Abstract

BackgroundShunxinzufang decoction is tutors, empirical formula and has been used in Chinese patients of HFpEF for several years. The aim of this study was to make into sustained release granules and select the best formula for the preparation of Shunxin sustained release granules and to evaluate its in vivo and in vitro drug release behavior.MethodsResponse surface methodology and Center composite design were applied to screen the optimal formula of Shunxin sustained release granules. HPLC was used to detect indicative ingredients—paeoniflorin, calycosin-7-glucoside and ferulic acid in Shunxin sustained release granules. The in vitro sustained release character of indicative ingredients was investigated in simulated digestive fluids. In-vivo process of active components was studied through pharmacokinetics.ResultsThe optimal formula of Shunxin sustained release granules consisted of 35% shunxinzufang extract and 65% HPMC/starch (HPMC/starch ratio = 2:1). Three indicative components can be separated well under selected HPLC conditions. Compared with Shunxinzufang extract, the active components of Shunxin sustained release granules have obvious sustained-release character and improved bioavailability.ConclusionShunxin sustained release granules has obvious sustained-release character and improved bioavailability.

Highlights

  • Shunxinzufang decoction is tutors, empirical formula and has been used in Chinese patients of Heart failure with preserved ejection fraction (HFpEF) for several years

  • Shunxinzufang decoction consisted of twelve herbs: Salviae Miltiorrhizae Radix Et Rhizoma (Danshen), Radix ginsen Grubra (Hongshen), Astragali Radix (Huangqi), Radix Paeonia Rubra (Chishao), Chuanxiong Rhizoma (Chuanxiong), Poria (Fuling), Glycyrrhiza Radix Et Rhizoma (Gancao) et al, which has been used in Chinese patients of HFpEF for several years

  • sodium carboxymethyl cellulose (CMC-Na) granules showed serious agglomeration, poor particle uniformity, and many fine powders. Both granules made with microcrystalline cellulose (MCC) and Hydroxy-propyl methyl cellulose (HPMC) were satisfied, but MCC is relatively expensive

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Summary

Introduction

Shunxinzufang decoction is tutors, empirical formula and has been used in Chinese patients of HFpEF for several years. The aim of this study was to make into sustained release granules and select the best formula for the preparation of Shunxin sustained release granules and to evaluate its in vivo and in vitro drug release behavior. HFpEF patients requires long-term treatment of integrated traditional Chinese and western medicine. In traditional Chinese medicine preparations, decoction is used to treat urgent diseases while pills or other solid dose forms are used to treat chronic diseases. Shunxinzufang decoction consisted of twelve herbs: Salviae Miltiorrhizae Radix Et Rhizoma (Danshen), Radix ginsen Grubra (Hongshen), Astragali Radix (Huangqi), Radix Paeonia Rubra (Chishao), Chuanxiong Rhizoma (Chuanxiong), Poria (Fuling), Glycyrrhiza Radix Et Rhizoma (Gancao) et al, which has been used in Chinese patients of HFpEF for several years. In order to provide a stable and portable Chinese materia medica preparation for

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