic generic preparations and reference preparation were inspected according to Chinese Pharmacopeia 2015. Then the basic solution for determining dissolution curve was established through preliminary experiment and validation for determination. The dissolution curves of domestic rifampicin capsules and reference preparation were compared in four dissolution mediums: HCl(pH 1. 2), PBS(pH 4. 0), PBS(pH 6. 8)and pure water, respectively. Results showed that the content and related substances of domestic generic and reference preparations complied with the quality standard, but impurity profile displayed that impurities in domestic generic preparations were less than those in the reference preparation, with the content of rifampin quinine being especially less. Furthermore, dissolution of domestic generic and reference preparations were compared, and their dissolution curves were not similar. It is suggested that consistency between domestic rifampicin capsules and reference preparation should be evaluated by bioequivalence test.

Article in Chinese | WPRIM | ID: wpr-335801


Traditional Chinese medicine (TCM) reference drug is a new form of TCM standard reference substance. The purpose of this guideline is to guide the establishment of the reference drug and standardize its investigation and application in national drug standards. Definition of TCM reference drug was specified and relating guideline and technical requirement were introduced in this paper. Its application in quality control of TCM was analyzed and the developing train was proposed. There is a wide prospect for the application of reference drug in quality control of TCM. Thus it has practical significance to explore and conduct the quality evaluation system by using TCM reference drug as the reference substance.