Integrating chemical similarity and bioequivalence: an overall evaluation of the quality consistency of traditional decoction and dispensing granule decoction of Amomum villosum.

OBJECTIVE: This study aims to investigate the quality consistency between traditional decoction (TD) of Amomum villosum and its dispensing granule decoction (DGD). Fifteen batches of TD and nine batches of dispensing granules (manufactured by A, B, and C) were prepared and evaluated for their consistency. METHODS: Firstly, The chemical similarity of TD and DGD was examined using GC and HPLC, coupled with hierarchical cluster analysis (HCA), criteria importance though intercrieria correlation(CRITIC) weighting method, and principal component analysis (PCA). Secondly, the gastrointestinal motility experiments in mice, along with the CRITIC weighting method, were employed to assess the bioequivalence of TD and DGD of Amomum villosum. Finally, the entropy weight technique-gray relative analysis(GRA) method was used to compare the quality of Amomum villosum decoctions. RESULTS: ①The CRITIC weighting method indicated significantly higher scores for TD than DGD (p < 0.01). HCA and PCA results demonstrated a clear distinction between TD and DGD. ②Gastrointestinal motility test results revealed no significant difference between TD and DGD in other indicators (p > 0.05).③Gray relative analysis results showed that the relative correlation of TD was more significant than that of DGD. CONCLUSION: The chemical composition of DGD and TD differed. The biological activity of DGD-A/B was consistent with that of TD, while the difference between DGD-C and TD was significant. A comprehensive evaluation showed that TD exhibited better quality than DGD. DGD manufacturers should optimize the preparation process to enhance product quality.

Comparative study on main compounds and hypoglycemic effects of dispensing granules of Coptidis Rhizoma and Scutellaria-Coptis herb couple with traditional decoction.

BACKGROUND: The clinical applications of dispensing granules (DG) have increased dramatically. However, it is controversial whether the DG has the same quality and efficacy compared with traditional decoction (TD). In this study, the contents of main compounds, hypoglycemic effects, and potential mechanism of Coptidis Rhizoma (CR) and Scutellaria-coptis (SC), constituted of a 1:1 mixture of CR and Scutellariae Radix (SR), in the forms of TD and DG were compared. METHODS: The quantitative analysis was performed on an UPLC-PDA method. The 6-weeks-old male db/db mice were used as Type 2 Diabetes Mellitus (T2DM) mouse modle to investigate the antidiabetic effects of CR and SC in TD form (CR TD and SC TD), as well as CR and SC in DG form (CR DG and SC DG). RESULTS: The total content of five alkaloids in CR TD ranged from 71.00 to 78.62 mg, whereas in CR DG it ranged from 38.77 to 53.68 mg in CR DG per 1 g of decoction pieces. Compared to CR TD, CR DG exhibited a 36% reduction on average. For SC samples, the precipitation occurred in the processing of TD but not in the DG, and the relative ratio of alkaloids to flavonoids was determined to be 1:1 in TD and 1:2 in DG. Furthermore, the animal experiments showed that the CR DG (equivalent to 3 g decoction pieces/kg) had almost the same hypoglycemic effect as CR TD when they were administered for 6 weeks. Compared with SC DG (equivalent to 6 g decoction pieces/kg), SC TD showed a better trend in ameliorating T2DM via ameliorating pancreatic structure and function, and activating Akt/AMPK/GLUT4 signaling pathways. CONCLUSION: This study indicated that the contents of main compounds were generally higher in CR TD than CR DG originated from the same raw materials. Additionally, changes in the contents of the primary components validated that the compound interactions are exclusive to SC TD during co-decoction, rather than SC DG. The disparate prossing of SC DG and SC TD caused differences both in chemical composition and hypoglycemic effect, suggesting that the substitutability of DG and TD requires further research.

Quality consistency evaluation of chemical composition and pharmacology of Shaoyao-Gancao decoction dispensing granules and traditional decoction.

Dispensing granules of Chinese medicine (DGCM) have emerged as a more convenient alternative to traditional decoction (TD) of Chinese medicine, gaining popularity in recent years. However, the debate surrounding the consistency of DGCM compared to TD remains unresolved. In this study, three batches of Baishao and Gancao DGCM were obtained from manufacturers A, B, and C, and 15 batches of crude drugs were procured from hospital pharmacies for the preparation of dispensing granule decoction (DGD) and TD of Shaoyao-Gancao decoction (SGD). The HPLC-UV method was employed to determine the levels of gallic acid, paeoniflorin, albiflorin, liquiritin, liquiritin apioside, isoliquiritin apioside, isoliquiritin, glycyrrhizic acid, and isoliquiritigenin. The analgesic and antispasmodic effects were assessed using the hot plate and acetic acid writhing test in mice. To evaluate the consistency of chemical constituents and pharmacological effects between the two decoctions, the Criteria Importance Though Intercriteria Correlation (CRITIC) method combined with chemometrics was employed. Grey relation analysis (GRA) was used to assess the comprehensive quality consistency of the two decoctions. The CRITIC results revealed certain differences in chemical constituents and pharmacological effects between the selected DGCM and TD. Notably, DGD-A/C exhibited a significant difference from TD (p > 0.05), whereas DGD-B demonstrated no significant difference from TD (p > 0.05). The GRA analysis demonstrated that the overall quality consistency between DGD-B and TD was the highest among the three manufacturers. This study presents a method for evaluating the quality consistency of DGCM and TD of SGD, offering novel insights into the evaluation of consistency between DGCM and TD.

Comparison of the fingerprint and multi-component contents between Liuwei dihuang powder decoction pieces and traditional decoction pieces with different decocting time / 中国药房

OBJECTIVE To compare the change law of multi-components in the extraction process between Liuwei dihuang powder decoction pieces and traditional decoction pieces （hereinafter referred to as powder decoction pieces and traditional decoction pieces）， and to provide scientific basis for the modern technology research of Liuwei dihuang formula. METHODS Taking powder decoction pieces and traditional decoction pieces as samples， the samples were taken when soaking for 60 min， at 0， 5， 10， 15， 20， 25， 30， 40， 50， 60 min of the first decocting and at 5， 10， 20， 30， 40 min of the second decocting， respectively. HPLC method was used to establish the fingerprints of 2 kinds of decoction pieces with different decocting time. The similarity evaluation and peak identification were performed. The contents of 8 components including 5-hydroxyfurfural， catechin， monoglycoside， loganin， swertin glycoside， dihydroquercetin， paeonol and benzoyl paeoniflorin were all determined. RESULTS With different decocting time， the similarties between 2 kinds of decoction pieces and their respective control fingerprints R were all greater than 0.98. In the fingerprints of traditional decoction pieces， five chromatographic peaks were identified， namely， 5- hydroxyfurfural， monetin， swertiaoside， dihydroquercetin and paeonol； in the fingerprints of powder decoction pieces， six chromatographic peaks were identified， namely， 5-hydroxyfurfural， monoglycoside， swertiamarin， dihydroquercetin， paeonol and benzoyl paeoniflorin. The results of content determination showed that in the first 5 minutes of the first decocting， the decocting rate of almost all the ingredients in the powder decoction pieces was faster than that of the traditional decoction pieces； after 40 min， the contents of other active ingredients were lower than those of traditional decoction pieces except for 5-hydroxyfurfural and paeonol. In the process of second decocting， except for paeonol and loganin， the contents of other ingredients in powder decoction pieces were higher than that in traditional decoction pieces； catechin was completely decocted from the traditional decoction pieces in the first decocting， while it could still be detected in the powder decoction pieces in the second decocting. There was little difference in the total decocted amount of the 8 ingredients in the two decoction pieces. CONCLUSIONS The chemical composition of powder decoction pieces of Liuwei dihuang formula has no obvious advantages compared with traditional decoction pieces， and can not save the decocting time and the amount of medicinal materials.

Research on Preparation Process and Quality Evaluation of Traditional Chinese Medicine Dispensing Granules and Its Consistency with Traditional Decoction： A Review / 中国实验方剂学杂志

Traditional Chinese medicine dispensing granules（TCMDGs）is the new type of decoction pieces with the development of modernization of TCM， which has received mixed opinions since its practical application. In 2021， the national departments issued Announcement on Ending the Pilot Work of TCMDGs， marking the end of the 28-year pilot work of TCMDGs， and eligible TCM enterprises can produce TCMDGs after filing. However， this does not mean that the preparation process， quality standard and efficacy research of TCMDGs have been developed and matured， on the contrary， there are still some problems that need to be solved and gradually improved. For example， in the production process， there are problems such as unclear， unified and non-standardized preparation parameters. In terms of quality control， there are some problems such as lack of producing area regulation， variety selection and processing specification. In terms of consistency evaluation with traditional decoction， there are problems such as unclear relationship between the chemical constituents and pharmacological effects of the two. Therefore， in view of some prominent problems of TCMDGs at present， this paper takes the published literature as the main data source and combines the specific requirements of the code or technical standards such as the 2020 edition of Chinese Pharmacopoeia， Publicity of the Unified Standard on the Varieties of TCMDGs， Quality Control and Standard Formulation Technical Requirements of TCMDGs. The production process of TCMDGs， the origin and variety of raw materials， the processing of decoction pieces， the quality control standard and the consistency evaluation of formula granules and traditional decoction were sorted out and visualized by literature mining， data analysis and list comparison. Based on the analysis results， the following suggestions were made. In terms of preparation process， the completeness and standardization of process parameters should be strengthened. In terms of quality evaluation， attention should be paid to the relationship between the authenticity， variety， processing and quality of medicinal materials. In the consistency evaluation of formula granules and traditional decoction， the deep difference and mechanism between TCMDGs and traditional decoction were discussed by combining structural Chinese medicine， quality marker（Q-Marker） theory and physicochemical characterization， so as to provide reference for the application and development of TCMDGs.

Achillea moschata Wulfen: From Ethnobotany to Phytochemistry, Morphology, and Biological Activity.

A multidisciplinary investigation on Achillea moschata Wulfen (Asteraceae) is outlined herein. This work, part of the European Interreg Italy-Switzerland B-ICE project, originated from an ethnobotanical survey performed in Chiesa in Valmalenco (Sondrio, Lombardy, Northern Italy) in 2019-2021 which highlighted this species' relevance of use in folk medicine to treat gastrointestinal diseases. In addition, this contribution included analyses of the: (a) phytochemical profile of the aqueous and methanolic extracts of the dried flower heads using LC-MS/MS; (b) morpho-anatomy and histochemistry of the vegetative and reproductive organs through Light, Fluorescence, and Scanning Electron Microscopy; (c) biological activity of the aqueous extract concerning the antioxidant and anti-inflammatory potential through cell-based in vitro models. A total of 31 compounds (5 phenolic acids, 13 flavonols, and 13 flavones) were detected, 28 of which included in both extracts. Covering and secreting trichomes were observed: the biseriate 10-celled glandular trichomes prevailing on the inflorescences represented the main sites of synthesis of the polyphenols and flavonoids detected in the extracts, along with volatile terpenoids. Finally, significant antioxidant and anti-inflammatory activities of the aqueous extract were documented, even at very low concentrations; for the first time, the in vitro tests allowed us to formulate hypotheses about the mechanism of action. This work brings an element of novelty due to the faithful reproduction of the traditional aqueous preparation and the combination of phytochemical and micromorphological research approaches.

A comparative study of consistency between Paeonia rubra hort traditional decoction and dispensing granule decoctions from different sources.

OBJECTIVE: To compare the consistency between the decoction of Paeonia rubra hort dispensing granules from different manufacturers and traditional decoction (TD), and to provide a reference for the clinical application of Paeonia rubra hort dispensing granules. METHODS: Nine batches of Paeonia rubra hort dispensing granules (from three manufacturers, A, B, and C) and 20 batches of Paeonia rubra hort decoction pieces were collected. The contents of four active components in vivo and in vitro were determined by HPLC and UPLC-MS/MS, respectively. The consistency of the Paeonia rubra hort decoction pieces and dispensing granules were compared based on the Criteria Importance Though Intercrieria Correlation (CRITIC) weighting method and the equivalent correction suggestions (1 g of dispensing granule equals the same amount of Chinese herbal samples) were put forward for the dispensing granules. RESULTS: The total content of active ingredients in vivo and in vitro of manufacturer A was significantly lower than that of TD (p < 0.05), and the total content of active ingredients in vivo of manufacturer C was significantly lower than that of TD (p < 0.05); The equivalent of manufacturer A and manufacturer C should be corrected from 1:11 and 1:5 to 1:5 and 1:4, respectively. CONCLUSION: The quality of Paeonia rubra hort dispensing granule decoction from some manufacturers aligns that of TD, but the other is slightly inferior to that of TD. After appropriate equivalent correction, quality consistency can be achieved with TD.

Comparative pharmacokinetics study of six effective components between two dosage forms of Qixue-Shuangbu Prescription in rats by UPLC-MS/MS.

Qixue-Shuangbu Prescription (QSP) is an efficacious prescription for treating heart failure, myocardial ischemia and other diseases. It is composed of nine Chinese herbs. This study investigated and compared the pharmacokinetics of QSP in rats by UPLC-MS/MS between two dosage forms of traditional decoction (TD) and compound tincture (CT). Owing to the complexity of the chemicals in QSP, ginsenoside Rg1, ginsenoside Re, ferulic acid, astragaloside IV, rhein and calycosin were chosen for the pharmacokinetics study. The method established for detecting serum specimens was shown to have acceptable selectivity, linearity, lower limit of quantitation, precision, accuracy, recovery, matrix effect and stability. The peak concentration, AUC0-t and AUC0-∞ of ginsenoside Re, ginsenoside Rg1, ferulic acid and rhein were significantly increased after oral administration of CT (P < 0.05), the half-life of ferulic acid in the CT group was lower than that in the TD group (P < 0.05) and the half-life and AUC0-∞ of astragaloside IV in the CT group were significantly increased (P < 0.05), which revealed that wine-processing could influence the bioavailability and the elimination of these compounds. For better clinical efficacy, we suggest that the CT dosage form of QSP should be selected.

Consistency evaluation between dispensing granule and traditional decoction from Coptidis Rhizoma by using an integrated quality-based strategy.

INTRODUCTION: Dispensing granule, an innovative product of traditional Chinese medicine decoction, is widely practiced in clinic. As a prerequisite to support the clinical medication, quality consistency between dispensing granule and traditional decoction need to be evaluated. Furthermore, a generally applicable strategy for consistency evaluation of dispensing granule is needed. OBJECTIVE: In this study, we aimed to propose an integrated quality-based strategy to assess consistency between dispensing granule and traditional decoction taking Coptidis Rhizoma (CR) as a case study. METHODOLOGY: For chemical consistency evaluation, efficacy-related Coptis alkaloids were quantified with high-performance liquid chromatography (HPLC). The "Mean ± 3SD" of analyte contents in traditional decoction was considered as the criterion of consistency. And, as auxiliary analysis, principal component analysis (PCA) was employed for data visualisation. For biological consistency evaluation, two one-side t-tests and 90% confidence intervals of the geometric mean ratio of antibacterial zone diameter and 50% inhibitory concentration (IC50 ) of α-glucosidase inhibition were calculated. The scope of 80.00% to 125.00% was taken as in vitro bioequivalence interval. It was considered internally consistent with traditional decoction when the chemical and biological indices of dispensing granule fulfilled the preset criteria simultaneously. RESULTS: Eight out of 20 batches of CR dispensing granule were demonstrated consistent with traditional decoction in chemistry and biological activities. CONCLUSIONS: A generally applicable strategy was recommended that integrates chemical and biological characteristics for consistency evaluation of dispensing granule.

Study on the Effects of the Integration of Field Processing and Decoction Piece Processing on Chemical Com- position of Ligusticum chuanxiong Decoction Pieces / 中国药房

OBJECTIVE：To investigate the effects of the integration of field processing and decoction piece processing （hereinafter called “Integration”for short ）on chemical composition of Ligusticum chuanxiong decoction pieces. METHODS ：Fresh L. chuanxiong were collected from Dujiangyan and Pengzhou of Sichuan ；integrated decoction pieces of L. chuanxiong were prepared after washing ，drying in the shade （to about 28％ moisture content ），slicing and drying ；traditional decoction pieces was prepared after drying in the shade ，adding water to moisten （to the core ），slicing and drying. HPLC fingerprints of two kinds of decoction pieces samples （with 10 batches in each type ）were established. The determination was performed on WondaSil C 18 column with mobile phase consisted of 1％ formic acid solution-acetonitrile （gradient elution ）at the flow rate of 1.0 mL/min. The column temperature was 30 ℃. The detection wavelength was set at 285 nm，and the sample size was 10 μL. Using ligusticolide A as reference ，HPLC fingerprints of 20 batches of samples were drawn. The similarity of the fingerprints was evaluated with Similarity Evaluation System for Chromatographic Fingerprint of TCM （2004A edition ），and then common peaks were confirmed. The contents of chlorogenic acid ，ferulic acid and ligusticolide A were determined by above chromatographic condition. Single factor variance analysis was performed for comparison of the contents. RESULTS ：The similarity of HPLC fingerprints among 20 batches of samples was above 0.900. A total of 16 common peaks were determined ，7 of which were chlorogenic acid ，ferulic acid，ligusticolide Ⅰ，pine cypress ferulinate ，ligusticolide A ，n-butylphthalide and ligustilide ，respectively. The linear range of chlorogenic acid ，ferulic acid and ligusticolide A were 0.008-0.200 mg/mL（r＝0.999 9），0.010-0.140 mg/mL（r＝0.999 2）and 0.100-0.600 mg/mL（r＝0.999 3）；the limits of quantification were 0.002 8，0.000 6 and 0.005 0 mg/mL，respectively；the limits of detection were 0.000 8，0.000 1 and 0.001 0 mg/mL，respectively；RSDs of precision ，reproducibility and stability tests were all lower than 3％，and average recoveries were 96.27％-102.02％（RSD＜2％，n＝6）. The contents of above compositions in the integrated decoction pieces and traditional decoction pieces were（1.677 0±0.311 0），（1.562 7±0.124 5），（9.494 0±1.351 3）mg/g and（1.300 2±0.469 2），（1.388 0±0.209 9），（9.811 7±1.098 9）mg/g，respectively；there was no statistical significance between 2 groups（P＞0.05）. CONCLUSIONS ：The chemical composition of each batch of samples of L. chuanxiong integrated decoction pieces and traditional decoction pieces is consistent ，and the content of index components as chlorogenic acid ，ferulic acid and ligusticolide A in the decoction pieces is not affected by the integration processing. This process is feasible to a certain extent.

Comparative in vivo constituents and pharmacokinetic study in rats after oral administration of ultrafine granular powder and traditional decoction slices of Chinese Salvia.

Salvia miltiorrhiza, one of the most well-known herbal medicines, is commonly used for the treatment of coronary heart diseases in China. Besides traditional decoction slices (TDS), another relatively new product of S. miltiorrhiza, ultrafine granular powder (UGP; D90 < 45 µm), is also increasingly being used. In this paper, a UHPLC-LTQ-Orbitrap MS technique was developed for a metabolite profile study after oral administration of UGP and TDS of S. miltiorrhiza. The results showed that the number of in vivo absorbed compounds from UGP was much greater than that from TDS, and different types of products from S. miltiorrhiza will have different metabolic processes in vivo. Furthermore, a UHPLC-Q-Trap MS/MS method for simultaneously determining four tanshinones (tanshinone IIA, dihydrotanshinone I, tanshinone I and cryptotanshinone) was established and applied to assess the pharmacokinetics of the two types of products. All of the analytes displayed significant higher area under the concentration-time curve and peak concentration after oral administration of UGP than after TDS, indicating that ultrafine powder product could improve the bioavailability and absorption of cryptotanshinon,tanshinone II A,dihydrotanshinonE I and tanshinone I in vivo. The present study provides scientific information for further exploration of the pharmacology of these two types of S. miltiorrhiza and offers a reference for clinical administration of S. miltiorrhiza.

Analysis of ingredients difference between Danggui Buxue Decoction and formula granule decoction based on HPLC fingerprint evaluation / 中草药

Objective: Taking Danggui Buxue Decoction (DBD) as the research object, the differences of chemical composition types and content among traditional decoction, self-made granule decoction and marketable granule decoction were compared, in order to provide scientific basis for clinical application of Chinese medicine formul granules. Methods: The fingerprint was established by HPLC. The value of the chemical composition, the content of the index components, the area of the common peak area, and the similarity of the fingerprint were evaluated, and the different dosage forms of the decoction of DBD were investigated. The effect of chemical composition on the chemical equivalence of traditional decoction and formula granules was compared. Results: The number of chromatographic peaks ranged from 15 peaks of traditional decoction to 13 (factory A), 12 (self-made), 11 (factory B), and 9 (factory C). The content of ferulic acid in formula granules was significantly different from that in traditional decoction (P formula granule decoction of factory A > self-made formula granule decoction > formula granule decoction of factory B > formula granule decoction of factory C. Content of campanulin was in order : self-made formula granule decoction > traditional decoction > formula granule decoction of factory A > formula granule decoction of factory B > formula granule decoction of factory C. The total peak area of formula granule decoction was lower than that of traditional decoction. If the traditional decoction was 1, the others (self-made and factories A, B, C) were equivalent to 0.95, 0.66, 0.40 and 0.47, respectively. Comparing with traditional decoction, self-made formula granule decoction and formula granules from factories A and B had higher similarity (0.97, 0.96, 0.98), while that from factory C was slightly lower (0.85). The main chromatographic peaks of DBD were found to be from the single herbs and no new chemical components were found. The disappearance of ingredients in formula granule Decoction was found. Conclusion: The content of index components and the number of chromatographic peaks of traditional decoction of DBD is higher than those in the formula granule decoction. There are some differences between them. This indicates that the clinical equivalence of formula granules is not consistent with the reality of decoction, so the recommended clinical equivalence of formula granules of traditional Chinese medicine should be corrected to promote rational clinical application, which can provide scientific research ideas for the unified management of the quality of formula granules of Chinese materia medica.

Comparison of the efficacy of dispensing granules with traditional decoction: a systematic review and meta-analysis.

BACKGROUND: Dispensing granules have been developed for about 20 years. However, whether they are as effective as the traditional decoction kept unclear. This systematic review and meta-analysis was made to assess the efficacy of dispensing granules compared with traditional decoction. METHODS: We searched four databases since their inception to 9th September in 2016. Two authors independently identified trials, extracted data and assessed risk of bias with Cochrane Reviewer's Handbook 5.0. We conducted meta-analysis with RevMan 5.1.0 software for eligible and appropriate trials. RESULTS: In the end, 7,035 participants from 51 randomized controlled trials (RCTs) which compared dispensing granules with traditional decoction were included in this systematic review. There were 33 different kinds of diseases for investigation, of which 8 RCTs observed common cold, 4 RCTs observed migraine. For rheumatoid arthritis, insomnia and hypertension, there were 3 RCTs reported respectively. The last RCTs reported different kinds of diseases in one or two trials. The majority of trials were in low methodological quality. Thirty-eight (74.5%) RCTs showed that the efficacy of dispensing granules were similar with traditional decoction, 6 (11.8%) RCTs reported that the therapeutic efficacy of dispensing granules were significantly better than traditional decoction. We conducted meta-analysis for 4 trials investigating patients with migraine. The results showed that dispensing granules reduced headache frequency by about 1.03 attacks per month as compared to traditional decoction. No evidence was found in terms of migraine intensity and duration. CONCLUSIONS: The low quality of RCTs and conflicting results made it difficult to draw a definite conclusion. In the future, it needs much more evidence to explore the efficacy and safety of dispensing granules. N-of-1 trials and fuzzy comprehensive evaluation methods may be better choices for assessing the efficacy of them than RCTs.

Content Comparison of Total Saponins and Total Polysaccharides between Formula Granules and Traditional Decoction of Sijunzi Decoction / 中国药师

Objective: To compare the content of total saponins and total polysaccharides between formula granule and traditional decoction of Sijunzi decoction.Methods: UV spectrophotometry was used to determine the content of total saponins and total polysaccharides in formula granule and traditional decoction of Sijunzi decoction respectively at the wavelength of 540 nm and 488 nm.Results: The absorbance of ginsenoside Re had a good linear correlation with the concentration within the range of 10.909-65.454 μg · ml-1 (r=0.999 7), and the average recovery was 98.49%(RSD=0.85%, n=6);the absorbance of D-anhydrous glucose had a good linear correlation with the concentration within the range of 2.160-12.960 μg · ml-1 (r=0.999 7), and the average recovery was 99.46%(RSD=0.73%, n=6).The contents of total saponins from 3 batches of formula granule were slightly higher than those from traditional decoction,and that of total polysaccharides in formula granule was slightly lower than that in traditional decoction,and there was no significant difference between the two groups (P>0.05)Conclusion: The difference of material basis between formula granule and traditional decoction of Sijunzi decoction is small, and formula granule is more feasible for clinical application.

Content Comparison of Specnuezhenide in Traditional Decoction and Granules of Zishenwufa Formula / 中国药师

Objective:To establish a method for the determination of specnuezhenide in traditional decoction and granules of Zish-enwufa formula, and compare the content between them. Methods:HPLC was used for the determination. The samples were analyzed on a Waters Symmetry C18 column (150 mm × 3. 9 mm,5 μm) with acetonitrile-water (16 ∶84) as the mobile phase. The flow rate was 1. 0 ml·min-1 and the detection wavelength was 224nm. Results: A good linearity of specnuezhenide was within the range of 0.179 2-3.316 μg(r=0.999 9),and the average recovery of berberine hydrochloride was 101.65% with RSD of 1.49%(n=6). Conclusion:The determination method is simple, accurate and sensitive with good reproducibility,which can be used for the determi-nation of specnuezhenide in the preparation. The content of specnuezhenide in the traditional decoction and granules of Zishenwufa for-mula is similar.

Comparative Study on the HPLC Fingerprint of Sini Decoction Prepared by Traditional Decoction and Mod-ern Machine Decoction / 中国药房

OBJECTIVE:To establish the HPLC fingerprints for Sini decoction and compare the differences of compositions of Sini decoction prepared by traditional decoction and modern machine decoction. METHODS:HPLC was performed on the column of Kromasil C18 with mobile phase of acetonitrile-0.1% phosphoric acid(gradient elution)at a flow rate of 1.0 ml/min,the detec-tion wavelength was 235 nm,column temperature was 30 ℃,and injection volume was 10 μl. The HPLC fingerprints of 10 batch-es of Sini decoction were determined with reference peak of liquiritin peaks,and common peak identification and similarity evalua-tion were conducted by using Chromatographic Fingerprint Similarity Evaluation System(2004 A edition). RESULTS:There were 18 common peaks and the similarity was no less than 0.982. According to the verification,the fingerprint of 10 batches of Sini de-coction showed good similarity with reference fingerprint,and the similarity of 10 batches of Sini decoction was high,which was prepared by the 2 methods. CONCLUSIONS:The established fingerprint is specific and stable,and can provide reference for quali-ty evaluation and control for Sini decoction;and there are no obvious differences in the main chemical compositions of Sini decoc-tion prepared by traditional decoction and modern machine decoction.

Comparison on six active constituents between formula granule and traditional decoction of Rehmanniae Decoction of six ingredients / 中草药

Objective: To compare the content of chemical components in each drug in formula granule and traditional decoction of Rehmanniae Decoction with six ingredients. Methods: By using high performance liquid chromatography analysis and various chromatographic conditions, the contents were determined respectively, which were listed as follows: acteoside, loganin, paeonol, allantoin, pachymic acid and alisol B 23-acetate. Results: The contents of acteoside, loganin, paeonol, allantoin, pachymic acid and alisol B 23-acetate in traditional decoction were 304.5, 2 473.6, 3 135.1, 708.8, 5.9, and 104.4 μg/g, and they were 289.6, 3 685.7, 706.5, 714.2, 17.4, and 217.8 μg/g correspondingly in formula granule. The contents of acteoside and allantoin were basically the same between them; The contents of loganin, pachymic acid, and alisol B 23-acetate in formula granule were significantly higher than those in the traditional decoction; The content of paeonol in formula granule was significantly lower than that in the traditional decoction. Conclusion: The content difference of the chemical components is related to its chemical character between formula granule and traditional decoction.

Comparison on Traditional and Machinery Decoctions for Da-cheng-qi Decoction Based on Chemical Ingredients, Pharmacological Functions, and Clinical Trials / 中草药·英文版

Objective: Patients and doctors often have questions about the equivalence of traditional and machinery decoctions. In this article, using Da-cheng-qi Decoction (DCQD) as a model of formula, traditional decoction (TD), machinery decoction under high pressure (MDHP), and machinery decoction under normal pressure (MDNP) were compared. Methods: For chemical components, HPLC fingerprints were established and evaluated using AHP combined with CRITIC weighing method; For animals' effects, the experiments of small intestinal propulsion were conducted; For clinical effects, a randomized clinical trial (RCT) was designed and performed. Results: Although there were some differences between TD and MDNP in chemical ingredients, there was no significant difference in animal experiments and clinical trials (P > 0.05). Conclusion: The traditional and machinery decoctions of DCQD could be used bioequivalently.

Comparison on content differences of four bioactive compounds in different Wujiwan decoction by HPCE internal standard method / 中草药

Objective: To study the content difference of berberine hydrochloride, palmatine hydrochloride, jatrorrhizine hydrochloride, and paeoniflorin in Wujiwan traditional decoction, granule prescription, and compound granule using HPCE internal standard method. Methods: Capillary zone electrophoresis (CZE) method was used for a complete separation of the components, which was achieved with 50 mmol/L borax buffer-methanol (2:1), constant voltage of 25 kV, pressure injection 5 kPa × 15 s, electrolyle sealing 5 kPa × 10 s, and column temperature of 15°C. Results: The capillary electrophoresis method is simple and accurate. The contents of the three alkaloids in the granule prescription were obviously higher than those in traditional decoction and compound granule. Conclusion: This method is instructive for clinical application and quality control of Wujiwan prescription and compound granule.

Comparison analysis of compositions of traditional decoction and dispensing granule decoction of Duhuo Jisheng Tang / 中国药学杂志

OBJECTIVE: To study and compare the compositions of traditional decoction and compatible granules of Duhuo Jisheng Tang and reveal their differences in inner quality. METHODS: The compositions of eight medicines, i.e., duhuo, sangjisheng, danggui, chuangxiong, fuling, baishao, qinjiao and gancao in traditional decoction and dispensing granule decoction, were identified by TLC. And the contents of paeoniflorin were determined by HPLC. RESULTS: There were more spots of the eight than dispensing granules. The content of peaoniflorin of the traditional decoction was 29.37mg·g-1. The content of peaoniflorin of the dispensing granule decoction is 2.59 mg·g-1. CONCLUSION: Composition contents in traditional decoction from Duhuo Jisheng Tang is higher than that of dispensing granule decoction.