Microbial Control in the Primary Packaging of Pills Using Ionizing Radiation and Its Effect on Characteristic Constituents for Quality Control in Irradiated Pills

Rumi Yamaoki,Shojiro Kimura,Satoshi Uno

doi:10.3390/pr10020300

Abstract

Pharmaceutical products that mix natural raw materials are subject to unavoidable contamination with microorganisms from the environment and animals. This study focused on the effect of radiation on the quality of primary packaged pills, which are crude drug products. The pills, which were sealed in a sack for primary packaging laminated with polyethylene terephthalate, polyethylene, and aluminum foil, were irradiated by gamma rays or electron beam (EB). The survival counts of bacteria were reduced to 103 CFU/g or less by 6 kGy of irradiation. The counts of the spore-forming bacteria Bacillus megaterium, B. cereus, and Brevibacillus brevis in the pills were reduced to not over 100 CFU/g after 10 kGy irradiation. Although some of the cinnamaldehyde in the pills was oxidized to cinnamic acid, the decomposition of swertiamarin, berberine, glycyrrhizin, and cinnamaldehyde in the pills after 10 kGy irradiation were within the analytical accuracy by high-performance liquid chromatography. Gamma-ray or EB treatment at the final production of crude drug preparations was within the permissible standard value for the non-aqueous preparations for oral administration, with no statistically significant change in the indicator ingredients of crude drugs.

Highlights

There are various dosage forms in herbal medicine products, including decoctions, injections, tablets, pills, and powders
The 30 pills for individual consumption were provided in a small sachet as the primary package, and the sachet was made from laminated polyethylene terephthalate (PET), polyethylene (PE), and aluminum foil
The counts of microbes in the sample pills conformed to the acceptance criteria for crude drugs, which are taken directly without the extraction process and are directly consumed crude drug preparations containing powdered crude drug

Summary

Introduction

There are various dosage forms in herbal medicine products, including decoctions, injections, tablets, pills, and powders. Pills are a popular formulation in traditional Chinese medicine (TCM) and Kampo medicine for oral administration and have been used as a convenient dosage form for carrying. Pills are traditionally produced by mixing crude drug powders and additives, which are formed into spheres, coated, and dried. Pills are dosage forms that can make the best use of the pharmacological effect of the combined action of each water- and fat-soluble component in crude drugs. The use of pills reduces the load on the environment during manufacturing by reducing plant waste, including extraction residue. It is unavoidable for herbal medicine to be contaminated with microorganisms derived from the environment or animals because of the use of natural products. For the European Pharmacopoeia, the Japanese Pharmacopoeia (JP), and the United States Pharmacopeia [1], the permissible standard values for the microbiological quality of non-aqueous preparations for oral administration of herbal medicine are

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