NGHIÊN CỨU BÀO CHẾ VIÊN NANG CỨNG CHỨA CAO CHUẨN HÓA TỪ LÁ SEN HỒNG (NELUMBO NUCIFERA GAERTN.)

Abstract

Background: Lotus is one of the few herbs with high biological value in all parts. Lotus can be found in all provinces of our country, with Dong Thap Muoi in Dong Thap and An Giang provinces being the most famous and popular. Furthermore, lotus leaf has long been a popular medicinal herb in folk medicine, used as medicine in traditional medicine, and included in some countries' Pharmacopoeia. Many studies in modern medicine show that lotus leaf is a medicinal herb containing many alkaloids with biological effects, of which nuciferine is a component with proven biological activities in vivo such as sedation, blood cholesterol reduction, cancer cell inhibition, and anti-oxidant. Currently, lotus leaf extract is used in a variety of herbal medicinal products that have therapeutic properties. Objectives: Developing formulation and preparation of capsules containing standardized extraction controlled nuciferine content from Lotus leaves collected in Dong Thap province. Materials and methods: The standardized extract from Lotus leaves collected in Dong Thap province met the Vietnamese Pharmacopoeia quality standards of 12% moisture content and no less than 10% nuciferin content. The wet milling method was chosen to investigate the formulations based on the physicochemical properties of the standardized extract and references to previous studies. The controlled nuciferine content of standardized extract capsules was quantified using high performance liquid chromatography coupled with a photodiode arrays detector (HPLC/PDA). Result: A dose of 1 capsule/time x 2-3 times/day has been prepared for capsules containing 300 mg of standardized extract from lotus leaves (equivalent to 30 mg nuciferin). The quantification of nuciferin content in each capsule by HPLC/PDA yielded results ranging from 85% to 115% of the labeled content based on the average weight of drug in the capsule. Other criteria, such as uniformity of weight, test for disintegration by the capsules. Conclusions: The capsules containing controlled nuciferine content of standardized extract from Lotus leaves collected in Dong Thap met the requirements for capsule quality, safety, and have sedative and anti-hyperlipidemia effects.