CN111658698A - 一种清开灵片及其制备方法 - Google Patents
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Abstract
本申请公开了一种清开灵片,其原料按重量份包括:胆酸30‑50份、珍珠母20‑40份、猪去氧胆酸15‑25份、栀子5‑8份、水牛角6‑14份、板蓝根4‑8份、黄芩苷2‑6份、金银花4‑8份、糊精3‑9份、玉米淀粉4‑8份、硬脂酸镁3‑9份、改性缓释包膜剂5‑15份。本发明还提出一种清开灵片的制备方法。本发明制备的清开灵片稳定性好,药物缓释效果好,药物吸收效果好。
Description
技术领域
本发明属于药物制备技术领域,具体涉及一种清开灵片及其制备方法。
背景技术
清开灵颗粒源自古代防治温疫病名方—安宫牛黄丸,严格按照中医的辨证论治原则组方,并经历了几百年的临床应用检验。其主要成分有胆酸、去氧胆酸、水牛角、珍珠母、黄芩、金银花、桅子、板蓝根等组成,具有清热解毒、镇静安神的作用,适用于温热病引起的高热、烦躁不安等症。方中胆酸、黄芩、桅子、金银花、板蓝根具有抗菌和抑菌作用;黄芩、金银花、板蓝根有抗病毒作用,退热作用迅速、持久、稳定,可预防高热惊厥的发生;此外,黄芩、胆酸、珍珠母有抗炎抗过敏作用,抑制肥大细胞释放组织胺;珍珠母可提高细胞免疫功能,抑制组织胺的释放;板蓝根能增加血液白细胞数和淋巴细胞数,增强单核细胞和巨噬细胞的吞噬作用;水牛角能使淋巴结和脾小结增生活跃,从而使血淋巴细胞增加。总之,清开灵颗粒剂具有调整和提高机体免疫功能,增强吞噬细胞功能,增强白细胞杀菌能力的作用。目前在清热解毒、镇静安神等方面有明显优势。但现有技术制备的清开灵片药物缓释效果差,吸收效果也比较差,故此继续开发一种清开灵片及其制备方法来解决现有技术中的问题。
发明内容
本发明的目的是提供一种清开灵片及其制备方法,以解决现有技术中清开灵片药物缓释和药物吸收效果差的问题。
为了解决以上技术问题,本发明采用以下技术方案:
一种清开灵片,其原料按重量份包括:胆酸30-50份、珍珠母20-40份、猪去氧胆酸15-25份、栀子5-8份、水牛角6-14份、板蓝根4-8份、黄芩苷2-6份、金银花4-8份、糊精3-9份、玉米淀粉4-8份、硬脂酸镁3-9份、改性缓释包膜剂5-15份。
优选地,所述改性缓释包膜剂的原料按重量份包括:α-淀粉15-25份、稻壳粉40-50份、壳聚糖15-25份、谷氨酸钠2-5份、阿胶8-16份、木薯粉4-8份、海藻3-9份、糖萜素3-6份、螺旋藻4-8份、脱壳素3-6份、大豆卵磷脂4-8份、聚乳酸12-24份、乙醇凝胶15-20份。
优选地,所述改性缓释包膜剂按如下工艺进行制备:将α-淀粉、稻壳粉、壳聚糖、谷氨酸钠、阿胶、木薯粉、海藻、糖萜素、螺旋藻、脱壳素和大豆卵磷脂混合均匀,于350r/min~650r/min转速搅拌20-30min,接着于-30℃~-50℃冷冻干燥机中干燥20min~40min,接着加入聚乳酸混合均匀,于4500r/min~5500r/min转速搅拌10min~20min,然后加入乙醇凝胶混合均匀,接着于250r/min~350r/min转速搅拌3h~5h,然后于8500r/min~12000r/min转速离心收集,纯化水洗后冷冻干燥得到改性缓释包膜剂。
优选地,所述板蓝根和栀子按如下工艺进行提取:将板蓝根和栀子混合均匀,加入水进行煎煮得到煎煮溶液;然后过滤煎煮溶液,得到药渣a和药液a,将药渣a继续煎煮后过滤得到药渣b和药液b;将药液a和药液b混合后浓缩,然后醇沉,取上清液后浓缩,得到浸膏a。
优选地,所述金银花按如下工艺进行提取:将金银花加入热水,浸泡后过滤得到药渣c和药液c,将药渣c继续煎煮得到药渣d和药液d,然后将药液c和药液d混合均匀并进行浓缩,接着醇沉取上清液,浓缩后得到浸膏b。
优选地,所述水牛角和珍珠母按如下工艺进行提取:
S1、水牛角加入氢氧化钡混合均匀,加热水解后得到药渣e和药液e;
S2、将珍珠母和硫酸混合均匀,加热水解后得到药渣f和药液f,将药液f放冷过滤得到滤液a和结晶体;
S3、将药液e、滤液a和氢氧化钡混合均匀,调节pH后,放置过滤得到沉淀物a和药液g,将药液g浓缩,再进行调节pH后,放置过滤得到沉淀物b和滤液b,然后将滤液b浓缩后得到浸膏c。
本发明还提出一种清开灵片的制备方法,包括如下步骤:
步骤I、称量浸膏a、浸膏b和浸膏c,将浸膏a、浸膏b和浸膏c干燥后粉碎,然后将粉碎料混合后得到浸膏粉;
步骤II、将浸膏粉、猪去氧胆酸、胆酸、黄芩苷、糊精和玉米淀粉混合制粒,干燥后整粒,然后加入硬脂酸镁混合均匀,压片后进行包衣操作,将改性缓释包膜剂包裹在压片的外周,包衣结束后冷却入库。
优选地,所述步骤I中,干燥的温度为70℃-90℃,干燥的时间为20min-40min。
本发明具有以下有益效果:清热解毒、镇静安神,用于外感风热时毒、火毒内盛所致发热,烦躁不安、咽喉肿痛、舌质红绛、苔黄、脉数者;上呼吸道感染、病毒性感冒、急性咽炎、急性气管炎等病症。
另外,本发明清开灵片在制备过程中,缓释助剂以α-淀粉、稻壳粉、壳聚糖、谷氨酸钠、阿胶、木薯粉、海藻、糖萜素、螺旋藻、脱壳素、大豆卵磷脂、聚乳酸和乙醇凝胶为原料制备得到,其中谷氨酸钠是一种谷氨酸的钠盐,属于自然形成的最丰富的非必需氨基酸之一,具有调鲜的作用,而用作清开灵片的制备中,能够改善清开灵片的口味,以抑制清开灵片中药物成分刺鼻的气味,且配合上α-淀粉和聚乳酸的使用,利用α-淀粉的黏性,聚乳酸的附着性,在制备过程中,谷氨酸钠均匀分散在清开灵片的各个附着位点上,使得清开灵片刺鼻的药味被有效控制;糖萜素是从山茶属植物种子饼粕中提取的三萜皂苷类与糖类的混合物,是一种棕黄色、无灰微细状结晶。能够明显提高动物机体神经内分泌免疫功能和抗病抗应激作用,能够清除自由基,且具有抗氧化的功能,促进蛋白质合成和消化酶活性,糖萜素与聚乳酸的配合,利用了聚乳酸表面的羟基,使得糖萜素附着在聚乳酸的表面,而聚乳酸具有降解性,生物相容性好,在食用后药物不会在体内积聚,安全性好,且在α-淀粉黏性作用下,充分揉入到本发明的清开灵片中,使得清开灵片具有优异的抗病性能,且能够使清开灵片药效得到有效发挥;螺旋藻是一类低等生物,原核生物,由单细胞或多细胞组成的丝状体,体长200-500μm,宽5-10μm,圆柱形,呈疏松或紧密的有规则的螺旋旋形弯曲,形如钟表发条,故而得名。具有减轻癌症放疗、化疗的毒副反应,提高免疫功能,降低血脂等功效。由于螺旋藻中的藻多糖和藻蓝蛋白均能增强骨髓细胞的增殖活力,促进胸腺、脾脏等免疫器官的生长和促进血清蛋白的生物合成,因此螺旋藻具有免疫增强作用。运用到本发明的清开灵片制备中,与聚乳酸配合,利用了聚乳酸表面的羟基,使得螺旋藻附着在聚乳酸的表面,而聚乳酸具有降解性,生物相容性好,充分发挥了螺旋藻增强动物免疫的作用,运用到清开灵片的制备中,能够有效提高了清开灵片的营养物质的缓释性能,提高了清开灵片的药效。
另外,稻壳粉的黏度之所以提高,是因为镁离子通过木薯粉和壳聚糖八面体和四面体层间的充分交换来实现的。由于棒晶间带有相同的电荷而形成静电斥力,从而防止棒晶的团聚而达到更好的分散作用,黏度随之提高,由于壳聚糖在弱酸溶剂中易于溶解,溶解后的溶液中含有氨基,这些氨基通过结合负电子来抑制细菌表面呼吸酶的活性,从而造成细菌失活,同时由于壳聚糖的多孔性以及表面大量的羟基,而阿胶、木薯粉、海藻、大豆卵磷脂在制备清开灵片中起到了协同作用,协同提高了清开灵片的药物释放效率和吸收效率,阿胶作为中药不仅具有补血滋阴,润燥,止血的功效且具有很好的黏性,木薯粉是一种从热带植物的块根中提取的淀粉,由于木薯原淀粉中支链淀粉与直链淀粉的比率高达80:20,因此具有很高的尖峰粘度,作为补强体系中黏性增强的原料,与阿胶配合,不仅能够提高清开灵片的成型的强度,使得清开灵片在进入食道后保持一定形状,使药物逐渐被人体吸收,有效提高了药效的吸收效率,壳聚糖具有更高的蛋白吸附能力;在降解酶的作用下,壳聚糖具降解性;壳聚糖很容易加工成线,适合做成线状或片状的医用材料;壳聚糖具有亲和力和溶解性,适用于生产各类衍生物;壳聚糖具有更高的化学活性;壳聚糖的持水性高;在血清中,壳聚糖易降解吸收;壳聚糖具有更高的生物降解性;壳聚糖表现出有选择性的高度抑制口腔链球菌生长的作用,同时并不影响其他有益细菌的生长,且其多孔吸附性为阿胶、木薯粉、海藻和大豆卵磷脂提供了附着位点,使得阿胶、木薯粉、壳聚糖、海藻、大豆卵磷脂能够作为补强体系运用到清开灵片的制备,提高了补强体系在清开灵片制备中的补强效果,其中海藻具有清热、软坚散结的功效,且含有丰富的蛋白质,运用到清开灵片的制备中,不仅能够有效补充中药饮片蛋白质的含量,还能有效补充无机元素钠、钾、铁、钙等元素,以及维他命B12、C及E、生物素及烟碱酸,使得本发明的清开灵片的保健功效更加合理,且海藻能够附着在壳聚糖的表面,使得其进入到人体后更易被人体肠道吸收。其中添加的大豆卵磷脂含有卵磷脂、脑磷脂、等,具延缓衰老、预防心脑血管疾病等作用,运用到本发明的清开灵片的制备中,能够修补被损伤的细胞膜,改善细胞膜功能,使细胞膜软化和年轻化,增加细胞活性。通过对卵磷脂的摄取,就可以提高人体的代谢能力、自愈能力和抗体组织的再生能力,增强人体的生命活力,从而使得清开灵片中的营养成分被人体充分吸收。
具体实施方式
为便于更好地理解本发明,通过以下实例加以说明,这些实例属于本发明的保护范围,但不限制本发明的保护范围。
在实施例中,一种清开灵片,其原料按重量份包括:胆酸30-50份、珍珠母20-40份、猪去氧胆酸15-25份、栀子5-8份、水牛角6-14份、板蓝根4-8份、黄芩苷2-6份、金银花4-8份、糊精3-9份、玉米淀粉4-8份、硬脂酸镁3-9份、改性缓释包膜剂5-15份。
所述改性缓释包膜剂按如下工艺进行制备:按重量份将15-25份α-淀粉、40-50份稻壳粉、15-25份壳聚糖、2-5份谷氨酸钠、8-16份阿胶、4-8份木薯粉、3-9份海藻、3-6份糖萜素、4-8份螺旋藻、3-6份脱壳素和4-8份大豆卵磷脂混合均匀,于350r/min~650r/min转速搅拌20-30min,接着于-30℃~-50℃冷冻干燥机中干燥20min~40min,接着加入12-24份聚乳酸混合均匀,于4500r/min~5500r/min转速搅拌10min~20min,然后加入15-20份乙醇凝胶混合均匀,接着于250r/min~350r/min转速搅拌3h~5h,然后于8500r/min~12000r/min转速离心收集,纯化水洗后冷冻干燥得到改性缓释包膜剂。
所述板蓝根和栀子按如下工艺进行提取:将板蓝根和栀子混合均匀,加入水进行煎煮得到煎煮溶液;然后过滤煎煮溶液,得到药渣a和药液a,将药渣a继续煎煮后过滤得到药渣b和药液b;将药液a和药液b混合后浓缩,然后醇沉,取上清液后浓缩,得到浸膏a。
所述金银花按如下工艺进行提取:将金银花加入热水,浸泡后过滤得到药渣c和药液c,将药渣c继续煎煮得到药渣d和药液d,然后将药液c和药液d混合均匀并进行浓缩,接着醇沉取上清液,浓缩后得到浸膏b。
所述水牛角和珍珠母按如下工艺进行提取:
S1、水牛角加入氢氧化钡混合均匀,加热水解后得到药渣e和药液e;
S2、将珍珠母和硫酸混合均匀,加热水解后得到药渣f和药液f,将药液f放冷过滤得到滤液a和结晶体;
S3、将药液e、滤液a和氢氧化钡混合均匀,调节pH后,放置过滤得到沉淀物a和药液g,将药液g浓缩,再进行调节pH后,放置过滤得到沉淀物b和滤液b,然后将滤液b浓缩后得到浸膏c。
本发明提出一种清开灵片的制备方法,包括如下步骤:
步骤I、称量浸膏a、浸膏b和浸膏c,将浸膏a、浸膏b和浸膏c干燥后粉碎,然后将粉碎料混合后得到浸膏粉;
步骤II、将浸膏粉、猪去氧胆酸、胆酸、黄芩苷、糊精和玉米淀粉混合制粒,干燥后整粒,然后加入硬脂酸镁混合均匀,压片后进行包衣操作,将改性缓释包膜剂包裹在压片的外周,包衣结束后冷却入库。
所述步骤I中,干燥的温度为70℃-90℃,干燥的时间为20min-40min。
实施例1
一种清开灵片,其原料按重量份包括:胆酸40份、珍珠母30份、猪去氧胆酸20份、栀子6.5份、水牛角10份、板蓝根6份、黄芩苷4份、金银花6份、糊精6份、玉米淀粉6份、硬脂酸镁6份、改性缓释包膜剂10份。
所述改性缓释包膜剂按如下工艺进行制备:按重量份将20份α-淀粉、45份稻壳粉、20份壳聚糖、3.5份谷氨酸钠、12份阿胶、6份木薯粉、6份海藻、4.5份糖萜素、6份螺旋藻、4.5份脱壳素和6份大豆卵磷脂混合均匀,于500r/min转速搅拌25min,接着于-40℃冷冻干燥机中干燥30min,接着加入19份聚乳酸混合均匀,于5000r/min转速搅拌15min,然后加入18份乙醇凝胶混合均匀,接着于300r/min转速搅拌4h,然后于9000r/min转速离心收集,纯化水洗后冷冻干燥得到改性缓释包膜剂。
所述板蓝根和栀子按如下工艺进行提取:将板蓝根和栀子混合均匀,加入水进行煎煮得到煎煮溶液;然后过滤煎煮溶液,得到药渣a和药液a,将药渣a继续煎煮后过滤得到药渣b和药液b;将药液a和药液b混合后浓缩,然后醇沉,取上清液后浓缩,得到浸膏a。
所述金银花按如下工艺进行提取:将金银花加入热水,浸泡后过滤得到药渣c和药液c,将药渣c继续煎煮得到药渣d和药液d,然后将药液c和药液d混合均匀并进行浓缩,接着醇沉取上清液,浓缩后得到浸膏b。
所述水牛角和珍珠母按如下工艺进行提取:
S1、水牛角加入氢氧化钡混合均匀,加热水解后得到药渣e和药液e;
S2、将珍珠母和硫酸混合均匀,加热水解后得到药渣f和药液f,将药液f放冷过滤得到滤液a和结晶体;
S3、将药液e、滤液a和氢氧化钡混合均匀,调节pH后,放置过滤得到沉淀物a和药液g,将药液g浓缩,再进行调节pH后,放置过滤得到沉淀物b和滤液b,然后将滤液b浓缩后得到浸膏c。
本发明提出一种清开灵片的制备方法,包括如下步骤:
步骤I、称量浸膏a、浸膏b和浸膏c,将浸膏a、浸膏b和浸膏c干燥后粉碎,然后将粉碎料混合后得到浸膏粉;
步骤II、将浸膏粉、猪去氧胆酸、胆酸、黄芩苷、糊精和玉米淀粉混合制粒,干燥后整粒,然后加入硬脂酸镁混合均匀,压片后进行包衣操作,将改性缓释包膜剂包裹在压片的外周,包衣结束后冷却入库。
所述步骤I中,干燥的温度为80℃,干燥的时间为30min。
实施例2
一种清开灵片,其原料按重量份包括:胆酸30份、珍珠母40份、猪去氧胆酸15份、栀子8份、水牛角6份、板蓝根8份、黄芩苷2份、金银花8份、糊精3份、玉米淀粉8份、硬脂酸镁3份、改性缓释包膜剂15份。
所述改性缓释包膜剂按如下工艺进行制备:按重量份将15份α-淀粉、50份稻壳粉、15份壳聚糖、5份谷氨酸钠、8份阿胶、8份木薯粉、3份海藻、6份糖萜素、4份螺旋藻、6份脱壳素和4份大豆卵磷脂混合均匀,于650r/min转速搅拌20min,接着于-50℃冷冻干燥机中干燥20min,接着加入24份聚乳酸混合均匀,于4500r/min转速搅拌20min,然后加入15份乙醇凝胶混合均匀,接着于350r/min转速搅拌3h,然后于12000r/min转速离心收集,纯化水洗后冷冻干燥得到改性缓释包膜剂。
所述板蓝根和栀子按如下工艺进行提取:将板蓝根和栀子混合均匀,加入水进行煎煮得到煎煮溶液;然后过滤煎煮溶液,得到药渣a和药液a,将药渣a继续煎煮后过滤得到药渣b和药液b;将药液a和药液b混合后浓缩,然后醇沉,取上清液后浓缩,得到浸膏a。
所述金银花按如下工艺进行提取:将金银花加入热水,浸泡后过滤得到药渣c和药液c,将药渣c继续煎煮得到药渣d和药液d,然后将药液c和药液d混合均匀并进行浓缩,接着醇沉取上清液,浓缩后得到浸膏b。
所述水牛角和珍珠母按如下工艺进行提取:
S1、水牛角加入氢氧化钡混合均匀,加热水解后得到药渣e和药液e;
S2、将珍珠母和硫酸混合均匀,加热水解后得到药渣f和药液f,将药液f放冷过滤得到滤液a和结晶体;
S3、将药液e、滤液a和氢氧化钡混合均匀,调节pH后,放置过滤得到沉淀物a和药液g,将药液g浓缩,再进行调节pH后,放置过滤得到沉淀物b和滤液b,然后将滤液b浓缩后得到浸膏c。
本发明提出一种清开灵片的制备方法,包括如下步骤:
步骤I、称量浸膏a、浸膏b和浸膏c,将浸膏a、浸膏b和浸膏c干燥后粉碎,然后将粉碎料混合后得到浸膏粉;
步骤II、将浸膏粉、猪去氧胆酸、胆酸、黄芩苷、糊精和玉米淀粉混合制粒,干燥后整粒,然后加入硬脂酸镁混合均匀,压片后进行包衣操作,将改性缓释包膜剂包裹在压片的外周,包衣结束后冷却入库。
所述步骤I中,干燥的温度为70℃,干燥的时间为40min。
实施例3
一种清开灵片,其原料按重量份包括:胆酸50份、珍珠母20份、猪去氧胆酸25份、栀子5份、水牛角14份、板蓝根4份、黄芩苷6份、金银花4份、糊精9份、玉米淀粉4份、硬脂酸镁9份、改性缓释包膜剂5份。
所述改性缓释包膜剂按如下工艺进行制备:按重量份将25份α-淀粉、40份稻壳粉、25份壳聚糖、2份谷氨酸钠、16份阿胶、4份木薯粉、9份海藻、3份糖萜素、8份螺旋藻、3份脱壳素和8份大豆卵磷脂混合均匀,于350r/min转速搅拌30min,接着于-30℃冷冻干燥机中干燥40min,接着加入12份聚乳酸混合均匀,于5500r/min转速搅拌10min,然后加入20份乙醇凝胶混合均匀,接着于250r/min转速搅拌5h,然后于8500r/min转速离心收集,纯化水洗后冷冻干燥得到改性缓释包膜剂。
所述板蓝根和栀子按如下工艺进行提取:将板蓝根和栀子混合均匀,加入水进行煎煮得到煎煮溶液;然后过滤煎煮溶液,得到药渣a和药液a,将药渣a继续煎煮后过滤得到药渣b和药液b;将药液a和药液b混合后浓缩,然后醇沉,取上清液后浓缩,得到浸膏a。
所述金银花按如下工艺进行提取:将金银花加入热水,浸泡后过滤得到药渣c和药液c,将药渣c继续煎煮得到药渣d和药液d,然后将药液c和药液d混合均匀并进行浓缩,接着醇沉取上清液,浓缩后得到浸膏b。
所述水牛角和珍珠母按如下工艺进行提取:
S1、水牛角加入氢氧化钡混合均匀,加热水解后得到药渣e和药液e;
S2、将珍珠母和硫酸混合均匀,加热水解后得到药渣f和药液f,将药液f放冷过滤得到滤液a和结晶体;
S3、将药液e、滤液a和氢氧化钡混合均匀,调节pH后,放置过滤得到沉淀物a和药液g,将药液g浓缩,再进行调节pH后,放置过滤得到沉淀物b和滤液b,然后将滤液b浓缩后得到浸膏c。
本发明提出一种清开灵片的制备方法,包括如下步骤:
步骤I、称量浸膏a、浸膏b和浸膏c,将浸膏a、浸膏b和浸膏c干燥后粉碎,然后将粉碎料混合后得到浸膏粉;
步骤II、将浸膏粉、猪去氧胆酸、胆酸、黄芩苷、糊精和玉米淀粉混合制粒,干燥后整粒,然后加入硬脂酸镁混合均匀,压片后进行包衣操作,将改性缓释包膜剂包裹在压片的外周,包衣结束后冷却入库。
所述步骤I中,干燥的温度为70℃-90℃,干燥的时间为20min-40min。
对比例1
采用中国专利申请文献“清开灵分散片(申请号:200510009783.0)”中具体实施例所述的方法制备的清开灵片。
测试一
对实施例1-3和对比例1制得的清开灵,置于25℃,相对湿度85%环境下保藏半年,然后进行大肠杆菌(ATYCC 258220)菌落总数测试,参照GBT 4789.2-2008食品卫生微生物检验菌落总数测定,具体测试结构见表1。
表1:菌落总数测试表cfu/g
大肠杆菌菌落总数,CFU/g | |
实施例1 | 31 |
实施例2 | 42 |
实施例3 | 39 |
对比例1 | 699 |
比较实施例1-3与对比例1,实施例1-3中添加了改性缓释包膜剂的清开灵片的防腐抗菌性能明显优于对比例1。
测试二
对实施例1-3和对比例1的清开灵片分别用铝塑复合膜袋密封包装,置于38℃温度下放置3个月,测定各试样中3月时的黄芩苷相对于该试验0月时的残余含量,测试方法参照董学畅等《黄芩苷标样制备及其固相萃取HPLC测定研究》,具体结果件表2。
表2:稳定性测试结构表单位:%
黄芩苷残余含量 | |
实施例1 | 99.8 |
实施例2 | 99.4 |
实施例3 | 98.9 |
对比例1 | 54.6 |
比较实施例1-3与对比例1,实施例1-3中添加了改性缓释包膜剂的清开灵片的稳定性明显优于对比例1。
以上内容不能认定本发明具体实施只局限于这些说明,对于本发明所属技术领域的普通技术人员来说,在不脱离本发明构思前提下,还可以做出若干简单推演或替换,都应当视为属于本发明由所提交的权利要求书确定的专利保护范围。
Claims (8)
1.一种清开灵片,其特征在于,其原料按重量份包括:胆酸30-50份、珍珠母20-40份、猪去氧胆酸15-25份、栀子5-8份、水牛角6-14份、板蓝根4-8份、黄芩苷2-6份、金银花4-8份、糊精3-9份、玉米淀粉4-8份、硬脂酸镁3-9份、改性缓释包膜剂5-15份。
2.如权利要求1所述的清开灵片,其特征在于,所述改性缓释包膜剂的原料按重量份包括:α-淀粉15-25份、稻壳粉40-50份、壳聚糖15-25份、谷氨酸钠2-5份、阿胶8-16份、木薯粉4-8份、海藻3-9份、糖萜素3-6份、螺旋藻4-8份、脱壳素3-6份、大豆卵磷脂4-8份、聚乳酸12-24份、乙醇凝胶15-20份。
3.如权利要求1所述的清开灵片,其特征在于,所述改性缓释包膜剂按如下工艺进行制备:将α-淀粉、稻壳粉、壳聚糖、谷氨酸钠、阿胶、木薯粉、海藻、糖萜素、螺旋藻、脱壳素和大豆卵磷脂混合均匀,于350r/min~650r/min转速搅拌20-30min,接着于-30℃~-50℃冷冻干燥机中干燥20min~40min,接着加入聚乳酸混合均匀,于4500r/min~5500r/min转速搅拌10min~20min,然后加入乙醇凝胶混合均匀,接着于250r/min~350r/min转速搅拌3h~5h,然后于8500r/min~12000r/min转速离心收集,纯化水洗后冷冻干燥得到改性缓释包膜剂。
4.如权利要求1所述的清开灵片,其特征在于,所述板蓝根和栀子按如下工艺进行提取:将板蓝根和栀子混合均匀,加入水进行煎煮得到煎煮溶液;然后过滤煎煮溶液,得到药渣a和药液a,将药渣a继续煎煮后过滤得到药渣b和药液b;将药液a和药液b混合后浓缩,然后醇沉,取上清液后浓缩,得到浸膏a。
5.如权利要求1所述的清开灵片,其特征在于,所述金银花按如下工艺进行提取:将金银花加入热水,浸泡后过滤得到药渣c和药液c,将药渣c继续煎煮得到药渣d和药液d,然后将药液c和药液d混合均匀并进行浓缩,接着醇沉取上清液,浓缩后得到浸膏b。
6.如权利要求1所述的清开灵片,其特征在于,所述水牛角和珍珠母按如下工艺进行提取:
S1、水牛角加入氢氧化钡混合均匀,加热水解后得到药渣e和药液e;
S2、将珍珠母和硫酸混合均匀,加热水解后得到药渣f和药液f,将药液f放冷过滤得到滤液a和结晶体;
S3、将药液e、滤液a和氢氧化钡混合均匀,调节pH后,放置过滤得到沉淀物a和药液g,将药液g浓缩,再进行调节pH后,放置过滤得到沉淀物b和滤液b,然后将滤液b浓缩后得到浸膏c。
7.一种如权利要求1-6任一项所述的清开灵片的制备方法,其特征在于,包括如下步骤:
步骤I、称量浸膏a、浸膏b和浸膏c,将浸膏a、浸膏b和浸膏c干燥后粉碎,然后将粉碎料混合后得到浸膏粉;
步骤II、将浸膏粉、猪去氧胆酸、胆酸、黄芩苷、糊精和玉米淀粉混合制粒,干燥后整粒,然后加入硬脂酸镁混合均匀,压片后进行包衣操作,将改性缓释包膜剂包裹在压片的外周,包衣结束后冷却入库。
8.如权利要求7所述的清开灵片的制备方法,其特征在于,所述步骤I中,干燥的温度为70℃-90℃,干燥的时间为20min-40min。
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