2009•Yiyao daobaoRequires access

A Determination on Release in vitro and Bioavailability of Sinomenine Hydrochloride Sustained-released Capsules in Dogs

HE Zhong-gui

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Abstract

Objective To study the pharmacokinetics and relative bioavailability of sinomenine hydrochloride sustained-released capsules in dogs. Methods Single oral dose of 120 mg sinomenine hydrochloride sustained-released capsules and zhengqing fengtongning sustained-released tables were given to 6 dogs in an open randomized crossover way to study the pharmacokinetics parameter and relative bioavailability.Sinomenine hydrochloride concentration in blood was determined by an HPLC method. Results The time-concentration curve of sinomenine hydrochloride sustained-released capsules was similar to that of zhengqing fengtongning sustained-released tables,and their AUC0-t was 13 503.40 and 13 057.73 ng·h·mL-1;Cmax was 893.12 and 1 334.45 ng·mL-1;t1/2 was 20.72 and 8.57 h;tmax was 9.83 and 2.67 h,respectively.The result showed that there was no significant difference between sinomenine hydrochlorid sustained-released capsules and zhengqing fengtongning sustained-released tablets. Conclusion The two formulations of sinomenine hydrochloride sustained-released capsules and zhengqing fengtongning sustained-released tables were bioequivalent,although the fore has a longer t1/2 and more postponed tmax.

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Objective To study the pharmacokinetics and relative bioavailability of sinomenine hydrochloride sustained-released capsules in dogs. Methods Single oral dose of 120 mg sinomenine hydrochloride sustained-released capsules and zhengqing fengtongning sustained-released tables were given to 6 dogs in an open randomized crossover way to study the pharmacokinetics parameter and relative bioavailability.Sinomenine hydrochloride concentration in blood was determined by an HPLC method. Results The time-concentration curve of sinomenine hydrochloride sustained-released capsules was similar to that of zhengqing fengtongning sustained-released tables,and their AUC0-t was 13 503.40 and 13 057.73 ng·h·mL-1;Cmax was 893.12 and 1 334.45 ng·mL-1;t1/2 was 20.72 and 8.57 h;tmax was 9.83 and 2.67 h,respectively.The result showed that there was no significant difference between sinomenine hydrochlorid sustained-released capsules and zhengqing fengtongning sustained-released tablets. Conclusion The two formulations of sinomenine hydrochloride sustained-released capsules and zhengqing fengtongning sustained-released tables were bioequivalent,although the fore has a longer t1/2 and more postponed tmax.

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Available abstract

Objective To study the pharmacokinetics and relative bioavailability of sinomenine hydrochloride sustained-released capsules in dogs. Methods Single oral dose of 120 mg sinomenine hydrochloride sustained-released capsules and zhengqing fengtongning sustained-released tables were given to 6 dogs in an open randomized crossover way to study the pharmacokinetics parameter and relative bioavailability.Sinomenine hydrochloride concentration in blood was determined by an HPLC method. Results The time-concentration curve of sinomenine hydrochloride sustained-released capsules was similar to that of zhengqing fengtongning sustained-released tables,and their AUC0-t was 13 503.40 and 13 057.73 ng·h·mL-1;Cmax was 893.12 and 1 334.45 ng·mL-1;t1/2 was 20.72 and 8.57 h;tmax was 9.83 and 2.67 h,respectively.The result showed that there was no significant difference between sinomenine hydrochlorid sustained-released capsules and zhengqing fengtongning sustained-released tablets. Conclusion The two formulations of sinomenine hydrochloride sustained-released capsules and zhengqing fengtongning sustained-released tables were bioequivalent,although the fore has a longer t1/2 and more postponed tmax.

Key concepts: Sinomenine, Bioavailability, Bioequivalence, Cmax, Pharmacokinetics, Chemistry, Pharmacology, Chromatography

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