目的:比较单剂量吸入混悬液剂量均一性不同测定方法得到的结果,提出合理的吸入液体制剂的剂量均一性检测及评价方法。方法:对不同企业生产的吸入混悬液采用完全转移和可提取体积法2种不同方式测定装量,并制备剂量均一性供试品溶液供HPLC测定含量,采用中国及欧美药典的不同评价方法对结果进行比较。结果:混悬液为非均一体系,以装量和完全转移的方法控制剂量均一性不能反映产品的最终质量的实际情况。单剂量吸入混悬液应以可提取体积法测定剂量均一性,并依据2020年版《中华人民共和国药典》四部通则0941“含量均匀度检查法”进行判定。此方法更加准确直观地反映了吸入混悬液剂量均一性的情况。结论:本文提出的方法更适合单剂量吸入混悬液剂量均一性的检测及评价。
Objective: To compare the results of uniformity of dosage units for single-dose inhalation suspension obtained by two methods, and to put forward a reasonable method for the uniformity test. Methods: The uniformity of dosage units of the aerosol suspensions for inhalation produced by two manufacturers were prepared by complete transfer method and extractable method for HPLC determination, as well as filling quantity. The results were discussed according to content uniformity testing program requirements of Chinese Pharmacopoeia, USP, and European Pharmacopoeia. Results: Suspension was different from solution in that it was a non-homogeneous system. The uniformity of dosage units by filling quantity and complete transfer method could not reflect the practical clinical application. The uniformity of dosage units of single-dose inhalation suspension should be determined by extrusion method and evaluated according to General Rule 0941 of Chinese Pharmacopoeia 2020 edition. The new method could reflect the quality of the uniformity of dosage units. Conclusion: The new method proposed in this study is more suitable for the uniformity of dosage units t of single-dose inhalation suspension.
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