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ObjectiveTo evaluate the methodological and reporting quality of clinical practice guidelines for Chinese patent medicine （CPM） with internationally recognized tools the appraisal of guidelines for research and evaluation （AGEREE） Ⅱ and reporting items for practice guidelines in healthcare （RIGHT）， thereby providing refe-rence for the clinical application and future development of CPM guidelines. MethodsDatabases including CNKI， VIP， Wanfang and Sinomed were searched for CPM guidelines， as well as medlive.cn， websites of China Association of Chinese Medicine and Chinese Medical Association， and reference lists of the included papers. The quality of the guidelines was evaluated using the AGREE Ⅱand RIGHT tools， and consistency tests were performed using Interclass Correlation Coefficient， and descriptive analysis and chi-square test were used to analyze the reporting rate for each domain and the average score for each item. ResultsFinally， 140 CPM guidelines were included， of which 51 were disease-oriented and 89 were drug-oriented， all of which were issued by China. For 51 disease-oriented CPM guidelines， the highest average score of all six AGREE Ⅱ domains was 73.32% for clarity， and the lowest was 26.80% for application； for 89 drug-oriented CPM guidelines， the highest average score was 55.62% for scope and purpose， and the lowest was 31.32% for rigour of development. In terms of the seven domains of the RIGHT checklist， the highest reporting rate was 68.26% for background， and lowest was 27.45% for other areas regarding the disease-oriented CPM guidelines； the highest reporting rate was 61.31% for background， and the lowest was 4.49% for other areas regarding drug-oriented CPM guidelines. The average reporting rate was higher for disease-oriented than drug-oriented CPM guidelines in three domains of AGREE Ⅱ （rigour of development， clarity of presentation， editorial independence）， as well as four domains of RIGHT checklist （basic information， evidence， funding and declaration and management of interests， and other areas）. ConclusionThe overall methodology and reporting quality of the current CPM guidelines still need to be improved. It is recommended that future guideline development teams should strictly refer to the AGREE Ⅱ and RIGHT checklist， and take into account of the characteristics of CPM guidelines and relevant methodo-logical suggestions in the development and reporting of CPM guidelines， thereby guiding the clinical use of CPM in a better way.
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With scarce resources, natural Bovis Calculus is expensive and hard to meet clinical demand. At the moment, four kinds of Bovis Calculus are available on the market: the natural product, in vitro cultured product, synthesized product, and the product formed in cow after manual intervention. In this study, papers on the four kinds of Bovis Calculus products and relevant Chinese patent medicines were searched from Web of Science, PubMed, and China National Knowledge Infrastructure(CNKI). CiteSpace, citexs AI, and CNKI were employed for bibliometric analysis and knowledge map analysis. On this basis, the status, trend, and focuses of research on Bovis Calculus and relevant Chinese patent medicines were summarized. The results suggested overall slow development in the research on Bovis Calculus and relevant Chinese patent medicines with three typical growth stages. It is consistent with the development of Bovis Calculus substitutes and the national policy for the development of traditional Chinese medicine. At the moment, the research on Bovis Calculus and relevant Chinese patent medicines has been on the rise. In recent years, there has been an explosion of research on them, particularly the quality control of Bovis Calculus and the Chinese patent medicines, the pharmacological efficacy of Chinese patent medicines, such as Angong Niuhuang Pills, and the comparison of the quality of various Bovis Calculus products. However, there is a paucity of research on the pharmacological efficacy and the mechanism of Bovis Calculus. This medicinal and the relevant Chinese patent medicines have been studied from diverse perspectives and China becomes outstanding in this research field. However, it is still necessary to reveal the chemical composition, pharmacological efficacy, and mechanism through multi-dimensional deep research.
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Animals , Cattle , Female , Bibliometrics , Biological Products , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Nonprescription DrugsABSTRACT
Jianwei Xiaoshi tablets， as a common variety of Chinese patent medicine with "one product with many manufacturers"， have many manufacturers and huge market sales. However， the phenomenon about uneven quality and discrepant price is prominent. Based on this， this study was carried out for the quality evaluation of Jianwei Xiaoshi tablets by applying the high-quality evaluation criteria with the quality as core for Chinese patent medicine， which was based on the full production cycle， from the multi-dimension including raw material selection， production process， quality control， post-marketing research and so on. The evaluation results showed that the quality evaluation scores of Jianwei Xiaoshi tablets from different manufacturers varied greatly （ranging from 35 to 66）， indicating that the quality was significantly different. In the actual production， generally inadequate attention was paid to the quality of raw materials， and the quality of raw materials was insufficient with the score ratio of 43%， especially the poor consistency control of them. The role of good manufacturing practice was obvious， and the scores of production process were generally high with the average score ratio of 62%， and the maximum up to 80%. The technological advancement of the manufacturer was outstanding. The score ratio of quality control was only 31% that the internal quality standard of each manufacture almost stayed at the qualified line， which was equal to the national standard， and the consistency of products was insufficient. The post-marketing research was lacking with the score ratio of 37%. Manufacturers with high brand awareness and market share were upper scores， while the others lagged far behind. The results of this evaluation are in line with the overall prediction， which can provide a reference for the high-quality evaluation of Chinese patent medicine， and supply the scientific data for high-quality and high-price application.
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ObjectiveTo evaluate the safety， efficacy， and economy of the four Chinese patent medicines （CPMs）， including Simotang oral liquid， Liuwei Anxiao capsule， Baohe pill， and Jianwei Xiaoshi oral liquid in the treatment of functional dyspepsia （FD） by a rapid health technology assessment （RHTA）， thus providing evidence support for clinical decision making. MethodChina National Knowledge Infrastructure （CNKI）， WanFang Database， VIP Chinese Technology Periodical Database （VIP）， China Biology Medicine disc （CBMdisc）， PubMed， EMBASE， Cochrane Library， and Web of Science were searched by computer from inception to March 2022. After literature screening， data extraction， and quality evaluation， the descriptive analysis of the results combined with visual charts was performed. Nineteen studies were included， involving 18 randomized controlled trials （RCTs） and 1 Meta-analysis. Neither economic studies nor health technology assessment （HTA） reports were retrieved. ResultThe four CPMs were safe and effective in the treatment of FD， but economic research was lacking. Among them， Simotang oral liquid could be used for children with FD and FD caused by qi and food stagnation， liver and spleen disharmony， and liver and spleen stagnation. Liuwei Anxiao capsule could be used for adult patients with FD caused by food stagnation. Baohe pill could be used for the elderly with FD. Jianwei Xiaoshi oral liquid could be used for children with FD caused by spleen and stomach weakness. ConclusionThe four CPMs have their advantages in the treatment of FD. Among them， the clinical universality of Simotang oral liquid is higher. However， the quality of clinical evidence is generally low， and comparative analysis among drug dosage forms is lacking. In the future， it is necessary to improve， apply， and promote RHTA for rapid evidence production while carrying out a more standardized and scientific evidence-based demonstration of the comprehensive clinical efficacy of CPMs.
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This study systematically and comprehensively sorted out the application status of Chinese patent medicines for the treatment of constipation in the clinic， to provide scientific evidence for future research directions and clinical drug use in this field. Based on the method of scoping review， the Chinese patent medicines for the treatment of constipation were retrieved from three drug lists to obtain the medicines that needed to be evaluated. A comprehensive and systematic search was carried out on the included studies on the treatment of constipation by Chinese patent medicines through eight Chinese and English databases， and the included studies were integrated and analyzed. The results were displayed in combination with charts. Thirty-four Chinese patent medicines and 118 studies were included in this study. According to the efficacies， Chinese patent medicines were divided into 4 categories， namely eliminating accumulation， purging fire， promoting Qi， and moistening bowels， involving 125 Chinese medicines. The overall attention of constipation research is on the rise. Marenwan （granules or soft capsules） gained the highest attention， with 42 studies， followed by Qirong Runchang oral liquid， with 21 studies， and Biantong tablets （capsules）， with 19 studies. There are 10 studies on Congrong Tongbian oral liquid. Seventeen Chinese patent medicines had no corresponding clinical research. There were 8 study design types， and all drugs were mainly randomized controlled trials except Danggui Longhui pill. Among the intervention types， the comparison between Chinese patent medicines and western medicines was the most. The highest outcome indicators were efficacy， safety evaluation， and main symptoms or scores， and there was a lack of a unified core outcome indicator set. There were few studies on adverse reactions and the economy. Only 11.86% of the studies were funded. Clinically， Chinese patent medicines are widely used in the treatment of constipation， and the amount of related research shows an increasing trend. However， some Chinese patent medicines lack corresponding clinical evidence， and the published research has problems such as unrigorous design， ununified criteria for efficacy evaluation， lack of comprehensive evidence studies， and insufficient funds. It is hoped that more investment will be made in this field in the future， and more attention will be paid to drugs with relatively blank research and constipation syndromes with few treatments. Comprehensive evidence studies such as systematic reviews should be carried out actively. And the study design should be standardized to provide reliable evidence for the treatment of constipation with Chinese patent medicines.
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ObjectiveTo investigate the compatibility rule of traditional Chinese patent medicines （TCPMs） against liver diseases through network analysis. MethodWith “liver” as the search term， TCPMs against liver diseases were retrieved from volume Ⅰ of Chinese Pharmacopoeia （2020 edition）， and the basic information of them was collected. TCPMs with same Chinese medicinal materials （CMMs）， usage， and indications， but different dosage forms， were unified as one formula. Mutual information entropy （MIE） of CMM couples was calculated to quantify the relationship between them， and the top 25% CMM pairs in MIE were used to construct the compatibility network， with CMM as node and the relationship between CMM pairs as the edge. Key CMM and frequently used CMM combinations were identified based on node centrality and cluster analysis， respectively. The indications of TCPMs related to the CMMs in clusters were recorded. Cytoscape 3.6.1 was employed for visualization and topology analysis of the compatibility network. ResultA total of 179 TCPMs， involving 428 CMMs， were retrieved. Angelicae Sinensis Radix， Paeoniae Radix Alba， and Glycyrrhizae Radix et Rhizoma were identified as key CMMs with high frequency， and Cuscutae Semen-Lycii Fructus， Citri Reticulatae Pericarpium-Cyperi Rhizoma， and Ecliptae Herba-Ligustri Lucidi Fructus combinations had high MIE. Furthermore， the CMMs were clustered into ten groups corresponding to different diseases which， however， all belonged to digestive diseases. ConclusionThis study unveils potential CMM pairs and common CMM combinations against liver diseases， which can serve as a reference for revealing compatibility rules of CMMs and research and development of Chinese medicine.
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This study aims to summarize the clinical research evidence on oral Chinese patent medicines for the treatment of influenza with the method of scoping review， and thus clarify the status quo and problems. Specifically， the target medicines were selected from related drug catalogues and diagnosis and treatment protocols， and the basic information of the medicines on the specifications was collected. Articles on these medicines were retrieved from Chinese and English databases for statistical analysis and visualization. Finally， 36 medicines and 87 articles were included. The main efficacy of the medicines is clearing heat and removing toxin， and the main components of the medicines are Lonicerae Japonicae Flos， Forsythiae Fructus， and Isatidis Radix. A total of 12 medicines can be used for the treatment of mumps and acute bronchitis in addition to influenza. Only 6 medicines have contraindications and adverse reactions labeled on the specifications. Papers on oral Chinese patent medicines in the treatment of influenza show an increasing trend， and the authors are from 25 provinces and cities in China. Among them， papers on Lianhuaqingwen preparations take up the largest proportion. The studies were mostly randomized controlled trials， non-randomized controlled trials， and retrospective research. A total of 13 studies were supported by national funding， and only 9 studies included more than 200 cases. The most frequently used method was the comparison of the intervention effect of Chinese patent medicines with western medicine， and the treatment course was generally 3-14 days. A total of 7 outcome indicators were used in the studies and the frequency was in the order of ① composite effective rate，② antipyretic effect， ③ symptom improvement， ④ safety indicator， ⑤ virological examination， ⑥ serum inflammatory factor， and ⑦ traditional Chinese medicine （TCM） syndrome score. The conclusions in the clinical studies show difference from the information in drug catalogues. The drug specifications are generally not standard. The available clinical studies have the limitations of small quantity， low in quality， and no demonstration of TCM advantages. In the future， it is necessary to optimize the specifications of Chinese patent medicines， enhance clinical research， further standardize the design of clinical research， and highlight the characteristics of Chinese patent medicines， thereby providing evidence to support the comprehensive clinical evaluation of oral Chinese patent medicines for influenza.
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Lingnan， locating on the southern coast of China， is a major distribution center of Chinese medicinal materials and imported southern medicine. It is also a well-known patent medicine production base and a foreign trade port. This paper collected relevant historical documents of traditional Chinese medicine （TCM） industry of Lingnan in different times， including Chinese herbs， decoction pieces， Chinese patent medicines and TCM shops. TCM industry of Lingnan originated from the Qin dynasty， and began to develop slowly from the Qin and Han dynasties to the southern and northern dynasties. Private drugstores appeared from the Tang and Song dynasties to the Yuan dynasty， and pharmaceutical commodity production appeared in the Ming dynasty. The TCM industry reached its peak in Qing dynasty， and the modern economic form of the TCM industry appeared during the Republic of China （1912—1949）. It is of great significance for the inheritance， development and innovation of TCM industry of Lingnan to sort out its development history and clarity its development context.
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Objective:To compare the efficacy and safety of 10 kinds of oral Chinese patent medicines combined with chemotherapy in the treatment of gastric cancer in a network Meta-analysis. Method:PubMed，Embase，Web of Science，Cochrane Library，CNKI，China biomedical literature service system，VIP，Wanfang database were retrieved to obtain Chinese and English literatures published before March 1，2020. The randomized controlled trials（RCTs） and data were screened and extracted. The quality of the included literatures was also evaluated. The pair-work Meta-analysis was conducted by Revman 5.3 software， and the Meta-analysis were conducted by ADDIS 1.16.7 software. Result:A total of 41 randomized controlled trials were eventually involved. All of them were two-arm，including 10 oral Chinese patent medicines，Cinobufotalin，Jinlong capsule，Pingxiao capsule，Shenyi capsule，Xihuang pill （or capsule），Xiaoaiping tablet，Yangzheng Xiaoji capsule，Zhenqi Fuzheng granule combined with chemotherapy for gastric cancer. The effective rate for treating cancer was significantly higher than that of chemotherapy alone （<italic>P</italic><0.05）. Zhenqi Fuzheng+chemotherapy was the best choice； the KPS improvement rate of Cinobufacin，Shenyi capsule，Yangzheng Xiaoji capsule，Zhenqi Fuzheng granule combined with chemotherapy in the treatment of gastric cancer was significantly increased（<italic>P</italic><0.05）. Shenyi capsule combined with chemotherapy might be the best regimen. The incidence rate of leukocyte decline was significantly lower in the treatment of gastric cancer（<italic>P</italic><0.05）. The combination of Zhenqi Fuzheng granule and chemotherapy was the best choice. Traditional Chinese medicine could not reduce the incidence of neurotoxicity（<italic>P></italic>0.05）. Cinobufufacin，Yangzheng Xiaoji capsule and Zhenqi Fuzheng granule combined with chemotherapy could increase CD4<sup>+</sup>/CD8<sup>+ </sup>in patients with gastric cancer， which was significantly higher than that of chemotherapy alone（<italic>P</italic><0.05）. Conclusion:All kinds of oral Chinese patent medicines can play a significantly role in the treatment of gastric cancer. Zhenqi Fuzheng granule，angzheng Xiaoji capsule and Shenyi capsule combined with chemotherapy are more effective in treating gastric cancer.
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Armeniacae Semen Amarum is one of the most commonly used Chinese medicinal materials， with the homology of medicine and food. It is mild toxicity， in addition to raw product， there are blazed and fried Armeniacae Semen Amarum and other processed products. The prescription， process and quality standard of Chinese herbal preparations containing Armeniacae Semen Amarum in the 2020 edition of Chinese Pharmacopoeia （volume Ⅰ）， were studied and analyzed in this paper. The quality control and safety problems of them were discussed， and the proposals were put forward：①To strengthen the quality control of medicinal materials from the origin， including processing， storage， producing area and so on. ②Production technology is the key factor affecting the safety and effectiveness of preparations， so it is necessary to strengthen the control of production process. ③To strengthen the quality research of Armeniacae Semen Amarum preparations， to develop safety quality control projects， and to further improve the quality standards of Armeniacae Semen Amarum preparations. ④To improve the safety tips of Armeniacae Semen Amarum preparations and standardize the instructions. These suggestions can provide reference for scientific understanding and evaluation of traditional Chinese medicine preparations containing Armeniacae Semen Amarum， in order to promote the quality control level of Chinese medicine preparation containing Armeniacae Semen Amarum and its processed products.
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Objective:To analyze the functions and indications， formulation， dosage form and medication characteristics of Chinese patent medicines in the 2020 edition of<italic> Chinese Pharmacopoeia</italic> （part Ⅰ） for treating cough of children， and to provide ideas for the clinical rational application and provide reference for the research and development of new cough medicines for children. Method:The name， dosage form， formulation， functions and indications， usage and dosage， and other information of Chinese patent medicines for cough were collected from the 2020 edition of <italic>Chinese Pharmacopoeia </italic>（part Ⅰ）， then relevant information was input into Integrative Pharmacology-based Research Platform of Traditional Chinese Medicine v2.0， and data analysis and mining were carried out through the analysis module of prescription medication rule， VOSviewer 1.6.14 was used to make drug clustering network view of Chinese patent medicines for the treatment of exogenous wind cold， exogenous wind heat and phlegm heat cough. Result:In the 2020 edition of <italic>Chinese Pharmacopoeia </italic>（part Ⅰ）， a total of 75 kinds of Chinese patent medicines for treating cough of children were collected， including 34 kinds of Chinese patent medicines for adults and children， 41 kinds of Chinese patent medicines for children only. There were 7 types of traditional Chinese medicine syndromes， such as wind-cold attacking the lung， wind-heat invading the lung and phlegm-heat obstructing the lung. There were 45 Chinese patent medicines for treating exogenous cough， accounting for 60%， among which 35 kinds were used for exogenous wind-heat cough and 10 kinds were used for wind-cold cough. There were 30 kinds of Chinese patent medicines for treating internal injury cough， including 19 kinds of medicines for phlegm heat obstructing the lung， 4 kinds of medicines for phlegm dampness containing the lung and phlegm food stagnation， 2 kinds of medicines for Yin-deficiency lung heat， 1 kind of medicine for the lung and spleen Qi-deficiency. The formulation analysis showed that Glycyrrhizae Radix et Rhizoma， Platycodonis Radix， Scutellariae Radix， Armeniacae Semen Amarum and Citri Reticulatae Pericarpium appeared frequently， which were mainly cold， bitter and sweet herbs， mainly belonged to the lung and stomach meridians. According to the analysis of administration and dosage forms， 71 kinds of Chinese patent medicines were administered through gastrointestinal tract， including 20 kinds of granules， 15 kinds of oral liquids， others included syrups， pills， capsules， tablets， powers， etc. Only 2 suppositories and 2 injections were administered by nongastrointestinal tract. The usage and dosage of most Chinese patent medicines were not clear. Conclusion:In the 2020 edition of <italic>Chinese Pharmacopoeia </italic>（part Ⅰ）， the main syndromes of Chinese patent medicines for cough of children are exogenous wind-heat and phlegm-heat obstruction in the lung. Most of the Chinese medicines are cold， bitter and sweet， and their meridians are mainly lung and stomach meridians. Scutellariae Radix， Lonicerae Japonicae Flos and Forsythiae Fructus are the most common medicines of exogenous wind heat syndrome. Perillae Folium， Citri Reticulatae Pericarpium and Ephedrae Herba are the most common medicines of exogenous wind cold syndrome. Meanwhile， Scutellariae Radix， Platycodonis Radix and Armeniacae Semen Amarum are the most common medicines of phlegm heat obstructing the lung syndrome. At present， the dosage forms of Chinese patent medicines used for treating cough of children are too few and the dosage labeling is not comprehensive， so it is necessary to further strengthen the research and development of new Chinese medicines suitable for characteristics of children.
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This study summarized and analyzed the current acne-relieving Chinese medicinal health products and Chinese patent medicines,aiming at providing references for the formulation and development of acne-relieving health products. The information on acne-relieving health products published by the Department of Special Food Safety Supervision and Management,the State Administration for Market Regulation( SAMR) was retrieved,and the Chinese patent medicines on DRUGDATAEXPY were searched. Microsoft Excel and the Traditional Chinese Medicine Inheritance Support System V2. 5( TCMISS) were employed to statistically analyze the characteristics of formulations. Forty-three acne-relieving health products were obtained,including 40 ones containing Chinese herbal medicines. Six Chinese herbal medicines showed a usage frequency ≥8,with 61 times in use totally,including Salviae Miltiorrhizae Radix et Rhizoma( 13),Lonicerae Japonicae Flos( 12),Taraxaci Herba( 11),ALOE( 9),Carthami Flos( 8),and Rhei Radix et Rhizoma( 8). A total of 29 Chinese patent medicines with similar efficacy were collected in DRUGDATAEXPY. Nine Chinese herbal medicines showed a usage frequency ≥6,with 63 times in use,including Rhei Radix et Rhizoma( 10),Glycyrrhizae Radix et Rhizoma( 8),Scutellariae Radix( 8),Lonicerae Japonicae Flos( 7),Angelicae Sinensis Radix( 6),Paeoniae Radix Rubra( 6),Astragali Radix( 6),Paeoniae Radix Alba( 6),and Gardeniae Fructus( 6). Through unsupervised hierarchical entropy-based clustering of the above-mentioned Chinese medicinal health products and Chinese patent medicines,five and three new formulas were obtained,respectively. The selection of Chinese herbal medicines was consistent with the principles of traditional Chinese medicine( TCM) theories in relieving acne,i. e.,dispelling exterior wind,ventilating lungs,clearing heat,dissipating mass,promoting diuresis,relaxing bowels,removing toxin,activating blood,resolving stasis,eliminating phlegm,and regulating Qi. According to the " lung governing skin and body hair" and " interior-exterior relationship between lung and large intestine" in TCM theories,the idea that acne could be treated by relieving constipation was proposed,which provided new methods and references for the research and development of Chinese medicinal health products.
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Humans , Acne Vulgaris/drug therapy , China , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Nonprescription DrugsABSTRACT
In 2018,Standardization Department of China Association of Chinese Medicine invited methodologists with the background of evidence-based medicine to discuss and draft a series of standards for expert consensus on clinical practice of Chinese patent medicines. These standards have been made by reference to the published standards for developing expert consensus and clinical practice guidelines. These standards were made based on full consideration of the current evidence status and the history of clinical practice of Chinese patent medicines. These standards were composed of four parts,namely information summary items,normative general items,normative technical items and information supplementary items,including cover,content,preface,introduction,title,scope,basic Information of Chinese patent medicine,suggestions for clinical application,safety,conflict of interest,appendix,and references,so as to provides reference for improving the quality of expert consensus-based compilation and enhancing the applicability of expert consensus.
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Humans , China , Consensus , Evidence-Based Medicine , Medicine, Chinese Traditional , Reference Standards , Nonprescription Drugs , Reference StandardsABSTRACT
The expert consensus on clinical practice of Chinese patent medicines shall be regarded as the same with clinical practice guidelines,which shall be concise,readable and applicable. Therefore,a formal expert consensus is unable to contain the whole compilation process and the content of its important process documents. It is necessary to write instructions for continuation,expansion and publicity. In 2018 Standardization Department of China Association of Chinese Medicine invited methodologists with the background of evidence-based medicine drafted a series of standards for expert consensus on clinical practice of Chinese patent medicines,including the guidance for compilation the instructions. It will be useful for readers of expert consensus to understand the work behind the compilation,so as to make the compilation process more transparent and standardized. We proposed nine requirements for compilation the instructions,namely content and requirements,work overview,main technical content,compilation process,process and basis for handling major disagreements,expert consensus implementation requirements and measure suggestions,other issues need to be explained,appendix and format for instructions.
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China , Consensus , Evidence-Based Medicine , Medicine, Chinese Traditional , Reference Standards , Nonprescription Drugs , Reference StandardsABSTRACT
Dosage is an important factor that affect clinical efficacy and safety of Chinese patent medicine, however, less study has been done on the analysis of dosage in Chinese patent medicine. Through the statistical analysis for dosage of 919 Chinese patent medicines in Chinese pharmacopoeia (2015 edition), it is found that the daily dose of most medicinal herbal pieces in Chinese patent medicines is less than the dose of single herbal medicine in the pharmacopoeia; And both the daily dose of single herbal medicine and the total daily dose of prescriptions are less than the commonly used dosage of decoctions in clinic. By exploring and discussing the related problems that affecting the dosage of Chinese patent medicine in the process of transformation from clinical effective prescription to Chinese patent medicine, this paper presented we should pay more attention to clinical effective dosage, strengthen the research of dose-effect relationship in the study of new traditional Chinese medicine from clinical effective prescription, and design and research high-quality Chinese patent medicine based on “quality by design, QbD” concept to reflect and exert the efficacy of original prescription. How to determine the dosage of new traditional Chinese medicine on the basis of clinical effective dosage is a question that needs to be concerned and answered.
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"Guiding herbs" is one of the characteristics of the special way of taking Chinese materia medica (CMM). However, some people have misunderstanding or lack of basic knowledge about how to choose the guiding herbs and its effect, leading to the poor clinical effect or even toxic effects because of improper decoction. This study attempts to analyze the action of the common guiding herbs in the Chinese Pharmacopoeia (2015 edition) from the perspective of reducing toxicity and increasing efficacy, returning drug to its channels, and put forward exploratory thinking on how to choose the guiding herbs to provide scientific evidence for promoting the rational use of drugs in clinic.
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Objective: To understand the combination use and rationality of Chinese patent drugs containing Salvia Miltiorrhiza or its active ingredients and western medicines to provide reference for regulating prescriptions and improving rational drug use level. Methods: The prescriptions of outpatients in our hospital during January 2016 and December 2016 were collected by a retrospective study method, and the ones with the combination use of Chinese patent drugs containing Salvia Miltiorrhiza or its active ingredients and western medicines were analyzed. The rationality of the combination use was analyzed in aspects of physicochemical properties, phar-macological effects, pharmacodynamics and pharmacokinetics. Results: Totally 257 730 prescriptions were examined selectively, and among them, 8 894 were with the combination use of western medicines and Chinese patent medicines containing Salvia Miltiorrhiza or its active ingredients including 1 213 irrational prescriptions (13. 64% ). The irrational prescriptions showed such problems as antago-nism in pharmacologic action causing decreased efficacy (510, 42. 04% ), overlaying in pharmacological effects causing increased effi-cacy (492, 40. 56% ), precipitation because of physical and chemical reactions and chemical taboos (299, 24. 65% ) and reduced bioavailability and affected efficacy due to complex reactions (174, 14. 34% ). Conclusion: The combination use of western medicines and Chinese patent medicines containing Salvia Miltiorrhiza or its active ingredients should be careful to avoid irrational problems. When they are auditing prescriptions and monitoring medication, clinical pharmacists should strengthen intervention of the combination use of Chinese patent medicines and western medicines reasonably combining with physical and chemical properties of medicines, phar-macological effects, pharmacodynamics and other characteristics.
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The quality stability of volatile oils in Chinese materia medica (CMM) is a prerequisite to ensure its clinical efficacy and safety. At present, the quality of volatile oils from CMM is uneven. There are great differences in the quality of volatile oils of same medicinal materials from different producing areas, different manufacturers, and different batches of herbs. This review analyzes the current situation and problems of the quality control of volatile oils from CMM, and proposes countermeasures for the standardization of cultivation and variety of Chinese herbal medicines, processing process, feeding parts, extraction process, and extraction equipment, etc. At the same time, the application status and quality control of volatile oils in Chinese patent medicines were briefly analyzed, aiming to provide reference for the effective control of the quality of volatile oils from CMM and Chinese patent medicines.
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Objective To understand the prevalence of prenatal supplementations of iron, iron-containing multi-micronutrients (IMMN) and antianemic Chinese patent medicines (ACPM) and associated factors in women in Shaanxi province. Methods A sample of 28367 childbearing-age women who gave birth during 2010-2013 and had specific information of the prenatal nutrients supplementation were recruited using stratified multistage cluster random sampling in Shaanxi province. The information about their basic characteristics and prenatal supplementation of nutrients were collected by a questionnaire survey. Descriptive analysis method was used to analyze the intake rate of iron, IMMN and ACPM during each period of pregnancy, and logistic regression model was used to identify associated factors. Results The overall prevalence of prenatal iron, IMMN and ACPM supplementation was low (28.99%), and the intake rate of iron was the lowest (5.33%). The prevalence of prenatal supplementation of iron, IMMN and ACPM were lower before pregnancy and in the first trimester than in the second and third trimester. The intake rates for consecutive 2 periods were very low (all were lower than 2.00%). The intake rates of iron, IMMN and ACPM significantly increased year by year. Women living in central Shaanxi had relatively high intake rates of iron (7.22%) and IMMN (16.55%), and women in southern Shaanxi had relatively high intake rate of ACPM (18.50%). The results of logistic regression analysis showed that higher educational level(OR=1.920, 95%CI: 1.617-2.279), antenatal care times≥6 (OR=1.832, 95%CI: 1.604-2.091), etc. were the positive factors for iron intake, and these positive factors were similar to those for IMMN intake. Additionally, rural residence was the negative factor for IMMN intake (compared with urban residence, OR=0.872, 95%CI:0.788-0.966). Conversely, higher educational level (OR=0.855, 95%CI:0.746-0.979), higher household income (OR=0.864, 95%CI: 0.796-0.938) were negative factors for ACPM intake, and rural residence was its positive factor (OR=1.285, 95% CI: 1.141-1.447). Conclusions The prevalence of prenatal supplementation of iron, IMMN and ACPM were low in women in Shaanxi, especially the intake rate of iron was the lowest. The prophylactic iron supplementation before pregnancy or in the first trimester was rare. Measures should be taken to improve the prenatal supplementation of iron in Shaanxi and to standardize the clinical use of ACPM.
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Objective To understand the prevalence of prenatal supplementations of iron, iron-containing multi-micronutrients (IMMN) and antianemic Chinese patent medicines (ACPM) and associated factors in women in Shaanxi province. Methods A sample of 28367 childbearing-age women who gave birth during 2010-2013 and had specific information of the prenatal nutrients supplementation were recruited using stratified multistage cluster random sampling in Shaanxi province. The information about their basic characteristics and prenatal supplementation of nutrients were collected by a questionnaire survey. Descriptive analysis method was used to analyze the intake rate of iron, IMMN and ACPM during each period of pregnancy, and logistic regression model was used to identify associated factors. Results The overall prevalence of prenatal iron, IMMN and ACPM supplementation was low (28.99%), and the intake rate of iron was the lowest (5.33%). The prevalence of prenatal supplementation of iron, IMMN and ACPM were lower before pregnancy and in the first trimester than in the second and third trimester. The intake rates for consecutive 2 periods were very low (all were lower than 2.00%). The intake rates of iron, IMMN and ACPM significantly increased year by year. Women living in central Shaanxi had relatively high intake rates of iron (7.22%) and IMMN (16.55%), and women in southern Shaanxi had relatively high intake rate of ACPM (18.50%). The results of logistic regression analysis showed that higher educational level(OR=1.920, 95%CI: 1.617-2.279), antenatal care times≥6 (OR=1.832, 95%CI: 1.604-2.091), etc. were the positive factors for iron intake, and these positive factors were similar to those for IMMN intake. Additionally, rural residence was the negative factor for IMMN intake (compared with urban residence, OR=0.872, 95%CI:0.788-0.966). Conversely, higher educational level (OR=0.855, 95%CI:0.746-0.979), higher household income (OR=0.864, 95%CI: 0.796-0.938) were negative factors for ACPM intake, and rural residence was its positive factor (OR=1.285, 95% CI: 1.141-1.447). Conclusions The prevalence of prenatal supplementation of iron, IMMN and ACPM were low in women in Shaanxi, especially the intake rate of iron was the lowest. The prophylactic iron supplementation before pregnancy or in the first trimester was rare. Measures should be taken to improve the prenatal supplementation of iron in Shaanxi and to standardize the clinical use of ACPM.