小儿感冒舒颗粒二次开发研究
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摘要
小儿感冒舒颗粒处方为中药临床经验方,由葛根、牛蒡子、荆芥、桔梗、玄参、甘草、蝉蜕、建曲等八味药材组成,是治疗小儿外感发热的有效制剂。本研究利用现代先进的生产工艺对小儿感冒舒颗粒进行二次研究、开发,从而解决生产中存在的问题,以提高产品的科技含量和竞争力。
本课题优选了小儿感冒舒颗粒制备工艺路线,采用高效液相色谱法建立了葛根素和牛蒡子苷的含量测定方法;对牛蒡子超临界萃取油进行了初步药效学评价。
确定了牛蒡子脱脂、渗漉提取和喷雾制粒等提取和制剂工艺条件,并通过中试验证小儿感冒舒颗粒的工艺合理性。以均匀设计试验法对牛蒡子脱脂工艺优选的最佳工艺为萃取压力32MPa、温度48℃、萃取时间40min;采用正交设试验计优选渗漉工艺的实验结果表明:乙醇浓度70%,乙醇收集5倍量,渗漉速度以每千克药材计14mL/min;以孔径50nm的陶瓷膜对渗漉液进行超滤,并向浓缩液中补加等体积的溶剂,收集1倍渗漉液量的超滤液;通过单因素分析确定:超滤液浓缩成相对密度为1.20(80℃)的浸膏,以糊精:糖粉=1:4为底料,在一次进风温度为110℃、物料温度为55～65℃、蠕动泵速度为20rph的条件下进行喷雾制粒,所得颗粒大小均匀,流动性好。
在质量标准中,对葛根、牛蒡子、荆芥和桔梗进行鉴别,斑点清晰可见,阴性无干扰;采用高效液相色谱法对葛根素和牛蒡子苷同时进行含量测定的方法。葛根素在13～300μg/mL(r=0.9999)和牛蒡子苷在5～110μg/mL(r=0.9999)呈良好的线性关系。葛根素平均回收率为100.9%,牛蒡子苷平均回收率为100.4%,上述方法具有良好的精密度、稳定性和重复性。
经过GC-MS分析后,牛蒡子油中以脂肪酸为主,主要成分为亚油酸和油酸,此外还含有豆甾醇等成分。药效实验结果表明,在36h内牛蒡子油的抑菌浓度为≥15%(v/v),抑菌作用较弱;且牛蒡子油无明显的抗炎、解热作用,初步确认传统工艺对牛蒡子脱脂的做法的合理性。
根据以上工作确定的制剂工艺具有生产工艺简单稳定、质量标准可控。
Xiao'er Ganmaoshu Granule is a clinical experience formula of Traitional Chinese Medicine, which is made up with Radix Puerariae, Fructus Arctii, Herba Schizonepetae, Radix Platycodonis, Radix Scrophulariae, Radix Rhizoma Glycyrrhizae, Periostracum Cicad and Jian Qu. It is a effective preparation for fever caused by exogenous pathogens. In order to solve the problems in the manufacture and improve the competition, this dissertation develops the Xiao'er Ganmaoshu Granule by the advanced technologies.
The dissertation optimized the preparation technology of Xiao'er Ganmaoshu Granule, and established analyzing method for the Puererin and Aretiin by HPLC. This study also eliminates the pharmacodynamics of the oils extracted from Fructus Arctii by supercritical fluid extraction.
Confirming the defatting technology of Fructus Arctii, percolate technology and spray-granulating technology, and verifying the responsibility of the manufacture technology by the pilot experiments. The defatting technology of Fructus Arctii was optimized by the uniform design: the pressure was 32MPa, the temperature was 48℃and the time was 40min; By the orthogonal experiment, the content of ethanol was 70%, the volume of ethanol was 5 times, and the velocity was 14mL/(min·kg); the percolating liquid was ultrafiltrated by ceramic membrane with 50nm, and finally the salvation was add to the concentrated liquid with the same volume, and the ultrafiltrated liquid of which the volume was the same with the percolating liquid was collected; when the relative density of the extractum was 1.20 (80℃) and the ratio of dextrin and sucrose was 1:4, the granules which were uniform size and well fluidity were prepared by spray granulation at the condition of 110℃(the temperature of entry), 55～65℃(the masteries' temperature) and 20rph(the velocity of peristaltic pump).
In the quality criteria, we add the TLC of Radix Puerariae and RadixPlatycodonis; the analyzing method for Puererin and Aretiin were established at thesame time. Puererin and Aretiin showed a satisfactory relation in 13～300μg/mL(r=0.9999) and 5～110μg/mL (r=0.9999) respectively. The average recovery rates ofPuererin and Aretiin was 100.9% and 100.4% respectively. The methods had satisfactory precision, stability and repetition.
The major content in the oil of Fructus Arctii is fatty acids, such as octadecadienoic acid and oleinic acid. Besides that, stigmasterine was finded in the oil. The results of pharmacological activity indicate that the content of bacteriostasis≥15% (v/v) and the effects of anti-inflammatory, febrifugal and bacteriostatic were not effective. The responsibility of defatting technology was affirmed initially.
Xiao'er Ganmaoshu Granule has satisfactory effects with simple and stable technology and controllable quality standard.
本课题优选了小儿感冒舒颗粒制备工艺路线,采用高效液相色谱法建立了葛根素和牛蒡子苷的含量测定方法;对牛蒡子超临界萃取油进行了初步药效学评价。
确定了牛蒡子脱脂、渗漉提取和喷雾制粒等提取和制剂工艺条件,并通过中试验证小儿感冒舒颗粒的工艺合理性。以均匀设计试验法对牛蒡子脱脂工艺优选的最佳工艺为萃取压力32MPa、温度48℃、萃取时间40min;采用正交设试验计优选渗漉工艺的实验结果表明:乙醇浓度70%,乙醇收集5倍量,渗漉速度以每千克药材计14mL/min;以孔径50nm的陶瓷膜对渗漉液进行超滤,并向浓缩液中补加等体积的溶剂,收集1倍渗漉液量的超滤液;通过单因素分析确定:超滤液浓缩成相对密度为1.20(80℃)的浸膏,以糊精:糖粉=1:4为底料,在一次进风温度为110℃、物料温度为55～65℃、蠕动泵速度为20rph的条件下进行喷雾制粒,所得颗粒大小均匀,流动性好。
在质量标准中,对葛根、牛蒡子、荆芥和桔梗进行鉴别,斑点清晰可见,阴性无干扰;采用高效液相色谱法对葛根素和牛蒡子苷同时进行含量测定的方法。葛根素在13～300μg/mL(r=0.9999)和牛蒡子苷在5～110μg/mL(r=0.9999)呈良好的线性关系。葛根素平均回收率为100.9%,牛蒡子苷平均回收率为100.4%,上述方法具有良好的精密度、稳定性和重复性。
经过GC-MS分析后,牛蒡子油中以脂肪酸为主,主要成分为亚油酸和油酸,此外还含有豆甾醇等成分。药效实验结果表明,在36h内牛蒡子油的抑菌浓度为≥15%(v/v),抑菌作用较弱;且牛蒡子油无明显的抗炎、解热作用,初步确认传统工艺对牛蒡子脱脂的做法的合理性。
根据以上工作确定的制剂工艺具有生产工艺简单稳定、质量标准可控。
Xiao'er Ganmaoshu Granule is a clinical experience formula of Traitional Chinese Medicine, which is made up with Radix Puerariae, Fructus Arctii, Herba Schizonepetae, Radix Platycodonis, Radix Scrophulariae, Radix Rhizoma Glycyrrhizae, Periostracum Cicad and Jian Qu. It is a effective preparation for fever caused by exogenous pathogens. In order to solve the problems in the manufacture and improve the competition, this dissertation develops the Xiao'er Ganmaoshu Granule by the advanced technologies.
The dissertation optimized the preparation technology of Xiao'er Ganmaoshu Granule, and established analyzing method for the Puererin and Aretiin by HPLC. This study also eliminates the pharmacodynamics of the oils extracted from Fructus Arctii by supercritical fluid extraction.
Confirming the defatting technology of Fructus Arctii, percolate technology and spray-granulating technology, and verifying the responsibility of the manufacture technology by the pilot experiments. The defatting technology of Fructus Arctii was optimized by the uniform design: the pressure was 32MPa, the temperature was 48℃and the time was 40min; By the orthogonal experiment, the content of ethanol was 70%, the volume of ethanol was 5 times, and the velocity was 14mL/(min·kg); the percolating liquid was ultrafiltrated by ceramic membrane with 50nm, and finally the salvation was add to the concentrated liquid with the same volume, and the ultrafiltrated liquid of which the volume was the same with the percolating liquid was collected; when the relative density of the extractum was 1.20 (80℃) and the ratio of dextrin and sucrose was 1:4, the granules which were uniform size and well fluidity were prepared by spray granulation at the condition of 110℃(the temperature of entry), 55～65℃(the masteries' temperature) and 20rph(the velocity of peristaltic pump).
In the quality criteria, we add the TLC of Radix Puerariae and RadixPlatycodonis; the analyzing method for Puererin and Aretiin were established at thesame time. Puererin and Aretiin showed a satisfactory relation in 13～300μg/mL(r=0.9999) and 5～110μg/mL (r=0.9999) respectively. The average recovery rates ofPuererin and Aretiin was 100.9% and 100.4% respectively. The methods had satisfactory precision, stability and repetition.
The major content in the oil of Fructus Arctii is fatty acids, such as octadecadienoic acid and oleinic acid. Besides that, stigmasterine was finded in the oil. The results of pharmacological activity indicate that the content of bacteriostasis≥15% (v/v) and the effects of anti-inflammatory, febrifugal and bacteriostatic were not effective. The responsibility of defatting technology was affirmed initially.
Xiao'er Ganmaoshu Granule has satisfactory effects with simple and stable technology and controllable quality standard.
引文
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