Current Status of Herbal Drug Standards in the Indian Pharmacopoeia

Prakash, Jai; Srivastava, Sushma; Ray, Ratnamala; Singh, Neha; Rajpali, Roshni; Singh, Gyanendra

doi:10.1002/ptr.5933

Cited by 25 publications

(13 citation statements)

References 19 publications

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“…It should be pointed out that medicinal plants are world widely used in the prevention and treatment of diseases, and are included in the Pharmacopoeias of countries such as Russia (Shikov et al, 2021), India (Prakash et al, 2017), Japan (Chen et al, 2017), Iran (Naghibi et al, 2014), andBrazil (Principe andSpira, 2009). As for the individual TCMs of GQD, Scutellariae Radix is officially recorded in the British Pharmacopoeia (2018) and the European Pharmacopoeia (9.0) (Wang et al, 2018), Puerariae Lobatae Radix is used in Japan and other East Asian countries (Wong et al, 2011).…”

Section: Pharmacological Effects Of Gqdmentioning

confidence: 99%

Constituents, Pharmacokinetics, and Pharmacology of Gegen-Qinlian Decoction

2021

Front. Pharmacol.

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Gegen-Qinlian decoction (GQD) is a classic traditional Chinese medicine (TCM) formula. It is composed of four TCMs, including Puerariae Lobatae Radix, Scutellariae Radix, Coptidis Rhizoma, and Glycyrrhizae Radix et Rhizoma Praeparata cum Melle. GQD is traditionally and clinically used to treat both the “external and internal symptoms” of diarrhea with fever. In this review, key words related to GQD were searched in the Web of Science, PubMed, China National Knowledge Infrastructure (CNKI), and other databases. Literature published mainly from 2000 to 2020 was screened and summarized. The main constituents of GQD could be classified into eight groups according to their structures: flavonoid C-glycosides, flavonoid O-glucuronides, benzylisoquinoline alkaloids, free flavonoids, flavonoid O-glycosides, coumarins, triterpenoid saponins, and others. The parent constituents of GQD that enter circulation mainly include puerarin and daidzein from Puerariae Lobatae Radix, baicalin and wogonoside from Scutellariae Radix, berberine and magnoflorine from Coptidis Rhizoma, as well as glycyrrhetinic acid and glycyrrhizic acid from Glycyrrhizae Radix et Rhizoma Praeparata cum Melle. GQD is effective against inflammatory intestinal diseases, including diarrhea, ulcerative colitis, and intestinal adverse reactions caused by chemotherapeutic agents. Moreover, GQD has significant effects on metabolic diseases, such as nonalcoholic fatty liver and type 2 diabetes. Furthermore, GQD can be used to treat lung injury. In brief, the main constituents, the pharmacokinetic and pharmacological profiles of GQD were summarized in this review. In addition, several issues of GQD including effective constituents, interactions between the constituents, pharmacokinetics, interaction potential with drugs and pharmacological effects were discussed, and related future researches were prospected in this review.

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Section: Pharmacological Effects Of Gqdmentioning

confidence: 99%

Constituents, Pharmacokinetics, and Pharmacology of Gegen-Qinlian Decoction

2021

Front. Pharmacol.

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“…More than half of the manufacturers use the traditional, physical, chemical and physiochemical methods to standardize raw materials and formulations. These tests have a certain amount of limitations due to the fact that there are no standard reference compounds for the herbal or plant compounds used in medicinal preparations (Prakash et al 2017).…”

Section: Current Status Of Indian System Of Medicinementioning

confidence: 99%

Phytopharmaceutical regulated new class: An Industrial initiative of Ayurvedic drugs towards the advancement of India system of medicine

Nirmal¹,

Singh²,

Kumar³

et al. 2022

World J. Adv. Res. Rev.

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Ethnopharmacological relevance: The growing demand for medicinal plants and their products has led to safety and efficacy concerns. The evaluation of herbal medicines, registration and regulation are important challenges to their safety and efficacy. The provisions for synthetic drugs do not apply to ayurvedic-based herbal products. Furthermore, the regulatory mechanism for ensuring the quality of herbal medicines has become a top priority for Indian drug regulators and drug manufacturers. Aim of study: The aim of this study is to identify and characterise the different features of Ayurveda-related government policies and efforts. AYUSH and CDSCO design and establish regulations for the development of phytopharmaceutical drugs as necessary, utilizing botanical-based medications that have a long history but have thus far lacked adequate documentation. Methods: We conducted a review of the literature on Ayurveda's history, principles, and current status. We have presented the data in a systematic manner that includes all of the initiatives brought forth by the Indian government. To conduct a thorough and comprehensive analysis, we went through various reports, policies, and ancient Ayurvedic texts, and consulted AYUSH-related websites, such as those run by the Ministry of AYUSH. Results: The Ministry's objective is to elevate AYUSH systems to the forefront of living and practise, and to make AYUSH methods the preferred method for achieving a healthy nation. The newer class of drugs allows the development of drugs through advanced solvent extraction, fractionation, modern formulation and pharmacokinetics, etc. Conclusion: The promotion and development of Ayurveda is being actively pursued by the government through its policies. The present commentary is designed to highlight core and assembled information on the regulatory requirement in contrast to the new category phytopharmaceuticals under AYUSH. Phytopharmaceuticals may be a balanced approach with guidelines in the United States of America, China, and other countries connecting scientific validation and data generation, including revalidation of AYUSH-regulated product specifications.

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“…Development of a chemical fingerprint of an herbal drug under investigation using high‐performance liquid chromatography, for example, should be a minimum requirement for any herbal drug to be investigated in a clinical trial (Cheng et al, 2017; Gagnier, Boon, Rochon, et al, 2006). In some countries, there are national Pharmacopeia with detailed guidelines for the quality of herbal drugs and monograph development (Prakash et al, 2017). Furthermore, the World Health Organization (WHO) has recently established guidelines on herbal processing in the post‐harvest stages with technical requirements for quality control in the manufacture of herbal drugs (WHO, 2018).…”

Section: Scientific Validitymentioning

confidence: 99%

Ethical considerations and challenges in herbal drug trials with the focus on scientific validity and risk assessment

Koonrungsesomboon

Morakote

Karbwang

2020

Phytotherapy Research

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Scientific validity and risk assessment are two main ethical issues which raise specific challenges and are unique to clinical trials investigating crude extracts/fractions from herbal materials. There are considerable challenges for both clinical investigators and ethics committee members in dealing with such issues, many of them remain unresolved, resulting in a large variation in ethical requirements, justification, and decisions. Despite a remarkable surge in herbal medicine research globally, a number of clinical investigators or even ethics committee members have limited confidence in dealing with related ethical issues. In this article, we extensively review and discuss the two main ethical issues (i.e., scientific validity and risk assessment) and highlight key considerations that are important for ethical review and justification for the conduct of herbal drug trials.

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Current Status of Herbal Drug Standards in the Indian Pharmacopoeia

Cited by 25 publications

References 19 publications

Constituents, Pharmacokinetics, and Pharmacology of Gegen-Qinlian Decoction

Constituents, Pharmacokinetics, and Pharmacology of Gegen-Qinlian Decoction

Phytopharmaceutical regulated new class: An Industrial initiative of Ayurvedic drugs towards the advancement of India system of medicine

Ethical considerations and challenges in herbal drug trials with the focus on scientific validity and risk assessment

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