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  • Author: Qing-sheng Shi x
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Abstract

The aim of this study was to investigate the in vitro and in vivo performance of salbutamol sulfate press-coated tablets for delayed release. The in vitro release behavior of press-coated tablets with the outer layer of PEG 6000/ Eudragit S100 blends (2:1) in pH 1.2 (0.1 mol L-1 HCl) and then pH 6.8 buffer solution was examined. Morphological change of the press-coated tablet during in vitro release was recorded with a digital camera. Release of salbutamol sulfate from press-coated tablets was less than 5 % before 3 h and was completed after 8 h in pH 6.8 phosphate buffer solution. In vivo gamma scintigraphy study carried out on healthy men indicated that the designed system released the drug in lower parts of the GI tract after a lag time of 5 hours. The results showed the capability of the system of achieving delayed release of the drug in both in vitro and in vivo gamma scintigraphy studies.

Objective To evaluate the efficacy and safety of traditional Chinese medicine (TCM) combined with Western medicine in the treatment of patients with common hand, foot and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial.

Methods A total of 452 patients with common HFMD were randomly assigned to receive Western medicine alone (n = 220) or combined with TCM (Reduning or Xiyanping injections) (n = 232). The primary outcome was the incidence rate of rash/herpes disappearance within 5 days, while secondary outcomes included the incidence rate for fever, cough, lethargy, agitation, and vomiting clearance within 5 days.

Results The rash/herpes disappearance rate was 45.5% (100/220) in Western medicine therapy group, and 67.2% (156/232) in TCM and Western medicine combined therapy group, with significant difference (P < 0.001). Moreover, TCM remarkably increased the incidence rate of secondary disappearance, which was 56.4% in Western medicine therapy group and 71.4% in TCM and Western medicine combined therapy group (P = 0.001). No drug-related adverse events were observed.

Conclusions It’s suggested that the integrative TCM and Western medicine therapy achieved a better therapeutic efficacy. TCM may become an important complementary therapy on relieving the symptoms of HFMD.