中藥制劑復(fù)方銀翹口服液制備工藝研究
發(fā)布時(shí)間：2019-03-18 09:57
【摘要】：中獸醫(yī)學(xué)具有數(shù)千年的悠久歷史,其理論源于生產(chǎn)和醫(yī)療實(shí)踐,在不斷完善的發(fā)展過程中,逐步形成了獨(dú)特的比較系統(tǒng)完整的醫(yī)學(xué)理論體系,具有不可超越的優(yōu)勢(shì)。許多經(jīng)典方在臨床動(dòng)物疾病的防治應(yīng)用中收到良好的效果。銀翹口服液是在法定處方銀翹散的基礎(chǔ)上研制而成,將傳統(tǒng)經(jīng)典方銀翹散由散劑劑型,應(yīng)用現(xiàn)代制藥技術(shù)研制成為口服液劑型,研究發(fā)現(xiàn)改型后的液體劑型與傳統(tǒng)散劑比較,具有使用方便、吸收快、療效高等優(yōu)點(diǎn)。藥理學(xué)研究表明,銀翹散具有的抗菌抗病毒、抗炎抗過敏、解熱鎮(zhèn)痛作用活性,并能調(diào)節(jié)機(jī)體免疫功能。在生產(chǎn)工藝研究中,為確保制備工藝的科學(xué)性,采用L9(34)正交試驗(yàn)設(shè)計(jì)表,以揮發(fā)油的提取量和水提液中綠原酸含量作為指標(biāo),分別對(duì)揮發(fā)油提取和水提工藝進(jìn)行優(yōu)化,最終得到了銀翹口服液的最佳制備工藝,為進(jìn)一步質(zhì)量控制研究奠定基礎(chǔ)。質(zhì)量控制研究中,對(duì)制劑中藥材進(jìn)行了薄層色譜鑒別研究,試驗(yàn)表明金銀花、連翹、牛蒡子、薄荷、荊芥、甘草有效成分在TLC色譜中斑點(diǎn)清晰,重現(xiàn)性良好,陰性無干擾,可快速確定銀翹口服液中以上六味中藥的存在。對(duì)金銀花中重要的活性成分綠原酸進(jìn)行了HPLC測(cè)定方法的研究,建立了理論塔板數(shù)高、分離度好的優(yōu)化色譜條件,經(jīng)過精密度考察、穩(wěn)定性考察、重復(fù)性考察等方法學(xué)驗(yàn)證,驗(yàn)證了該方法的準(zhǔn)確度和重現(xiàn)性,最終確定以綠原酸作為標(biāo)志物對(duì)產(chǎn)品質(zhì)控。實(shí)驗(yàn)室抑菌實(shí)驗(yàn):以5株雞源大腸桿菌臨床分離株和禽E.coli O78標(biāo)準(zhǔn)株(C84008)為供試菌,牛津杯法測(cè)定銀翹口服液體外抑菌活性;以試管二倍稀釋法測(cè)定其最小抑菌濃度(MIC)。結(jié)果顯示銀翹口服液對(duì)雞大腸桿菌具有較好的抑制作用,對(duì)大腸桿菌標(biāo)準(zhǔn)株的MIC為32 mg/mL,對(duì)5株大腸桿菌臨床分離株的MIC分別為52、52、83、83、104 mg/mL。銀翹口服液和銀翹散對(duì)人工感染雞大腸桿菌病的治療試驗(yàn),以編號(hào)11-29的雞源大腸桿菌臨床分離株為攻毒菌株,攻毒劑量為3.0×108CFU/只,銀翹口服液為治療組,銀翹散為對(duì)照藥物組。結(jié)果顯示銀翹口服液高劑量組、中劑量組的死亡率與攻毒對(duì)照組比較,差異極顯著(p0.01),銀翹口服液低劑量組、銀翹散對(duì)照組的死亡率與攻毒對(duì)照組比較,差異顯著(p0.05)。治療有效率、死亡率以及體增重,銀翹口服液高、中劑量組治療效果均優(yōu)于銀翹散對(duì)照組,差異顯著(p0.05),銀翹口服液低劑量組與銀翹散對(duì)照組比較,無顯著差異。
[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.
【學(xué)位授予單位】：山東農(nóng)業(yè)大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2015
【分類號(hào)】：S853.73
本文編號(hào)：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.
【學(xué)位授予單位】：山東農(nóng)業(yè)大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2015
【分類號(hào)】：S853.73
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