Pharmacokinetics of diltiazem hydrochloride sustained-release capsule in healthy volunteers

OBJECTIVE To study the pharmacokinetics of diltiazem hydrochloride sustained-release capsule in healthy volunteers.METHODS 60mg and 120mg diltiazem hydrochloride sustained-release capsules were given orally in a single dose to 12 healthy volunteers in a cross-over way.The diltiazem concentrations in serum were determined by RP-HPLC.The pharmacokinetic parameters were fitted and calculated by 3P87 program. RESULTS The main pharmacokinetics parameters of diltiazem hydrochloride sustained-release capsules after oral 60mg,120mg were as follows :T 1/2 K a( 0.60± 0.356),( 0.7± 0.4)h;T 1/2 K( 15.8± 2.7),( 13.9± 4.4)h;V( 33.2± 11.9),( 29.8± 11.8)L·kg -1;Cl( 1.4± 0.4),( 1.5± 0.5)L·h·kg -1;T max( 4.8± 0.9),( 4.6± 1.0)h;C max( 28.9± 10.8),( 65.6± 24.8)ng·ml -1;AUC( 751.2± 211.1),( 1487.4± 533.1)μg·h·L -1.CONCLUSIONS The parameters such as T 1/2 K, K , T max ,C max/D 0 and AUC/D 0 etc.in two kinds of dosage had no significant difference(P 0.05). It's pharmacokinetics were linear.