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Objective To establish the method for the simultaneous determination of hypoxanthine, inosine, guanosine and adenosine in Dilong formula granules by HPLC and compare the fingerprints of Dilong formula granules from different manufacturers by HPLC chromatogram. Methods The contents of hypoxanthine, inosine, guanosine and adenosine were determined by Thermo AcclaimTM120C18 column (4.6 mm×250 mm 5 μm). The mobile phase was acetonitrile-water. Gradient elution with flow rate of 0.6 ml/min was used. Column temperature was 25 ℃. Detection wavelength was 254 nm. 10 batches of samples were tested. The HPLC chromatogram were compared and analyzed by using the similarity Evaluation system of chromatographic fingerprint of traditional Chinese Medicine (version 2012.130723). Results The linear ranges for the detection of hypoxanthine, inosine, guanosine and adenosine showed good linear relationships within their own ranges (r≥0.999 9). The average recoveries were 99.20%~102.98% with RSD of 0.26 %~0.71%. The contents of 4 components in 10 batches of samples were 0.740 0~4.457 4 mg/g, 2.132 3~7.805 0 mg/g, 0.325 4~1.596 1 mg/g, 0.537 2~2.222 9 mg/g respectively. The similarity between HPLC chromatogram and control fingerprints of Dilong formula granules from different manufacturers was greater than 0.91. Conclusion The method could be used to determine the contents of hypoxanthine, inosine, guanosine and adenosine in Dilong formula granule. HPLC fingerprints could be used to evaluation the quality in Dilong formula granule. The similarity of HPLC fingerprints from different manufacturer production of Dilong formula granule is high, but 4 contents in composition are difference.
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OBJECTIVE In order to analyze the current situation of policy tool allocation in China’s TCM formula granule industry， and provide a theoretical basis for the high-quality development of the industry. METHODS Based on the perspective of policy tools，“ TCM formula granules” was used as the keyword to retrieve the official websites of departments directly under the State Council such as the National Medical Products Administration and the National Administration of Traditional Chinese Medicine， as well as provincial governments. The relevant clauses in the policy documents related to TCM formula granules in China from 1993 to 2022 were encoded， and then the application of policy tools was summarized and classified. RESULTS & CONCLUSIONS A total of 12 national documents and 77 provincial documents were ultimately selected， involving 556 relevant policy clauses. It was found that among the relevant policy tools， environmental policy tools had the highest degree of attention， accounting for 62.6%； the proportions of demand-oriented policy tools and supply-oriented policy tools were less， accounting for 17.8% and 19.6%， respectively. From the perspective of policy tools， the use of demand-oriented policy tools in current policy texts was relatively simple， and various policy tools were given low attention； from the perspective of policy objectives， the proportion of use of environmental， demand-oriented and supply-oriented policy tools were not balanced enough. It is suggested to increase the proportion of demand- oriented policy tools to meet international competition； emphasize the use of supply-oriented policy tools to strictly control product quality； consolidate the use of environmental policy tools to standardize quality standards. On this basis， we will coordinate the overall situation， balance the use of various policy tools and promote the development of TCM formula granule industry.
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Objective:To study the HPLC fingerprints of Coptidis Rhizoma- Magnoliae Officmalis Cortex formula granules and the differences of active ingredients in different proportions; To explore the content changes of key components in different proportions of Coptidis Rhizoma- Magnoliae Officmalis Cortex. Methods:HPLC was used to determine the contents of several alkaloids and total phenol of Magnolia officinalis in Coptidis Rhizoma- Magnoliae Officmalis Cortex formula granules and their fingerprints, and the similarity evaluation, cluster analysis and principal component analysis were performed. Results:The similarity of fingerprint of 10 batches of Coptidis Rhizoma- Magnoliae Officmalis Cortex was > 0.950. 17 common peaks were identified, and 6 components were identified. Compared with single medicine, the contents of alkaloids and total phenols in the Coptidis Rhizoma- Magnoliae Officmalis Cortex formula granules were significantly reduced. The contents of multiple alkaloids and total phenols in the Coptidis Rhizoma- Magnoliae Officmalis Cortex formula granules in different proportions were different, and the contents of alkaloids and total phenols were the highest when the proportion of Coptidis Rhizoma- Magnoliae Officmalis Cortex was 2∶1. Conclusion:The contents of main components of Coptidis Rhizoma- Magnoliae Officmalis Cortex formula granules with different proportions are different, which can provide a certain basis for studying the compatibility mechanism of TCM couplet medicines.
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ObjectiveIn order to ensure the safety and effectiveness of clinical drug use ， the identification method of mixed and adulterated specific polymerase chain reaction （PCR） identification of Pheretima aspergillum and its processed products was established. MethodBased on the cytochrome C oxidase subunit I sequence of P. aspergillum， primers were designed to cover the whole sequences， and the stable DNA ranges suitable for the identification of Pheretima （P. aspergillum） formula granule were screened out. Specific primers were designed according to the specific single nucleotide polymorphisms （SNP） of P. aspergillum in the stable DNA range. The P. aspergillum and its mixture were collected respectively， the PCR reaction system was established and optimized， and PCR reaction system and procedure were optimized， and the tolerance and applicability were investigated. ResultWhen the annealing temperature was 62 ℃ and the cycle number was 36， both P. aspergillum formula granule and its formula particles could amplify a single specific identification band of about 170 bp， and the other 20 adulterants and negative controls had no band. ConclusionThe allele-specific PCR identification method established in this study can quickly and accurately identify the P. aspergillum formula granule. The orgin of Chinese herbal medicine and decoction pieces and P. aspergillum were accurately identified. It can also provide a reference for other studies on the quality standard research of other Chinese herbal formula granule.
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The application of traditional Chinese medicine(TCM) formula granules in clinical practice is gradually extensive. However, TCM formula granules is still lacking rapid and simple quality control standards. In this study, allele-specific PCR and enzyme-linked immunoassay(ELISA) was used for rapid detection of the quality of Lonicerae Japonicae Flos formula granules. The authenticity of Lonicerae Japonicae Flos formula granules was identified by allele-specific PCR and index component was detected by ELISA. Thus, it lays a foundation for the establishment of rapid quality detection standard for Lonicerae Japonicae Flos formula granules, and also provides reference for other studies on the quality standard of traditional Chinese medicine formula granules.
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Chromatography, High Pressure Liquid , Drugs, Chinese Herbal/analysis , Enzyme-Linked Immunosorbent Assay , Lonicera/chemistry , Medicine, Chinese Traditional , Polymerase Chain Reaction , Quality ControlABSTRACT
Objective: To establish an HPLC fingerprint of Cnidii Fructus formula granule analysis method for simultaneous determination of six main coumarin components, including osthol, xanthotoxin, xanthotol, bergapten, imperatorin and isopimpinellin, in order to provide reference for the study of the material basis of Cnidii Fructus formula granule. Methods: The method was performed by high performance liquid chromatography with a Waters XBridge C18 (250 mm × 4.6 mm, 5 μm) column and methanol (A)-0.1% acetic acid (B) as the mobile phase for gradient elution. The flow rate was 0.5 mL/min, the injection volume was 10 μL and the column temperature was 40 ℃. The detection wavelength was set at 320 nm. The chromatographic fingerprint evaluation system published by the State Pharmacopoeia Commission (2012 Edition) was used to establish the fingerprint of Cnidii Fructus formula granule, and the content of six main coumarin components was simultaneously determined. Results: The research on the 18 batches of Cnidii Fructus formula granule showed that the fingerprint similarity was greater than 0.992 and 19 common peaks were calibrated with satisfied peak resolution. The content determination results showed that the content of both xanthotoxin and osthol were the main coumarin components in Cnidii Fructus formula granule. According to the methodological investigation, the precision RSD values were all less than 1.6%. The sample was stable within 48 h and this method had good repeatability. The average recovery rates of xanthotol, xanthotoxin, imperatorin, isopimpinellin, bergapten and osthol were 100.69%, 101.03%, 99.48%, 100.88%, 101.27% and 100.35%, respectively. All of these coumarin components’ RSD were less than 2.5%. The six components showed a good linear relationship within a certain concentration range. The results of the content determination of xanthotol, xanthotoxin, isopimpinellin, bergapten, imperatorin and osthol respectively were 8.01-8.29, 2.37-2.63, 4.30-4.61, 4.04-4.40, 3.45-3.90 and 6.02-6.80 mg/g among the 18 batches of the Cnidii Fructus formula granule. Conclusion: The fingerprint method and the determination method of six main coumarin components in the Cnidii Fructus formula granule established in this study are simple, stable, accurate and reliable. This method can be used for the quality control of the Cnidii Fructus formula granule.
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OBJECTIVE: To establish the HPLC fingerprint of Jinyinhua formula granules (JYHFG), and compare the qualities of the products from nine enterprises by chemical metrology analysis. METHODS: HPLC was used to establish fingerprint at 254 nm. Twenty-nine batches of products from nine enterprises were determined, and the quality of JYHFG of different batches was evaluated through similarity evaluation, clustering analysis (HCA) and principal component analysis (PCA). RESULTS: Seventeen common peaks were confirmed in the HPLC fingerprint of 29 batches of JYHFG, and 10 of them were identified. The similarity of JYHFG was 0.84-0.99, and the samples could be grouped into one category according to enterprise, among which the characteristic peak of chlorogenic acid had the greatest influence on the fingerprint. CONCLUSION: The establishment of HPLC fingerprint and the identification of chemical pattern provide a more comprehensive reference for the quality control of JYHFG. It provides a reliable method for scientific evaluation and effective quality control.
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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.
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Medicine, Chinese Traditional , Pharmaceutical Preparations , Reference Standards , ResearchABSTRACT
Objective:To establish the fingerprints of standard decoction of Gentianae Macrophyllae Radix-dried products by different methods,and to evaluate the quality correlation. Method:HPLC,InertSustain C18 chromatographic column(4.6 mm×250 mm,5 μm),Gradient elution was performed for the mobile phase of acetonitrile-phospho,detection wavelength at 240 nm and flow rate of 0.8 mL·min-1,and column temperature was 40℃. The quality correlation analysis of different methods for different kinds of Gentianae Macrophyllae Radix standard decoction was carried out from the aspects of chemical composition consistency,common chemical composition consistency,main chemical composition content and transfer rate. Result:The control fingerprint of Gentianae Macrophyllae Radix standard decoction was established. According to the peak matching data,there were 10 common peaks in the fingerprint of 15 batches of Gentianae Macrophyllae Radix standard decoction.Among the 10 common peaks,5 chemical constituents of loganic acid,6'-O-β-D-glucosyl gentiopicroside,swertiamarin,gentiopicroside and swertia glycosides were identified. The results of quality correlation analysis showed that the three different drying methods were consistent with the chemical composition and quantity of Gentianae Macrophyllae Radix standard decoction. But in terms of the content consistency of common chemical components and the transfer rate of main chemical components,the quality correlation between the products obtained from vacuum drying and the standard decoction was lower than that obtained from spray drying and freeze-drying. Conclusion:The fingerprint of different method of Gentianae Macrophyllae Radix standard decoction was established. Through the analysis of the mass correlation of chemical composition consistency,common chemical composition content consistency,main chemical composition content and transfer rate,the mass correlation between them was comprehensively reflected. It is suggested that spray drying or freeze drying should be used for the key drying process of Gentianae Macrophyllae Radix granules. This study provides a reference for the preparation process and quality control of Gentianae Macrophyllae Radix granules.
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Objective To establish the quality evaluation system of Berberidis Radix (BR) standard decoction. Methods According to the preparation requirements of BR standard decoction, 15 batches of BR standard decoction powder was prepared, and, the index components in BR standard decoction was identified by using TLC chromatography. The content of index components was then detected by using HPLC, and the transfer rate of the index composition and the yield of the paste were calculated. Using infrared spectrometer to scan 15 batches of three standard decoctions. The infrared fingerprint spectrum was established, and the correlation between each batch was analyzed by using the two-index sequence analysis method. UV-vis spectrophotometer was used to respectively scan 15 batches of three needle standard medicinal broth for, establishing ultraviolet control map. The similarity between the fingerprint of sample and control was analyzed by SPSS software. Results The yield of 15 batches of standard decoction was 3.42%-6.36%. The content of berberine hydrochloride was 7.53%-13.98%, and the total transfer rate was 39.64%-73.62%. The same colored fluorescent spots were appeared at the corresponding positions of BR standard decoction, the berberine hydrochloride control, and BR control solution and the spots were in the same position of the same silica gel G thin layer. The lower limit of total peak rate of IR fingerprint was 50.0%, and the variation peak rate was 0.0%-62.5%. The similarity of UV fingerprints was all greater than 0.9, and the variation acceptable range was 0.768-1.000. Conclusion A stable and reliable method for the comprehensive quality evaluation of BR standard decoction was established, which can provide reference for the quality control of BR formula granules.
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OBJECTIVE: To establish an HPLC method to simultaneously determine the contents of geniposidic acid, caffeic acid, acteoside and isoacteoside in Plantaginis Semen formula granules, in order to provide basis for studying its quality standards. METHODS: An HPLC method was developed. Kinetex C18 column (2.1 mm×100 mm, 2.6 μm)was used and eluted with mobile phase of 0.5% acetic acid-acetonitrile at the flow rate of 0.3 mL·min-1. The wavelength was set at 239 nm for geniposidic acid, 325 nm for caffeic acid, and 330 nm for acteoside and isoacteoside. The column temperature was maintained at 30℃. RESULTS: The good linear relationships between the concentration and peak area were in the range of 0.292 1-2.92 1 μg for geniposidic acid, 0.003 4-0.033 6 μg for caffeic acid, 0.047 6-0.476 μg for acteoside and 0.102 7-1.027 μg for isoacteoside (r≥0.999 8), respectively. The average recoveries were 99.32%, 98.62%, 98.23% and 98.51% with RSDs of 1.47%, 1.36%, 1.62% and 1.53%, respectively. CONCLUSION: The method is simple, feasible and reproducible and can be used for the quality control of Plantaginis Semen formula granules.
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OBJECTIVE: To establish the preparation technology of Moutan Cortex standard decoction and formula granules. METHODS: Moutan Cortex standard decoction was prepared by decocting pot and the parameters and fingerprints of 15 batches of decoction were established.To improve the preparation process of Moutan Cortex formula granules, paeonol was quickly recovered by using volatile oil collection device in the process of vacuum concentration, and the collected paeonol was added back to the concent rated solution.Then, the formula granules of Moutan Cortex were prepared by spray drying and dry granulating.The correlation between the decoction pieces, extract, concentrate, powder, formula granules and standard decoction were compared by taking the contents of paeoniflorin, paeonol and fingerprint as indexes. RESULTS: The range of parameters for Moutan Cortex standard decoction(70%-130% of the average value) were as follows:the dry extract rate was 19.46%-36.14%. The content of paeoniflorin was in the range of 1.83%-3.40%, and the transfer rate was 60.32%-100.00%. The content of paeonol was 1.25%-2.33%, and the transfer rate was 14.42%-26.78%.The contents of paeoniflorin and paeonol in the formula granules of Moutan Cortex conformed to the range of standard decoction parameters. CONCLUSION: The parameters of Moutan Cortex standard decoctions prepared by decocting pot are confirmed, and a new preparation process of Moutan Cortex formula granules is established.Both of standard decoction and formula granules have good consistency in the contents of the index components,which could provide a certain scientific basis for the guidance of actual production.
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To establish a robust and accuracy molecular method to identify Achyranthis Bidentatae Radix and Cyathulae Radix formula granules. ITS sequences of Achyranthes bidentata and Cyathula officinalis were aligned, specific SNPs (single nucleotide polymorphisms) were excavated, specific primers were designed and allele-specific PCR method was established. The genomic DNA was successfully extracted from the herbal medicine and its formula granules by using an improved CTAB (cetyltrimethyl ammonium bromide) method and then performed PCR with the designed primers. The 187 bp specific band could be amplified only in the presentation of C. officinalis and its granules when use of C. officinalis specific primers, whereas the 162 bp band could be amplified only in the presentation of A. bidentata and its granules when use of A. bidentata specific primers. This method was also successfully applied in the identification of commercial formula granules.
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OBJECTIVE:To improve dispensing quality of small package of TCM formula granule, reduce the rate of dispensing error and shorten dispensing time. METHODS:Key influential factors for small package of TCM formula granule dispensing in our hospital were found out from 5 respects of"man,machine,environment,method,material";two cycles of PDCA cycle management intervention were conducted. Dispensing internal error and dispensing time were compared before PDCA cycle management intervention (Jul.-Dec. 2015,group A),first cycle of PDCA cycle management intervention (Jan.-Jun. 2016, group B) and second cycle of PDCA cycle management intervention (Jul.-Dec. 2016,group C),the effects of management were evaluated. RESULTS:By improving dispensing environment,establishing dispensing standard operation procedure,formulating reward and punishment system,staff training,after 2 cycles of PDCA cycle management intervention,the rate of small package of TCM formula granule dispensing error in TCM pharmacy of our hospital decreased from 4.19％(170/4061) before intervention that of group A to 1.69％(85/5043) and 0.98％(53/5408) in group B and C after intervention (P<0.05 or P<0.01). Average dispensing time of each prescription with 7 doses were shortened from(9.08±2.56)min before intervention(group A)to(7.37± 1.98),(5.97±1.64)min in group B and C after intervention(P<0.05). CONCLUSIONS:PDCA cycle management intervention in our hospital can reduce the rate of small package of TCM formula granule dispensing error and shorten dispensing time.
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Chinese materia medica (CMM) formula granule is made from CMM extract powder and suitable pharmaceutical excipients, powder properties of CMM extract powder such as the particle size, hydroscopicity, and fluidity directly affect thepelleting quality of CMM formula granule. Drying is one of the indispensable operating units for preparations of CMM extract, which has great influence on the powder properties of CMM extract powder. Therefore, there is a certain correlation between the drying process and pelleting quality of CMM formula granule. Through the literature research, this paper summarizes the engineering principle and characteristics of each main granulation method, analysis of the evaluation factors of pellet quality, and combines with experimental research to explore the correlation between the drying process of CMM extract and pelleting quality of CMM formula granule in the perspective of powder properties. Finally, we puts forward that more attention should be payed to study the drying process of CMM extract, in order to further improve the quality of pelleting quality of CMM formula granule.
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The development of Chinese materia medica formulations has a long history, and gradually formed various dosage forms such as soup, wine, tea, powder, cream, pills, boluses and so on. In recent years, formula granules have developed rapidly.The price factors, storage conditions, convenience, efficacy and other aspects of Chinese materia medica decoction, concrete and formula granules were compared, and the results have shown that each formulation has advantages and disadvantages that restrict their development. With the development of science and technology, Chinese materia medica formula granules would have more room for development.
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Formula granule of traditional Chinese medicine (TCM) has been characterized as a safe medication with the advantages of accurate dosage and easy to carry.In this study,references over current status of the development of TCM formula granule were retrieved,so were those of the market situation and its application to intelligent pharmacy of TCM.Then the key problems restricting the development of the application of TCM granules were discussed,in hope of providing a reference for the development and its application to the intelligent pharmacy of TCM.
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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.
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Traditional authentication method is hard to identify herb's authenticity of traditional Chinese medicine(TCM) formula granules because they have lost all their morphological characteristics. In this study, a new allele-specific PCR method was established for identifying the authentication of Jinyinhua formula granule (made from Lonicerae Japonicae Flos) based on an SNP site in trnL-trnF fragment. Genomic DNA was successfully extracted from Lonicerae Japonicae Flos and its formula granules by using an improved spin column method and then PCR was performed with the designed primer. Approximately 110 bp specific bands was obtained only in the authentic Lonicerae Japonicae Flos and its formula granules, while no bands were found in fake mixed products. In addition, the PCR product sequence was proved from Lonicerae Japonicae Flos trnL-trnF sequence by using BLAST method. Therefore, DNA molecular authentication method could make up the limitations of character identification method and microscopic identification, and quickly identify herb's authenticity of TCM formula granules, with enormous potential for market supervision and quality control.
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Based on the reviewing of development and disadvantages of Chinese medicine formula granules, the concept of standard decoction of traditional Chinese medicine was proposed in this study, and it was used as the standard mode of Chinese medicine formula granules to standardize the production process and quality standards of formula granules. The standard was unified according to the principles of "standardization of medicinal materials, standardization of process, intellectualization of production, standardization of quality, normalization of packaging, and informatization of storage"; and consistency evaluation was carried out by the analysis of chemical components, pharmacological activities and clinical efficacy of the standardized decoction and the traditional decoction, interpreting the scientific questions to ensure the stability and uniformity of Chinese medicine formula granule as well as the safety and effectiveness of its clinical application.