April, 2017 2017; Vol1; Issue3 http://iamresearcher.online To Cite This Article: Asmaa Ahmed Hamed, Khaled Aly Khaled, Hanaa Khalaf Fathelbab, Emad Allam Abdel Naeem. Evaluation of Silibinin Enriched Silymarin in Chronic HCV Patients. International Annals of Medicine. 2017;1(3). https://doi.org/10.24087/IAM.2017.1.3.91 Evaluation of Silibinin Enriched Silymarin in Chronic HCV Patients Asmaa Ahmed Hamed 1 , Khaled Aly Khaled 2 , Hanaa Khalaf Fathelbab 3 , Emad Allam Abdel Naeem 4 1 Assistant lecturer, clinical pharmacy department, Faculty of Pharmacy, Deraya University. 2 Professor of Pharmaceutics, Faculty of Pharmacy, Minia University. 3 Assistant professor of Endemic Diseases, Faculty of Medicine, Minia University. 4 Assistant Professor of Clinical Pathology, Faculty of Medicine, Minia University. Corresponding Author: Asmaa Ahmed Hamed asmaa_201526@yahoo.com ABSTRACT Background/ Aim: Silymarin is a polyphenolic compound with anti-hepatotoxic activity. It has low oral bioavailability due to its poor aqueous solubility. Thus enhancement of its dissolution may lead to a better bioavailability. The objective of the presented study was to prepare fast dissolving enriched silymarin preparation via the preparation of enriched silymarin as solid dispersion and compare it with Legalon capsules in chronic HCV patients in a clinical study. Method: Enriched silymarin solid dispersion was prepared in sufficient amount. A clinical study was conducted including 24 patients. The patients were divided into two groups; each group had 12 patients. One group received the solid dispersion. The second group received Legalon capsules. Patients received capsules 3 times daily for 12 weeks. All these patients had been subjected to full medical history, abdominal ultrasonography, laboratory investigations and quality of life assessment at baseline and after treatment. Results: Solid dispersion had significantly faster dissolution rate. It is effective in reducing AST, ALT, total bilirubin, improving prothrombin concentration, prothrombin time and quality of life. Conclusion: Silymarin solid dispersion is a promising preparation. Large scale and longer duration may be required to ascertain its effects. Keywords: Silymarin, solid dispersion, HCV, liver enzymes, quality of life 1. INTRODUCTION HCV is known as the sole member of genus Hepacivirus belonging to a group of genetically diverse RNA viruses of family Flaviviridae (Reed and Rice 2000). In 1989 HCV was cloned using a molecular biological approach where many other techniques had failed(Choo, Kuo, et al. 1989). According to recent estimates, more than 185 million people around the world have been infected with HCV, of whom 350 000 die each year (Mohd Hanafiah, Groeger, et al. 2013). The high incidence of HCV makes it one of the greatest health threats facing the world today. Fifty to eighty % cases of chronic hepatitis with viral persistence being at risk to develop liver inflammation, fibrosis, cirrhosis and HCC (Timm and Roggendorf 2007). HCV is endemic in Egypt. The genotype distribution in Egypt is mainly genotype 4 (HCV G4) (Abdel-Aziz, Habib, et al. 2000). The recently released Egyptian Demographic Health Survey [EDHS] tested a representative sample of the