ABSTRACT
Objective: To prepare valsartan tablets and optimize the parameters of rolling granulation process. Methods: The par-ticle size (D50, Y1/μm), tablet hardness (Y2/N), and 30-min drug dissolution (Y3/%) as the evaluation indices, the critical process variables were studied by Plackett-Burman experiment design firstly, and then Box-Behnken response surface method was used to optimize the parameters of rolling granulation process. Results: Plackett-Burman experimental design showed that the rolling pressure and mesh size had significant effect on the granule size (P<0. 05). The rolling pressure, rolling nip and mesh size had significant effect on the tablet hardness (P<0. 05). The optimum rolling parameters based on Box-Behnken response surface method were as fol-lows: the rolling pressure was 30 bar, the rolling nip was 3. 0 mm and the mesh size was 2. 0 mm. Valsartan tablets had good compres-sibility and high drug dissolution, which was similar to the in vitro dissolution profile of commercial reference preparations. Conclu-sion: The experimental designs to optimize the rolling granulation process of valsartan tablets can improve the controllability of the prod-uct quality.
ABSTRACT
One hundred patients with early diabetic nephropathy were randomly divided into control group and study group with 50 cases in each group.All patients received conventional antidiabetic therapy with valsartan tablets 80mg, q.d;patients in study group were given additional TCM Jiawen Dihuang decoction.TCM syndrome scores, relevant biochemical testing and renal function changes were evaluated before and after treatment in two groups.After 8 weeks of treatment, the results showed than the TCM scores in both groups were significantly reduced (study group: 18.9±1.6 vs.7.2±5.1, control group 18.8±1.5 vs.10.3±6.2.both P<0.05);the improvement rate of TCM syndrome in study group was significantly higher than that of control group (90% vs.68%, x2=5.3,P<0.05);and the improvement of relevant biochemical index and renal function in study group was more marked than that in control group.The study indicates that the integrated TCM and Western medicine can enhance the efficacy in treatment of early diabetic hephropathy.
ABSTRACT
Objective To develop a formulation of generic Valsartan Tablets and evaluate the quality consistency in vitro.Methods Diovan(R)~ HCT (80 mg) was used as the reference drug.In order to determine the best formulation and the best preparation processing,the single factor experiments were applied to determining the best formulation and the best preparation processing.And dissolution test was used as the evaluation index in the single factor experiments.Meanwhile the dissolubility of generic Valsartan Tablets and original preparation was investigated in four different media to evaluate the similarity of dissolution by calculating similar factor (f2).Results The dissolution was above 85％ of three batches of generic Valsartan Tablets in the phosphate buffer (pH 6.8).The similar factors were all more than 50 in the water,hydrochloric acid solution (pH 1.2),and acetate buffer solution (pH 4.5).Conclusion The f2 similarity factor results indicate a similarity in the reference drug and generic Valsartan Tablets which were developed by single factor experiments,which means the quality of genetic Valsartan Tablets is qualified.