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Abstract：
BACKGROUND: In the context of current distrust of antimicrobial preservatives, the quantities of these substances in two pharmaceutical formulas were studied: an ophthalmic solution of cysteamine preserved benzalkonium chloride at 1mg/5mL and Glycerotone(®) preserved with sorbic acid at 0.1g/100g. The purpose of this work was to verify that a reduction of the quantities of preservative continues to fulfil the requirements for antimicrobial preservation.
METHODS: The Test of efficacy of antimicrobial preservation, section 5.1.3 of the 8th edition of the European Pharmacopoeia, was carried out on each formulation prepared with decreasing quantities of preservative.
RESULTS: The results show that formulations whose preservative concentration was reduced by a factor of four remained compliant with standards. It is to be noted that in formulas without preservative, fungal growth was observed in both the solution of Glycerotone(®) and the ophthalmic solution containing cysteamine.
CONCLUSIONS: Although there is no question that an antimicrobial preservative is necessary, the quantity of preservative can be reduced without deteriorating the quality of the pharmaceutical product but the minimal effective concentration remains to be determined.
CONCLUSIONS: The formulations of many pharmaceutical products should therefore be examined in order to limit the quantities of preservative while continuing to guarantee patient\'s safety.
METHODS: The Test of efficacy of antimicrobial preservation, section 5.1.3 of the 8th edition of the European Pharmacopoeia, was carried out on each formulation prepared with decreasing quantities of preservative.
RESULTS: The results show that formulations whose preservative concentration was reduced by a factor of four remained compliant with standards. It is to be noted that in formulas without preservative, fungal growth was observed in both the solution of Glycerotone(®) and the ophthalmic solution containing cysteamine.
CONCLUSIONS: Although there is no question that an antimicrobial preservative is necessary, the quantity of preservative can be reduced without deteriorating the quality of the pharmaceutical product but the minimal effective concentration remains to be determined.
CONCLUSIONS: The formulations of many pharmaceutical products should therefore be examined in order to limit the quantities of preservative while continuing to guarantee patient\'s safety.
摘要：
背景：在当前对抗菌防腐剂不信任的背景下，研究了两种药物配方中这些物质的含量：半胱胺保存的苯扎氯铵1mg/5mL的眼用溶液和山梨酸保存的甘油酮（®）0.1g/100g。这项工作的目的是验证防腐剂量的减少继续满足抗微生物保存的要求。
方法：抗菌防腐效果试验，欧洲药典第8版第5.1.3节，在用减少量的防腐剂制备的每种制剂上进行。
结果：结果表明，防腐剂浓度降低了四倍的制剂仍符合标准。值得注意的是，在没有防腐剂的配方中，在甘油酮(®)溶液和含有半胱胺的眼用溶液中均观察到真菌生长。
结论：尽管毫无疑问需要抗菌防腐剂，防腐剂的量可以减少，而不会降低药品的质量，但最低有效浓度仍有待确定。
结论：因此，应检查许多药品的配方，以限制防腐剂的用量，同时继续保证患者的安全性。
方法：抗菌防腐效果试验，欧洲药典第8版第5.1.3节，在用减少量的防腐剂制备的每种制剂上进行。
结果：结果表明，防腐剂浓度降低了四倍的制剂仍符合标准。值得注意的是，在没有防腐剂的配方中，在甘油酮(®)溶液和含有半胱胺的眼用溶液中均观察到真菌生长。
结论：尽管毫无疑问需要抗菌防腐剂，防腐剂的量可以减少，而不会降低药品的质量，但最低有效浓度仍有待确定。
结论：因此，应检查许多药品的配方，以限制防腐剂的用量，同时继续保证患者的安全性。
