Preparation Technology Of Shuanghuanglian Dropping Pills

Shuanghuanglian (for short SHL) are composed by Honeysuckle, Baicalin and Forsythia, with the effectiveness of heat-clearing and detoxicating, acrid-cold herbs relieving superficies. The clinical dosage forms commonly used are powder, oral liquid, injectable powder, granules, soft capsule. According to the technological features that Honeysuckle, Forsythia contain volatile oil and dropping pills preparation contain , we improved its agent for the dropping pills. The experiment was conducted to study the technology of SHL extraction, volatile oil inclusion and preparation of SHL Dropping Pills and active ingredients Determination; to proceed the acute toxicity acute toxicity test and bacteriostasis test in vitro.By orthogonal design method for extracting the volatile oil of Honeysuckl and Forsythia ,we got the best technology of the volatile oil of Honeysuckle and Forsythia extracting and Inclusion. According to the factors which influence volatile oil extraction of Honeysuckle, we select extraction temperature, extraction time, and water volume as investigation factors, designing three levels; and selected the extraction rate of volatile oil as investigation indexes to design L9 (3 ) Orthogonal test .The results showed that the volatile oil of honeysuckle is the most when extraction time is 10 h, extraction temperature is 80℃, and the water volume was eight times. And variance analysis showed that the extraction rate of volatile oil of Honeysuckle cann't be obviously affected by extraction time, extraction temperature and water volume; the validated test proved the volatile oil extraction conditions of Honeysuckle is stable. According to the factors which influence volatile oil extraction of Forsythia, we selected extraction temperature, the extraction time, and crush degree as investigation factors, designing three levels; and select the extraction rate of volatile oil as investigation indexes to design Orthogonal Test .The results showed that the volatile oil of Forsythia is the most when the extraction time is 12 h, extraction temperature is 80℃, and the crush degree is 40 meshes. The variance analysis showed that the extraction rate of volatile oil of Forsythia cann't be obviously affected by the extraction time, the extraction temperature and the water volume; the validated test proved the extraction conditions is stable. The volatile oil of Honeysuckle and Forsythia were used inclusion ofβ-cyclodextrin at the experiment. In accordance with factors which effect the effect of the volatile oil. Inclusion, we selected the proportion of oil:β-CD, inclusion temperature and stirring time as the main factors , select integrated score as the indicators, to determine L9 (3~4) orthogonal test. The results showed the optimum condition of Honeysuckle volatile oil inclusion is proportion of oil:β-CD is 1:6, inclusion time is 60min and inclusion temperature is 60℃while the best condition of Forsythia volatile oil inclusion is proportion of oil:β-CD is 1:8, inclusion temperature is 20℃and inclusion time is 60 min.By inspecting the factors which affect the preparation for Dropping Pills such as the temperature of drug and refrigerant, dropping speed and space in dropping process, we selected coefficient of weight variation, dissolution time as inspection factors to further screen the best technology using orthogonal indicators. The results showed the best formulation process was PEG4000, dissolution temperature is 80℃, matching of base is 1∶1.5. The refrigerant is dimethyl silicone oil, the coolant temperature in the top 5-10℃. while the bottom temperature is below 5℃, the dripping space is 5- 10 cm ,drip rate 40 drops/min.According to Chinese Pharmacopoeia, we enacted the standards for product quality control draft of Shuanghuanglian. Dropping Pills suiting to the business requirements. The study showed that the production process of SHL Dropping pills has meeted the requirements of production of veterinary drug. We established the determination methods of baicalin from Shuanghuanglian dripping Pills with HPLC and the standard curve regression equation: Y = 53225000X -8651.8 (r = 0.99994).The results showed that: when the Content of baicalin is 0.003-0.015 mg/mL, and the linear relationship is very good; The samples is stability within 24h while RSD is 0.5333 percent; the average recovery was 105.08 and RSD is 2.3473 percent. All the detections have meeted the relevant requirements of china veterinary pharmacopoeia and the initial validity period is 2 years.The acute toxicity test of recommended preliminary clinical dose and the test for antibacterial sensitiveness to Escherichia coli and Staphylococcus aureus of SHL dropping pills ,the results showed that the toxicity of SHL dropping Pills is very low; SHL dropping pills is more sensitive to Escherichia coli and Staphylococcus aureus than SHL Oral Liquid.