Integrated serum pharmacochemistry, network pharmacology, and pharmacokinetics to clarify the effective components and pharmacological mechanisms of the proprietary Chinese medicine Jinkui Shenqi Pill in treating kidney yang deficiency syndrome.

The proprietary Chinese medicine Jinkui Shenqi Pill (PCM-JKSQP) is a classic compound used for the effective clinical treatment of kidney yang deficiency syndrome (KYDS), a metabolic disease accompanied by kidney injury. However, its active ingredients and therapeutic mechanisms are not clear. This study employed serum pharmacochemistry, network pharmacology, and pharmacokinetics (PK) to identify the bioactive components of PCM-JKSQP and preliminarily clarify its mechanism in treating KYDS. One hundred and forty chemical components of PCM-JKSQP, 47 (20 parent compouds and 27 metabolites) of which were absorbed into the blood, were identified by ultra-high-performance liquid chromatography-quadrupole-orbitrap high-resolution mass spectrometry (UHPLC-Q-Orbitrap HRMS). The topological parameters of network pharmacology and high concentrations in blood found six parent components as PK markers (cinnamic acid, paeonol, loganin, morroniside, apigenin, and poricoic acid A). PK analysis further identified these six compounds as active ingredients. Protein-protein interaction (PPI) analysis and molecular docking simulation predicted and verified eight core targets (TP53, ESR1, CTNNB1, EP300, EGFR, AKT1, ERBB2, and TNF). Most were concentrated in the MAPK, HIF-1, and PI3K-AKT signaling pathways, indicating that these six active ingredients may mainly exert therapeutic effects through these three pathways via their core targets. The PK results also showed these six components were absorbed quickly, although cinnamic acid and paeonol were rapidly metabolized, with a short half-life and retention time. Loganin and morroniside did not have high peak concentrations, and apigenin and poricoic acid A had long retention times. This study provides a new overall perspective for exploring the bioactive components and mechanisms underlying the effects of PCM-JKSQP in treating KYDS.

Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of China.

Background: Proprietary Chinese medicine (PCM) is widely used in the Guangdong-Hong Kong-Macau Greater Bay Area (GBA) of China. However, the regulatory frameworks and procedures for PCM registration in the region are not well-established, and there are differences among the three jurisdictions. The study is aimed to compare the legal basis, regulatory guidelines, application requirements, and evaluation criteria in each jurisdiction. Methods: We conducted a comprehensive review of the registration application processes for PCMs in the Chinese mainland, Hong Kong, and Macau based on publicly available information from respective regulators. Results: The study found that the registration application process in the GBA was complex and time-consuming, with differences in requirements and procedures among the three jurisdictions. The study also identified several challenges faced by PCM manufacturers, such as the lack of harmonisation of regulatory requirements and procedures and the requirement of package inserts and labelling for PCM products. The study proposed recommendations for improving the registration process and promoting the development of the PCM industry in the GBA. Conclusion: This study provides a comprehensive understanding of the PCM product license application procedures and requirements in the GBA, coupled with discernment of their similarities and disparities, equips applicants with the knowledge to formulate an appropriate strategy for obtaining product approval. Exploring potential methods for harmonising the regulatory process stands to benefit manufacturers, regulators, and patients by improving efficiency and curtailing costs.

Treatment of Chronic Gastritis with Traditional Chinese Medicine: Pharmacological Activities and Mechanisms.

Chronic gastritis (CG) is a common clinical digestive system disease, which is not easyily cured and is prone to recurrence. Traditional Chinese medicine (TCM) plays a significant role in the treatment of CG and has attracted increasing attention for clinical applications. In recent years, a large number of reports have shown that TCM has good therapeutic effect on CG. The aim of this paper is to investigate the pharmacological activities and mechanism of action of TCM in the treatment of CAG. Therefore, by searching the databases of Pubmed, China National Knowledge Infrastructure, Wanfang, and Baidu academic databases, this paper has summarized the molecular mechanisms of TCM in improving CG. The results show that the improvement of GC by TCM is closely related to a variety of molecular mechanisms, including the inhibition of Helicobacter pylori (Hp) infection, alleviation of oxidative stress, improvement of gastric function, repair of gastric mucosa, inhibition of inflammatory response, and apoptosis. More importantly, IRF8-IFN-γ, IL-4-STAT6, Hedgehog, pERK1/2, MAPK, PI3K-Akt, NF-κB, TNFR-c-Src-ERK1/2-c-Fos, Nrf2/HO-1, and HIF-1α/VEGF signaling pathways are considered as important molecular targets for TCM in the treatment of GC. These important findings will provide a direction and a basis for further exploring the pathogenesis of GC and tapping the potential of TCM in clinical treatment. This review also puts forward a bright prospect for future research of TCM in the treatment of CG.

Oral proprietary Chinese medicine for lupus nephritis: A bayesian network meta-analysis.

Objective: To analyze the efficacy and safety of proprietary Chinese medicines for the treatment of Lupus Nephritis (LN) based on the reticulated meta analysis. The study aim to provide evidence-based evidence for the clinical treatment of LN. Methods: The studies related to the randomized controlled studies (RCTs) on the treatment of LN with oral proprietary Chinese medicines were obtained from China National Knowledge Infrastructure (CNKI), Database for Chinese Technical Periodicals (VIP), SinoMed, Wanfang, PubMed, Web of Science, Embase and Cochrane Library databases since its inception-August 2022. Cochrane tools were used for risk bias assessment, Stata 13.0 and ADDIS 1.16.5 software were used for net evidence analysis.Results.1) 41 RCTs with 3124 L N patients were included, involving 9 types of proprietary Chinese medicines.2) The meta-analysis showed that in terms of efficacy, the top 3 Chinese patent medicine interventions were Xin Gan Bao Capsule (XGB) +western medicines (WM), Huang Kui Capsule (HK) + WM, Kun Xian Capsule (KX) + WM; in terms of reducing adverse event rate, the top 3 Chinese patent medicine interventions were Yi Shen Hua Shi Granules (YSHS) + WM, Jin Shui Bao Capsule (JSB) + WM, HK + WM; in terms of reducing 24 h urine protein, the top 3 Chinese patent medicine interventions were XGB + WM, YSHS + WM, Bai Ling Capsule (BL) + WM; in terms of reducing blood creatinine (Cr), the top 3 Chinese patent medicine interventions were Yi Shen Granules (YS) + WM, JSB + WM, KX + WM; in terms of reducing urea nitrogen (BUN), the top 3 Chinese patent medicine interventions were Shen Kang Capsule (SK) + WM, HK + WM, JSB + WM; in terms of reducing systemic lupus erythematosus disease activity index (SLEDAI) scores, the top 3 Chinese patent medicine interventions were JSB + WM, BL + WM, YSHS + WM; in terms of improving complement C3, the top 3 Chinese patent medicine interventions were HK + WM, XGB + WM, BL + WM; in terms of improving complement C4, the top 3 Chinese patent medicine interventions were KX + WM, YSHS + WM, BL + WM. Conclusion: Xin Gan Bao Capsule has a good efficacy in improving efficiency and the level of complement C3, lowering 24 h urine protein. Jin Shui Bao Capsule and Huang Kui Capsule have a good efficacy in treating LN. However, more multicentre, large sample and high quality RCTs are needed for validation the results.

Network Pharmacology and Data Mining Approach Reveal the Medication Rule of Traditional Chinese Medicine in the Treatment of Premenstrual Syndrome/Premenstrual Dysphoric Disorder.

Premenstrual syndrome (PMS) is a common disorder that affects women of reproductive age. It is characterized by periodic mental and somatic symptoms such as irritability, depression, and breast pain during the luteal phase. Premenstrual dysphoric disorder (PMDD) is the most severe form of PMS. In recent years, the incidence of PMS/PMDD has been increasing year after year. However, due to the complex symptoms and ambiguous classification of PMS/PMDD, the limitations of present treatments, such as their poor efficacy rate, have become increasingly apparent. With its unique benefits such as syndrome differentiation and high cure rate, traditional Chinese medicine (TCM) has sparked new diagnosing and treating of PMS/PMDD. This study uses data mining methods, and statistical analysis revealed that Xiaoyao San and Chaihu Shugan San were the commonly used TCM to treat PMS/PMDD. A detailed investigation of regularly used single herbs revealed that most TCM is used as cold herbs that penetrate the liver meridian, with predominant bitter, sweet, and pungent flavors. The network pharmacology method analyzes the interactions between diseases, targets, and herbs. Meanwhile, the deep action targets and molecular mechanisms of 10 commonly used herbs for the treatment of PMS/PMDD are studied, revealing that it involves several ingredients, many targets, and different pathways. This interaction provides insight into the mechanism of action of TCM in the synergistic treatment of PMS/PMDD. It is now clear that we can begin treating PMS/PMDD with TCM using the target and mechanism revealed by the abovementioned findings in the future. This serves as an essential reference for future research and clinical application of TCM in the treatment of PMS/PMDD.

[Research advances of Zaoren Anshen prescription preparations].

Zaoren Anshen prescription preparations(ZRASs), which are prepared from three traditional Chinese herb medicines, namely fried Zizyphi Spinosae Semen, Salvia Miltiorrhizae Radix et Rhizoma and vinegar-processed Schisandrae Chinensis Fructus, are a series of proprietary Chinese medicines for the treatment of insomnia, amnesia and dizzy in clinic. In recent years, pharmacodynamic effect, chemical constituents and quality control of ZRASs had been extensively studied for the purpose of ensuring their safety, efficacy and stability, and a great progress had been made. However, there is no review of the research advance of ZRASs up to date. The present review summarized the research advance of ZRASs in quality control standards, chemical constituents, pharmacodynamic effects, and chemical analysis for the first time, with the aim to provide a reference for further studies on the effective constituents and quality control of ZRASs.

A Comparative Study for License Application Regulations on Proprietary Chinese Medicines in Hong Kong and Canada.

Ethnopharmacological Relevance: Chinese Medicine plays a symbolic role among traditional medicines. As Chinese Medicine products are widely used around the globe, regulations for Chinese Medicine products are often used as models for the efficient regulation of natural products that are safe, and high-quality. Aim of the Study: We aimed to compare the regulatory registration requirements for Proprietary Chinese Medicines in Hong Kong and Canada. Materials and Methods: We compared registration requirements for Proprietary Chinese Medicine in Hong Kong and Canada based on publicly available information provided by the respective Regulators. A marketed product, Zhizhu Kuanzhong Capsule (SFDA approval number Z20020003; NPN approval number 80104354), was used as a case study to demonstrate the similarities and differences of the requirements in both Hong Kong and Canada. Results: There were similarities and differences between the two regulatory systems in terms of the quality, safety and efficacy requirements. Despite the superficial appearance of similar categories and groups/classes, Hong Kong requires significantly more primary test data compared to Canada's reliance on attestation to manufacturing according the standards outlined in approved reference pharmacopeias/texts. Conclusion: Improved understand of the similarity and differences will enable applicants to plan appropriate strategies for gaining product approval. Exploring ways to harmonize the regulatory process has the potential to benefit manufacturers, regulators, and patients by increasing efficiency and decreasing costs.

Research advances of Zaoren Anshen prescription preparations / 中国中药杂志

Zaoren Anshen prescription preparations(ZRASs), which are prepared from three traditional Chinese herb medicines, namely fried Zizyphi Spinosae Semen, Salvia Miltiorrhizae Radix et Rhizoma and vinegar-processed Schisandrae Chinensis Fructus, are a series of proprietary Chinese medicines for the treatment of insomnia, amnesia and dizzy in clinic. In recent years, pharmacodynamic effect, chemical constituents and quality control of ZRASs had been extensively studied for the purpose of ensuring their safety, efficacy and stability, and a great progress had been made. However, there is no review of the research advance of ZRASs up to date. The present review summarized the research advance of ZRASs in quality control standards, chemical constituents, pharmacodynamic effects, and chemical analysis for the first time, with the aim to provide a reference for further studies on the effective constituents and quality control of ZRASs.

Effect of Shuangjinlian mixture on oral ulcer model in rat.

OBJECTIVE: To observe the effect of common clinical drug Shuangjin Lian mixture on rats with oral ulcer and discuss its mechanism. METHODS: Sodium carboxymethyl cellulose caused leukocyte aggregation in rats, observed the anti-inflammatory effect of Shuangjin mixture. 3 mm * 3 mm size ulcer surface in the oral cavity of rats was caused by 90% phenol solution, to observe the therapeutic effect and anti-inflammatory effect of Shuangjinlian mixture on rats with oral ulcers. RESULT: The low, middle and high dose Shuangjinlian mixture can inhibits the accumulation of white blood cells caused by sodium carboxymethyl cellulose in rats significantly (P < 0.01). And reduce the degree of edema and hyperaemia around the ulcer tissue significantly (P < 0.01), improve the ulcer healing probability, and reduce the level of TNF-α, VEGF levels and increase IL-2 level in the serum of rats with oral ulcers significantly (P < 0.01). Pathological examination showed that the lesion of ulcer tissue in each treatment group was obviously alleviated. CONCLUSION: Shuangjinlian mixture had anti-inflammatory effect and was effective for the prevention and treatment of oral ulcer in rats.

Evolution of the registration regulations for proprietary Chinese medicines in China.

In this review, we provide a comprehensive overview on the registration of proprietary Chinese medicines (PCMs) in China over the past century by examining published literature and historical data. We will examine this evolving administrative practice for PCMs registration in China, which is divided to the following five stages: (1) initial measures (1915-1948); (2) early development (1949-1965); (3) provincial approval and trial implementation of the "approval number" system (1966-1984); (4) legislation and cleanup (1985-1999); and (5) centralized national approval (2000 until now), offering a panoramic view on the characteristics of PCMs registration management in China.

Evolution of the registration regulations for proprietary Chinese medicines in China / 中国天然药物

In this review, we provide a comprehensive overview on the registration of proprietary Chinese medicines (PCMs) in China over the past century by examining published literature and historical data. We will examine this evolving administrative practice for PCMs registration in China, which is divided to the following five stages: (1) initial measures (1915-1948); (2) early development (1949-1965); (3) provincial approval and trial implementation of the "approval number" system (1966-1984); (4) legislation and cleanup (1985-1999); and (5) centralized national approval (2000 until now), offering a panoramic view on the characteristics of PCMs registration management in China.

Investigation and Analysis on Clinical Application of Proprietary Chinese Medicine by Clinicians in Integrat-ed Medical Institutions / 中国药房

OBJECTIVE:To understand the application of proprietary Chinese medicine by clinicians in integrated medical insti-tutions,and provide reference for its rational use. METHODS:The questionnaire was designed,including related issues of proprie-tary Chinese medicine clinical application(such as medication basis of proprietary Chinese medicine,combined medication,clini-cal efficacy and its influencing factors,medication for special groups and so on)and suggestions;the questionnaires were delivered to the clinicians who worked in some second and third grade of integrated medical institutions located in southwestern regions and Chengdu,and the questionnaires was in the form of an anonymous;relevant data of available questionnaire were collected statisti-cally;the application situation of proprietary Chinese medicines and the existence question were analyzed,and suggestions were put forward. RESULTS:Totally 300 questionnaires were sent out,264 were effectively received,with effective rate of 88.0%. The clinicians involved in investigation were mainly in undergraduate,mostly the resident physicians and attending physician;only 6.8%of the physicians received the training of basic theory of traditional Chinese medicine after work;36.4%physicians often pre-scribe proprietary Chinese medicines,and the medication basis was mainly in package insert (64.0%) and clinical experience (55.3%);51.1% thought unclear indications affected the application of proprietary Chinese medicines,64.0% thought package in-sert can not meet clinical needs. In terms of answers in brief questions,the surveyed clinicians generally considered the package in-sert was too simple,which needed further perfected. CONCLUSIONS:The problems in clinical application of proprietary Chinese medicines should not be ignored. The relevant departments should strengthen the supervision of clinical application of proprietary Chinese medicines,and strengthen the re-evaluation of proprietary Chinese medicines market,as to provide data support for the continuous improvement of package insert. Medical institutions should carry out training timely for the physicians who prescribe pro-prietary Chinese medicines,the pharmacists should strengthen checking of proprietary Chinese medicines prescription and special prescription comment,and ensure prescription checking and comment play a active role in promoting rational drug use based on“proprietary Chinese medicines clinical application guiding principle”“prescription management method”.

Analysis of Adverse Drug Reactions Associated with Proprietary Chinese Medicine from 2002 to 2006 in Beijing Hospital / 药物流行病学杂志

Objective:To analyze adverse drug reactions(ADRs)associated with proprietary Chinese medicine occurring in Beijing Hospital.Method:The ADRs associated with proprietary Chinese medicine between 2002 and 2006 were collected and the associated information was retrospectively analyzed.Result:a total of 179 ADRs were analyzed. Most of them occurring in women patients(76.1%)with hyperplasia of mammary glands who took Xiaojin pills and Xi- huang pills(22.1% & 12%).The herbal medicine injections were the other most associated ones.The clinical appearances of ADRs were rash and bodily manifestation of hypersensitiveness.Condusion:The investigation of Chinese medicine ADR plays a very important role in the modernization of Chinese medicine.