Study On The Preparation And Quality Standards Of Forsythia And Amoxicillin Powder

The forsythia and amoxicillin powder was a compound preparation which contains forsythia suspense extract and amoxicillin. It has an efficacy with antipyretic detoxicate and eliminating stagnation subsiding swelling. It was mainly used for treatment and prevention of the disease because of Streptococcus suis. The drug resistance of Streptococcus suis with amoxicillin was inhibited by extract of forsythia suspense which has the efficacy with therapy and resistance inhibitor and to solve the question of bacterial drug resistance. In order to determination the advisable preparation industrial arts and formula, based on the results of literatures investigation and the active ingredients, forsythia suspense combined with amoxicillin first time. Using analysis technologies such as the thin layer chromatography (TLC) method and the high performance liquid chromatography (HPLC), quality standards of the preparation were set up. It settle the base on controllability, safety and availability of the compound preparationIn order to determination the physico-chemical property of forsythia suspense extract, based on the method of"The People's Republic of China veterinary Pharmacopoeia"determination its dissolubility and power of hydrogen. The result suggest that extract of forsythia suspense easy deliquescence in purified water and 0.9% Nacl and hardly deliquescence or non-deliquescence in methanol and alcohol. The power of hydrogen was 7.0±0.05 in water.There are contains the selection of pharmacopoeia and proportional in prescription bolting. Amoxicillin and amoxicillin sodium was selection in different percentage with forsythia suspense extract by ultraviolet spectrophotometer to ensure the effect with forsythiaside. Adjuvant was consideration hygroscopicity,optical density and anti-oxidizing ability and to make sure there little action by ultraviolet spectrophotometer. The resule suggest that the moisture absorption rate of forsythia suspense extract, amoxicillin, glucose, sucrose, lactose is 67%, 77%, 79%, 80% and 82%; there is no CRH about calcium carbonate because it is an-water solubility adjuvant. The biggest CRH is Lactose and the smallest is glucose; Each adjuvant is no phanero-effect with remedium cardinale. Through the test above the pharmaceutical formulation was forsythia suspense extract: amoxicillin (3:1), adjuvant was calcium carbonate.The process research is ensured the breed of medicinal sieve by pharmacodynamic test in vivo. The result suggest that the death rate of non-medication administration team is sixty persent and the number of bacterial exceed three hundred; the death rate of medication administration team which medicine through the fourth medicinal sieve is thirty-three point three persent and the number of bacterial is two hundred fourty-six; there is no death in the team of medication administration team which medicine through the sixth medicine. Adoption the result above, ensure the technic is Forsythia suspense extract and Calcium Carbonate was screen analysis by number six in three minutes and compound with amoxicillin, after that to divide, check and casing.The TLC method was selected to identify forsythiaside in forsythia suspense extract and establish the quality standards. The standard forsythiaside were used as standard preparation. The result suggests that the relevant spots were clear and specific strong compared with their control. The Content of forsythiaside and amoxicillin active component in forsythia suspense was working by HPLC. The chromatographic condition of amoxicillin was analytical columns (C₁₈) thermostated at 35℃; mobile phase phosphate buffer (pH=4): methanol (95:10); wave-length was 231 nm; flow rate at 1 ml/min; as a result, the regression equation of the amoxicillin was y=15883x+247.7(r²=0.9948)and the calibration curve was linear within a range of 0.203～0.012 mg, The average recovery rate was 101.65% and the RSD was 0.7%,according to the measuring results of pilot products it is containing amoxicillin no less than 1600IU in Forsythia suspense combined with amoxicillin powert every milligram; The chromatographic condition of forsythiaside was analytical(416 mm×250 mm,5μm) columns (C₁₈); mobile phase of forsythiaside was methyl cyanides: water: glacial acetic (14.5: 84.5: 0.4); thermostated at 35℃; wave-length was 332 nm; flow rate at 1 ml/min; as a result, the regression equation of the forsythiaside was y=5801.5x-158.26(r²=0.9996)and the calibration curve was linear within a range of 0.124～1.990μg/ml, The average recovery rate was 98.42% and the RSD was 1.7% ,according to the measuring results of pilot products it is containing forsythiaside no less than 0.03 mg in Forsythia suspense combined with amoxicillin powert every milligram. Caffeic acid was assayed by HPLC as special contamination. The chromatographic condition of caffeic acid below: analytical(416 mm×250 mm,5μm) columns (C₁₈); mobile Phase of forsythiaside was methyl cyanides: water: glacial acetic (14.5: 84.5: 0.4); thermostated at 35℃; wave-length was 323 nm; flow at 1 ml/minmobile; as a result, the regression equation of the caffeic acid was y=21636x+1156.4(r²=0.9996)and the calibration curve was linear within a range of 0.0355～0.568 mg/ml, The average recovery rate was 98.11% and the RSD was 0.07%, according to the measuring results of pilot products it is containing coffee acid not more than 0.03 mg in Forsythia suspense combined with amoxicillin powert every milligram. Influencing factor test,accelerated rest and long term stability test was had after quality standard method was determination, the result indicate that it has drug stability well.In one word,the Preparation of forsythia suspense combined with amoxicillin dust was applicable,and the quality of the preparations cou1d be controlled. Further studies was value to be carried out to develop a new medicine.