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Article in Chinese | WPRIM | ID: wpr-878859


In response to no national standard for Gynostemma pentaphyllum, a market survey was carried out, and 17 batches of gypenosides extract and 29 batches of Gypenosides Tablets on the market were collected. With gypenoside A as an index, the TLC qualitative identification and HPLC quantitative evaluation method of gypenosides extract and tablets was established. Based on the determination results of 17 batches of gypenosides extract and 29 batches of Gypenosides Tablets, the quality standards of gypenosides extract and tablets were formulated respectively, so as to give suggestions for improving the quality standards of gypenosides extract and tablets. Compared with the existing ministerial standards, the qualitative identification and quantitative detection of specific components were added, in order to provide scientific basis and suggestions for the revision of the quality standard of gypenosides extract and tablet preparation.

Gynostemma , Plant Extracts , Reference Standards , Tablets
Article in Chinese | WPRIM | ID: wpr-773128


To construct a quality management model for the whole industry chain of compound Danshen Tablets,and quality control system for all key links in the production of compound Danshen Tablets. In this paper,with salvianolic acid B as internal reference substance,three batches of mix standards were prepared,and three sets of relative correlation factors between salvianolic acid B and other phenolic acids were calculated in parallel. Finally,the correlation factors are obtained on average. The quality transfer process was studied by optimizing the concentration of Salvia miltiorrhiza extract. The results showed that RSD among three sets of relative correlation factors ranged between 1. 7%-4. 1%,with no significant difference between the quantitative result of two methods. In addition,the quality transfer study showed that with the rise of the concentration temperature,the content of phenolic acid components changed,which had a significant effect on the salvianolic acid B at more than 80 ℃. It was suggested to rationally control the concentration temperature during the industrial production. The results of this study provide a methodology for the establishment of the quality control system for the whole industry chain of compound Danshen Tablets,and quality control methods for the improvement of the quality of medicinal materials and finished medicine products.

Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Chemistry , Hydroxybenzoates , Quality Control , Salvia miltiorrhiza , Chemistry , Tablets
Article in Chinese | WPRIM | ID: wpr-687374


To determine the contents of salvianolic acid B and borneol in compound Danshen tablet (composed of Salviae Miltiorrhizae Radix et Rhizome, Notoginseng Radix et Rhizome and Borneolum Syntheticum) by near-infrared spectroscopy (NIR) and to establish a dependency model for rapid quantitative analysis. NIR data of 74 batches of compound Danshen tablet from different companies were collected; the contents of salvianolic acid B and borneol were determined by using high performanceliquid chromatography (HPLC) and gas chromatography (GC) respectively to establish the dependency model for salvianolic acid B and borneol. The results showed that the best waveband for salvianolic acid B was 10 846.2-10 013, 9 195.3-8 362.2, 6 719.1-4 242.8 cm⁻¹; root-mean-squares error of cross-validation (RMSECV), coefficient of determination ² and regression point displacement (RPD) of salvianolic acid B were 1.72 mg·g⁻¹, 91.05% and 7.93 mg·g⁻¹, respectively. While the best wavebands, RMSECV, ² and RPD of borneol were 10 846.2-5 060.5 cm⁻¹, 1.2 mg·g⁻¹, 96.11% and 6.71 mg·g⁻¹,respectively. The relative error of the established model as validation results for validation set samples was 2.67% and 4.64%, respectively.With the good predictability, the models can be applied to the real time monitoring and quality control of compound Danshen tablet.

Article in Chinese | WPRIM | ID: wpr-771709


To investigate the differences of chemical compositions in Gynostemma pentaphyllum leaves prepared by different processing methods. Ultra performance liquid chromatography-quadrupole time-of-flight mass spectrometry(UPLC-Q-TOF-MS) was used to compare the chemical compositions between shade-dried processing and drum-dried processing. Forty six gypenosides were identified by control comparison, liquid chromatography-mass spectrometry(LC-MSn) fragmentation information, and literature data. The mass spectral peak area statistics was combined with principal component analysis(PCA), and the results showed that eight batches of Gynostemma pentaphyllum leaves samples were divided into two groups according to the two different processing methods; ten chemical compositions with significant differences were screened according to mass spectrum information combined with partial least-squares discriminant analysis(PLS-DA). The result showed that most parent nucleus of the gypenosides contained three to four glycosides in drum-dried samples, and one to two glycosides in the shade-dried samples. It was inferred from further MS analysis that desugarization of gypenosides was present to produce secondary glycosides with the effect of glucosidase in the shade-drying, thus resulting in difference in compositions. This study provided data support for harvesting, processing and quality control of Gynostemma pentaphyllum leaves.

Chromatography, High Pressure Liquid , Gynostemma , Chemistry , Mass Spectrometry , Plant Leaves , Chemistry , Saponins , Chemistry
Article in Chinese | WPRIM | ID: wpr-350181


To optimize the purification process of gynostemma pentaphyllum saponins (GPS) based on "adjoint marker" online control technology with GPS as the testing index. UPLC-QTOF-MS technology was used for qualitative analysis. "Adjoint marker" online control results showed that the end point of load sample was that the UV absorbance of effluent liquid was equal to half of that of load sample solution, and the absorbance was basically stable when the end point was stable. In UPLC-QTOF-MS qualitative analysis, 16 saponins were identified from GPS, including 13 known gynostemma saponins and 3 new saponins. This optimized method was proved to be simple, scientific, reasonable, easy for online determination, real-time record, and can be better applied to the mass production and automation of production. The results of qualitative analysis indicated that the "adjoint marker" online control technology can well retain main efficacy components of medicinal materials, and provide analysis tools for the process control and quality traceability.

Article in Chinese | WPRIM | ID: wpr-256089


As an outstanding representative of traditional Chinese medicine(TCM) prescriptions accumulated from famous TCM doctors' clinical experiences in past dynasties, classical TCM excellent prescriptions (cTCMeP) are the most valuable part of TCM system. To support the research and development of cTCMeP, a series of regulations and measures were issued to encourage its simplified registration. There is still a long-way to go because many key problems and puzzles about technology, registration and administration in cTCMeP R&D process are not resolved. Based on the analysis of registration and management regulations of botanical drug products in FDA of USA and Japan, and EMA of Europe, the possible key problems and countermeasures in chemistry, manufacture and control (CMC) of simplified registration of cTCMeP were analyzed on the consideration of its actual situation. The method of "reference decoction extract by traditional prescription" (RDETP) was firstly proposed as standard to evaluate the quality and preparation uniformity between the new developing product under simplified registration and traditional original usages of cTCMeP, instead of Standard Decoction method in Japan. "Totality of the evidence" approach, mass balance and bioassay/biological assay of cTCMeP were emphatically suggested to introduce to the quality uniformity evaluation system in the raw drug material, drug substance and final product between the modern product and traditional decoction.