Стандатизация и контроль качества фенсулкала в мягких лекарственных формах

Аннотация

Subjects of the inquiry: fensulkal substance, “Fensulkal suppositories”, “Fensulkal 3% ointment”. Aim of the inquiry: standardization and quality control of fensulkal in semisolid medicinal forms. Study of phannacopocial tests for elaboration and approval of normative documents for the medicinal forms obtained. Methods of the inquiry: thin-layer chromatography, high-performance liquid chromatography, UV-spcctrophotomctry, chromato-spcctrophotomctry, mathematic modeling in respect of the two chambered model. The results achieved and their novelty: the unified methodological approach to standardization of fensulkal vaginal suppositories with using of HPLC method was offered. The carried out studies allowed to determine the scientifically based criteria for authenticity and purity required for development of normative documentation. Methods of analysis of Fensulkal suppositories were validated and unified with the aim of carrying out the pharmacopoeial tests such as “Identification”, “Related substances (purity)” and “Assay”. Mathematic modeling of pharmacokinetic parameters in respect of two chambered model obtained as a result of in vivo tests did not show any accumulation of fensulkal in organs. Practical value: the obtained preclinical and clinical experimental results allowed to recommend “Fensulkal suppositories” as a new effective and safe antiinflammatory drug for national pharmacy. Degree of embed and economic effectivity: the temporary pharmacopoeial article for “Fensulkal suppositories” was elaborated and approved. The elaborated HPLC analytical procedure was offered for changing in the normative documentation for “Fensulkal 3% ointment” in the following pharmacopoeial tests: “Identification”, “Purity” and “Assay”. Sphere of usage: pharmaceutical industry, medicine.