The Ayurvedic Pharmacopoeia of India - Part I (Volume - VIII)

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The Ayurvedic Pharmacopoeia of India, Pt.I, Vol.V11i is a legal document of standards for quality of Single Drugs, their powder and extracts (hydro-alcoholic and water) included therein (under the Drug and Cosmetic Act, 1940). This volume comprises 60 monographs on 15 single drugs consisting of raw material, their powder and hydro-alcoholic and water extracts.

The monographs (raw drug, aqueous and hydro-alcoholic) contain Identity, Purity and Strength, Quantitative parameters, Other requirements, Assay and Additional requirements. The quantitative parameters contain loss on drying, total ash, acid- insoluble ash, whereas raw drug also contain foreign matter, alcohol-soluble extractive and water soluble extractive and extracts (hydro-alcoholic & water) also contain pH and total soluble solids; other requirements contain heavy metals, microbial contarninatron, Pesticide residues and aflatoxins. Under additional requirements packaging and storage, labeling, API reference standards are given.

Detailed information on monographs on raw drug are provided also consisting of description, constituents, properties and action, important formulations, therapeutic uses and dose. The description of raw drug arid powder includes macro- and microscopic details of raw drugs and its powder. Identification contains thin layer chromatography; properties and action contain Rasa, Guna, Virya, Vipaka and Karma. Under monograph of extracts method of preparation are also given.

This volume is a" publication in this series on single drug but monographs on plant extracts are presented for first time, to ensure the quality of selected 15 widely used single plant drugs & their powders, extracts for prescribing Pharmacopoeia standards along with chromatographic fingerprint profile using photo-chemical reference standards (PRS) and also assay. The standards have been consciously kept modest so that the implementation by the manufacturing companies becomes easily acceptable in order to maintain quality.

The appendices of this volume contain the details of protocols used in the determination of various standards as well as methods of testing. This book in general is more users friendly for the manufacturers, scientists and students and teachers in the standardization of single drugs.

This book is included in the first schedule of Drug and Cosmetic Act, 1940. Users are welcome to give their suggestions on this monographs so that these suggestions are evaluated and followed in the forthcoming volumes of Ayurvedic Pharmacopoeia of India, Part-I.

For the implementation of the Drugs and Cosmetics Act and Rules there under, it is necessary to work out standards for establishing the quality of the drugs. The Department of A YUSH with the. help of Ayurvedic Pharmacopoeia Committee (APC), has already prescribed standards for 519 single plant drugs, 21 minerals and metals, which have been published till now in seven volumes of the Ayurvedic Pharmacopoeia of India, Part I (API-I). The Department has also published standards for 152 classical compound formulations and given in API, part II (Formulations) in 3 volumes.

Updating the existing monographs and adding new monographs with standards are the ongoing activities of the APC. The Drugs and Cosmetic Act in recent Rule 158 (B) clause IV has provided for the use of Aushadh Ghanas which include aqueous, hydro-alcoholic extracts and other than aqueous and hydro- alcoholic extracts both wet and dry, using plants mentioned in the books in the first Schedule to Act. In order to ensure the quality of such Aushadh Ghanas, APC selected 15 most widely used single plant drugs, their powders and their extracts for prescribing pharmacopoeia standards along with chromatographic finger print profile using Phyto-chemical Reference Standard (PRS) and also assays. Such standards allow the establishment of source plants used for the preparation of their extracts. These monographs also provide the SOPs for the preparation of their extracts, and form the Volume VIII of Part I of the API. This volume contains 60 monographs on 15 medicinal plants and their extracts. The Ayurvedic Pharmacopoeia Committee and the three industries involved in this new initiative of introducing quality standards of Aushadh Ghanas (medicinal plant extracts) in API Part-I, Vol. VIII deserve appreciation.

I want to place my appreciations on record for Ayurvedic Pharmacopoeia Committee, Prof. S.S. Handa, Dr. S.K. Sharma, Advisor (Ayurveda), Dr. Ramesh Babu, DG- CCRAS and APC entire team to bring this scientific work for the use of industry and other stakeholders of Ayurveda.

It is hoped that the addition of the volume VIII of API Part I will be of great utility to all the stakeholders.

Contrary to popular preparation, Ayurvedic therapeutic 'modes' or presentations m current usage have had a long history of development. Ayurvedic techniques of formulating compound mixtures (yogas) developed gradually from the pre-Vedic period through the Vedic, the Samhita, and the Sangraha periods and continue to develop. In the Samhita period, ancient indigenous science was at the peak of its glory and we find that almost all the pharmaceutical modes, now identified as 'classical' were known during this period.

From the scanty evidences and interpretations available about the pre-Vedic period, one naturally concluded that the pre-Vedic Indian employed only a few pharmaceutical modes and that methods in pharmacy were rather simple. Raw materials were used in their crude form, whole, or at best comminuted, to assist application. Extraction was limited to expression of fresh juice or extracting by decoction.

During the Vedic period preparation of medicines might have gained importance, as fire and pyre sacrifices were popular practices followed during the period, but complex formulations and combination of drugs did not appear during this period. Single drugs, their juices and pastes were the main forms in use. It is doubtful whether the formulation, in its contemporary sense, was practiced in the Vedic period. In the Vedas, we famed praises of single drugs. No complex mixtures of medicines are traceable in the Vedic literature.

We find that systematized information on Ayurvedic pharmacy appears in the compendia of the Samhita period. It is in these texts that complicated compounding procedures as well as multi-ingredient formulations are recorded. Tips on formulations, concepts of compatibility and incompatibility among ingredients, systematic classification of preparations, etc. are also available in these books. Though the oldest available Samhita contains references to almost all the classical pharmaceutical modes, it is not logical to conclude that all of them developed simultaneously. Hence, we may consider that primary preparations or basic modes were the most ancient. These work technically termed "kasaya kalpana". Five primary preparations, such as expressed juice (SV ARASA), paste (KALKA), decoction (KVATHA), cold infusion (SEETA KASA Y A) and hot infusion (PHANT' A KASHA Y A) are mentioned in the ancient classics. All these modes have very short shelf life and hence were prepared as and when needed. More stable forms generated as secondary and tertiary preparations or derived modes such as medicated fatty preparations (oils, ghrahita, etc.), Jelly or semi solid preparations (AV ALEHA) , fermented products (ARI~TA, ASAVA, etc.) Pills (Gorki) were yet another means of presentation of drugs. Apart from many other factors, fats, sugar and alcohol were known to be natural preservatives.

During the Sangraha period, we find from recorded literature that formulations based on metals and minerals gained usage. This is on par with the development of Ayurvedic introduction chemistry known as Rasasastra. Some pharmaceutical modes such as syrups also appeared in Ayurvedic pharmacy. This was mainly due to the influence of Unani medicine that emanated from Middle East. In fact, it started even as early as the invasion of Alexander the Great, but attained great growth due to the active contribution by Mughals in Medieval India.

A gradual shift in practice from extemporaneous and need based production, to a more organized and planned long term production ensured ready medicines round the year. This trend was evident as early as the 10" century AD, but got established at the dawn of the 20" century, resulting in a change in the pattern of drug production, and improvement in its technology. Ayurvedic pharmacy by this time faced challenges from Western medicines and modem methods of pharmacy during the British rule. There were efforts to replace aqueous decoctions of indigenous medicines with tinctures but such changes faced stiff opposition from the conservative section of Ayurvedic physicians.

Present trend

Since the last half a century, Ayurveda has had to compete with modem medicines, which are proven to be quick-acting, strong and effective. Convenience and acceptability of these medicines by patients was another factor that necessitated the Ayurvedic fraternity to modernize. Many manufacturers shifted their traditional preparation like Vatis and Gutikas to compressed tablets and capsules. There were attempts to achieve greater shelf life for traditional medicines, by adopting newer techniques of extraction, chemical preservation and application of modern principles in Ayurvedic pharmacy.

A recent trend in Ayurvedic manufacturing pharmacy aims at (1) enhancement of potency and reduction in bulk of dosage form (2) convenience in administering doses and (3) acceptability by improving palatability.

This trend is an outcome of significant gains in knowledge of photo-chemical contents of the source plant, and improved methods of assessing the pharmacological and therapeutic actions of such photochemical contents. A direct development of this awareness is the introduction of extracts of plants as a more effective means of obtaining desirable results.

EXTRACTS

Extraction, as the term is used in Pharmacy, involves the separation of medicinally active portion from plant or animal tissues using selective solvents through standard extraction procedures. The general techniques of extraction of medicinal plants include maceration, infusion, percolation, digestion, decoction, hot continuous extraction (sox let), aqueous alcoholic extraction by fermentation (such as Asvas) counter current extraction (CCE), microwave assisted extraction, ultrasound extraction (sonication), supercritical fluid extraction (SFE), etc. Such extraction techniques separate out soluble plant metabolites leaving behind insoluble cellular marc. The product so obtained from plants are relatively complex mixtures of a number of groups of plant metabolites.