Background: the assessment of microbiological quality of medicinal products is one of control stages in medicinal products saft, because the holder of a manufacturing authorization must drug so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization and do not place patients at risk due to inadequate safety, quality or efficacy. Objective: To assess microbial limit test for hospital preparation 'compound alum powder'. Methods: The results of strain culture and analysis were used to evaluate the drug quality of 'compound alum powder'. The objective is 'compound alum powder' (approval number: Z20140229) was made by the First Affiliated Hospital of Jinan University. Their batch numbers include: 201019, 200818, 200701. Validation tests were carried out in accordance with the standards of the Chinese Pharmacopoeia (2020 edition). Three parallel independent validations were conducted to calculate the recovery rate of each test bacterium and investigate whether each test bacterium was detected in the control bacterial inspection. Result: The recovery ratio of the total number of aerobic bacteria, molds and yeast in the control group was in the range of 0.5 ~ 2, and the results of the control group were positive, and the results of each control group met the requirements. The results show that the membrane filtration method is suitable for the microbial limit test of 'compound alum powder'. Conclusion: this microbial limit test method control and ensure the quality of drug production by solving the problem of interference of antimicrobial components in drugs. It can eliminate the bacteriostasis of boric acid, phenol and alum.
Background: Contamination of pharmaceuticals with microorganisms may lead to deleterious effects on the therapeutic properties of the drug, and may potentially cause injuries to intended recipients. Iodine can inhibit and kill microorganisms in pharmaceutical preparations. The risk of microbial contamination of cellular products can be reduced when cultured in the presence of iodine. This however, may impact the sensitivity of microbiological tests. Iodine-containing Preparations does not guarantee sterility but may just reduce the proliferation rate of microorganisms, microbiological testing of medicinal products remains obligatory. Thus, an appropriate method to test for microbial contamination of iodine-containing products has to be validated. Objective: To establish a method that would allow microbial limit testing of four iodine-containing preparations (concentrated iodine tincture, compound iodine oral solution, iodine tincture, and iodine glycerin). Methods: To specifically determine the degree of contamination in the four in-house iodine preparations, sodium thiosulfate was used to reduce the iodine molecules to iodide ions, thereby eliminating the intrinsic antibacterial property of the preparations. Then, the suitability of this method was evaluated according to the regulations for non-sterile microbial limit tests. Results: The neutralization method effectively eliminated the interference of the antibacterial iodine component, rendering the control bacteria detectable. The recovery ratio of the test strains met the required standards. Conclusion: The neutralization method with sodium thiosulfate as the iodine neutralizer is suitable for microbial limit testing of concentrated iodine tincture, compound iodine oral solution, iodine tincture, and iodine glycerin, with the results being accurate and reliable.
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