Analysis of Excretion Behavior of GK-A from Ginkgo Semen in Urine and Bile of Rats / 中国实验方剂学杂志

Objective::To investigate excretion of GK-A, a antitussive compound separated from Ginkgo Semen, in the urine and bile of rats. Method::UPLC-MS/MS was used to determine the concentration of GK-A in rat urine and bile samples. The separation was performed on a C18 column, the mobile phase consisted of 0.1%formic acid aqueous solution (A) and acetonitrile (B) for gradient elution (0-1 min, 95%A; 1-3 min, 95%-85%A; 3-7.5 min, 85%-40%A; 7.5-8 min, 40%A). The detection was carried out by a triple quadrupole mass spectrometer in the positive ion mode with an electrospray ionization (ESI). Multiple reaction monitoring (MRM) mode was employed. After intragastric administration of GK-A, the urine and bile samples were collected at different time points, and the contents of GK-A in the samples were determined, and the cumulative excretion and cumulative excretion rate were calculated. Result::After 72 h of administration, the cumulative excretion of GK-A in urine was (12.35±2.69) μg, and the cumulative excretion rate was (0.58±0.13)%. Meanwhile, after 24 h of administration, the cumulative excretion of GK-A in bile was (55.16±29.22) μg, and the cumulative excretion rate was (1.57±0.83)%. Only a small amount of GK-A was excreted from urine and bile of rats with a slow speed. Conclusion::After intragastric administration, the excretion of GK-A in rat urine and bile is not the main elimination pathway.

Evaluation and analysis of high-quality products of Liuwei Dihuang Pills / 中国中药杂志

Liuwei Dihuang Pills is a typical traditional Chinese medicine with "the same product made by many manufacturers". The quality and price of products made in various factories was different obviously. In this study, the quality differences of Liuwei Dihuang Pills were evaluated over multi-dimensions and throughout the whole production cycle involving raw materials, production process, quality control and post-marketing re-studies based on the "Chinese patent medicine evaluation standard with quality at the core" established earlier by our research group. The research results showed that the product quality of various manufacturers was significantly different, and the product quality was positively correlated with the market shares of enterprises, indicating that enterprises with more market shares paid more attention to product quality; and the sales determined the concern degree of enterprises on products, which was in line with general cognition. During the single-item evaluation of Liuwei Dihuang Pills, the score of raw material selection was relatively low, and the enterprises paid less attention to the initial raw materials. The whole production process was better, and the national compulsory implementation of "Production Quality Management Standard"(GMP) had a positive effect in improving product quality. Quality control could basically guarantee product quality. Intelligent manufacturing promoted by the government was beneficial to ensure product uniformity. The score rate of "quality evaluation" item was basically qualified, which indicated that the quality control level of Liuwei Dihuang Pills was acceptable as a whole, but there was still room for improvement. "Re-evaluation and Brand Construction" had the lowest scores, reflecting that enterprises did not pay enough attention to in-depth study and re-evaluation of "the same product made by many manufacturers". The evaluation results were in line with expectations, provided a reference example for the evaluation of high-quality Chinese patent medicine, a basis for the high-quality and good price of Chinese patent medicine, scientific data for improving medical insurance bidding, and thus facilitated promoting the healthy development of the traditional Chinese medicine industry.

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.

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 evaluation criteria over quality as core index of high grade Chinese patent medicine / 中国中药杂志

"One drug was produced by many companies" is common in Chinese patent medicines. The quality and price of products from different manufacturers varies widely, and the efficacy is inconsistency. In order to ensure the quality of Chinese patent medicines and promote "Healthy national program" implementation, it is necessary to study the current status of Chinese patent medicines and carry out the evaluation criteria over quality as the core management of high grade Chinese patent medicines, which is set up to reflect the evaluation strategy and method of Chinese patent medicines from raw material, production, quality control, reevaluation and competitive power to the whole chain of brand construction. It aims to reveal the quality discrepancy from different manufacturers over the same Chinese patent medicines. The research and application will select a serials of high grade quality products, and provide reference basis for the scientific and reasonable price formation mechanism of Chinese patent medicines and purchasing drugs by centralized bidding, guide healthy competition in the market and promote the implementation of "healthy China 2030 program".

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.

Explore a method for formulation of limit standard of toxic components in traditional Chinese medicine:aristolochic acid as a case study / 中国中药杂志

It is urgent to establish the limit standard of toxic components of Chinese herbal medicine, since the safety of traditional Chinese medicine (TCM) has attracted more and more attention.This paper analyzes the present situation and problems in the study of the limit standard of toxic components of Chinese herbal medicine. In addition, the current methods for setting the limit standards of toxic ingredients of TCM are reviewed in this paper, and we also propose a theoretical calculation method for setting the limit standards of toxic ingredients of TCM. Employing aristolochic acid as a case study, we formulate the limit standard of toxic components of Chinese herbal medicine. We believe this paper would provide some useful suggesting for formulating limits standard of toxic components of TCM.

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.

Research and development strategies in classical herbal formulae / 中国中药杂志

As an outstanding representative of traditional Chinese medicine prescription, classical herbal formulae are the essence of traditional Chinese medicine great treasure. To support the development of classical herbal formulae, the state and relevant administrative departments have successively promulgated the relevant encouraged policies.But some key issues of classic herbal formulae in the development process have not reached a unified consensus and standard, and these problems were discussed in depth here.The authors discussed the registration requirements of classical herbal formulae, proposed the screening specific indicators of classical herbal formulae, determination basis of prescription and dosage,screening method of production process, and the basic principle of clinical localization, in order to bring out valuable opinions and provide a reference for classical herbal formulae development and policy formulation.

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.