Pharmacopeial Flashcards
It is a legal and official book issued by
recognized authorities usually appointed
by Government of each country. It comprises list of pharmaceutical
substances, formulae along with their
description and standards.
PHARMACOPOEIA
TYPES OF PHARMACOPOEIAS: • BRITISH PHARMACOPOEIAS (B.P.) • UNITED STATES PHARMACOPOEIAS (U.S.P.) • EUROPIAN PHARMACOPOEIAS (E. U) • INTERNATIONAL PHARMACOPOEIAS (I.P) • BRITISH PHARMACOPOEIAL CODEX (BPC)
- BRITISH PHARMACOPOEIAS (B.P.)
- UNITED STATES PHARMACOPOEIAS (U.S.P.)
- EUROPIAN PHARMACOPOEIAS (E. U)
- INTERNATIONAL PHARMACOPOEIAS (I.P)
- BRITISH PHARMACOPOEIAL CODEX (BPC)
is the national pharmacopoeia of the United Kingdom. An important statutory component in the control of medicines. Along with the British National Formulary (BNF), it defines the UK’s pharmaceutical standards.
British Pharmacopoeia (BP)
1st USP ____
1st pharmacy school _______ _______
APA- ____ by ___ ____(regarded as father of pharmacy)
NF - 1888
1820 1821 in philadelphia (US) American pharmacy association- 1852 William Proctor National Formulary-1888
Is a pharmacopoeia that aims to provide common quality standards throughout Europe to control the quality of medicines and the substances used to manufacture them.
European Pharmacopeia
is an autonomous institution of the Ministry of Health and Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India.
The set of standards are published under the title Indian Pharmacopoeia (IP)
Indian Pharmacopoeia Commission (IPC)
The year ___ marked the birth of pharmacy in Madras state of India. Medical students use to practice.
- ____ in Bengal institutes were started to train compounders.
- ____ _____ university started B.Pharmacy course in the year 1937 (Mahadeva lal schroff)
- ____ university in ___
1st Indian pharmacopoeia -____
1870 1881 Banaras Hindu,1937 Punjab,1944 1955
is a book,pamphlet or document that is complete in itself or a detailed written study of a single specialized subject or an aspect of it
Researchers publish their findings in _____ so their peers can review and validate their findings.
monograph
PURPOSE OF MONOGRAPH:
- Provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plant.
- Facilitate information exchange among Member States.
- The goal of the monograph project is to protect those who have an interest in traditional medicines (patient, prescriber, pharmacist, manufacturer, health authority, medicines regulatory body) against medicine of poor quality.
TYPES OF MONOGRAPH:
STANDARD MONOGRAPH
THERAPETUIC MONOGRAPH
COMBINED MONOGRAPH
STANDARD MONOGRAPH:
- Botanical features
- Distribution
- Identity tests
- Purity requirements
- Chemical assay
- Chemical constituents
THERAPEUTIC MONOGRAPH:
- Definition Of The Plant Drug
- Clinical applications
- Pharmacology
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Posology (Form of administration, Duration of use)
COMBINED MONOGRAPH:
Standard monograph + Therapeutic monograph
IMPORTANT CONTENT OF A MONOGRAPH:
- DEFINITION
- SYNONYMS AND VERNACULAR NAMES
- DESCRIPTION
- GEOGRAPHICAL DISTRIBUTION
- MAJOR CHEMICAL CONSTITUENTS
- IDENTITY, PURITY, & STRENGTH
- THE QUANTITATIVE TEST
- CHROMATOGRAPHIC & SPECTROSCOPIC EVALUATION
- TOXICOLOGY
- SAFETY
- ADVERSE DRUG REACTION
This section provides the Latin binomial pharmacopoeial name, the most important criterion in quality assurance.
Definition
Those names used by local consumers. The vernacular names listed are a selection of names from individual countries worldwide, in particular from areas where the medicinal plant is in common use.
SYNONYMS AND VERNACULAR NAMES
A detailed botanical ____ is intended for quality assurance at the stages of production and collection.
✓Macroscopy
✓Microscopy
Description
included here to provide additional quality assurance information.
GEOGRAPHICAL DISTRIBUTION
Each medicinal plant & the specific plant part used (the drug) contain active or major chemical constituents with a characteristic profile that can be used for chemical quality control & quality assurance.
MAJOR CHEMICAL CONSTITUENTS
Under the heading “Identification” tests are provided as an aid to identification and are described in their respective monographs. It includes Foreign Matter & Quantitative tests.
IDENTITY, PURITY AND STRENGTH
The quantitative tests:
o Total ash o Acid-insoluble ash o Water-soluble ash o Alcohol-soluble extractive o Water-soluble extractive o Ether-soluble extractive o Moisture content o Volatile oil content o Bitterness valves
TLC, HPTLC, HPLC methods will provide qualitative & quantitative information about the main active constituents present in the crude drug
CHROMATOGRAPHIC AND SPECTROSCOPIC EVALUATION
Important for the poisonous plant. It includes the study of adverse effect of drugs as the same substance can be a drug or a poison depending on the dose.
TOXICOLOGY
If no specific toxicity is reported, it is considered to be safe in the dose traditionally used.
SAFETY
It give the information about any change which is suspected to be due to drug, occurs at doses normally used in man and indicates caution in the future use of the same drug. ADR may develop promptly or after prolonged medication or even after stop age of the drug.
ADVERSE DRUG REACTION
