ABSTRACT
In order to standardize the quality control of traditional Chinese medicine（TCM） dispensing granules， the Chinese Pharmacopoeia Commission has promulgated and implemented 200 national drug standards for TCM dispensing granules， but there are still varieties of TCM dispensing granules without unified standards. Many provinces have actively invested in the formulation of provincial standards for TCM dispensing granules to make up for the gaps in standards for varieties of traditional Chinese medicine dispensing granules other than the national standards. By the end of July 2022， 29 provincial-level administrative regions have successively promulgated and implemented a total of 5 602 provincial standards for TCM dispensing granules， involving more than 400 varieties. In order to better understand the formulation and characteristics of provincial standards， this study took 105 provincial standards that have been promulgated and implemented in Henan province as an example， and comprehensively analyzed the formulation and characteristics through quality control indicators such as dry extract rate of raw materials， contents of index components and their transfer rates， specifications and so on. The formulation and characteristics of the same TCM dispensing granules in the provincial standards of different provinces were further analyzed， in order to provide reference for the formulation of provincial standards of TCM dispensing granules and the implementation of national standards.
ABSTRACT
Objective:To explore the quality transmitting relationship between decoction pieces and substance benchmarks with the fingerprint， index component content and dry extract rate as evaluation indexes， and investigate the key quality attributes of 15 batches of substance benchmarks of Yihuangtang， and establish the quality standard of this substance benchmarks. Method:Fifteen batches of Yihuangtang substance benchmarks freeze-dried powder samples were prepared， the fingerprint and index component content of 15 batches of decoction pieces and substance benchmarks were determined by high performance liquid chromatography （HPLC）， the mobile phase was acetonitrile （A）-0.1% phosphoric acid aqueous solution （B） for gradient elution （0-6 min， 97%B； 6-12 min， 97%-92%B； 12-25 min， 92%-90%B； 25-35 min， 90%-89%B； 35-50 min， 89%-82%B； 50-75 min， 82%-72%B； 75-85 min， 72%-35%B）， the detection wavelength was set at 230 nm， combined the dry extract rate to clarify the attribution of characteristic peaks and the range of similarity with the control chromatogram， the content range and transfer rate range of geniposidic acid and berberine hydrochloride， the dry extract rate range and the variation range of the substance benchmarks. Result:The established HPLC fingerprint had good precision， repeatability and stability， and could be used for the simultaneous determination of decoction pieces and substance benchmarks of Yihuangtang. The similarities between the control chromatogram and fingerprint of substance benchmarks were >0.99. A total of 15 characteristic peaks were assigned， and 8 characteristic peaks were identified by the reference substances， of which 6 were from Phellodendri Chinensis Cortex processed with salt， 1 was from Plantaginis Semen processed with wine， and 1 was from stir-fried Dioscoreae Rhizoma. The content ranges of geniposidic acid and berberine hydrochloride in 15 batches of substance benchmarks of Yihuangtang were 0.10%-0.16% and 0.63%-1.05%， the transfer rate ranges of them were 20.91%-32.65% and 19.60%-29.59%， respectively. The dry extract rate range of the substance benchmarks was 8.45%-9.92%. Conclusion:The quality standard of Yihuangtang substance benchmarks can be preliminarily formulated by the combination of fingerprint， dry extract rate and determination of index component， which can provide the basis for the quality control of Yihuangtang and the development of related preparations.
ABSTRACT
Objective: To establish a quality control method of standard decoction of Aurantti Fructus Immaturus(AFI),and to provide reference for quality evaluation of AFI dispensing granules and other related products of AFI. Method: A total of 16 batches of AFI pieces with different quality were collected from the market,including 13 batches of Citrus aurantium and 3 batches of C. sinensis,and the standard decoction of AFI was prepared according to the standard decoction process.Transfer rate of synephrine,dry extract rate and others of the standard decoction were regarded as evaluation indicators and relative assessment are conducted. Result: Transfer rates of synephrine in 13 batches of standard decoction of AFI(C. aurantium) were ranged from 35.7% to 92.7% with the average value was 61.9%;dry extract rates were varied from 20.7% to 43.8% and the average value was 28.4%;pH values were 4.48-5.32 with the average value was 4.99;the HPLC fingerprint similarities were >0.9 by comparing with the corresponding control fingerprint,6 common peaks were found and 3 of them were identified as naringin,hesperidin and neohesperidin.Transfer rates of synephrine in 3 batches of standard decoction of AFI(C. sinensis) were changed from 53.1% to 84.4%,and the average value was 73.2%;dry extract rates were shifted from 13.8% to 17.6% and the average value was 15.4%;pH values were 4.77-5.38 with the average value was 5.06;the HPLC fingerprint similarities were >0.9 by comparing with the corresponding control fingerprint,2 common peaks were found and one of them were identified as hesperidin. Conclusion: From the HPLC fingerprint of standard decoction of AFI,we can easily understand that the number of peaks in C. aurantium is obviously more than that of C. sinensis.This method has good precision,reproducibility and stability,it is suitable for quality evaluation for related products of AFI.Simultaneously,the research provides a good reference for identifying sources of AFI.
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Objective:To establish the fingerprint of standard decoction of Citri Reticulatae Pericarpium and evaluate its quality. Method:According to the preparation conditions of the standard decoction,15 batches of standard decoction of Citri Reticulatae Pericarpium were prepared.HPLC was employed to determine the content of hesperidin in this standard decoction.Ultraviolet spectroscopy(UV) and infrared spectroscopy(IR) were used to establish the fingerprint of standard decoction of Citri Reticulatae Pericarpium.The correlation coefficient method and double index sequence analysis method were used to compare and analyze the spectra of different batches of this standard decoction. Result:The content of hesperidin in 15 batches of this standard decoction were 0.82%-2.60%,and the measured value of dry extract rate was 32.02%-46.11%.Compared with ultraviolet and infrared control fingerprint,the fingerprint similarities of the standard decoction of each batch were > 0.897 and > 0.942,respectively.The double index analysis results showed that the common peak ratio was more than 62.50%,variation peak ratio was less than 46.67%. Conclusion:The quality evaluation method established in this study can be used for systematic evaluation of standard decoction of Citri Reticulatae Pericarpium,and it can provide theoretical reference for the formulation of quality standard of Citri Reticulatae Pericarpium dispensing granules and other related preparations.
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Objective: To prepare standard decoction of Alismatis Rhizoma (AR) and establish its quality evaluation system, and provide reference for the development of dispensing granules of AR. Methods: A total of 18 batches of AR decoction pieces were collected to prepare standard decoction of AR according to the standard process. Quality evaluation system of standard decoction of AR was established with pH value, dry extract rate, fingerprint similarity and transfer rate of alisol B 23-acetate as indexes. Results: The mass fraction of alisol B 23-acetate in AR decoction pieces was 0.057%—0.267% with the average value of 0.156%, water content was 9.2%—12.8% with the average value of 10.44%; the pH value of standard decoction of AR was 4.11—5.60, dry extract rate was 10.25%—17.09%; transfer rate of alisol B 23-acetate from decoction pieces to standard decoction was 10.49%—17.49%. Conclusion: The established quality evaluation method is stable and feasible, which is suitable for the development and quality evaluation of standard decoction of AR, which can provide reference for the development of dispensing granules of AR and related classic formulas.
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Objective To explore the relevance between the quality of standard decoction and the marker component amygdalin of decoction slices of blazing Armeniacae Semen Amarum (BASA) by mathematical model. Methods The BASA standard decoction was prepared, and three linear regression models of the amygdalin content and dry extract rate, the content of amygdalin in standard decoction and decoction slices, and the transfer rate in standard decoction and the content of amygdalin in decoction slices were established by using Design-Expert 8.0.6 software, respectively. Results The dry extract rate of BASA was 8.97%-12.12%; The content of amygdalin in standard decoction was 21.74%-30.32%; And the transfer rate of amygdalin was 70.39%-90.54%. The R2 values of three linear regression models were all greater than 0.8. The P values of each partial regression coefficient were less than 0.05, which indicated that the three models were significant. Then the accuracy of three linear regression models was verified. The relative deviation between the predicted and measured values was less than 10%, and the average relative deviation was not greater than 5%. Conclusion The models established in this study could predict the quality of standard decoction prepared from different BASA, and provide a certain reference value for the establishment of standard decoction quality standard.
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Objective To optimize the extracting process for Weiningsu Capsule.Methods With dry extract rate and naringin content as the inspection indicators,orthogonal test was used to investigate the influence of four extracting factors (water volume,extracting time,times of extracting and soak time of herbal) on the extracting process.Results The optimum extracting process was A3B2C2D3,i.e.the water volume being 10 times of the weight of medicinal material,extraction for two times and 1.5 hours each time,and soaking for 1.5 hours.Conclusion Optimization of extracting process for Weiningsu Capsule by orthogonal test is a simple,quick and accurate method.