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OBJECTIVE: To screen out suitable antibacterial agent and reasonable dosage for timolol maleate eye drops. METHODS: According to the method of bacteriostatic effect test in Chinese Pharmacopoeia (Ch.P) 2015, the antimicrobial effectiveness of antimicrobial preservatives at different concentrations was tested to screen out the optimal agent and dosage. RESULTS: The eye drops added with ethyl hydroxybenzoate met the B-level requirements of bacteriostatic efficacy, which was the same as the sample without antibacterial agent, so ethyl hydroxybenzoate was not suitable as the antimicrobial preservative. The growth of five kinds of test microorganisms was inhibited effectively by 0.03 mg·mL-1 benzalkonium bromide. The timolol maleate eye drops with 0.03 mg·mL-1 benzalkonium bromide met the requirement of the quality standard. CONCLUSION: Benzalkonium bromide can be used as the antimicrobial preservative for timolol maleate eye drops.
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Objective:To determine and evaluate the antimicrobial effectiveness of 10% chloral hydrate solution. Methods:The determination of antimicrobial effectiveness of 10% chloral hydrate solution from two different manufacturers was carried out according to Chinese Pharmacopoeia (2015 edition). Results:The antimicrobial effectiveness of 10% chloral hydrate solution met the require-ments of Chinese Pharmacopoeia (2015 edition). Conclusion:10% Chloral hydrate solution shows adequate antimicrobial effective-ness.
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Objective: To investigate the content of ethylparaben in potassium chloride solution.Methods: According to the guidance for antibacterial effect test stated in Chinese Pharmacopoeia(the 4th volume of 2015 edition), 5 standard bacterial strains including Staphylococcus aureus,Escherichia coli,Pseudomonas aeruginosa,Candida albicans and Aspergillus niger were used as the challenging strains.Using the logarithm decrease of bacteria number as the index, the antimicrobial effectiveness of ethylparaben at different concentrations was studied to screen out the optimal concentration in the solution.Results: The growth of the 5 standard bacterial strains was inhibited effectively by potassium chloride solution containing 0.05% ethylparaben, which was also the minimum effective concentration.Conclusion: 0.05% Ethylparaben is suitable as the bacteriostatic agent for potassium chloride solution.
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OBJECTIVE: To establish an HPLC method for rapid screening and simultaneous determination of 10 preservatives in eye drops and assess their antimicrobial effectiveness. METHODS: A Waters XBridge C18 column (4.6 mm × 150 mm, 5 μm) was used, and the mobile phase was 0.1% phosphoric acid-methanol-THF eluted in gradient mode at a flow rate of 1.0 mL·min-1. The detection wavelength was set at 214 nm. The antimicrobial effectiveness of the preservatives was assessed according to Ch. P 2015. RESULTS: The calibration curves were linear in the range of the corresponding test concentrations (r=0.999 3 -1.000 0). The recoveries were between 96.1%-101.8%. One of the eye drops products did not meet the requirement of Ch. P 2015. CONCLUSION: The established method is rapid and inexpensive. And it ensures excellent simplicity, sensitivity, specificity, and reproducibility and can be used for rapid screening and determination of the contents of preservatives in eye drops. The amount of preservatives should be established during the R&D period or determined according to the results of antimicrobial effectiveness test rather than using empirical values.
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Objective To establish a HPLC method to determine the antiseptics in compound dexamethasone acetate cream and evaluate the usage rationality of antimicrobial preservatives. Methods The content of ethyl hydroxybenzoate was calculated by external standard with HPLC.The effectiveness of antimicrobial preservatives was measured according to the preservative effectiveness test in ChP(2015edition) by inoculating 5 kinds of test microorganisms including Pseudomonas aeruginosa,Escherichia coli,Staphylococcusaureus,Candida albicans and Aspergillusniger.Results The linear ranges of ethyl hydroxybenzoate was 6.63-132.6 μg/mL ( r =0.999 7 ) .The average recoveries was 99.2%.The samples from different batche had different antimicrobial effectiveness due to the content of ethyl hydroxybenzoate.Conclusion The described method can be used in the determination of the preservatives of ethyl hydroxybenzoate in compound dexamethasone acetate cream.At present the use of antibacterial agent is arbitrary, it is necessary to strengthen research and supervision.
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Objective:To evaluate the antimicrobial effectiveness of Zhenzhu Mingmu eye drops according to the requirements de-scribed in Chinese pharmacopoeia (2010 edition). Methods:Totally 7 batches of Zhenzhu Mingmu eye drops from 7 enterprises were evaluated. All the samples were tested according to the requirements described in Chinese pharmacopoeia, and the testing points of 6h and 24h were added. Results:As for bacteria, the reduction value of staphylococcus aureus in 7 days treated with Zhenzhu Mingmu eye drops from enterprise e was 0. 61g, and that in 14 days was 1. 01g. That in 7 days treated with the eye drops from the other enter-prises was all above 1. 01g, that in 14 days was above 3. 01g, and that in 14-28 days kept stable. As for fungi, the number was stable from the beginning with the treatment of the eye drops from the seven enterprises. Conclusion:Although the type and content of bacte-riostatic agent in domastic Zhenzhu Mingmu eye drops are the same, there is difference in the antimicrobial effectiveness of the product from different enterprise. The eye drops from one enterprise can't meet the requirements for type I product described in Chinese pharma-copoeia,and the others meet the requirements.