Research progress of natural medicine Astragalus mongholicus Bunge in treatment of myocardial fibrosis.

ETHNOPHARMACOLOGICAL RELEVANCE: Myocardial fibrosis (MF) is a common pathological manifestation of many cardiovascular diseases at a certain stage, with excessive accumulation of collagen fibers, excessive increase in collagen content, and a significant increase in collagen volume as the main pathological changes. There are currently no effective drugs for the treatment of myocardial fibrosis. Traditional Chinese medicine (TCM), the main component of the medical practice used for more than 5000 years, especially in China, often exerts a wider action spectrum than previously attempted options in treating human diseases. In recent times, the great potential of TCM in the treatment of MF has received much attention. Especially many experimental studies on the treatment of MF by Astragalus mongholicus Bunge have been conducted, and the effect is remarkable, which may provide more comprehensive database and theoretical support for the application of Astragalus mongholicus Bunge in the treatment of MF and could be considered a promising candidate drug for preventing MF. AIM OF THE REVIEW: This review summarizes the chemical components of Astragalus mongholicus Bunge, Astragalus mongholicus Bunge extract, Astragalus mongholicus Bunge single prescription, and Astragalus mongholicus Bunge compound preparation in the treatment of MF, and provides comprehensive information and a reliable basis for the exploration of new treatment strategies of botanical drugs in the therapy of MF. METHODS: The literature information was obtained from the scientific databases on ethnobotany and ethnomedicines (up to August 2022), mainly from the PubMed, Web of Science, and CNKI databases. The experimental studies on the anti-myocardial fibrosis role of the effective active components of Astragalus mongholicus Bunge and the utility of its compound preparation and the involved mechanisms were identified. The search keywords for such work included: "myocardial fibrosis" or "Cardiac fibrosis ", and "Astragalus mongholicus Bunge", "extract," or "herb". RESULTS: Several studies have shown that the effective active components of Astragalus mongholicus Bunge and its formulas, particularly Astragaloside IV, Astragalus polysaccharide, total saponins of Astragalus mongholicus Bunge, triterpenoid saponins of Astragalus mongholicus Bunge, and cycloastragenol, exhibit potential benefits against MF, the mechanisms of which appear to involve the regulation of inflammation, oxidant stress, and pro-fibrotic signaling pathways, etc. Conclusion: These research works have shown the therapeutic benefits of Astragalus mongholicus Bunge in the treatment of MF. However, further research should be undertaken to clarify the unconfirmed chemical composition and regulatory mechanisms, conduct standard clinical trials, and evaluate the possible side effects. The insights in the present review provided rich ideas for developing new anti-MF drugs. THESIS: Myocardial fibrosis (MF) with excessive accumulation of collagen fibers, excessive increase in collagen content, and a significant increase in collagen volume as the main pathological changes is a common pathological manifestation of many cardiovascular diseases at a certain stage, which seriously affects cardiac function. At present, there is still a lack of effective drugs for the treatment of MF. Traditional Chinese medicine (TCM), the main component of the medical practice used for more than 5000 years especially in China, often exerts wider action spectrum than previously attempted options in treating human diseases. In recent times, the great potential of TCM in the treatment of MF has received much attention. Especially many experimental studies on the treatment of MF by Astragalus mongholicus Bunge have been conducted, and the effect is remarkable, which may provide more comprehensive data base and theoretical support for the application of Astragalus mongholicus Bunge in the treatment of MF and could be considered a promising candidate drug for preventing MF.

Shuxie-1 Decoction Alleviated CUMS -Induced Liver Injury via IL-6/JAK2/STAT3 Signaling.

Introduction: Chronic stress has been shown to cause liver damage in addition to psychological depression. Besides, drug-induced liver injury is frequently caused by antidepressants. Shuxie-1 decoction (SX-1) is a formula of traditional Chinese medicine commonly used in nourishing liver blood, and relieving depression. However, the underlying molecular mechanism remains unclear. Therefore, this study was designed to explore the effects and mechanisms of SX-1 in treating chronic stress-induced depression as well as liver injury. Methods: Chronic unpredictable mild stress (CUMS) was applied to male Wistar rats for 4 weeks, with or without administration of SX-1 at low-dose and high-dose for 6 weeks, using Fluoxetine (Flu) as a positive control. Body weight was monitored once every 2 weeks. In the sixth week, the sugar preference test and open field test were carried out to evaluate the depression status. After that, the serum and liver tissues were collected. The quality control of SX-1 decoctions and drug-containing serum was controlled by UHPLC-QE-MS. The cell viability was measured by Cell Counting Kit-8 (CCK8). Enzyme-linked immunosorbent assay (Elisa), Western Blot and immunohistochemistrical staining was obtained to detect the protein levels in the plasma and the hepatic tissues, respectively. Results: CUMS led to decreased 1) body weight, 2) the preference for sugar water, 3) the desire to explore in open field, and increased serum levels of corticosterone. All these factors were completely reversed by SX-1 treatment. Hematoxylin-eosin staining (HE) showed that SX-1 improved the hepatocyte vacuolization in CUMS treated rats, decreased the serum levels of alanine aminotransferase (ALT) and the deposition of type I collagen (Col I) in hepatocytes as well. CUMS increased the levels of hepatic Interleukin-6 (IL-6), and provoked the activation of Janus kinase 2 (JAK2) and signal transducer and activator of transcription 3 (STAT3), which was abrogated by SX-1 treatment. Cobalt chloride (CoCl2) increased the protein expression of IL-6 and p-STAT3 in AML12 cells. Besides, nuclear pyknosis was observed under electron microscope, which were recovered after rat SX serum. Conclusion: SX-1 effectively ameliorated CUMS-induced depression-like behaviors as well as hepatic injuries, probably by the blockade of hepatic IL-6/JAK2/STAT3 signaling.

Textual Research of Classical Prescription Da Jianzhongtang / 中国实验方剂学杂志

Da Jianzhongtang， which is from Synopsis of Golden Chamber（《金匮要略》）， is one of the hundred ancient classical formulas. In this textual research， a total of 46 records on this prescription from 42 ancient books and 207 records from modern literature were screened out. Through systematic research on its name， dosage， processing， evolution of the meaning on prescription compatibility， indications， decocting methods， usage， and precautions， this paper aims to lay a literature basis for further research on Da Jianzhongtang. The results show that the converted dosages for the components are 3 g of Zanthoxyli Pericarpium， 12 g of Zingiberis Rhizoma， 6 g of Ginseng Radix et Rhizoma， and 30 g of Saccharum Granorum. The efficacy can be labeled on the prescription instruction as warming the middle and tonifying deficiency， descending adverse Qi and relieving pain. According to modern literature， the main indications include diseases in digestive system， circulatory system， orthopedic system， urinary system， and ophthalmic system， particularly the intestinal obstruction， gastric ulcer， chronic gastritis， and duodenal ulcer in the digestive system. The core pathogenesis of the above diseases is "deficiency-cold of middle energizer and internal exuberant cold". Precautions are as follows. ① For the processing of Zanthoxyli Pericarpium， stir-frying can alleviate its toxicity and increase the decoction rate of effective ingredients. ② For the dosage， overdosage will lead to dry cough， edema， etc. ③ As to the contraindications after the medication， raw， cold， or indigestible food should not be taken after medication. ④ For the syndrome taboos， this prescription should be used with caution for patents with Yin deficiency， congealing cold， and Qi stagnation， and be forbidden for patients with spleen and stomach dampness-heat. The above results lay a basis for the research and development of the compound preparation for Da Janzhongtang and provide a reference for its instructions.

Predictive quality control for compound liquorice tablets by the intelligent mergence fingerprint method combined with the systematic quantitative fingerprint method.

INTRODUCTION: Compound liquorice tablet (CLT) is a herbal compound preparation and is used as a classic antitussive and expectorant in China. It is composed of liquorice extract powder, opioid powder, star anise oil, camphor, and sodium benzoate. The complexity of herbal materials brings a huge challenge in producing compound preparations with stable and uniform quality consistency. OBJECTIVE: To establish a new intelligent model for predicting the quality of CLT. METHODS: The HPLC fingerprints of raw materials including liquorice extract powder, powdered opium, star anise oil, and sodium benzoate were tested and merged to generate the intelligent mergence fingerprints, whose correlation with the raw materials and the CLT samples was studied. The consistency of the intelligently merged fingerprints with the standard fingerprints was observed by using the systematic quantitative fingerprint method in order to calculate quality evaluation results. RESULTS: The intelligent mergence fingerprints covered all the main fingerprint peaks of four raw materials and had a good correlation with the CLT sample fingerprint. There were no significant quality differences either among the six intelligent mergence models obtained by combining different batches of raw materials or between the reference fingerprint of the intelligent mergence connection fingerprints (RFPIMFC ) and the theoretical standard preparation (RFPS ). CONCLUSION: The computer-aided model of intelligent mergence fingerprints could be used to predict the quality of herbal compound preparations based on raw materials. In this way, preproduction quality prediction can be realised in order to avoid low-quality medicinal materials and improve the quality consistency among different batches.

Safety, Tolerability, and Pharmacokinetics of Tazarotene Clindamycin Cream: A Single-Dose, 3-Period Crossover Study.

The current study compared the safety, tolerability, and pharmacokinetics of the new compound pharmaceutical preparation tazarotene clindamycin cream, and 2 single pharmaceutical preparations, tazarotene cream and clindamycin phosphate gel. Twelve healthy volunteers were enrolled in this single-center, single-blind, 3-treatment, 3-period crossover, single-dose randomized study. An 800-cm2 area on volunteers' backs was evenly smeared with 1.6 g of the test preparation to form a film. Blood samples were collected at predetermined time points for pharmacokinetic analysis. Safety and tolerability were assessed via skin reaction evaluation and clinical laboratory tests. The incidences of skin reactions were 18.2% for tazarotene clindamycin cream, 25.0% for tazarotene cream, and 18.2% for clindamycin phosphate gel. There were no significant differences in safety or tolerability among the 3 groups. Erythema, desquamation, and pruritus occurred in 7 volunteers, but no burning or tingling occurred. All adverse events were mild and resolved spontaneously, and there were no severe adverse events. The respective maximum plasma concentrations of tazarotenic acid after local administration of tazarotene clindamycin cream and tazarotene cream were 11 ± 5 pg/mL and 18 ± 12 pg/mL, and the areas under the curve within 72 hours were 444 ± 341 pg · h/mL and 692 ± 462 pg · h/mL.

Textual Research on Ancient Literature of Classical Prescription Kaixinsan and Its Associated Prescription / 中国实验方剂学杂志

The classical prescription Kaixinsan，which is recorded in an ancient medical book named Beiji Qianjin Yaofang，is one of the famous prescriptions used by ancient physicians to treat amnesia. Research on classical prescriptions has attracted more and more attention from scientific research institutions and related enterprises. Based on ancient books，textual research on origins and development of prescriptions，combing the evolution of prescriptions，preparations，oral ways，taboos and others are the important contents of the study on classical prescriptions. The research results show that the creation of Kaixinsan in Beiji Qianjin Yaofang can be traced back to Kaixinsan recorded in Jiyanfang and Dingzhiwan recorded in Gujinluyanfang. Later generations of physicians created many associated prescriptions in the process of applying Kaixinsan，and the efficacy of these prescriptions was constantly expanded with the development of the times. In the Tang and Song dynasties，Kaixinsan and its associated prescriptions were mainly used to treat amnesia，sorrow，fear，and other diseases. In the Jin and Yuan dynasties，these prescriptions were also used to treat convulsions and yawning. In the Ming dynasty， they were mainly for the treatment of hyperopia， myopia， sprematorrhea，and constipation. In the Qing dynasty，these herbs could be used to treat auricular deafness， aging and sweating. The dosage of Ginseng Radix et Rhizoma and Poria should be increased in the treatment of farsightedness，spermatorrhea and blurred urine，and in the treatment of nearsightedness，the dosage of Polygalae Radix and Haliotidis Concha should be increased. The main pathogenesis of the disease that Kaixinsan and its associated prescriptions treated could be summarized as the deficiency of heart and spleen，imbalance between heart-Yang and kidney-Yin，and the internal resistance of phlegm stagnation. By summarizing the contents of the preparation of tradition Chinese medicine products for Kaixinsan and its associated prescriptions，it is suggested that the dosage form of Kaixinsan can be pills，with the specification size confroming to the most record of ancient generations of physicians，as big as Firmiana platanifolia's fruit.The volume of a single pill is about 0.25 mL and the weight is about 0.3 g. The initial dosage is fifteen pills，which can be modified according to the severity of the illness，with no more than forty pills for each time，three times a day. Also，some excitant food like the sour food，sweet food and mutton should be avoided during the medication. The above research results can provide literature basis for the development of compound tradition Chinese Medicine preparation of Kaixinsan.

Relation Textual Research Between Effect Variation and Dosage of Famous Classical Formula Kaixinsan / 中国实验方剂学杂志

Kaixinsan recorded in an ancient medical book named Beiji Qianjin Yaofang is one of the famous classical formula，which is one of the common prescriptions used by ancient physicians to treat amnesia. In the process of using this prescription，later generations of physicians derived many kinds of associated prescriptions. The effect and indications of these prescription have been inherited and expanded from those in the Beiji Qianjin Yaofang because of the changes in dosages. Therefore，it is necessary to verify the effect and indications of the formulas and the rules of dosage changes. The research results showed that its basic effects included to nourish the mind，induce resuscitation，strengthen the spleen and calm the mind，and keep balance between heart-Yang and kidney-Yin. The main indications included amnesia，sorrow and sadness，fright and fear，and so on，which may differ slightly in different dynasties. In Song，Jin and Yuan dynasties，it also demonstrated the effect of warming the heart and Yang，clearing away heat and relieving wind besides the basic effects， with basically the same indications （slightly different from those in previous dynasties）. In Ming dynasty，it demonstrated the effect of nourishing Yin，clearing away heat and nourishing blood besides the basic effects，and the indications expanded to farsightedness，nearsightedness，spermatorrhea and blurred urine. In the Qing dynasty，its effect also included to nourish the heart and kidney on the basis of the Ming dynasty，and the indications were basically the same with those in the previous dynasties. The compatibility ratio of ancient physicians in the application of this prescription and its associated prescriptions showed some remarkable features，for example，Ginseng Radix et Rhizoma and Poria should be increased and their ratio was≈1∶1 in the treatment of amnesia，sorrow，sadness，fright，fear，farsightedness，spermatorrhea and blurred urine，with ratio of Polygalae Radix to Acori Tatarinowii Rhizoma≈1∶1； the dosage of Polygalae Radix and Acori Tatarinowii Rhizoma should be increased in the treatment of nearsightedness，and their ratio was≈1∶1. The compatibility ratio of Polygalae Radix-Ginseng Radix et Rhizoma-Poria-Acori Tatarinowii Rhizoma=2∶3∶3∶2 was the most frequent，which basically included the indications of this prescription and its associated prescriptions. According to statistics，the average dosages that ancient physicians used were significantly higher than those in the modern times，Polygalae Radix 57 g，Ginseng Radix et Rhizoma 62 g，Poria 70 g，and Acori Tatarinowii Rhizoma 54 g，respectively in ancient times，while Polygalae Radix 11 g，Ginseng Radix et Rhizoma 15 g，Poria 17 g，and Acori Tatarinowii Rhizoma 9.5 g，respectively in modern times. The above textual research results can provide some reference for preparation of tradition Chinese medicine products of Kaixinsan.

Bayesian Network Meta-analysis of Therapeutic Efficacy and Safety of Chinese Patent Medicine Compound Preparation Combined with Conventional Therapy for Psoriasis Vulgaris / 中国药房

OBJECTIVE：To systematically evaluate the therapeutic efficacy and safety of Chinese patent medicine compound preparation combined with conventional therapy for psoriasis vulgaris ，and to provide evidence-based reference for clinical drug use. METHODS ：Retrieved from CNKI ，Wanfang database ，VIP，CBM，PubMed，the Cochrane Library and Web of Science ， RCTs about Chinese patent medicine compound preparation combined with conventional therapy versus conventional therapy in the treatment of psoriasis vulgaris were collected during the inception to Feb. 2020. After literature retrieval and data extraction ，the quality of the included studies was evaluated with risk bias assessment tool recommended by the Cochrane evaluation manual handbook 5.1. Bayesian network Meta-analysis was perfor med by using Stata 15.0 software，Addis 1.16.6 software and Markov Chain Monte Carlo method. RESULTS ：A total of 41 RCTs were included ，involving 4 122 patients. 5 kinds of interven- tion measures included Compound qingdai capsule ，Xiaoyin SF-010） granule， Keyin pill ，Yujin yinxie tablet and conventional therapy. Results of network Meta-analysis showed that in terms of improving the total effective rate ， compared with conventional therapy ，4 kinds of Chinese patent medicine compound preparations combined with conventional therapy could significantly improve the total effective rate （P＜0.05）；the results of network Meta-analysis were as follows ：Keyin pill combined with conventional therapy ＞Compound qingdai capsule combined with conventional therapy ＞Xiaoyin granule combined with conventional therapy ＞Yujin yinxie tablet combined with conventional therapy ＞conventional therapy. In terms of reducing psoriasis area and severity index （PASI）score after treatment ，compared with conventional therapy ，Keyin pill and Xiaoyin granule combined with conventional therapy could significantly reduce the PASI score （P＜0.05），while Compound qingdai capsule and Yujin yinxie tablet combined with conventional treatment had no significant difference （P＞0.05）；the results of network Meta-analysis showed that Xiaoyin granule combined with conventional therapy ＞Keyin pill combined with conventional therapy ＞ Compound qingdai capsule combined with conventional therapy ＞Yujin yinxie tablet combined with conventional therapy ＞ conventional therapy. In terms of reducing serum inflammatory factor level ，compared with conventional therapy ，Compound qingdai capsule and Xiaoyin granule combined with conventional therapy could significantly reduce the level of IL- 17（P＜0.05）， but Keyin pill and Yujin yinxie tablet combined with conventional therapy had no significant difference （P＞0.05）；the results of network Meta-analysis showed that Xiaoyin granule combined with conventional therapy ＞Compound qingdai capsule combined with conventional therapy ＞Yujin yinxie tablet combined with conventional therapy ＞Keyin pill combined with conventional therapy＞conventional therapy. In terms of safety ，there was no statistical significance in the incidence of ADR between 4 kinds of Chinese patent medicine combined with conventional therapy and conventional therapy （P＞0.05）；the results of network Meta-analysis showed that Compound qingdai capsule combined with conventional therapy ＞Xiaoyin granule combined with conventional therapy ＞Keyin pill combined with conventional therapy ＞conventional therapy ＞Yujin yinxie tablet combined with conventional therapy . CONCLUSIONS ：Compared with conventional therapy ，additional use of 4 kinds of Chinese patent medicine compound preparations can improve the curative effect of psoriasis vulgaris patients with blood heat syndrome ，and Keyin pill is the best ；Xiaoyin granule is the best in reducing the degree of skin lesions and serum inflammatory factors ；additional use of 4 kinds of Chinese patent medicine compound preparations show good safety ，and Compound qingdai capsule is the best.

Application of " Basaga" in Mongolian Medicine Compound Preparations in Inner Mongolia / 中国实验方剂学杂志

" Basaga" is one of the commonly used medicinal materials in Mongolian medicine. It has a long history and effects in cooling blood, stopping stabbing pain and detoxifying. The " Basaga" in Mongolian medicine compound preparations have been widely used in various Mongolian hospitals because of its remarkable clinical efficacy. However, due to the differences in inheritance, medicinal parts and plants in Inner Mongolia, the phenomena of homonym and synonym in the application of " Basaga" have been very obvious, which leads to confusion in clinical use, and challenges the safety and effectiveness of this kind of Mongolian medicine. To understand the application of " Basaga" in Mongolian medicine compound preparation, and collect and summarize the types of " Basaga" preparations and the variety of " Basaga" used in preparations and formulations, functional indications and clinical applications were analyzed and collected based on standards and specifications of Mongolian medicine, the application of Mongolian medicine hospitals and Mongolian medicine hospital' s preparation room in Inner Mongolian, and relevant documents in recent years were reviewed. The data can provide references for optimizing and improving " Basaga" , Mongolian medicine standards and the overall standard level. What' s more, the basic data for strengthening the comprehensive development and research of " Basaga" in Mongolian medicine compound preparations in future, so as to ensure and improve the accuracy and clinical effectiveness of " Basaga" in prescriptions of Mongolian patent medicine, and lay a foundation for rational use and modern research of " Basaga" Mongolian medicine.

Overview of Famous Classical Formulas and Discussion on Its Exploitation / 中国实验方剂学杂志

The famous classical formulas （FCF）， which occupy the most important position in the prescription theory， had been brought out following the progress of traditional Chinese medicine （TCM）. Its formation and exploitation， essentially the ingredient constitution and preparation technology， is an objective trend of TCM. The development of related product under the guidance of relevant national policies has its historical inevitability， as the development of formula granules in recent decades had laid a solid foundation for it. The key to exploit these FCF is to refine and standardize the clinical applications through the ages with the guidance of TCM theory， for the process design of massive industrial production. As a result of the analysis of its definition and connotation， it is clear that the core connotation of FCF is the medicinal substances with fixed formula compatibility and stable preparation process. Furthermore， the screening strategy， the exploitation value， and the applicability between ancient prescriptions and nowadays diseases， had also been discussed based on the current policy situation and research status.

[Safety evaluation of heavy metals contaminated Xiaochaihu Tang using health risk assessment model].

In order to further improve the quality and safety evaluation standards of traditional Chinese medicine compound preparation,Xiaochaihu Tang compound preparations were selected to analyze the pollution level of heavy metals deeply,and the potential health risks were evaluated under taking such kind of compound preparations. In this study,the contents of copper( Cu),arsenic( As),cadmium( Cd),mercury( Hg),and lead( Pb) in different Xiaochaihu Tang compound preparations were determinated by the method of inductively coupled plasma mass spectrometry( ICP-MS). Moreover,combined with target hazard coefficient method and in vitro artificial system,the bioaccessibility and health risk level was investigated in three main consumption ways including powder,decoction and granule. The result was showed that,under the maximum residual limit set by International Standard Organization,only one batch of raw herb was eight times exceeded the Hg MRL,however,in water decoctions and granules,the heavy metal residue rate was reduced to 2. 02%( Hg in granules)-42. 85%( Cd in granules). So,the heavy metal pollutions and health risks can be reduced to safe region in spite of the serious pollution in raw herbs. Besides,the THQ and CR values of the three consumption methods were lower than the standard values of non-carcinogenic and carcinogenic risks of each heavy metal. It can be seen that even if the heavy metals in the raw herbs exceed the standard,the use of Xiaochaihu Tang decoction and granules can reduce the harm of heavy metals to the human body. Above all,the establishment of this health risk assessment model can be provided experimental basis and reference value for improving the safety evaluation standard of other heavy metals contained traditional Chinese medicine( TCM) compound preparations,and further improving the quality control methods of other different toxic compounds in clinical use.

Key Points and Strategies of Textual Research in Development of Famous Classical Formulas / 中国实验方剂学杂志

Textual research is the first step, ensuring the safety and effectiveness of the clinical application, and also one of the main bases for determining the research scheme and experimental parameters in the development of famous classical formulas. It involves the origin and historical evolution of the prescription, the main function, the meaning of the prescription, the decoction method, as well as the original part, origin, dosage, processing method of the medicinal materials in the prescription. In view of these points, the author believes that the ancient and modern literature information should be comprehensively and accurately collected according to the standardized procedures and methods, combined with the historical continuation and cross-sectional analysis, in order to ensure the efficacy and safety of traditional Chinese medicine (TCM) famous classical formulas. The research and development plan of famous classical formulas was formulated from the perspectives of TCM theoretical characteristics, formula historical evolution, modern clinical value and practical feasibility. Under the premise of "compliance with the ancients", we should understand the common problems in the process of research and development, such as the origin, processing, dosage and decoction of TCM from the perspective of history and development, so as to widely gather the industry consensus and jointly explore the precious treasure of the famous classical formulas.

Research and Development Strategy of Classical Formula Compound Preparation / 中国实验方剂学杂志

Although the country has promulgated a list of 100 classical famous formula,there are still many confusions and choices in the development of compound preparations from classical prescriptions. In this paper,the development strategy of classical formula compound preparation was elaborated from three aspects:the evaluation of draggability,the consideration of industrialization and the clinical orientation. The draggability evaluation includes pharmacy and preclinical safety. It should focus on the factors such as substance benchmark,dosage,toxic herbal medicines,clinical use and so on. Industrialization considerations need to focus on how to use modern industrialization methods to prepare modern compound preparations with the same quality as material benchmarks. The use of extracts may be an effective way to solve the problems of low utilization rate of decoction pieces and inadequate industrial advantages. Clinical orientation should be clear about the main effect,take into account the secondary effect, pay attention to the negative effect, and consider the level of clinical value. A series of corresponding development strategies and ideas are proposed in order to provide references for enterprises and researchers who select and layout classical famous formula, to promote the development of classical prescription compound preparation.

Meta-analysis of Efficacy and Safety of TCM Compound Preparation for Tonifying Kidney and Activating Blood Circulation in the Treatment of Postmenopausal Osteoporosis / 中国药房

OBJECTIVE： To systematically evaluate the efficacy and safety of TCM compound preparation for tonifying kidney and activating blood circulation， and to provide evidence-based reference for rational drug use in the clinic. METHODS： By retrieving Cochrane library， PubMed， Embase， CBM， CNKI， VIP and Wanfang database， randomized controlled trials （RCTs） about TCM compound preparation for tonifying kidney and activating blood circulation （trial group） versus calcium or non-calcium agents （control group） in the treatment of postmenopausal osteoporosis were included. After literature screening， data extraction and quality evaluation with bias risk evaluation tool and Jadad scale of Cochrane system evaluator manual 5.1.0， Meta-analysis was conducted by using Stata 12.0 software， and trial sequential analysis （TSA） was conducted by using TSA 0.9 software. RESULTS： Totally 18 RCTs were included， involving 1 408 patients. The results of Meta-analysis showed that total response rate [RR＝1.35，95％CI（1.17，1.54），P＜0.000 1] and bone density[SMD＝0.24，95％CI（0.16，0.32），P＜0.000 1] of trial group were significantly higher than those of control group； blood calcium [SMD＝－0.05，95％CI（－0.09，0.00）， P＝0.033] of trial group was significantly lower than that of control group. There was no statistical significance in the levels of urine creatinine [SMD＝－1.60，95％CI（－5.94，2.74），P＝0.470]， urinary calcium/urine creatinine ratio [SMD＝－0.05，95％CI（－0.14，0.04），P＝0.295]， urinary hydroxyproline/urine creatinine ratio [SMD＝－0.16，95％CI（－1.04，0.72），P＝0.726]， ALT [SMD＝0.51，95％CI（－3.26，4.28），P＝0.790]， AST [SMD＝0.23，95％CI（－5.22，4.77），P＝0.929]， serum alkaline phosphatase [SMD＝－0.22，95％CI（－0.68，0.25），P＝0.361]， serum phosphate [SMD＝－0.02，95％CI（－0.11，0.07），P＝0.639]， urea nitrogen [SMD＝－0.19，95％CI（－0.70，0.31），P＝0.453]， estradiol [SMD＝0.62，95％CI（－0.28，1.52），P＝0.177]， IL-6 [SMD＝－1.78，95％CI（－4.86，1.30），P＝0.258] or VAS [SMD＝0.55，95％CI（－1.03，2.13），P＝0.496] between 2 groups. No server ADR was found in 2 groups. TSA showed that there were extract evidences for total response rate of TCM compound preparation in the treatment postmenopausal osteoporosis. CONCLUSIONS： TCM compound preparation for tonifying kidney and activating blood circulation shows significant therapeutic efficacy for postmenopausal osteoporosis， and can improve serum calcium and bone density with good safety.

Design of Chinese materia medica compound preparation based on clinical value and inheritance and innovation / 中草药

Chinese materia medica (CMM) compound is the quintessence of traditional Chinese medicine culture, the main form in clinic of traditional Chinese medicine, the main categories and direction of research and registration of new CMM products, and an important carrier for traditional Chinese medicine inheritance and innovation. Due to the characteristics of complicated chemical constituents, weak research foundation, unclear effective components and multi-target effects, coupled with the limitations of research methods and evaluation of CMM compound preparation, how to scientifically carry out the design of CMM compound preparation has become a difficult question to answer. In this paper, from the basic attributes and requirements of drugs, combined with the discussion of research and development path, rule, strategy of new CMM compound preparation, it is proposed that the design of CMM compound preparation should be based on clinical value and inheritance and innovation, in the principle of the safety and effectivity of preparations, respecting traditional medicine experience, quality by design, whole quality evaluation, and quality uniformity and stability, etc. The pretreatment, dosage, process, dosage form, formulation design, equipment selection and industrial production in the CMM compound preparation design are also discussed.

Safety evaluation of heavy metals contaminated Xiaochaihu Tang using health risk assessment model / 中国中药杂志

In order to further improve the quality and safety evaluation standards of traditional Chinese medicine compound preparation,Xiaochaihu Tang compound preparations were selected to analyze the pollution level of heavy metals deeply,and the potential health risks were evaluated under taking such kind of compound preparations. In this study,the contents of copper( Cu),arsenic( As),cadmium( Cd),mercury( Hg),and lead( Pb) in different Xiaochaihu Tang compound preparations were determinated by the method of inductively coupled plasma mass spectrometry( ICP-MS). Moreover,combined with target hazard coefficient method and in vitro artificial system,the bioaccessibility and health risk level was investigated in three main consumption ways including powder,decoction and granule. The result was showed that,under the maximum residual limit set by International Standard Organization,only one batch of raw herb was eight times exceeded the Hg MRL,however,in water decoctions and granules,the heavy metal residue rate was reduced to 2. 02%( Hg in granules)-42. 85%( Cd in granules). So,the heavy metal pollutions and health risks can be reduced to safe region in spite of the serious pollution in raw herbs. Besides,the THQ and CR values of the three consumption methods were lower than the standard values of non-carcinogenic and carcinogenic risks of each heavy metal. It can be seen that even if the heavy metals in the raw herbs exceed the standard,the use of Xiaochaihu Tang decoction and granules can reduce the harm of heavy metals to the human body. Above all,the establishment of this health risk assessment model can be provided experimental basis and reference value for improving the safety evaluation standard of other heavy metals contained traditional Chinese medicine( TCM) compound preparations,and further improving the quality control methods of other different toxic compounds in clinical use.

Clinical effects observation of compound preparation Femoston on treatment of perimenopausal syndrome in women / 中国生化药物杂志

Objective To study and analyze the clinical efficacy of compound preparation Femoston for the treatment of perimenopausal syndrome in women. Methods 60 women with perimenopausal syndrome from April 2016 to July 2017 were selected and randomly divided into the control group and the experimental group, 30 cases for each group. The control group was given estradiol valerate tablets, and the experimental group was treated with compound preparation Femoston, one tablet a day. The treatment time of the two groups was 6 months, and the clinical efficacy of the experimental group and the control group were compared and analyzed. Results After the corresponding treatment, 4 patients were ineffective in the experimental group. In the control group, 7 patients were ineffective, 10 cases were effective, and 13 cases were good effective. The effective rate of the experimental group was 86.67%, which was significantly higher than that (76.67%) of the control group with statistical significance (P<0.05). The level of FSH in the experimental group was (24.10 ± 15.24) U/L, which was significantly better than that of the control group (42.72 ±15.56) U/L with statistical significance (P<0.05). There were no obvious adverse reactions in the two groups, and the rate of adverse reactions such as vomiting, abdominal pain and breast pain were 3.33% and 6.67%, respectively, and there was no statistical significance. Conclusion The clinical efficacy of compound preparation Femoston for treating perimenopausal syndrome is ideal. Femoston could significantly improve the hormone levels in patients with high safety.

Clinical effects observation of compound preparation Femoston on treatment of perimenopausal syndrome in women / 中国生化药物杂志

Objective To study and analyze the clinical efficacy of compound preparation Femoston for the treatment of perimenopausal syndrome in women. Methods 60 women with perimenopausal syndrome from April 2016 to July 2017 were selected and randomly divided into the control group and the experimental group, 30 cases for each group. The control group was given estradiol valerate tablets, and the experimental group was treated with compound preparation Femoston, one tablet a day. The treatment time of the two groups was 6 months, and the clinical efficacy of the experimental group and the control group were compared and analyzed. Results After the corresponding treatment, 4 patients were ineffective in the experimental group. In the control group, 7 patients were ineffective, 10 cases were effective, and 13 cases were good effective. The effective rate of the experimental group was 86.67%, which was significantly higher than that (76.67%) of the control group with statistical significance (P<0.05). The level of FSH in the experimental group was (24.10 ± 15.24) U/L, which was significantly better than that of the control group (42.72 ±15.56) U/L with statistical significance (P<0.05). There were no obvious adverse reactions in the two groups, and the rate of adverse reactions such as vomiting, abdominal pain and breast pain were 3.33% and 6.67%, respectively, and there was no statistical significance. Conclusion The clinical efficacy of compound preparation Femoston for treating perimenopausal syndrome is ideal. Femoston could significantly improve the hormone levels in patients with high safety.

Quality design, quality improvement and evaluation requirement by stages on new traditional chinese medicine compound preparation / 中草药

Chinese materia medica (CMM) compound is the quintessence of traditional Chinese medicine culture, the main form and method of clinical medicine of CMM, the main categories and direction of the research and registration of new CMM products, the important part of “inheritance and development” of CMM culture, and mainly reflects the characteristics of CMM. According to the evaluation practice for many years, the research path and the knowledge of the research rules for new drugs of CMM compound were discussed, and the requirements for pharmaceutical research works of new CMM compound preparation. The pharmaceutical research on new CMM compound preparation is a process of quality design and quality improvement. The evaluation requirements of different stages for new CMM compound preparation were elaborated. It is the conclusion that the discussion of R&D path, R&D law, and R&D strategy on new CMM compound preparation will improve the technical evaluation standard system with the characteristics of CMM, increase the ability of R&D for CMM new products, promote the innovation of CMM, and accelerate the new CMM products to go on market.

Effects of Compound Preparation of Milkvetch Root and Breviscapine on Memory Ability and SOD, MDA and LDH in Blood and Brain of Alzheimer's Disease Rats / 中国药师

Objective: To observe the effect of compound preparation of milkvetch root and breviscapine (HDs) on the activity of superoxide dismutase (SOD) and lactate dehydrogenase(LDH), the concentration of malondialdehyde (MDA) in blood and brain and memory impairment in Alzheimer's disease rats.Methods: The rats were randomly divided into 5 groups (10 rats /group): the normal control group, Alzheimer's disease (AD) model group induced by AlCl3(5 mg·kg -1·d-1,ig) and D-gal (40 mg·kg-1·d-1,ip), and 3 AD groups respectively treated with different drugs including piracetam (0.15 g·kg-1·d-1,ig), HDs1(1.5 ml·kg-1·d-1,ip) and HDs2 (3 ml·kg-1·d-1,ip).After 90-day treatment, the step-down test was used to detect the learning and memory ability, and SOD and LDH activity and MDA concentration in blood and brain were examined as well.Results: Compared with that in AD model group, the ability of learning and memory was improved, the activity of SOD and LDH increased significantly, the concentration of MDA decreased significantly in blood and brain in HDs treated groups.The differences were statistically significant (P<0.05 or P<0.01), but they were not restored to normal levels.Some indexes of HDs2 group were better than those of piracetam positive control group and HDs1 group (P<0.05 or P<0.01).Conclusion: HDs can effectively reduce MDA concentration, increase SOD and LDH activity in blood and brain, and improve the ability of learning and memory of AD rats.