CN108743728A - Egcg茶氨酸三七片及其制备工艺 - Google Patents
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Abstract
本发明涉及医药制剂领域,具体为EGCG茶氨酸三七片及其制备工艺,包括表没食子茶素没食子酸酯(ECGC)、L‑茶氨酸、平卧菊三七粉、枸杞子提取物、白果粉、糊精、二氧化硅、粘合剂;经过搅拌、糊化、粘合、成型、压片制成片剂;本发明提供的EGCG茶氨酸三七片可预防并缓解三高、心血管疾病、肿瘤等相关病患,提供抗疲劳、抗自由基、提高记忆力、安神补脑等保健功效;药材配比合理,符合中药学中“君臣佐使”理论;在制作过程中,采用创新的三级糊化工艺,有效提高糊化效率,保证产品质量;在糊化过程中,采用超声波辅助工艺,激化分子运动,提高各种成分混合均匀性,进而提高产品使用功效。
Description
技术领域
本发明涉及医药制剂领域,具体为EGCG茶氨酸三七片及其制备工艺。
背景技术
平卧菊三七是菊科、三七属植物、蛇接骨、Gynura procumbcns(Lour)morr,为多年生草本药食两用植物,民间用此植物治疗跌打损伤、风湿性关节炎、支气管炎、肺炎、肾炎等疾病;《中华本草》记载平卧菊三七有通经活络、散淤消肿、支气管炎、肺炎、肺结核、肿毒痛疮有很好的疗效。近年来,国外发现该植物对急性感冒、皮疹、肾病、高血压、糖尿病有较好的疗效。
中国专利库中公开了一种对口腔、咽喉具有保健和治疗作用的平卧菊三七片剂(CN200710051831.1),含有1~20%平卧菊三七提取物、75~90%辅料、1~10%填充剂、0.1~2%食用香精,还可加入0.1~0.4%的薄荷油、0.1~0.8%的薄荷脑。该片剂具有较好的抗菌、消炎、止痛、止血的作用,同时具有一定的抗病毒的作用,对口腔、咽喉均有保健和治疗作用,且口感好、无异味、无副作用。
中国专利库中公开了一种复方三七片的制备方法(CN03118655.6),其特征是处方中部分药材打细粉备用,部分药材打粗粉水蒸煮并收集挥发油备用。细粉、蒸煮液浓缩的干膏粉、挥发油包合物按处方要求投料、混均、压片,包衣而完成整套制作。该药是在现有散剂、胶囊剂基础上的工艺改革,提高了质量控制标准。该药具有化瘀止血,消肿止痛的功能;用于跌打损伤,瘀血肿痛,外伤出血,挫伤、扭伤、骨外伤等。携带、使用方便,是临床受欢迎的安全、稳定、有效的药品,是现代制药企业理想的产品。
虽然现在已有一些三七属植物的应用,但明显不够,如何利用中药理论和现代制药技术充分利用三七属植物的功效,需要继续研究。
发明内容
本发明的目的是提供EGCG茶氨酸三七片及其制备工艺,采用现代制药工艺制备EGCG茶氨酸三七片,预防并缓解三高、心血管疾病、肿瘤等相关病患,提供抗疲劳、抗自由基、提高记忆力、安神补脑等保健功效。
为了实现上述目的,本发明采用以下技术方案
EGCG茶氨酸三七片,包括,表没食子茶素没食子酸酯(ECGC)、L-茶氨酸、平卧菊三七粉、枸杞子提取物、白果粉、糊精、二氧化硅、粘合剂。
优选地,EGCG茶氨酸三七片,按重量比计,包括,表没食子茶素没食子酸酯(ECGC)40.00-65.00%、L-茶氨酸6.00-20.00%、平卧菊三七粉6.00-20.00%、枸杞子提取物2.00-15.00%、白果粉4.00-15.00%、糊精0.20-1.10%、二氧化硅0.20-1.10%、粘合剂0.20-1.10%。
优选地,EGCG茶氨酸三七片,按重量比计,包括,表没食子茶素没食子酸酯(ECGC)50.00-55.00%、L-茶氨酸11.00-15.00%、平卧菊三七粉12.00-15.00%、枸杞子提取物5.00-10.00%、白果粉8.00-12.00%、糊精0.50-0.80%、二氧化硅0.50-0.80%、粘合剂0.50-0.80%。
优选地,所述粘合剂为淀粉、食用甘油、食用明胶、卡拉胶、黄原胶中的一种或几种组合。
EGCG茶氨酸三七片的制备工艺,包括以下步骤:
A)搅拌,(1)向磁力搅拌机中加入表没食子茶素没食子酸酯(ECGC),启动搅拌机,常温下以1000-3000rpm低速运行;
(2)将L-茶氨酸、平卧菊三七粉、枸杞子提取物、白果粉依次加入,搅拌5-10m;
B)糊化,(1)向搅拌均匀的混合物中加入糊精,继续搅拌,搅拌速度3000-5000rpm,时间1-3m;
(2)维持转动速度,在2min内快速升温至60℃,同时启动超声波辅助;
(3)在5min内匀速升温至75℃,在75℃时保持10-15min;
(4)在5min内匀速升温至85℃,在85℃时保持3-5min;
C)粘合,在完全糊化的混合物中加入称量好的粘合剂,继续搅拌,搅拌速度3000-5000rpm,保持温度75-85℃;
D)成型,(1)维持搅拌速度,加入二氧化硅,继续搅拌3-5min,保持温度70-85℃;
(2)停止搅拌,在无菌环境中匀速冷却至常温;
E)压片,采用自动压片机进行生产,在无菌环境中进行包装。
优选地,在A)中,表没食子茶素没食子酸酯(ECGC)、L-茶氨酸、平卧菊三七粉、枸杞子提取物、白果粉、糊精、二氧化硅、粘合剂使用前都要过500目筛。
优选地,在B)中,超声波设备的功率为,步骤(2)中为120W,步骤(3)中为200W,步骤(4)中为240W。
优选地,在D)中,降温幅度三分钟内不超过10℃。
优选地,在E)中,压片后对片剂采用减压干燥。
本发明的有益效果:本发明提供的EGCG茶氨酸三七片可预防并缓解三高、心血管疾病、肿瘤等相关病患,提供抗疲劳、抗自由基、提高记忆力、安神补脑等保健功效;药材配比合理,符合中药学中“君臣佐使”理论;在制作过程中,采用创新的三级糊化工艺,有效提高糊化效率,保证产品质量;在糊化过程中,采用超声波辅助工艺,激化分子运动,提高各种成分混合均匀性,进而提高产品使用功效。
具体实施方式
下面对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其它实施例,都属于本发明保护的范围。
EGCG茶氨酸三七片,包括,表没食子茶素没食子酸酯(ECGC)、L-茶氨酸、平卧菊三七粉、枸杞子提取物、白果粉、糊精、二氧化硅、粘合剂。
配方搭配合理,符合中医中君臣佐使的理论,结合本发明,表没食子茶素没食子酸酯(ECGC)为君,L-茶氨酸为臣,平卧菊三七粉为佐,枸杞子提取物、白果粉为使;糊精增强药片的弹性和韧性,并改善服用时的口感;二氧化硅防止药品成分结块;粘合剂起到粘合其他成分的作用。
实施例1
EGCG茶氨酸三七片,按重量比计,包括,表没食子茶素没食子酸酯(ECGC)50.00%、L-茶氨酸15.00%、平卧菊三七粉12.00%、枸杞子提取物10.00%、白果粉8.00%、糊精0.50%、二氧化硅0.80%、粘合剂0.50%。
其中,粘合剂选用食用明胶。
本实施例的EGCG茶氨酸三七片的制备工艺,包括以下步骤:
A)搅拌,(1)向磁力搅拌机中加入表没食子茶素没食子酸酯(ECGC),启动搅拌机,常温下以1000rpm低速运行;
(2)将L-茶氨酸、平卧菊三七粉、枸杞子提取物、白果粉依次加入,搅拌5m;
B)糊化,(1)向搅拌均匀的混合物中加入糊精,继续搅拌,搅拌速度3000rpm,时间1m;
(2)维持转动速度,在2min内快速升温至60℃,同时启动超声波辅助,超声波功率120W;糊精的糊化温度较高,需要快速升温至糊化临界温度;
(3)在5min内匀速升温至75℃,在75℃时保持10min,超声波功率200W;在75℃时完成糊化的大部分过程,而且维持温度一段时间,使其糊化的更彻底;
(4)在5min内匀速升温至85℃,在85℃时保持3min,超声波240W;在85℃时可保证糊精百分百糊化,由于只有少部分糊精的糊化温度超度75℃,所以,在85℃的温度点保持时间少于75℃;采用超声波辅助,可激化分子运动速度,使糊化过程中,其他成分混合更均匀,也间接提高了服药后的有效性;
C)粘合,在完全糊化的混合物中加入称量好的食用明胶,继续搅拌,搅拌速度3000rpm,保持温度75℃;
D)成型,(1)维持搅拌速度,加入二氧化硅,继续搅拌3min,保持温度70℃;
(2)停止搅拌,在无菌环境中匀速降温,30m内降温至常温;
E)压片,采用自动压片机进行生产,在无菌环境中进行包装。
实施例2
EGCG茶氨酸三七片,按重量比计,包括,表没食子茶素没食子酸酯(ECGC)53.33%、L-茶氨酸13.33%、平卧菊三七粉13.33%、枸杞子提取物8.00%、白果粉10.00%、糊精0.67%、二氧化硅0.67%、粘合剂0.67%。
其中,粘合剂选用食用甘油。
本实施例的EGCG茶氨酸三七片的制备工艺,包括以下步骤:
A)搅拌,(1)向磁力搅拌机中加入表没食子茶素没食子酸酯(ECGC),启动搅拌机,常温下以2000rpm低速运行;
(2)将L-茶氨酸、平卧菊三七粉、枸杞子提取物、白果粉依次加入,搅拌8m;
B)糊化,(1)向搅拌均匀的混合物中加入糊精,继续搅拌,搅拌速度4000rpm,时间2m;
(2)维持转动速度,在2min内快速升温至60℃,同时启动超声波辅助,超声波功率120W;
(3)在5min内匀速升温至75℃,在75℃时保持10-15min,超声波功率120W;
(4)在5min内匀速升温至85℃,在85℃时保持3-5min,超声波功率120W;
C)粘合,在完全糊化的混合物中加入称量好的食用甘油,继续搅拌,搅拌速度4000rpm,保持温度80℃;
D)成型,(1)维持搅拌速度,加入二氧化硅,继续搅拌4min,保持温度80℃;
(2)停止搅拌,在无菌环境中匀速降温,45m内降温至常温;
E)压片,采用自动压片机进行生产,在无菌环境中进行包装。
实施例3
EGCG茶氨酸三七片,按重量比计,包括,表没食子茶素没食子酸酯(ECGC)55.00%、L-茶氨酸11.00%、平卧菊三七粉15.00%、枸杞子提取物5.00%、白果粉12.00%、糊精0.80%、二氧化硅0.50%、粘合剂0.50%。
其中,粘合剂选用黄原胶。
本实施例的EGCG茶氨酸三七片的制备工艺,包括以下步骤:
A)搅拌,(1)向磁力搅拌机中加入表没食子茶素没食子酸酯(ECGC),启动搅拌机,常温下以3000rpm低速运行;
(2)将L-茶氨酸、平卧菊三七粉、枸杞子提取物、白果粉依次加入,搅拌10m;
B)糊化,(1)向搅拌均匀的混合物中加入糊精,继续搅拌,搅拌速度5000rpm,时间3m;
(2)维持转动速度,在2min内快速升温至60℃,同时启动超声波辅助,超声波功率120W;
(3)在5min内匀速升温至75℃,在75℃时保持10-15min,超声波功率120W;
(4)在5min内匀速升温至85℃,在85℃时保持3-5min,超声波功率120W;
C)粘合,在完全糊化的混合物中加入称量好的黄原胶,继续搅拌,搅拌速度5000rpm,保持温度85℃;
D)成型,(1)维持搅拌速度,加入二氧化硅,继续搅拌5min,保持温度85℃;
(2)停止搅拌,在无菌环境中匀速降温,60m内降温至常温;
E)压片,采用自动压片机进行生产,在无菌环境中进行包装。
实施例4
一种盒式包装,每盒内部包括两瓶,每瓶包括750mg*60粒,每粒含量:表没食子茶素没食子酸酯(ECGC)400mg、L-茶氨酸100mg、平卧菊三七粉100%mg、枸杞子提取物60mg、白果粉75mg、糊精5mg、二氧化硅5mg、粘合剂5mg。
食用方法:每日一次,每次2片。
对比例1
对比对象:EGCG茶氨酸压片糖果;
对比例配方:食用玉米淀粉、L-茶氨酸、麦芽糊精、表没食子儿茶素没食子酸酯、食品添加剂:木糖醇。
将120位三高患者(病情及患病时间差别不大,而且每位患者都至少有三高中的两种症状)分成AB两组,每组中60人,分别服用对比例的EGCG茶氨酸压片糖果和实施例2,一日一次,每次两粒;在服药过程中每天早上分别检测两组患者的三高数据。
服用半个月后,A组中有33人不适的症状消失,22人症状减轻,5人改善不明显,从三高数据上来看,58人数据改善,或是血压降低、血糖温度,或是血脂降低,27人恢复健康;B组中45人不适症状消失,15人症状减轻,从三高数据上来看,60人数据都得到改善,或是血压降低、血糖温度,或是血脂降低,其中39人数据恢复正常值。
服用一个月后,A组中,56人恢复健康,三高数据恢复正常值且数据连续几天稳定;4人症状消失,但三高数据还没有恢复正常值;B组中,60人都恢复健康,三高数据恢复正常值。
第二个月,继续服药,用量改为一天一次,一次一粒,改为每周检测一次三高数据。
接下来一个月,在正常饮食的情况下,两组中的实验者三高数据都在正常值范围内。
第三个月,停止服药,每周检测一次三高数据。
接下来一个月,在正常饮食的情况下,A组中6人出现血压升高或血糖升高的情况;B组中也有1人出现了血压升高。
本发明与对比例对比来看,本发明在改善三高时效果更好,疗程更短且药效期更长。
对比例2
对比对象:平卧菊三七无糖含片;
对比例配方:平卧菊三七提取物、甜味剂、香精、润滑剂和粘合剂。
1、选用咽喉肿疼、口腔溃疡症状的20人,分为AB两组,每组10人,分别服用平卧菊三七无糖含片和实施例2,平卧菊三七无糖含片可以不间断使用,实施例2一天一次,一次两粒;
服用1天后,A组中6人症状减轻,B组中没有改善;
服用3天后,A组中9人症状减轻,其中四人症状消失;B组中4人症状减轻;
继续服用实施例2,5天后,7人症状减轻,2人症状消失。
在抗菌抗病毒消炎等方面,实施例2虽然也有疗效,但不如直接用平卧菊三七含片效果好;其原因在于实施例2中含有其他成分,不能服用太多,在给药量方面不如平卧菊三七含片。
2、选用三高患者20人(病情及患病时间差别不大,而且每位患者都至少有三高中的两种症状),分为AB两组,每组10人,分别服用平卧菊三七无糖含片和实施例2,平卧菊三七无糖含片两小时含服一片,实施例2一天一次,一次两粒;
服用5天后,A组中2人症状减轻,B组中有7人症状改善,其中3人三高数据恢复正常;
服用10天后,A组中5人症状减轻,其中1人三高数据恢复正常;B组中全部人症状减轻,8人三高数据恢复正常;
A组继续服用平卧菊三七无糖含片,服用15天后,全部人症状减轻,其中4人三高数据恢复正常。
在降三高、降血脂方面,平卧菊三七无糖含片也具有改善三高的作用,但相比实施例2,效果不好,而且服药期较长;其原因在于实施例2内含有表没食子茶素没食子酸酯(ECGC)、L-茶氨酸等成分,这些成分都有改善三高的疗效,所以在治疗三高时,药效作用更直接且针对性给药量更多,几种药物相配合,君臣佐使,药效作用更充分,更彻底。
下面对本发明中具体成分详细解析
表没食子儿茶素没食子酸酯(EGCG)
表没食子儿茶素没食子酸酯(EGCG)是从绿茶中提取的一种成份,它是绿茶主要的活性和水溶性成份,它是绿茶儿茶素类中最有效的活性成份。绿茶儿茶素类包括EGCG、EGC、EC、GCG等,其中抗氧化性以EGCG最强。因为具有特殊的立体化学结构,EGCG具有非常强的抗氧化活性,在抗癌和心血管疾病方面担当了重要的角色。
1降血脂机理:
调节胆固醇代谢:通过抑制肠道内外源性胆固醇的吸收,提高卵磷脂胆固醇酰基转移酶活性和HDL-C(高密度脂蛋白)水平,加速胆固醇的代谢及促进胆固醇的排泄来调节TC代谢;
调节甘油三酯代谢:通过抑制胰脂肪酶的活性而降低对外源性TG的吸收,降低脂肪酸合成酶的活性,从而减少脂肪酸的合成,增强肝脂酶活性以加速TG的代谢及促进脂肪酸的排泄来调节TG代谢。
2抗血栓机理:
EGCG可明显抑制血小板聚集,抑制人富含血小板血浆产生TXB2(血栓素B2),且可下调血小板膜糖蛋白P-selectin水平,从而抑制血小板的活化、聚集;
EGCG能明显抑制凝血酶诱导的血小板内钙的升高,减少钙的内流,减少凝血酶诱导的PKC(蛋白激酶C)及酪氨酸激酶磷酸化,降低酪氨酸激酶(Syk及Lyn)水平,从而抑制凝血酶蛋白水解酶活性,而达到抑制血小板活化的作用。
3抗血液肿瘤、血管新生机理:
EGCG能通过抑制VEGF(血管内皮生长因子)mRNA的表达,减少VEGF的分泌,达到抑制血管新生的作用;
EGCG能抑制HUVEC(血管内皮细胞)的迁移,从而抑制血管新生。
4阻止动脉粥样硬化发展,预防冠心病
通过调节血脂水平和脂蛋白受体功能,延缓动脉粥样硬化的形成和发展;
通过对抗氧化应激,阻止动脉斑块的形成。可以抑制皮内细胞诱导的LDL(低密度脂蛋白),降低自由基对细胞的损伤,阻止动脉斑块的形成,发挥心脏保护作用。
5对心肌梗塞的治疗作用
抑制心肌梗塞大鼠血清中心脏标志性酶活力,恢复脂质结构和电解质水平;
EGCG可显著降低心肌梗塞模型大鼠升高的血清胆固醇、甘油三酯、磷脂、心脏游离脂肪酸、LDL(低密度脂蛋白)和VLDL(极低密度脂蛋白)水平,降低胆固醇/磷脂比例和动脉粥样硬化指数,可明显升高LCAT(卵磷脂胆固醇酰基转移酶)活力,从而阻止脂质积累。
6对心肌缺血再灌注的保护作用
通过结合心肌肌钙蛋白C的C末端,抑制Ca2+和cTnC(心肌肌钙蛋白C)结合,对抗心脏收缩反应时其他质子对Ca2+敏感性的抑制作用;
通过清除自由基、抑制心肌细胞PKC(蛋白激酶C)和G蛋白保护心肌细胞。
7对心肌肥大的保护作用
可以有效的减轻心肌重构,阻止心肌细胞凋亡和氧化应激反应,抑制心肌成纤维细胞的异常增殖而改善心肌重构;
通过抑制氧化应激,抑制心肌肥厚中H2O2诱导端粒缩短而引起的心肌细胞凋亡、端粒重复序列结合因子2丢失,减少血清和心肌中MDA(丙二醛)浓度,升高SOD(超氧化物歧化酶)和谷胱甘肽过氧化物酶活力,清除活性氧自由基而调控Ca2+,保护心室肌细胞钠离子通道。
8对心脏离子通道和心肌收缩力的调节作用。
L-茶氨酸
茶氨酸-是1950年日本学者在玉露绿茶中被发现的一种非蛋白质氨基酸。早在1985年,美国食品和药物管理局(FDA)就认可了茶氨酸,并确认合成的茶氨酸是一般公认为安全的物质(GBAS),在使用过程中不作限制用量的规定。
1调节血压机理
通过调节脑中神经递质的浓度来发挥降压作用,茶氨酸降低血清素(5-羟色胺,对中枢神经有抑制作用)的合成,抑制血清素释放,促进其分解;
通过调节中枢及末梢递质儿茶酚胺和5-羟色胺(血清素)的分泌量来调节血压。儿茶酚胺和5-羟色胺均属于血管收缩剂。L-茶氨酸可降低两者分泌量,减少血管收缩,进而达到降血压的目的。
2抑制肿瘤血管生成
通过抑制内皮细胞增殖、促进其凋亡、抑制内皮细胞小管形成能力等多步骤抑制肿瘤血管生成。
3其他保健作用
安神放松作用;促进大脑功能作用;抗肿瘤作用;抗疲劳作用;提高学习记忆能力。
平卧菊三七粉(救心菜)
平卧菊三七-为菊科三七属植物,2012年5月被国家卫生部批准为新资源普通食品。主要活性成分有绿原酸、黄酮类、生物碱、萜烯类、香豆素类、挥发油等。
黄酮类化合物能降低血中和肝脏中TG和TC浓度;
绿原酸能降低高胆固醇诱导高血脂大鼠血中TG的浓度;
乙醇提取物能降低小鼠血糖浓度。
白果粉-降低血清胆固醇,扩张冠状动脉:银杏叶中含有莽草酸、白果双黄酮、异白果双黄酮、甾醇等,近年来用于治疗高血压及冠心病、心绞痛、脑血管痉挛、血清胆固醇过高等病症都有一定效果。1972年西德学者获得应用银杏叶提取物治疗心脑血管疾病的专利。1984年法国学者发现银杏内脂对血小板活化因子的强效拮抗剂。
枸杞子提取物-对免疫力有促进作用,同时具有免疫调节作用。降血脂、保肝及抗脂肪肝、降血糖、降血压作用。
在本说明书的描述中,参考术语“一个实施例”、“示例”、“具体示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中,对上述术语的示意性表述不一定指的是相同的实施例或示例。而且,描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施例或示例中以合适的方式结合。
最后需要说明的是,以上公开的本发明优选实施例只是用于帮助阐述本发明。优选实施例并没有详尽叙述所有的细节,也不限制该发明仅为所述的具体实施方式。显然,根据本说明书的内容,可作很多的修改和变化。本说明书选取并具体描述这些实施例,是为了更好地解释本发明的原理和实际应用,从而使所属技术领域技术人员能很好地理解和利用本发明。本发明仅受权利要求书及其全部范围和等效物的限制。
Claims (9)
1.EGCG茶氨酸三七片,其特征在于:包括:表没食子茶素没食子酸酯(ECGC)、L-茶氨酸、平卧菊三七粉、枸杞子提取物、白果粉、糊精、二氧化硅、粘合剂。
2.根据权利要求1所述的EGCG茶氨酸三七片,其特征在于:按重量比计,包括,表没食子茶素没食子酸酯(ECGC)40.00-65.00%、L-茶氨酸6.00-20.00%、平卧菊三七粉6.00-20.00%、枸杞子提取物2.00-15.00%、白果粉4.00-15.00%、糊精0.20-1.10%、二氧化硅0.20-1.10%、粘合剂0.20-1.10%。
3.根据权利要求1所述的EGCG茶氨酸三七片,其特征在于:按重量比计,包括,表没食子茶素没食子酸酯(ECGC)50.00-55.00%、L-茶氨酸11.00-15.00%、平卧菊三七粉12.00-15.00%、枸杞子提取物5.00-10.00%、白果粉8.00-12.00%、糊精0.50-0.80%、二氧化硅0.50-0.80%、粘合剂0.50-0.80%。
4.根据权利要求1所述的EGCG茶氨酸三七片,其特征在于:所述粘合剂为淀粉、食用甘油、食用明胶、卡拉胶、黄原胶中的一种或几种组合。
5.根据权利要求1-4任一所述的EGCG茶氨酸三七片的制备工艺,其特征在于:包括以下步骤:
A)搅拌,(1)向磁力搅拌机中加入表没食子茶素没食子酸酯(ECGC),启动搅拌机,常温下以1000-3000rpm低速运行;
(2)将L-茶氨酸、平卧菊三七粉、枸杞子提取物、白果粉依次加入,搅拌5-10m;
B)糊化,(1)向搅拌均匀的混合物中加入糊精,继续搅拌,搅拌速度3000-5000rpm,时间1-3m;
(2)维持转动速度,在2min内快速升温至60℃,同时启动超声波辅助;
(3)在5min内匀速升温至75℃,在75℃时保持10-15min;
(4)在5min内匀速升温至85℃,在85℃时保持3-5min;
C)粘合,在完全糊化的混合物中加入称量好的粘合剂,继续搅拌,搅拌速度3000-5000rpm,保持温度75-85℃;
D)成型,(1)维持搅拌速度,加入二氧化硅,继续搅拌3-5min,保持温度70-85℃;
(2)停止搅拌,在无菌环境中匀速冷却至常温;
E)压片,采用自动压片机进行生产,在无菌环境中进行包装。
6.根据权利要求5所述的EGCG茶氨酸三七片的制备工艺,其特征在于:在A)中,表没食子茶素没食子酸酯(ECGC)、L-茶氨酸、平卧菊三七粉、枸杞子提取物、白果粉、糊精、二氧化硅、粘合剂使用前都要过500目筛。
7.根据权利要求5所述的EGCG茶氨酸三七片的制备工艺,其特征在于:在B)中,超声波设备的功率为,步骤(2)中为120W,步骤(3)中为200W,步骤(4)中为240W。
8.根据权利要求5所述的EGCG茶氨酸三七片的制备工艺,其特征在于:在D)中,降温幅度三分钟内不超过10℃。
9.根据权利要求5所述的EGCG茶氨酸三七片的制备工艺,其特征在于:在E)中,压片后对片剂采用减压干燥。
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