Quality Control of Standard Decoction of Aurantii Fructus Immaturus / 中国实验方剂学杂志

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.

Discussion and research progress in standard decoction of medicinal slices / 中国中药杂志

Standard decoction of medicinal slices has gradually acquired the height of researcher,government and enterprise for approval. And much consensus are increasingly reached. But there are lots of problem needing further discussing.This article summaries the published literature about standard decoction of medicinal slices in recent 3 years. And clarifies the origin of standard decoction of medicinal slices,explain the definition. The study status of standard decoction was reviewed and further analyzed in detail. And then the application fields of standard decoction of medicinal slices are listed. Combined with the research examples of groups,the problem in the study of standard decoction of medicinal slices was discussed. And relevant suggestions are put forward. All this is expected to provide reference in standard decoction research,the quality criterion o of formula granule and study of classical traditional Chinese medicine( TCM) excellent prescriptions.

Exploration of objective quality evaluation parameter of Alismatis Rhizoma decoction pieces / 中国中药杂志

To establish a quality constant evaluation system of Alismatis Rhizoma decoction pieces,in order to provide reference for regulating the market circulation of this decoction pieces. A total of 18 batches of Alismatis Rhizoma decoction pieces were collected from different pharmaceutical factories,and the morphological parameters of each sample were tested. The content of alisol B 23-acetate in Alismatis Rhizoma decoction pieces was determined by HPLC in the 2015 edition of Chinese Pharmacopoeia,and the parameters such as quality constant and relative quality constant were calculated. The quality constant range of 18 batches of Alismatis Rhizoma decoction pieces was 0. 390-2. 076. If 18 batches of Alismatis Rhizoma decoction pieces were divided into 3 grades,taking 80% of the maximum quality constant as first grade,50% to 80% as second grade,and the rest as third grade,then the quality constant of firstgrade samples was ≥1. 66,the quality constant of second-grade samples was ≥1. 04 and <1. 66,and the quality constant of third-grade samples was <1. 04. The established quality constant evaluation method is objective and feasible,which can be used to classify the grade of Alismatis Rhizoma decoction pieces and provide a reference method to control the quality of this decoction pieces.

Research on grades evaluation of Glycyrrizae Radix et Rhizoma Praeparata Cum Melle based on Chinese medicine quality constant / 中国中药杂志

Grade of Chinese medicine slices is the most clear and most direct way to characterize the quality of Chinese medicine slices,also the basis of realizing " good quality and good prices",and it can guarantee the industry health development. Therefore,grade evaluation of Chinese medicine slices( GECMS) is highly valued and has grown rapidly in the industry. In recent years,due to the comprehensive and measureable features,the Chinese medicine quality constant evaluation method has been gradually recognized and applied.The paper is to establish a method of grades evaluation of Glycyrrizae Radix et Rhizoma Praeparata Cum Melle( GRRPCM) based on the Chinese medicine quality constant. 20 batches of samples were collected from Chinese herbal slices enterprises and 14 batches of qualified samples were selected to determine their external morphological indexes and inner quality indexes,then their Chinese medicine quality constants were calculated and the grades were determined. The results revealed that the relative quality constant of these samples ranged from 0. 70 to 14. 08,with a percentage quality constant from 4. 95 to 100. 00. If these samples were divided into three grades: the relative quality constant shall be ≥11. 27 or percentage quality constant ≥80. 03 for the first grade; the relative quality constant shall be <11. 27 but ≥7. 04,or percentage quality constant <80. 03 and ≥49. 99 for the second grade; while for the third grade,the relative quality constant shall be <7. 04 or the percentage quality constant <49. 99. This research indicates that Chinese quality constant can be used to objectively grade the herbal slices,providing reference for grades standard development of complex processing slices. In addition,the connotation of GECMS that has evaluate the mass discrepancy is discussed for expanding application.

Grading of Gastrodia elata pieces based on quality constant / 中国中药杂志

The grade of Gastrodia elata pieces is evaluated by quality constant evaluation method.Fifteen batches of G. elata pieces collected were measured for their appearance and morphological indexes. The contents of gastrodin,p-hydroxybenzyl alcohol,barrisoside A,B and E were taken as index components for the content determination. The traditional grading standards were combined with modern quality control indicators,and the quality constants were calculated to grade the pieces.The results showed that the quality constants of 15 batches of G. elata ranged between 143. 3 and 1 027. 3. If the percentage mass constant( ≥80%) was the first grade,the percentage mass constant between 50%-80% indicated the second grade,and the remaining percentage mass constant indicated the third grade. The quality constant of the first gradepieces was sality,that of the second grade pieces ranged between 513. 0-821. 0,and that of the third grade pieces was <513. 0. On the basis of the study for the grading method of quality constants,and the natural morphology and cutting characteristics of the pieces,a grading model for the quality constants of the pieces cut along texture was established,which made the method scientific,rational as well as " personalized". The model method is applied in grading G. elata pieces,so as to specify the grading method,further enrich the study data of the grading evaluation of G. elata pieces and provide a useful reference for the grading evaluation of G. elata pieces. Meanwhile,the grading method of mass constants could be further applied and promoted to prove its rationality,scientificity and practicability.

High quality and superior effect of Dachuanxiong Formula based on quality constant grading evaluation technology of Chinese medicine pieces / 中国中药杂志

Quality constant is a kind of grading evaluation method of traditional Chinese medicine pieces based on the combination of traditional knowledge and modern quality control. This method has been successfully applied in the grading evaluation of Glycyrrizae Radix et Rhizome pieces and traditional Chinese medicine pieces,and with a positive influence in the industry. With Dachuanxiong Formula for example,different grades of Ligusticum chuanxiong and Gastrodia elata pieces formed high-quality,moderate and qualified Dachuanxiong Formula on the basis of the grading evaluation of the pieces,and the pharmacodynamics method was used to evaluate its efficacy. The results showed that the maximum vascular diastolic rates of Dachuanxiong Formula in the three grades were( 80. 3±5. 2) %,( 67. 0±6. 1) %and( 60. 3±6. 5) %,and the strength of pharmacodynamics was positively correlated with the grade of L. chuanxiong and G. elata pieces.The quality constant technique can objectively and quantitatively classify single decoctions,and has important correlations and prompts for the efficacy of traditional Chinese medicine prescriptions composed of these pieces,with important significance in promoting hierarchical management of the industry,implementing better price for high quality and defining high quality and superior effect.

Preparation and quality standard of standard decoction of Phellodendri Chinensis Cortex pieces / 中国中药杂志

To prepare standard decoction of Phellodendri Chinensis Cortex pieces, establish quality standards, and provide reference for evaluating the quality of formula granule of Phellodendri Chinensis Cortex. 15 batches Phellodendri Chinensis Cortex pieces in different levels of quality were collected from market. The standard extraction process was used to prepare the standard decoction, and then the transfer rate of the index components berberine and phellodendrine was calculated to measure dry extraction ratio and pH value. So the method for Phellodendri Chinensis Cortex's fingerprint and content determination of index components was established. The result revealed that the extraction ratio was from 12.81% to 19.41%, with an average value of 16.54%. The transfer rate of berberine was at the range of 36.4%-56.6%, with an average value of 48.9%. The transfer rate of Phellodendri Chinensis Cortex piece was at the range of 47.5%-83.3%, with an average value of 63.1%. The pH value was between 5.2 and 5.9. The Similarity Evaluation System for Chromatographic Fingerprint of traditional Chinese medicine TCM (2012A) was used to analyze and compare the fingerprint and the similarity between the fingerprint of formula granule of Phellodendri Chinensis Cortex and the reference fingerprint was over 0.9. The preparation method in this paper showed good precision, stability and repeatability in fingerprint analysis, suitable for quality evaluation of Phellodendri Chinensis Cortex pieces standard decoction.

Research on standard decoction of processed Curcumae Longae Rhizoma containing volatile oil / 中国中药杂志

To prepare processed Curcumae Longae Rhizoma standard decoction, establish its quality standard, provides quality reference for formulated Jianghuang granules and lay a foundation for standard decoction research for the pieces containing volatile oil. Thirteen batches of processed Curcumae Longae Rhizoma standard decoctions were prepared according to the preparation requirements for standard decoction of Chinese herbal medicine containing volatile oil. With curcumin as the detection index, the transfer rate and extraction ratio were calculated; the pH value was determined and HPLC fingerprint analysis method was established. The results showed that the transfer rate ranged from 0.67% to 2.24%; the extraction rate was at a range of 9.95% to 18.36% and pH value was 3.86 to 6.05. Then the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine (2012A) was used to analyze and compare the fingerprint. Sixteen common peaks were determined and three were identified including bisdemethoxycurcumin (peak 7), demethoxycurcumin (peak 8) and curcumin (peak 9). Moreover, the similarity was over 0.78 in the similarity evaluation of 13 batches of samples. HPLC fingerprint analysis method of processed Curcumae Longae Rhizoma standard decoction was established, showing good precision, stability and repeatability with certain identification effect, suitable for the quality control of formulated Jianghuang granules.

Research on quality standard of processed Cinnamomi Cortex decoction pieces containing volatile oil / 中国中药杂志

To build the quality standard of processed Cinnamomi Cortex standard decoction and provide quality reference for Cinnamomi Cortex formula granules. Fourteen batches of Cinnamomi Cortex standard decoction pieces were prepared according to the preparation requirements for standard decoction of Chinese herbal medicine containing volatile oil. With cinnamaldehyde as the quantitative index, the transfer rate and extraction rate were calculated; pH value was determined and HPLC fingerprint analysis method was established. By the measurement of 14 batches of standard decoction, the transfer rate ranged from 25.0% to 68.4%; the extraction rate was at a range of 3.7% to 10.1% and pH was 3.72 to 5.48. Then the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine (2012A) was used to analyze and compare the fingerprints. Four common peaks were determined and three were identified including coumarin (peak 1), cinnamic acid (peak 2) and cinnamaldehyde (peak 3). Moreover, the similarity was 1.0. This study established an HPLC fingerprint analysis method of processed Cinnamomi Cortex standard decoction. The method showed good precision, stability and repeatability in fingerprint analysis, with significance in identification.

Preparation and quality standard of standard decoction of Chinese herbal medicine containing volatile components-case study of Moutan Cortex / 中国中药杂志

To prepare the standard decoction of Moutan Cortex, and research its quality standard. According to the preparation principle of standard decoction of Chinese herbal medicines, the extraction conditions were optimized, and the 14 batches of standard decoction of Moutan Cortex were prepared. The content of paeonol was determined by HPLC; the transfer rate was calculated; and the extraction rate, pH value and the fingerprint of the decoction were determined. The results showed that the transfer rate of paeonol in the standard decoction of 14 batches of samples was at the range of 43.9%-67.3%; the range of extraction rate was 22.0%-38.7%, and the pH value range was 3.98-4.77. At the same time, the fingerprints of 14 batches of Moutan Cortex standard decoction were established; 9 common peaks were determined, and the similarities were more than 0.9. The preparation method in this study was standardized with good reproducibility, and can be used for the preparation and quality standard of standard decoction of Moutan Cortex, providing reference for the quality evaluation of Moutan Cortex dispensing granules.

Application of relative quality constant in grades evaluation of Glycyrrizae Radix et Rhizome pieces / 中国中药杂志

Quality constant evaluation is a comprehensive method for grades evaluation of traditional Chinese medicine pieces, but when it comes to Glycyrrizae Radix et Rhizome pieces, grades evaluation is diverged due to significant difference in contents of liquiritin and glycyrrhizic acid and unreasonable weight of index. To solve this problem, we have established a relative quality constant method in this paper to evaluate grades of Glycyrrizae Radix et Rhizome pieces. Twenty-nine batches of different quality samples were collected and tested, and finally, 17 batches of them were chosen as researcher objects. The results revealed that the range of the relative quality constant of these samples was from 1.78 to 11.49. When Glycyrrizae Radix et Rhizome pieces are divided into three grades: the relative quality constant of first grade is greater than or equal to 9.19; the second grade is greater than or equal to 5.75 but less than 9.19; while the third grade is less than 5.75. This research indicates that relative quality constant can divide the grades of herbal pieces in a scientific, reasonable, objective and specific way and remedy the shortage of quality constant perfectly. It provides a novel mode for grading pieces of Chinese medicine that contains multi-target ingredients.

Grades evaluation of Phellodendri chinensis cortex pieces based on quality constant / 中国中药杂志

Quality constant is a comprehensive grades evaluation method for traditional Chinese medicine decoction pieces, which is better but based on traditional way. In this paper, a new grading mode for Phellodendri chinensis pieces was established based on quality constant evaluation method. The results showed that the range of relative quality constant for 15 batches of different samples was from 0.41 to 0.96. As customary, if these samples were divided into three grades: the relative quality constant shall be ≥0.77 for first grade; <0.77 but ≥0.48 for the second grade; and ＜0.48 for the third grade. This research indicated that the quality constant mode can be used to effectively grade the P. chinensis pieces in a scientific, reasonable, objective and specific way. Simultaneously, it provided a beneficial reference for grading cortex herbal pieces or medicines.

Standard decoction of Leonuri Herba / 中国中药杂志

To build an evaluation standard for quality of Leonuri Herba standard decoction. 13 batches of Leonuri Herba standard decoction with different quality were prepared. The contents of leonurine hydrochloride and stachydrine hydrochloride were determined; then the transfer rate and the extract rate were calculated and pH value was measured; and HPLC fingerprint method was established for analysis. The results of 13 batches of samples revealed that the transfer rate of leonurine hydrochloride and stachydrine hydrochloride was 30.0%-53.4% and 67.0%-82.6%, respectively; the extract rate was 12.1%-18.3% and the pH value was 5.87-6.22. Moreover, 12 common chromatographic peaks were determined based on fingerprint by using Similarity Evaluation System for Chromatographic fingerprint of Traditional Chinese Medicine (2012A). The similarity of 13 batches of samples was analyzed and compared, and the results showed that the similarity was higher than 0.9. In this study, the preparation method for Leonuri Herba decoction was standard, with high similarity in fingerprint, showing high precision, stability and repeatability in fingerprint analysis. Thus, this study can provide a reference for the quality control of Leonuri Herba dispensing granules.

Grades evaluation of Scutellariae Radix slices based on quality constant / 中国中药杂志

By measuring the morphological indexes and the marker components content of 22 batches of Scutellariae Radix slices as well as calculating the quality constant, this research was aimed to establish a new method of evaluating the specifications and grades of Scutellariae Radix slices. The quality constants of these samples were in the range of 0.04-0.49, which can be divided into several grades based on the real requirement. If they were divided into three grades, the quality constant was ≥0.39 for the first grade, <0.39 but ≥0.24 for the second grade, and <0.24 for the third grade. This work indicated that the quality constants characterizing both apparent parameters and intrinsic quality can be used as a comprehensive evaluation index to classify the grades of traditional Chinese medicine quantitatively, clearly and objectively. The research results in this paper would provide new ideas and references for evaluating the specifications and grades of traditional Chinese medicines.

Establishment of quality standard and discussion on standard decoction containing volatile oil pieces-Cinnamomi Ramulus pieces / 中国中药杂志

To prepare Cinnamomi Ramulus pieces standard decoction and establish its quality standard, provide quality reference for formula granules and other clinic non-traditional forms of medicines, and lay a foundation for standard decoction research for the pieces containing essential oil. 14 batches of Cinnamomi Ramulus pieces with different quality were collected from market and their extraction process was further improved based on the preparation principle of standard decoction to prepare the standard decoction of Cinnamomi Ramulus pieces. Then its transfer rate of Cinnamaldehyde, dry extract rate and pH value were calculated to evaluate its process stability; and a method for chromatographic fingerprint and content determination was also established. Results revealed that the dry extract rate for standard decoction of Cinnamomi Ramulus pieces was from 6.06%-8.95%, with an average value of 7.18%; the transfer rate of cinnamaldehyde was at the range of 29.6%-54.3%, with an average of 43.2%; and the pH value was at the range of 4.33-4.82. The fingerprint similarities between 14 batches of standard decoction of Cinnmomi Rammulus pieces and reference fingerprint were all>0.9. The established method for standard decoction was stable and its quality standard was perfect, suitable for evaluating the quality of standard decoction of Cinnanomi Ramulus pieces.