CN112717117A - 一种蟾龙定喘软胶囊的制备方法 - Google Patents
一种蟾龙定喘软胶囊的制备方法 Download PDFInfo
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Abstract
一种蟾龙定喘软胶囊的制备方法,步骤是:将地龙、红参、黄芪、麻黄、五味子、补骨脂、淫羊藿、桂枝、当归、白芍、陈皮、清半夏、杏仁、炙甘草、桔梗和紫苏叶;叶经水提、浓缩,得到中药浸膏A;取蟾蜍,碎断后,与干姜、猪胆汁,经水提醇沉、浓缩,得到中药浸膏B;中药浸膏A和中药浸膏B混合并干燥,加入脂肪酸甘油酯、大豆油,得到胶囊填充液;将水、甘油依次投入化胶罐中,投入山梨醇、二氧化钛、氧化铁黄和明胶,制作胶液;将胶囊填充液、胶液在软胶囊机中进行压制胶丸,经定型、洗丸、干燥,得到蟾龙定喘软胶囊。优点是:制作方法简单、成本低廉,避免软胶囊渗油,内容物可长期保持稳定,且内容物均一性佳,崩解效果好。
Description
技术领域
本发明涉及一种蟾龙定喘软胶囊的制备方法。
背景技术
蟾龙定喘合剂是依据张仲景《伤寒论》中的小青龙汤加减化裁而来,蟾龙定喘合剂经多年临床实践是治疗慢性哮喘非常有效的中成药。其具有散寒化痰、补肺、健脾、益肾、止咳平喘之功效;用于肺脾肾气阳虚之慢性支气管炎、慢性支气管炎合并肺气肿、慢性支气管炎合并肺心病、支气管哮喘;能迅速止咳、化痰平喘,改善肺功能,抗菌消炎,调节免疫功能。
蟾龙定喘合剂虽然疗效确切,药理作用与现代研究表明,它具有增强免疫、抗炎、抗过敏、强心、解除支气管痉挛、平喘止咳的作用。但由于处方多味药材具有特殊药性,制成的合剂具有强烈的苦、腥气味,让患者难以接受。严重制约了该药的临床推广。影响了应有的经济和社会效益。
软胶囊是将一定量的药材或/和提取物加适量内容物辅料密封于球形、椭圆形或其它形状的软胶囊中,封闭的囊壳内的产品制剂。(1)中药软胶囊常出现装量不准确,内容物形状不均匀、易分层的缺点。(2)中药软胶囊主要以明胶为囊材,在储存过程中明胶易发生交联反应,引起明胶结构中的胶原胶束发生变形,阻碍水分子进入明胶内部,使软胶囊难以崩解,中药软胶囊崩解迟缓。
发明内容
本发明要解决的技术问题是提供一种制作方法简单、成本低廉,避免软胶囊渗油,内容物可长期保持稳定,且内容物均一性佳,崩解效果好的蟾龙定喘软胶囊的制备方法。
一种蟾龙定喘软胶囊的制备方法,其具体步骤如下:
(1)称取原料药组分A:地龙、红参、黄芪、麻黄、五味子、补骨脂、淫羊藿、桂枝、当归、白芍、陈皮、清半夏、杏仁、炙甘草、桔梗和紫苏叶;
取地龙、红参洗净,并将地龙碎断、红参切片,与黄芪、麻黄、五味子、补骨脂、淫羊藿、桂枝、当归、白芍、陈皮、清半夏、杏仁、炙甘草、桔梗和紫苏叶经水提,滤过,滤液浓缩,得到中药浸膏A;
(2)取蟾蜍,碎断后,与干姜、猪胆汁,经水提醇沉,浓缩成膏,得到中药浸膏B;
(3)、化胶
将处方量水、甘油依次投入化胶罐中,加热温度至70℃时,开始投入山梨醇、二氧化钛、氧化铁黄和明胶,所述明胶与水的质量比为1:1,明胶与甘油的质量比为18:9,明胶与山梨醇的质量比为18:5,控制化胶罐温度在70℃±2℃之间,搅拌使明胶全部溶解,开启真空泵,在-0.08MPa条件下进行脱气1小时,至胶液气泡全部脱尽;放料,过120目滤袋,将过滤后的胶液置不锈钢保温桶中静置,保温温度50℃-60℃之间,即得胶液,待用;
(4)配料
将步骤(2)得到的中药浸膏A和中药浸膏B混合并干燥,得到混合药粉;按照脂肪酸甘油酯与大豆油、混合药粉质量比分别为1:(2-10)、1:(2-8)称重,将大豆油装入配料罐中,加热至80℃,加入脂肪酸甘油酯,保持温度70℃-80℃之间,搅拌均匀,待油温降至40℃-55℃之间时,投入混合药粉,搅拌50min使混合均匀,然后过胶体磨磨3次,减压在真空-0.08MPa条件下进行脱气,即得胶囊填充液;
(5)压丸
将胶囊填充液、胶液在软胶囊机中进行压制胶丸,将喷体温度设定在48-54℃,调整两侧胶皮厚度至0.58mm-0.62mm之间,待喷体温度达到设定温度,调整两滚模间压力,压丸,控制内容物重量为0.34-0.36之间,环境温度18℃-25℃,相对湿度45%-65%;
(6)定型
20-24℃之间,冷风干燥4小时,相对湿度30%-40%,将软胶囊定型;
(7)洗丸
将软胶囊用质量浓度为95%食用酒精洗去表面油脂;
(8)干燥
将所得的软胶囊平铺于白钢盘内,置于干燥间内,在24-25℃,相对湿度29%-31%的条件下通风干燥,每隔2小时轻翻胶囊1次,干燥时间36小时,使软胶囊的水分含量为10%-12%,得到蟾龙定喘软胶囊。
进一步的,所述蟾龙定喘软胶囊的原料药按照重量份数组成如下:蟾蜍5份、地龙250份、红参10份、黄芪100份、麻黄250份、五味子100份、补骨脂75份、淫羊藿150份、桂枝75份、当归75份、白芍100份、陈皮50份、清半夏75份、杏仁100份、干姜50份、猪胆汁50份、炙甘草75份、桔梗50份和紫苏叶150份。
进一步的,所述大豆油、混合药粉质量比为1:1。
进一步的,制备中药浸膏A时,取地龙、红参洗净,并将地龙碎断、红参切片,与黄芪、麻黄、五味子、补骨脂、淫羊藿、桂枝、当归、白芍、陈皮、清半夏、杏仁、炙甘草、桔梗和紫苏叶原料药加占原料药组分A总质量8倍量的水,提取三次,提取温度100℃,每次2小时,合并煎液,滤过,滤液浓缩。通过水提有效提取和保留了中药挥发性有效成分,有效成分含量高,且生物利用率高。
进一步的,制备中药浸膏B时,取蟾蜍,碎断后,与猪胆汁和干姜混合后,加入占蟾蜍、干姜和猪胆汁总质量8倍量的水,提取三次,提取温度100℃,每次2小时,合并煎液,滤过,滤液浓缩至稠膏,浓缩稠膏的质量与蟾蜍、干姜和猪胆汁三味药等质量;然后加入占稠膏质量3倍量的浓度为70%乙醇,搅拌10分钟,密闭,静置24小时,吸取上清液,浓缩。通过水提醇沉有效提取和保留了中药挥发性有效成分,有效成分含量高,且生物利用率高。
将蟾龙定喘合剂改为软胶囊制剂后,由于原料药经提取,其有效成分直接、完全气密封入胶囊,内容物可长期保持稳定。服用后内容物迅速释放体内利用率、吸收率高,内容物均一性佳,囊皮可掩盖内容物的异味等优点。可解决蟾龙定喘合剂的口味问题,且解决了中药软胶囊长期存放交联溶出差的质量问题。
本发明的有益效果:
(1)将中药成分提取后,浓缩成浸膏并制成粉,经胶体磨超微粉碎后,原料药提取制粉获得的药粉在大豆油中分散性好,避免软胶囊渗油,内容物可长期保持稳定,且内容物均一性佳。
(2)原料药提取制粉后,利用脂肪酸甘油酯溶解药物,可提高有效成分的生物利用度,均可提高药物的疗效,同时也增加药物稳定性。在囊壳成分中引入甘油和山梨醇,并控制生产过程中干燥时间和相对湿度,使软胶囊具有较好的崩解效果,进入胃肠易崩解以达到被人体吸收的目的。
(3)将蟾龙定喘合剂的合剂剂型改成软胶囊剂型,可将药物密封于软胶囊中,口感好,能很好地掩盖不良气味,且便于携带,改成软胶囊剂后对该药的临床推广就有重要意义。
具体实施方式
实施例1
(1)称取原料药组分A:地龙250kg、红参10kg、黄芪100kg、麻黄250kg、五味子100kg、补骨脂75kg、淫羊藿150kg、桂枝75kg、当归75kg、白芍100kg、陈皮50kg、清半夏75kg、杏仁100kg、炙甘草75kg、桔梗50kg和紫苏叶150kg;
取地龙、红参洗净,并将地龙碎断、红参切片,与黄芪、麻黄、五味子、补骨脂、淫羊藿、桂枝、当归、白芍、陈皮、清半夏、杏仁、炙甘草、桔梗和紫苏叶原料药加占原料药组分A总质量8倍量的水,提取三次,提取温度100℃,每次2小时,合并煎液,滤过,滤液浓缩,得到中药浸膏A;
(2)取蟾蜍5kg,碎断后,与干姜50kg和猪胆汁50kg混合后,加入占蟾蜍、干姜和猪胆汁总质量8倍量的水,提取三次,提取温度100℃,每次2小时,合并煎液,滤过,滤液浓缩至稠膏至105kg;然后加入占稠膏质量3倍量的浓度为70%乙醇,搅拌10分钟,密闭,静置24小时,吸取上清液,浓缩,得到中药浸膏B;
(3)化胶
将处方量水、甘油依次投入化胶罐中,加热温度至70℃时,开始投入山梨醇、二氧化钛、氧化铁黄和明胶,所述明胶与水的质量比为1:1,明胶与甘油的质量比为18:9,明胶与山梨醇的质量比为18:5,控制化胶罐温度在70℃±2℃之间,搅拌使明胶全部溶解,开启真空泵,在-0.08MPa条件下进行脱气1小时,至胶液气泡全部脱尽;放料,过120目滤袋,将过滤后的胶液置不锈钢保温桶中静置,保温温度50℃-60℃之间,即得胶液,待用;
(4)配料
将步骤(1)和(2)得到的中药浸膏A和中药浸膏B混合并干燥,得到混合药粉;按照脂肪酸甘油酯与大豆油、混合药粉质量比为1:2:2称重,将大豆油装入配料罐中,加热至80℃,加入脂肪酸甘油酯,保持温度70℃-80℃之间,搅拌均匀,待油温降至40℃时,投入混合药粉,搅拌50min使混合均匀,然后过胶体磨磨3次,减压在真空-0.08MPa条件下进行脱气,即得胶囊填充液;
(5)压丸
将胶囊填充液、胶液在软胶囊机中进行压制胶丸,将喷体温度设定在48-50℃,调整两侧胶皮厚度至0.58mm-0.62mm之间,待喷体温度达到设定温度,调整两滚模间压力,压丸,内容物每粒装0.35g;在操作开始后,持续监测装量,稳定后每隔1小时测定一次囊重,每次10粒,逐粒称重,控制内容物重量为0.35g±0.01g,环境温度12℃-25℃,相对湿度45%-50%;
(6)定型
20-24℃之间,冷风干燥4小时,相对湿度38%-40%,将软胶囊定型;
(7)洗丸
将软胶囊用质量浓度为95%食用酒精洗去表面油脂;
(8)干燥
将所得的软胶囊平铺于白钢盘内,置于干燥间内,在24-25℃,相对湿度29%-31%的条件下通风干燥,每隔2小时轻翻胶囊1次,干燥时间36小时,使软胶囊的水分含量为11%,得到蟾龙定喘软胶囊。
实施例2
(1)称取原料药组分A:地龙250kg、红参10kg、黄芪100kg、麻黄250kg、五味子100kg、补骨脂75kg、淫羊藿150kg、桂枝75kg、当归75kg、白芍100kg、陈皮50kg、清半夏75kg、杏仁100kg、炙甘草75kg、桔梗50kg和紫苏叶150kg;
取地龙、红参洗净,并将地龙碎断、红参切片,与黄芪、麻黄、五味子、补骨脂、淫羊藿、桂枝、当归、白芍、陈皮、清半夏、杏仁、炙甘草、桔梗和紫苏叶原料药加占原料药组分A总质量8倍量的水,提取三次,提取温度100℃,每次2小时,合并煎液,滤过,滤液浓缩,得到中药浸膏A;
(2)取蟾蜍5kg,碎断后,与干姜50kg和猪胆汁50kg混合后,加入占蟾蜍、干姜和猪胆汁总质量8倍量的水,提取三次,提取温度100℃,每次2小时,合并煎液,滤过,滤液浓缩至稠膏至105kg;然后加入占稠膏质量3倍量的浓度为70%乙醇,搅拌10分钟,密闭,静置24小时,吸取上清液,浓缩,得到中药浸膏B;
(3)、化胶
将处方量水、甘油依次投入化胶罐中,加热温度至70℃时,开始投入山梨醇、二氧化钛、氧化铁黄和明胶,所述明胶与水的质量比为1:1,明胶与甘油的质量比为18:9,明胶与山梨醇的质量比为18:5,控制化胶罐温度在70℃±2℃之间,搅拌使明胶全部溶解,开启真空泵,在-0.08MPa条件下进行脱气1小时,至胶液气泡全部脱尽;放料,过120目滤袋,将过滤后的胶液置不锈钢保温桶中静置,保温温度50℃-60℃之间,即得胶液,待用;
(4)配料
将步骤(1)和(2)得到的中药浸膏A和中药浸膏B混合并干燥,得到混合药粉;按照脂肪酸甘油酯与大豆油、混合药粉质量比1:5:5称重,将大豆油装入配料罐中,加热至80℃,加入脂肪酸甘油酯,保持温度70℃-80℃之间,搅拌均匀,待油温降至50℃之间时,投入混合药粉,搅拌50min使混合均匀,然后过胶体磨磨3次,减压在真空-0.08MPa条件下进行脱气,即得胶囊填充液;
(5)压丸
将胶囊填充液、胶液在软胶囊机中进行压制胶丸,将喷体温度设定在50-52℃,调整两侧胶皮厚度至0.58mm-0.62mm之间,待喷体温度达到设定温度,调整两滚模间压力,压丸,内容物每粒装0.35g;在操作开始后,持续监测装量,稳定后每隔1小时测定一次囊重,每次10粒,逐粒称重,控制内容物重量为0.35g±0.01g,环境温度20℃-22℃,相对湿度55%-60%;
(6)定型
20-24℃之间,冷风干燥4小时,相对湿度30%-33%,将软胶囊定型;
(7)洗丸
将软胶囊用质量浓度为95%食用酒精洗去表面油脂;
(8)干燥
将所得的软胶囊平铺于白钢盘内,置于干燥间内,在24-25℃,相对湿度29%-31%的条件下通风干燥,每隔2小时轻翻胶囊1次,干燥时间36小时,使软胶囊的水分含量为10%,得到蟾龙定喘软胶囊。
实施例3
(1)称取原料药组分A:地龙250kg、红参10kg、黄芪100kg、麻黄250kg、五味子100kg、补骨脂75kg、淫羊藿150kg、桂枝75kg、当归75kg、白芍100kg、陈皮50kg、清半夏75kg、杏仁100kg、炙甘草75kg、桔梗50kg和紫苏叶150kg;
取地龙、红参洗净,并将地龙碎断、红参切片,与黄芪、麻黄、五味子、补骨脂、淫羊藿、桂枝、当归、白芍、陈皮、清半夏、杏仁、炙甘草、桔梗和紫苏叶原料药加占原料药组分A总质量8倍量的水,提取三次,提取温度100℃,每次2小时,合并煎液,滤过,滤液浓缩,得到中药浸膏A;
(2)取蟾蜍5kg,碎断后,与干姜50kg和猪胆汁50kg混合后,加入占蟾蜍、干姜和猪胆汁总质量8倍量的水,提取三次,提取温度100℃,每次2小时,合并煎液,滤过,滤液浓缩至稠膏至105kg;然后加入占稠膏质量3倍量的浓度为70%乙醇,搅拌10分钟,密闭,静置24小时,吸取上清液,浓缩,得到中药浸膏B;
(3)、化胶
将处方量水、甘油依次投入化胶罐中,加热温度至70℃时,开始投入山梨醇、二氧化钛、氧化铁黄和明胶,所述明胶与水的质量比为1:1,明胶与甘油的质量比为18:9,明胶与山梨醇的质量比为18:5,控制化胶罐温度在70℃±2℃之间,搅拌使明胶全部溶解,开启真空泵,在-0.08MPa条件下进行脱气1小时,至胶液气泡全部脱尽;放料,过120目滤袋,将过滤后的胶液置不锈钢保温桶中静置,保温温度50℃-60℃之间,即得胶液,待用;
(4)配料
将步骤(1)和(2)得到的中药浸膏A和中药浸膏B混合并干燥,得到混合药粉;按照脂肪酸甘油酯与大豆油、混合药粉质量比1:10:8称重,将大豆油装入配料罐中,加热至80℃,加入脂肪酸甘油酯,保持温度70℃-80℃之间,搅拌均匀,待油温降至55℃时,投入混合药粉,搅拌50min使混合均匀,然后过胶体磨磨3次,减压在真空-0.08MPa条件下进行脱气,即得胶囊填充液;
(5)压丸
将胶囊填充液、胶液在软胶囊机中进行压制胶丸,将喷体温度设定在52-54℃,调整两侧胶皮厚度至0.58mm-0.62mm之间,待喷体温度达到设定温度,调整两滚模间压力,压丸,内容物每粒装0.35g;在操作开始后,持续监测装量,稳定后每隔1小时测定一次囊重,每次10粒,逐粒称重,控制内容物重量为0.35g±0.01g,环境温度18℃-20℃,相对湿度60%-65%;
(6)定型
20-24℃之间,冷风干燥4小时,相对湿度35%-38%,将软胶囊定型;
(7)洗丸
将软胶囊用质量浓度为95%食用酒精洗去表面油脂;
(8)干燥
将所得的软胶囊平铺于白钢盘内,置于干燥间内,在24-25℃,相对湿度29%-31%的条件下通风干燥,每隔2小时轻翻胶囊1次,干燥时间36小时,使软胶囊的水分含量为10%,得到蟾龙定喘软胶囊。
参照药典方法检测实施例1-实施例3的药物崩解时间,结果如表1所示。
表1是本发明实施例1-3药物崩解的检测数据
以上仅为本发明的具体实施例而已,并不用于限制本发明,对于本领域的技术人员来说,本发明可以有各种更改和变化。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (5)
1.一种蟾龙定喘软胶囊的制备方法,其特征是:
具体步骤如下:
(1)称取原料药组分A:地龙、红参、黄芪、麻黄、五味子、补骨脂、淫羊藿、桂枝、当归、白芍、陈皮、清半夏、杏仁、炙甘草、桔梗和紫苏叶;
取地龙、红参洗净,并将地龙碎断、红参切片,与黄芪、麻黄、五味子、补骨脂、淫羊藿、桂枝、当归、白芍、陈皮、清半夏、杏仁、炙甘草、桔梗和紫苏叶经水提,滤过,滤液浓缩,得到中药浸膏A;
(2)取蟾蜍,碎断后,与干姜、猪胆汁,经水提醇沉,浓缩成膏,得到中药浸膏B;
(3)化胶
将水、甘油依次投入化胶罐中,加热温度至70℃时,开始投入山梨醇、二氧化钛、氧化铁黄和明胶,所述明胶与水的质量比为1:1,明胶与甘油的质量比为18:9,明胶与山梨醇的质量比为18:5,控制化胶罐温度在70℃±2℃之间,搅拌使明胶全部溶解,开启真空泵,在-0.08MPa条件下进行脱气1小时,至胶液气泡全部脱尽;放料,过120目滤袋,将过滤后的胶液置不锈钢保温桶中静置,保温温度50℃-60℃之间,即得胶液,待用;
(4)配料
将步骤(2)得到的中药浸膏A和中药浸膏B混合并干燥,得到混合药粉;按照脂肪酸甘油酯与大豆油、混合药粉质量比分别为1:(2-10)、1:(2-8)称重,将大豆油装入配料罐中,加热至80℃,加入脂肪酸甘油酯,保持温度70℃-80℃之间,搅拌均匀,待油温降至40℃-55℃之间时,投入混合药粉,搅拌50min使混合均匀,然后过胶体磨磨3次,减压至真空,
在-0.08MPa条件下进行脱气,即得胶囊填充液;
(5)压丸
将胶囊填充液、胶液在软胶囊机中进行压制胶丸,将喷体温度设定在48-54℃,调整两侧胶皮厚度至0.58mm-0.62mm之间,待喷体温度达到设定温度,调整两滚模间压力,压丸,控制内容物重量为0.34-0.36之间,环境温度18℃-25℃,相对湿度45%-65%;
(6)定型
20-24℃之间,冷风干燥4小时,相对湿度30%-40%,将软胶囊定型;
(7)洗丸
将软胶囊用质量浓度为95%食用酒精洗去表面油脂;
(8)干燥
将所得的软胶囊平铺于白钢盘内,置于干燥间内,在24-25℃,相对湿度29%-31%的条件下通风干燥,每隔2小时轻翻胶囊1次,干燥时间36小时,使软胶囊的水分含量为10%-12%,得到蟾龙定喘软胶囊。
2.根据权利要求1所述的蟾龙定喘软胶囊的制备方法,其特征是:
所述蟾龙定喘软胶囊的原料药按照重量份数组成如下:蟾蜍5份、地龙250份、红参10份、黄芪100份、麻黄250份、五味子100份、补骨脂75份、淫羊藿150份、桂枝75份、当归75份、白芍100份、陈皮50份、清半夏75份、杏仁100份、干姜50份、猪胆汁50份、炙甘草75份、桔梗50份和紫苏叶150份。
3.根据权利要求1所述的蟾龙定喘软胶囊的制备方法,其特征是:所述大豆油、混合药粉质量比为1:1。
4.根据权利要求1所述的蟾龙定喘软胶囊的制备方法,其特征是:制备中药浸膏A时,取地龙、红参洗净,并将地龙碎断、红参切片,与黄芪、麻黄、五味子、补骨脂、淫羊藿、桂枝、当归、白芍、陈皮、清半夏、杏仁、炙甘草、桔梗和紫苏叶原料药加占原料药组分A总质量8倍量的水,提取三次,提取温度100℃,每次2小时,合并煎液,滤过,滤液浓缩。
5.根据权利要求1所述的蟾龙定喘软胶囊的制备方法,其特征是:制备中药浸膏B时,取蟾蜍,碎断后,与猪胆汁和干姜混合后,加入占蟾蜍、干姜和猪胆汁总质量8倍量的水,提取三次,提取温度100℃,每次2小时,合并煎液,滤过,滤液浓缩至稠膏,浓缩稠膏的质量与蟾蜍、干姜和猪胆汁三味药等质量;然后加入占稠膏质量3倍量的浓度为70%乙醇,搅拌10分钟,密闭,静置24小时,吸取上清液,浓缩。
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