中药制剂复方银翘口服液制备工艺研究
发布时间：2019-03-18 09:57
【摘要】：中兽医学具有数千年的悠久历史,其理论源于生产和医疗实践,在不断完善的发展过程中,逐步形成了独特的比较系统完整的医学理论体系,具有不可超越的优势。许多经典方在临床动物疾病的防治应用中收到良好的效果。银翘口服液是在法定处方银翘散的基础上研制而成,将传统经典方银翘散由散剂剂型,应用现代制药技术研制成为口服液剂型,研究发现改型后的液体剂型与传统散剂比较,具有使用方便、吸收快、疗效高等优点。药理学研究表明,银翘散具有的抗菌抗病毒、抗炎抗过敏、解热镇痛作用活性,并能调节机体免疫功能。在生产工艺研究中,为确保制备工艺的科学性,采用L9(34)正交试验设计表,以挥发油的提取量和水提液中绿原酸含量作为指标,分别对挥发油提取和水提工艺进行优化,最终得到了银翘口服液的最佳制备工艺,为进一步质量控制研究奠定基础。质量控制研究中,对制剂中药材进行了薄层色谱鉴别研究,试验表明金银花、连翘、牛蒡子、薄荷、荆芥、甘草有效成分在TLC色谱中斑点清晰,重现性良好,阴性无干扰,可快速确定银翘口服液中以上六味中药的存在。对金银花中重要的活性成分绿原酸进行了HPLC测定方法的研究,建立了理论塔板数高、分离度好的优化色谱条件,经过精密度考察、稳定性考察、重复性考察等方法学验证,验证了该方法的准确度和重现性,最终确定以绿原酸作为标志物对产品质控。实验室抑菌实验:以5株鸡源大肠杆菌临床分离株和禽E.coli O78标准株(C84008)为供试菌,牛津杯法测定银翘口服液体外抑菌活性;以试管二倍稀释法测定其最小抑菌浓度(MIC)。结果显示银翘口服液对鸡大肠杆菌具有较好的抑制作用,对大肠杆菌标准株的MIC为32 mg/mL,对5株大肠杆菌临床分离株的MIC分别为52、52、83、83、104 mg/mL。银翘口服液和银翘散对人工感染鸡大肠杆菌病的治疗试验,以编号11-29的鸡源大肠杆菌临床分离株为攻毒菌株,攻毒剂量为3.0×108CFU/只,银翘口服液为治疗组,银翘散为对照药物组。结果显示银翘口服液高剂量组、中剂量组的死亡率与攻毒对照组比较,差异极显著(p0.01),银翘口服液低剂量组、银翘散对照组的死亡率与攻毒对照组比较,差异显著(p0.05)。治疗有效率、死亡率以及体增重,银翘口服液高、中剂量组治疗效果均优于银翘散对照组,差异显著(p0.05),银翘口服液低剂量组与银翘散对照组比较,无显著差异。
[Abstract]:Chinese veterinary medicine has a long history of thousands of years. Its theory originates from production and medical practice. In the process of continuous improvement, it has gradually formed a unique relatively systematic and complete medical theoretical system, which has an insuperable advantage. Many classical prescriptions have achieved good results in the prevention and treatment of clinical animal diseases. Yinqiao Oral liquid was developed on the basis of the legal prescription Yinqiao Powder. The traditional classic prescription Yinqiao Powder was developed from the powder form to the oral liquid form by modern pharmaceutical technology. The study found that the modified liquid formulation was compared with the traditional powder. The utility model has the advantages of convenient use, fast absorption and high curative effect. Pharmacological studies show that Yinqiao Powder has antibacterial and antiviral, anti-inflammatory, anti-allergic, antipyretic and analgesic activities, and can regulate the immune function of the body. In order to ensure the scientificity of the preparation process, the extraction of volatile oil and the content of chlorogenic acid in water extract were optimized by using L9 (34) orthogonal design table, and the extraction amount of volatile oil and the content of chlorogenic acid in water extract were taken as the indexes to optimize the extraction of volatile oil and the content of chlorogenic acid in water extract. Finally, the best preparation technology of Yinqiao oral liquid was obtained, which laid a foundation for further research on quality control. In the study of quality control, TLC identification of Chinese medicinal materials was carried out. The results showed that the effective components of Lonicera Lonicerae, Forsythia forsythia, Fructus arctii, mint, Fructus thaliana and Glycyrrhiza were clearly spotted, reproducible and negative without interference in TLC chromatography. Yinqiao oral liquid can quickly determine the existence of above six kinds of traditional Chinese medicine. The HPLC method for the determination of chlorogenic acid, an important active component in honeysuckle, was studied. The optimized chromatographic conditions with high number of theoretical trays and good separation were established. The results were verified by precision, stability, repeatability and so on. The accuracy and reproducibility of the method were verified. Finally, chlorogenic acid was used as a marker to control the product quality. Laboratory bacteriostatic test: using 5 clinical isolates of Escherichia coli from chicken and E.coli O78 standard strain (C84008) as test bacteria, the antibacterial activity of Yinqiao oral liquid was determined by Oxford cup method. Determination of minimal inhibitory concentration (MIC).) in vitro by double dilution method The results showed that Yinqiao oral liquid had a good inhibitory effect on chicken Escherichia coli. The MIC of YJ oral liquid to Escherichia coli standard strain was 32 mg/mL, and the MIC of 5 clinical isolates was 52, 52, 83, 83104 mg/mL., respectively. The therapeutic effects of Yinqiao oral liquid and Yinqiao powder on artificially infected chicken colibacillosis were studied. The clinical isolates of chicken-derived Escherichia coli (No. 11) were used as the attacking strains, and the dosage was 3.0 脳 108CFU/, while the Yinqiao oral liquid was used as the treatment group. Yinqiao Powder was used as control group. The results showed that the mortality of the high-dose and middle-dose groups of Yinqiao oral liquid was significantly higher than that of the attacking control group (p0.01), the mortality of the low-dose Yinqiao oral liquid group and the Yinqiao powder control group was significantly higher than that of the attacking control group. The difference was significant (p0.05). The effective rate, mortality and body weight gain of Yinqiao oral liquid were higher than those of Yinqiao powder control group (p0.05). There was no significant difference between the low-dose Yinqiao oral liquid group and Yinqiao powder control group (P < 0.05), but no significant difference was found between the low-dose Yinqiao oral liquid group and the Yinqiao powder control group.
【学位授予单位】：山东农业大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：S853.73
本文编号：2442748
[Abstract]:Chinese veterinary medicine has a long history of thousands of years. Its theory originates from production and medical practice. In the process of continuous improvement, it has gradually formed a unique relatively systematic and complete medical theoretical system, which has an insuperable advantage. Many classical prescriptions have achieved good results in the prevention and treatment of clinical animal diseases. Yinqiao Oral liquid was developed on the basis of the legal prescription Yinqiao Powder. The traditional classic prescription Yinqiao Powder was developed from the powder form to the oral liquid form by modern pharmaceutical technology. The study found that the modified liquid formulation was compared with the traditional powder. The utility model has the advantages of convenient use, fast absorption and high curative effect. Pharmacological studies show that Yinqiao Powder has antibacterial and antiviral, anti-inflammatory, anti-allergic, antipyretic and analgesic activities, and can regulate the immune function of the body. In order to ensure the scientificity of the preparation process, the extraction of volatile oil and the content of chlorogenic acid in water extract were optimized by using L9 (34) orthogonal design table, and the extraction amount of volatile oil and the content of chlorogenic acid in water extract were taken as the indexes to optimize the extraction of volatile oil and the content of chlorogenic acid in water extract. Finally, the best preparation technology of Yinqiao oral liquid was obtained, which laid a foundation for further research on quality control. In the study of quality control, TLC identification of Chinese medicinal materials was carried out. The results showed that the effective components of Lonicera Lonicerae, Forsythia forsythia, Fructus arctii, mint, Fructus thaliana and Glycyrrhiza were clearly spotted, reproducible and negative without interference in TLC chromatography. Yinqiao oral liquid can quickly determine the existence of above six kinds of traditional Chinese medicine. The HPLC method for the determination of chlorogenic acid, an important active component in honeysuckle, was studied. The optimized chromatographic conditions with high number of theoretical trays and good separation were established. The results were verified by precision, stability, repeatability and so on. The accuracy and reproducibility of the method were verified. Finally, chlorogenic acid was used as a marker to control the product quality. Laboratory bacteriostatic test: using 5 clinical isolates of Escherichia coli from chicken and E.coli O78 standard strain (C84008) as test bacteria, the antibacterial activity of Yinqiao oral liquid was determined by Oxford cup method. Determination of minimal inhibitory concentration (MIC).) in vitro by double dilution method The results showed that Yinqiao oral liquid had a good inhibitory effect on chicken Escherichia coli. The MIC of YJ oral liquid to Escherichia coli standard strain was 32 mg/mL, and the MIC of 5 clinical isolates was 52, 52, 83, 83104 mg/mL., respectively. The therapeutic effects of Yinqiao oral liquid and Yinqiao powder on artificially infected chicken colibacillosis were studied. The clinical isolates of chicken-derived Escherichia coli (No. 11) were used as the attacking strains, and the dosage was 3.0 脳 108CFU/, while the Yinqiao oral liquid was used as the treatment group. Yinqiao Powder was used as control group. The results showed that the mortality of the high-dose and middle-dose groups of Yinqiao oral liquid was significantly higher than that of the attacking control group (p0.01), the mortality of the low-dose Yinqiao oral liquid group and the Yinqiao powder control group was significantly higher than that of the attacking control group. The difference was significant (p0.05). The effective rate, mortality and body weight gain of Yinqiao oral liquid were higher than those of Yinqiao powder control group (p0.05). There was no significant difference between the low-dose Yinqiao oral liquid group and Yinqiao powder control group (P < 0.05), but no significant difference was found between the low-dose Yinqiao oral liquid group and the Yinqiao powder control group.
【学位授予单位】：山东农业大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：S853.73
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