ABSTRACT
PURPOSE: A pharmacopoeia is a compendium of guidelines and criteria for drug quality. It was established by a national or regional entity and has legal significance. This applies to administration of drugs in a particular nation or region. METHOD: In this study, the differences and similarities of microbiological acceptance criteria, specifications for microbial enumeration of herbal drugs and herbal drug preparations in 14 national and international pharmacopeias were investigated. RESULTS: It was found that 12 pharmacopeias have given separate microbial limits for total aerobic microbial count (TAMC) and total yeast and mold count (TYMC), and a list of specified microorganisms for which acceptance criteria are defined. However, similarities were noticed in Ph.Eur, Ph. Helv and, BP. Salmonella, and Escherichia coli are the most common pathogens specified for herbal preparations in which boiling water is added prior to use and for internal use in all Pharmacopoeias because they serve as indicators of potential contamination. CONCLUSION: From this study, it can be concluded that the differences in microbial limit tests and their acceptance criteria as specified in the various pharmacopoeias need to be harmonized. It will become a more convenient option for global drug manufacturers to import/export herbal drugs, and this would also eliminate the burden of performing various analytical methods and comply with different microbial acceptance criteria set by various pharmacopoeias. The comparative data obtained from this study will be used to develop strategies for revisions of pharmacopoeias in a harmonized manner with respect to microbiological acceptance criteria, specifications for microbial enumeration of herbal drugs and herbal drug preparations.
Subject(s)
Drug Contamination , Pharmacopoeias as Topic , Plant Preparations , Plant Preparations/standards , Drug Contamination/prevention & control , Pharmacopoeias as Topic/standards , Colony Count, Microbial , Quality Control , HumansABSTRACT
A Laryngectomee is a person whose vocal cords i.e. voice box is surgically removed owing to cancer or due to automobile accidents, burns or trauma. The patient, therefore permanently loses the ability to speak normally. An Electrolarynx is an electronic speech aid that enables the Laryngectomee to communicate with other people as quickly as possible after the successful removal of the larynx. A neck type Electrolarynx has been designed. Earlier designs could not alter frequency and intensity simultaneously during conversation. The Electrolarynx developed can control both frequency and intensity simultaneously during conversation. The device has been tested on the patient and found to be very effective. A portable, pocket size, battery powered voice amplifier (PA system) has also been developed which uses an electret condenser microphone as the input. The voice amplifier developed is a two stage amplifier which uses a preamplifier stage and a power amplifier stage. The output of the power amplifier is connected to a speaker. The device is being used by the patient and found to be very useful.
