ABSTRACT
Objective: To establish the quality control methods for the standard decoction of Zingiberis Rhizoma. Method: DNA barcode primitives were identified for the medicinal materials from different origins; according to the standard of Chinese herbal medicine decoction preparation principle,the identified Zingiberis Rhizoma was prepared into standard decoction for analysis. Meanwhile, the extraction method and analysis method were validated from methodologies, and the transfer rate of 6-gingerol as well as the extraction rate of standard decoction of Zingiberis Rhizoma were calculated. In addition,the quality standard of standard decoction of Zingiberis Rhizoma was also established based. The structures of main chromatographic peaks were identified by ultra-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS) to clarify the main chemical constituents in the standard decoction of Zingiberis Rhizoma. Result: All the samples were identified as Zingiberis Rhizoma. Under the conditions established in this paper,the standard curve of 6-gingerol was Y=661.56X+2.493 3(r=0.999 3),and the RSD was 0.5%in precision test, indicating that the instrument precision was good. The repeatability test showed that the RSD was 0.3%, indicating that the method had good repeatability. The stability test showed that the RSD was 0.4%, indicating that the test solution had good stability within 24 h. The recovery rate was 97.2%and the RSD was 0.6%,indicating that the method was accurate and reliable. 6-gingerol's transfer rate ranged from 31.8%to 57.4%and the extraction rate was within the range of 9.6%-23.1%. The fingerprint similarity of 12 batches of Zingiberis Rhizoma standard decoction was>90%. Conclusion: The established quality control method for Zingiberis Rhizoma was stable and feasible; meanwhile, the standard preparation method for Zingiberis Rhizoma and its quality evaluation system were also established in this study.
ABSTRACT
Objective: To establish the quality control methods for the standard decoction of Puerariae Thomsonii Radix.Method:According to the preparation principles for traditional Chinese medicine (TCM) standard decoction,13 batches of Puerariae Thomsonii Radix from different origins were analyzed under the chromatography conditions established in this study and verified with methodology.By referring to Chinese Pharmacopoeia of 2015,puerarin was used as a quantitative indicator to calculate the transfer rate.In this study,the structures of main chromatographic peaks were also identified to clarify the main chemical constituents in the standard decoction.Result:The 13 batches of medicinal herbs were identified as Puerariae Thomsonii Radix,with a recovery rate of 98.0%,and RSD of 1.1%,indicating that the method was accurate and reliable.The transfer rate ranged from 41.4% to 60.0%,and the extraction rate was within the range of 15.7%-34.3%.The corresponding fingerprints were prepared for 13 batches of the standard decoction,and their similarities were all greater than 90.0%.The chemical constituents from Puerariae Thomsonii Radix were identified by mass spectrometry analysis,including citric acid,4'-O-glucosyl puerarin/daidzein-4',7-diglucoside,3'-hydroxy puerarin/genistein puerarin,puerarin apioside,daidzin puerossid A and daidzein,etc.Conclusion: The 13 batches of Puerariae Thomsonii Radix decoction in different origins had consistent properties with the basic properties of medicinal decoction pieces.The established method of quality evaluation can be used to systematically evaluate the standard decoction,providing reference for quality control of related decoction preparations of Puerariae Thomsonii Radix.
ABSTRACT
Decoction of single medicinal herb is a reference for the standardization of different dosage forms of Chinese medicine and it provides a new direction for solving the problems existing in the quality of Chinese medicinal granules such as no uniform dosage form and no clear quality standard. In this paper, the quality evaluation method of standard decoction of rhubarb was established to provide reference for the quality control of common dosage forms such as clinical decoction and formula granule. 10 batches of representative Rhei Radix et Rhizoma were collected to establish UPLC fingerprints were established. The chemical structures of main peaks were identified with ultra-performance liquid chromatography with quadrupole-time-of-flight mass spectrometry (UPLC-Q-TOF-MS) and the main components in the decoction were Anthraquinones. The extraction ratio of the standard decoction was (28.1±3.8)% and the transfer rate was (19.9±6.3)%. The method for the quality evaluation of standard decoction of Rhei Radix et Rhizoma was established in this study, providing reference for the quality control method of terminal products from decoction of Rhei Radix et Rhizoma.
ABSTRACT
Decoction of single medicinal herb is a reference for the standardization of different dosage form of Chinese medicine and it provides a new direction for solving the problems existing in the quality of Chinese medicinal granules such no uniform dosage forms and no clear quality standard. There are few reports on the idea, method and preparation of single herb standard decoction. Our country is in urgent need of that information in order to improve the consistency and stability of traditional Chinese medicine products. Here, Lonicerae Japinicae Flos was selected as an example to elucidate the preparation and quality evaluation of Chinese single herbal medicine decoction. Twelve batches of representative Lonicerae Japinicae Flos were collected, UPLC fingerprints were established, and the chemical structures of main peaks were identified with UPLC-QTOF-MS and standard compounds. The main components in the decoction are organic acids and iridoids. The extract rate of the standard decoction was (34.2±2.9)% and the transfer rate is (78.6±8.4)% in the form of chlorogenic acid, within the range of 75%-125% of mean. This paper established a method for the quality evaluation of standard decoction of Lonicerae Japinicae Flos and provided reference for the quality control method of terminal products from decoction of Lonicerae Japinicae Flos.
ABSTRACT
The quality of Danshen extract granules on market is largely different from each other mainly due to the heterogeneous quality of raw materials of Salvia miltiorrhiza, various producing procedures and lack of good quality evaluation method. Formula granule and "standard decoction" have the same quality. In this paper, a systematic evaluation method for the quality of Danshen decoction was established from the perspective of "standard decoction", in order to explore the main factors affecting the quality uniformity of Danshen extract granules. Danshen standard decoction was prepared; then the fingerprint method was developed to determine the content of salvianolic acid B; and the main peaks in the fingerprint were identified with UPLC-QTOF/MS to clarify the chemical compositions of Danshen decoction. Three indexes were calculated to evaluate the stability of whole process, including the extraction ratio; transfer rate of index components and pH value. The results showed that the main components of Danshen decoction were phenolic acids, while the extraction rate, the transfer rate of salvianolic acid B and pH value were in a relatively stable level, and the similarity in the fingerprint of standard decoction was high, indicating that the preparation procedure was stable. The level of salvianolic acid B in the standard decoction was in a large range, which was mainly due to the difference in the quality of Salviae Miltiorrhizae Radix et Rhizoma.
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To establish the quality control methods for the standard decoction of Ephedrae Herba, and provide the reference for quality evaluation method of all Chinese herbal medicine decoction.Standard decoction of Ephedrae Herba was prepared, and UPLC-UV fingerprint was established to determine the total contents of ephedrine and pseudoephedrine. Then UPLC-QTOF/MS was used to confirm the major common peaks in the fingerprint to clarify the main chemical constituents in the decoction. In addition, the stability of the process was evaluated by calculating the parameters such as the extraction ratio, transfer rate of the index components and the pH values.In the decoction of Ephedrae Herba, the total average concentration of ephedrine and pseudoephedrine was (2.11±0.70) g•L⁻¹; the similarities of all the fingerprints were more than 0.85; there were 10 major common peaks in the fingerprint, including alkaloids, flavonoids and organic acids; the extraction ratio was (17±3.2)%, and the overall transfer rate of ephedrine and pseudoephedrine was (32.4±8.1)%.The method for evaluating the quality of standard decoction of Ephedrae Herba was established in this article, providing reference for the quality control of products which were stemmed from the water extract of Ephedrae Herba.
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In order to clarify the chemical constituents of Si-Wu Decoction rapidly and holistically, we analyzed the ethanol extract of Si-Wu Decoction by UPLC/Q-TOF-MSE and UNIFI which based on traditional Chinese medicine database, the probable structures of 113 compounds were identified. The results show that this method can rapidly and effectively characterize the chemical compounds of Si-Wu Decoction and provide a new solution for identification of components from complex TCM extract.