Importance of Standardization of Plant Materials –Critical to GMP:

Importance of Standardization of Plant Materials –Critical to GMP:

A Medisynth Perspective

Dr. Prakash Joshi

* Dr. Prakash Joshi

Technical Advisor

Medisynth Chemicals Pvt. Ltd.

Address for correspondence

Dr. Prakash Joshi

D-282, MIDC Turbhe,

Navi Mumbai – 400705

Ph: 022-27681116

website: www.medisynth.com

Abstract

The standardization/testing of medicinal plant material is a matter of paramount concern in homoeopathic drug industry. Mother tincture prepared from plants can vary in quality and chemical constituent profile, if there are any variations in botanical materials. Standardization of herbal drug entails a process of prescribing a set of standards, constant parameters, definitive quality value that carry an assurance of quality, efficacy, safety and reproducibility of the finished products. It is a process of developing and agreeing upon technical standards.

A significant factor which can add consistent quality to medicinal plants is satisfactory standardization. A complete array of authentication and evaluation tools can be utilized to provide a well-rounded scientific approach to the standardization of medicinal plant material. It is vital that the authenticity of plant material be established/tested using appropriate analytical tools before it is processed for making mother tincture. The use of homoeopathic medicine has increased tremendously over the past few decades.The quality control and standardization of medicinal plants is getting more attention in recent years since the commercialization of homoeopathic medicines has increased many folds.A wide range of methods can be applied for standardization/quality control of medicinal plants.Moreover,the Homoeopathic Pharmacopoeia of India (HPI) and other international pharmacopoeias propose organoleptic, macroscopic, microscopic, TLC, chemical and UV studies for standardization/quality control of homoeopathic medicines. The Government of India has published 10 volumes of HPI and revision of monographs is also undertaken. This shows the commitment of the Government of India towards quality of homoeopathic medicines.

A general layout for pharmacognostic (standardization) evaluation of plants based on HPI and other international pharmacopoeias is shown in Fig.1.

A Double Blind Homoeopathic Pathogenetic Trial of Zingiber Officinalis                25-29

Dr. K.Rajamaickam, Dr. L.Rajaganapathy

*Guide & HODPG Department of homoeopathic pharmacy

Vinayaka Missions Homoeopathic Medical College and Hospital

Address for correspondence

Dr. K. Rajamaickam

Vinayaka Missions Homoeopathic Medical College and Hospital

(A constituent college of  VMRF – Deemed to be University)

Abstract

Objective:The study was conducted to elicit the pathogenetic response of Zingiber officinalis in homoeopathic potency 30C on healthy human volunteers.

Methodology:The drug Zingiber Officinalis was reproved in Vinayaka Mission Homoeopathic Medical College and Hospital through randomized, double-blind, placebo-controlled method.  The proving was conducted in the Department of Homoeopathic pharmacy, Vinayaka Mission’s Homoeopathic Medical College and Hospital Salem. The drug was proved in 30th centesimal potency on 36 apparently healthy volunteers who were selected after conducting pre-trial medical examinations by the medical specialists and routine laboratory investigations. 18 of them were kept on interventional drug trial and remaining, under  placebo. As per the proving protocol, 56 dose schedule [i.e., 56 doses of drug/placebo were consumed by a prover in each batch] was followed while at drug proving in Vinayaka Missions Homoeopathic Medical College and Hospital. The symptoms generated during the trial period were noted by the volunteers and elaborated by the proving masters which were compiled at Homoeopathic drug proving cum data processing unit of Homoeopathic Pharmacy Vinayaka Missions Homoeopathic Medical College and Hospital.

Result:Out of 18 provers who were on the interventional drug trial, only 16 manifested symptoms. The drug was able to produce symptoms in 30C potencies, 17 symptoms appeared during proving in Vinayaka Mission Homoeopathic Medical College & Hospital.

Conclusion:The drug pathogenesis evolved indicate its therapeutic use for  migraine, acute rhinitis, gastritis, APD, ulcerative colitis and diarrheal conditions, urethritis, laryngitis, lower respiratory tract infections, etc.

Introduction

Ginger (Zingiber Officinale Roscoe, Zingiberacae) is a medicinal plant that has been widely used in Chinese, Ayurvedic and Tibb-Unani herbal medicines all over the world, since antiquity, for a wide array of unrelated ailments that include arthritis, rheumatism, sprains, muscular aches, pains, sore throats, cramps, constipation, indigestion, vomiting, hypertension, dementia, fever, infectious diseases and helminthiasis.[2]

The Rhizome of Zingiber is widely used for preparing medicines in Indian traditional system and homoeopathy medicine is prepared to form the rhizome of the Zingiber.

The constituents present in ginger have potent antioxidant and anti-inflammatory activities. Phytochemical screening revealed the presence of alkaloids, saponins, tannins, flavonoids, terpenoid and phlobotannins in the ethanol extracts.[6]