Study On Preparation Technology And Quality Standard Of Fufang Lianyu Capsules

Objective:Fufang Lianyu capsules are for the treatment of typeⅡdiabetes and its prescription is a vaild empirical formula and has been offered clinically for many years. It consists of rhizoma coptidis, Fructus cornus, Rhizoma dioscoreae and other herbs, with a function of invigorating kidney yin. In order to better use for clinic, convenient to take and improve the drug bioavailability, the subject which is on the basis of clinical use and pharmacology studies will develope Zhen QingFang into capsules- Fufang Lianyu capsules, focusing on the capsules of the preparation technology and quality standard and laying on the basis of Pharmacy for future development as a new drug.Methods: The subject studies on preparation technology and quality standard of Fufang Lianyu Capsules.Preparation technology methods1. Extraction process study: A single extraction experiment for rhizoma coptidis was used with ethanol. Used the L9 (34) orthogonal design method.In order to choose the optimal extraction process, the dosage and concentration of alcohol, extraction time and extraction frequency were investigated as the factor.Other herbs used the water-extraction and alcohol-precipitation methods. Effects of three factors, water volume,extraction time,extraction times on extraction were evaluated by orthogonal design; effects of three factors, alcohol volume,concentration of condensed solution,reaction time on content of Fufang Lianyu capsules of alcohol precipitation were also evaluated by orthogonal design.2. Preparation formation process study: Using comparative approach, fluidity of the power, the percentage of moisture, relative humidity and other factors were do the indexes. Selected appropriate materials and determine the best preparation formation process; Quality standard methods: According to the capsule of the relevant regulations in Chinese Pharmacopoeia of 2005, the definite quality standards for Fufang Lianyu capsules was established.Results: Preparation results: The optimum extraction process condition for the single extraction experiment of rhizoma coptidis is as follows: 60% as extraetion concentration, 6 times as extraction dosage, recirculating and extracting two times, 1.5 hours every time.Combining the extracts water, filtrating, recycling ethanol, acid precipitation, salting out, vacuum drying the sediment that is berberine dry extract.Other four herbs used water as the extracting solvent, extracting two times, 1.5hours each time, 8 times solvent to the decoction pieces;and then combined the extracts water, filtrated, concentrated and alcohol precipitation.The alcohol precipitation process was that 60% of precipitation concentration, concentrated volume ratio of extraction was 1:1.2, the alcohol deposit lasted 24 hours. Dried the supernatant fluid, vacuum drying and reserved the extractum.Grinded the dry extracts, berberine extract, yam powder (to take prescription yam 1/3 of the amount using as the formation materials) as fine powder and blended, sieving. Dry extract powder mixed with appropriate amount of microcrystalline cellulose and calcium phosphate dibasic, and then plus 95% ethanol, granulate, dry, sieve, encapsulate. The humidity of mass production and store was below 62%.Results of quality standards: Coptidis rhizoma, cornus, were identified by TLC. Spots were clear and the methods were specific. The contents of loganin and berberine hydrochloride which is effective element in the capsules were determined by HPLC. With C18 chemical bonded silica gel as a solid phase, acetonitrile-0.1% phosphoric acid as the mobile phase (28:72), flow rate 1.0mL·min^-1; detection wavelength was 265nm, column temperatureof 30℃for the determination of berberine hydrochloride; With C18 chemical bonded silica gel as a solid phase,acetonitrile-0.05% phosphoric acid as mobile phase (11:89), flow rate 1.0mL·min^-1, detection wavelength 236nm, column temperature of 30℃for the determination of loganin. The method is validation and convenient. According to Objective:Fufang Lianyu capsules are for the treatment of typeⅡdiabetes and its prescription is a vaild empirical formula and has been offered clinically for many years. It consists of rhizoma coptidis, Fructus cornus, Rhizoma dioscoreae and other herbs, with a function of invigorating kidney yin. In order to better use for clinic, convenient to take and improve the drug bioavailability, the subject which is on the basis of clinical use and pharmacology studies will develope Zhen QingFang into capsules- Fufang Lianyu capsules, focusing on the capsules of the preparation technology and quality standard and laying on the basis of Pharmacy for future development as a new drug.Methods: The subject studies on preparation technology and quality standard of Fufang Lianyu Capsules.Preparation technology methods1. Extraction process study: A single extraction experiment for rhizoma coptidis was used with ethanol. Used the L9 (34) orthogonal design method.In order to choose the optimal extraction process, the dosage and concentration of alcohol, extraction time and extraction frequency were investigated as the factor.Other herbs used the water-extraction and alcohol-precipitation methods. Effects of three factors, water volume,extraction time,extraction times on extraction were evaluated by orthogonal design; effects of three factors, alcohol volume,concentration of condensed solution,reaction time on content of Fufang Lianyu capsules of alcohol precipitation were also evaluated by orthogonal design.2. Preparation formation process study: Using comparative approach, fluidity of the power, the percentage of moisture, relative humidity and other factors were do the indexes. Selected appropriate materials and determine the best preparation formation process;...