2007•Zhōnghuá yàoxué zázhìRequires access

Studies on Pharmacokinetics and Relative Bioavailability of Sinomenine Hydrochloride Sustained-Released Capsules in Dogs

Lingyan Jian

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Abstract

OBJECTIVE To study the pharmacokinetics and bioavailability of sinomenine hydrochloride sustained-release capsules in dogs.METHODS 120 mg single oral dose of sinomenine hydrochloride sustained-release capsules and sinomenine hydrochloride sustained-release tablets were given to 6 dogs in an open randomized crossover way.sinomenine hydrochloride concentration in blood was assayed by HPLC method.RESULTS The relative bioavailability of sinomenine hydrochloride sustained-release capsules was(88.97%).The time-concentration curve of sinomenine hydrochloride sustained-release capsules was similar to that of sinomenine hydrochloride sustained-released tablets,and their AUC20-30 were(13 797.04±4 915.68) and(15 507.17±6 263.07)μg·h·L-1;ρ2max were(1 012.23±510.82) and(1 031.66±546.15)μg·L-1;t21/2 were(25.19±10.94) and(20.48±6.55)h;t2max were(8.67±1.63) and(5.7±1.51)h,respectively.The statistical analysis on above parameters showed that there was no significant difference between sinomenine hydrochloride sustained-release capsules and sinomenine hydrochlorid sustained-release tablets.CONCLUSION Two formulations are bioequivalent.

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OBJECTIVE To study the pharmacokinetics and bioavailability of sinomenine hydrochloride sustained-release capsules in dogs.METHODS 120 mg single oral dose of sinomenine hydrochloride sustained-release capsules and sinomenine hydrochloride sustained-release tablets were given to 6 dogs in an open randomized crossover way.sinomenine hydrochloride concentration in blood was assayed by HPLC method.RESULTS The relative bioavailability of sinomenine hydrochloride sustained-release capsules was(88.97%).The time-concentration curve of sinomenine hydrochloride sustained-release capsules was similar to that of sinomenine hydrochloride sustained-released tablets,and their AUC20-30 were(13 797.04±4 915.68) and(15 507.17±6 263.07)μg·h·L-1;ρ2max were(1 012.23±510.82) and(1 031.66±546.15)μg·L-1;t21/2 were(25.19±10.94) and(20.48±6.55)h;t2max were(8.67±1.63) and(5.7±1.51)h,respectively.The statistical analysis on above parameters showed that there was no significant difference between sinomenine hydrochloride sustained-release capsules and sinomenine hydrochlorid sustained-release tablets.CONCLUSION Two formulations are bioequivalent.

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Available abstract

OBJECTIVE To study the pharmacokinetics and bioavailability of sinomenine hydrochloride sustained-release capsules in dogs.METHODS 120 mg single oral dose of sinomenine hydrochloride sustained-release capsules and sinomenine hydrochloride sustained-release tablets were given to 6 dogs in an open randomized crossover way.sinomenine hydrochloride concentration in blood was assayed by HPLC method.RESULTS The relative bioavailability of sinomenine hydrochloride sustained-release capsules was(88.97%).The time-concentration curve of sinomenine hydrochloride sustained-release capsules was similar to that of sinomenine hydrochloride sustained-released tablets,and their AUC20-30 were(13 797.04±4 915.68) and(15 507.17±6 263.07)μg·h·L-1;ρ2max were(1 012.23±510.82) and(1 031.66±546.15)μg·L-1;t21/2 were(25.19±10.94) and(20.48±6.55)h;t2max were(8.67±1.63) and(5.7±1.51)h,respectively.The statistical analysis on above parameters showed that there was no significant difference between sinomenine hydrochloride sustained-release capsules and sinomenine hydrochlorid sustained-release tablets.CONCLUSION Two formulations are bioequivalent.

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

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