CN115282264A - 降血糖提高免疫力的复合物制剂及制备方法 - Google Patents
降血糖提高免疫力的复合物制剂及制备方法 Download PDFInfo
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- CN115282264A CN115282264A CN202211057399.8A CN202211057399A CN115282264A CN 115282264 A CN115282264 A CN 115282264A CN 202211057399 A CN202211057399 A CN 202211057399A CN 115282264 A CN115282264 A CN 115282264A
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- improving immunity
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Abstract
本发明公开了降血糖提高免疫力的复合物制剂及制备方法,属于制药技术领域,包括超敏蛋白复合酶2‑3份、酵素4‑6份和格列苯脲0.05‑0.08份;超敏蛋白复合酶应用于代谢类慢性疾病调控及治疗是基于中医药配伍理论、生物平衡理论、系统平衡理论研发出的生物制剂;该降血糖提高免疫力的复合物制剂相比常用的蛋白类药物可以在常温下运输、保管及服用,使用方便;酵素中富含多种中药的脂溶性和水溶性的提取物,有助于调节人体免疫力;超敏蛋白复合酶能刺激激活休眠的胰腺细胞工作,应答性分泌胰岛素,逐步消减人体对外源性胰岛素的依赖;超敏蛋白酶和酵素协同格列苯脲发挥降血糖和提高免疫力的功效,作用效果明确显著。
Description
技术领域
本发明属于制药技术领域,具体涉及降血糖提高免疫力的复合物制剂及制备方法。
背景技术
超敏蛋白复合酶是以多种植物单体酶或植物提取物为原料,经过独特的低温有氧发酵、螯合而成的以蛋白形式存在的复合酶,可以运用于鸡、鸭和猪等禽畜养殖,减少禽畜的疫病和应激死亡;使用超敏蛋白复合酶的稀释液浸泡水果蔬菜可以去除果蔬上残留的农药,保证了入口安全。
但是还没有将超敏蛋白复合酶应用在人类疾病调控上的先例,所以提出一种含有超敏蛋白复合酶的复合物制剂。
发明内容
本发明的目的在于提供降血糖提高免疫力的复合物制剂及制备方法,以解决背景技术中的问题。
本发明的目的可以通过以下技术方案实现:降血糖提高免疫力的复合物制剂,按质量份计包括如下原料:
超敏蛋白复合酶2-3份、酵素4-6份和格列苯脲0.05-0.08份。
降血糖提高免疫力的复合物制剂的制备方法,包括如下步骤:
步骤S1:将中药组合物清洗并干燥,粉碎后过60-80目筛,得到混合粉末;将混合粉末放入烧瓶中,向烧瓶中加入混合粉末3-5倍质量的正己烷并搅拌3-4h,静置0.5-1h后将上层含有油脂的黄色液体倒出;向烧瓶中加入与上一步相同质量的正己烷并搅拌2-3h,静置0.5-1h后倒出上层黄色液体,重复上述步骤,直至上层液体呈无色,取下层沉淀在25-30℃的条件下烘干,粉碎,得到脱脂药粉;收集上层黄色液体采用汽提法使正己烷与油脂分离,收集油脂备用;
步骤S2:将脱脂药粉加入烧瓶中然后加入去离子水,搅拌20-30min后得到浆液,向浆液中滴加质量分数为32%的氢氧化钠溶液,调节浆液的pH值为10后继续搅拌1-1.5h,完成第一次浸提,在4000r/min的条件下冷冻离心20-30min,收集第一次浸提的上清液,备用;向第一次浸提的残渣中加入去离子水,搅拌20-30min后用质量分数为32%的氢氧化钠溶液调节pH值为10,继续搅拌1-1.5h,完成第二次浸提,在4000r/min的条件下冷冻离心20-30min,收集第二次浸提的上清液和残渣,备用;
合并两次浸提的上清液,用质量分数为37%的盐酸溶液调节pH值至5.5,静置30-40min,在4000r/min的条件下冷冻离心20-30min,收集上层清液,取沉淀并用去离子水洗涤至pH值呈中性,得到蛋白提取物,在-80℃的条件下冷冻干燥储存,备用;收集上层清液和沉淀的洗涤液,然后用质量分数为32%的氢氧化钠溶液调节pH值至中性,得到基液;
步骤S3:将步骤S1中收集的油脂和步骤S2中收集的第二次浸提的残渣和基液加入发酵罐中,煮沸后降温至微沸状态煎煮1.5-2h,冷却至室温后加入干酵母,在20-30℃的条件下发酵15-20h,过滤去除滤渣并收集发酵液,将发酵液在105-115℃的条件下采用高温瞬时灭菌法灭菌,将灭菌后的发酵液冷却,混入上一步制备的蛋白提取物,再加入肌醇和微量元素后置于螯合桶中螯合3-5天,过滤后得到超敏蛋白复合酶,将滤液浓缩干燥后得到酵素;
步骤S4:将超敏蛋白复合酶、酵素和格列苯脲搅拌混合,制粒,得到粉状颗粒,然后用胶囊分装得到降血糖提高免疫力的复合物制剂;每粒胶囊中填充的粉状颗粒的质量为0.4g。
进一步地,中药组合物按质量份计包括如下原料:山药15-20份、红参10-12份、天花粉10-12份、地黄15-20份、枸杞8-10份、黄芪8-10份、山茱萸8-10份、知母10-12份、葛根15-20份、天冬8-10份、茯苓5-6份、五味子8-10份、鸡内金5-6份、桦褐孔菌5-6份。
进一步地,步骤S3中发酵液、蛋白提取物、肌醇和微量元素的用量比为200-300mL:10g:0.08g:0.005-0.01g。
进一步地,微量元素为维生素B族。
本发明的有益效果:超敏蛋白复合酶应用于代谢类慢性疾病调控及治疗是基于中医药配伍理论、生物平衡理论、系统平衡理论研发出的生物制剂;超敏蛋白复合酶在生物体的微生态环境中,使生物体内有益微生物活性增强,数量增多,从而抑制有害微生物的繁殖,使生物体的“微生态”达到健康平衡状态,与我国传统中医药阴阳平衡理论一脉相承。
该降血糖提高免疫力的复合物制剂相比常用的蛋白类药物可以在常温下运输、保管及服用,使用方便;酵素中富含多种中药的脂溶性和水溶性的提取物,有助于调节人体免疫力;超敏蛋白复合酶还能刺激激活休眠的胰腺细胞工作,应答性分泌胰岛素,逐步消减人体对外源性胰岛素的依赖;超敏蛋白酶和酵素协同格列苯脲发挥降血糖和提高免疫力的功效,作用效果明确显著。
具体实施方式
下面将结合本发明实施例,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。
实施例1
制备降血糖提高免疫力的复合物制剂,包括如下步骤:
步骤S1:将1.5kg山药、1kg红参、1kg天花粉、1.5kg地黄、0.8kg枸杞、0.8kg黄芪、0.8kg山茱萸、1kg知母、1.5kg葛根、0.8kg天冬、0.5kg茯苓、0.8kg五味子、0.5kg鸡内金和0.5kg桦褐孔菌混合,得到中药组合物;将中药组合物清洗并干燥,粉碎后过60目筛,得到混合粉末;将2kg混合粉末放入烧瓶中,向烧瓶中加入混合粉末5倍质量的正己烷并搅拌3h,静置0.5h后将上层含有油脂的黄色液体倒出;向烧瓶中加入与上一步相同质量的正己烷并搅拌2h,静置0.5h后倒出上层黄色液体,重复上述步骤,直至上层液体呈无色,取下层沉淀在25℃的条件下烘干,粉碎,得到脱脂药粉;收集上层黄色液体采用汽提法使正己烷与油脂分离,收集油脂备用;
步骤S2:将脱脂药粉加入烧瓶中然后加入去离子水,搅拌20min后得到浆液,向浆液中滴加质量分数为32%的氢氧化钠溶液,调节浆液的pH值为10后继续搅拌1h,完成第一次浸提,在4000r/min的条件下冷冻离心20min,收集第一次浸提的上清液,备用;向第一次浸提的残渣中加入去离子水,搅拌20mi n后用质量分数为32%的氢氧化钠溶液调节pH值为10,继续搅拌1h,完成第二次浸提,在4000r/min的条件下冷冻离心20min,收集第二次浸提的上清液和残渣,备用;
合并两次浸提的上清液,用质量分数为37%的盐酸溶液调节pH值至5.5,静置30min,在4000r/min的条件下冷冻离心20min,收集沉淀并用去离子水洗涤至pH值呈中性,得到蛋白提取物,在-80℃的条件下冷冻干燥储存,备用;收集上层清液和沉淀的洗涤液,然后用质量分数为32%的氢氧化钠溶液调节pH值至中性,得到基液;
步骤S3:将步骤S1中收集的油脂和步骤S2中收集的第二次浸提的残渣和基液加入发酵罐中,煮沸后降温至微沸状态煎煮1.5h,冷却至室温后加入干酵母,在20℃的条件下发酵15h,过滤去除滤渣并收集发酵液,将发酵液在105℃的条件下采用高温瞬时灭菌法灭菌;
取20L灭菌后的发酵液并冷却,混入1kg蛋白提取物、8g肌醇和0.5g维生素B族后置于螯合桶中螯合3天,过滤后得到超敏蛋白复合酶,将滤液浓缩干燥后得到酵素;
步骤S4:将200g超敏蛋白复合酶、400g酵素和5g格列苯脲搅拌混合,制粒,得到粉状颗粒,然后用胶囊分装得到降血糖提高免疫力的复合物制剂;每粒胶囊中填充的粉状颗粒的质量为0.4g。
实施例2
制备降血糖提高免疫力的复合物制剂,包括如下步骤:
步骤S1:将1.8kg山药、1.1kg红参、1.1kg天花粉、1.6kg地黄、0.9kg枸杞、0.9kg黄芪、0.9kg山茱萸、1.1kg知母、1.8kg葛根、0.9kg天冬、0.55kg茯苓、0.9kg五味子、0.55kg鸡内金和0.55kg桦褐孔菌混合,得到中药组合物;将中药组合物清洗并干燥,粉碎后过70目筛,得到混合粉末;将2kg混合粉末放入烧瓶中,向烧瓶中加入混合粉末4倍质量的正己烷并搅拌3.5h,静置0.8h后将上层含有油脂的黄色液体倒出;向烧瓶中加入与上一步相同质量的正己烷并搅拌2.5h,静置0.8h后倒出上层黄色液体,重复上述步骤,直至上层液体呈无色,取下层沉淀在28℃的条件下烘干,粉碎,得到脱脂药粉;收集上层黄色液体采用汽提法使正己烷与油脂分离,收集油脂备用;
步骤S2:将脱脂药粉加入烧瓶中然后加入去离子水,搅拌20-30min后得到浆液,向浆液中滴加质量分数为32%的氢氧化钠溶液,调节浆液的pH值为10后继续搅拌1.2h,完成第一次浸提,在4000r/min的条件下冷冻离心25min,收集第一次浸提的上清液,备用;向第一次浸提的残渣中加入去离子水,搅拌25min后用质量分数为32%的氢氧化钠溶液调节pH值为10,继续搅拌1.2h,完成第二次浸提,在4000r/min的条件下冷冻离心25min,收集第二次浸提的上清液和残渣,备用;
合并两次浸提的上清液,用质量分数为37%的盐酸溶液调节pH值至5.5,静置35min,在4000r/min的条件下冷冻离心25min,收集沉淀并用去离子水洗涤至pH值呈中性,得到蛋白提取物,在-80℃的条件下冷冻干燥储存,备用;收集上层清液和沉淀的洗涤液,然后用质量分数为32%的氢氧化钠溶液调节pH值至中性,得到基液;
步骤S3:将步骤S1中收集的油脂和步骤S2中收集的第二次浸提的残渣和基液加入发酵罐中,煮沸后降温至微沸状态煎煮1.8h,冷却至室温后加入干酵母,在25℃的条件下发酵18h,过滤去除滤渣并收集发酵液,将发酵液在110℃的条件下采用高温瞬时灭菌法灭菌;
取20-30L灭菌后的发酵液并冷却,混入1kg蛋白提取物、8g肌醇和0.8g维生素B族后置于螯合桶中螯合4天,过滤后得到超敏蛋白复合酶,将滤液浓缩干燥后得到酵素;
步骤S4:将250g超敏蛋白复合酶、500g酵素和6g格列苯脲搅拌混合,制粒,得到粉状颗粒,然后用胶囊分装得到降血糖提高免疫力的复合物制剂;每粒胶囊中填充的粉状颗粒的质量为0.4g。
实施例3
制备降血糖提高免疫力的复合物制剂,包括如下步骤:
步骤S1:将2kg山药、1.2kg红参、1.2kg天花粉、2kg地黄、1kg枸杞、1kg黄芪、1kg山茱萸、1.2kg知母、2kg葛根、1kg天冬、0.6kg茯苓、1kg五味子、0.6kg鸡内金和0.6kg桦褐孔菌混合,得到中药组合物;将中药组合物清洗并干燥,粉碎后过80目筛,得到混合粉末;将2kg混合粉末放入烧瓶中,向烧瓶中加入混合粉末3倍质量的正己烷并搅拌4h,静置1h后将上层含有油脂的黄色液体倒出;向烧瓶中加入与上一步相同质量的正己烷并搅拌3h,静置1h后倒出上层黄色液体,重复上述步骤,直至上层液体呈无色,取下层沉淀在30℃的条件下烘干,粉碎,得到脱脂药粉;收集上层黄色液体采用汽提法使正己烷与油脂分离,收集油脂备用;
步骤S2:将脱脂药粉加入烧瓶中然后加入去离子水,搅拌30min后得到浆液,向浆液中滴加质量分数为32%的氢氧化钠溶液,调节浆液的pH值为10后继续搅拌1.5h,完成第一次浸提,在4000r/min的条件下冷冻离心30min,收集第一次浸提的上清液,备用;向第一次浸提的残渣中加入去离子水,搅拌30min后用质量分数为32%的氢氧化钠溶液调节pH值为10,继续搅拌1.5h,完成第二次浸提,在4000r/min的条件下冷冻离心30min,收集第二次浸提的上清液和残渣,备用;
合并两次浸提的上清液,用质量分数为37%的盐酸溶液调节pH值至5.5,静置40min,在4000r/min的条件下冷冻离心30min,收集沉淀并用去离子水洗涤至pH值呈中性,得到蛋白提取物,在-80℃的条件下冷冻干燥储存,备用;收集上层清液和沉淀的洗涤液,然后用质量分数为32%的氢氧化钠溶液调节pH值至中性,得到基液;
步骤S3:将步骤S1中收集的油脂和步骤S2中收集的第二次浸提的残渣和基液加入发酵罐中,煮沸后降温至微沸状态煎煮2h,冷却至室温后加入干酵母,在30℃的条件下发酵20h,过滤去除滤渣并收集发酵液,将发酵液在115℃的条件下采用高温瞬时灭菌法灭菌;
取30L灭菌后的发酵液并冷却,混入1kg蛋白提取物、8g肌醇和1g维生素B族后置于螯合桶中螯合5天,过滤后得到超敏蛋白复合酶,将滤液浓缩干燥后得到酵素;
步骤S4:将300g超敏蛋白复合酶、600g酵素和8g格列苯脲搅拌混合,制粒,得到粉状颗粒,然后用胶囊分装得到降血糖提高免疫力的复合物制剂;每粒胶囊中填充的粉状颗粒的质量为0.4g。
实施例4
对实施例1中制得的超敏蛋白复合酶进行毒性试验:
1.材料和方法
(1)受试物:超敏蛋白复合酶用两倍质量的去离子水稀释。
(2)实验动物:SPF级KM种小鼠,体重:18g-22g,共20只,雌、雄各半。试验动物由斯贝福(北京)生物技术有限公司提供,饲养条件为:温度20℃-26℃,相对湿度40%-70%,光照12h明暗交替。试验动物在饲养期间自由饮水,饲以标准块状维持饲料,该饲料购自斯贝福(北京)生物技术有限公司。
(3)试验方法:采用限量试验法,对供试小鼠一次性经口给予受试物。灌胃剂量为10000mg/kg.BW。受试物现用现配,给予小鼠受试物前禁食4h,不禁水,实验当日称重、标记,灌胃体积为20mL/kg.BW,单次经口灌胃给予小鼠受试物,给予小鼠受试物2h后给予饲料。给予受试物后连续观察2h-4h,之后每天观察1次,观察期为14天。
通过观察是否存在与受试物相关的动物死亡,确定受试物经口毒性,并确定是否有必要采用霍恩氏法进行后续试验。记录小鼠中毒体征、症状出现和消失,以及动物死亡时间。结果如表1和表2所示:
表1
由表1可以看出,实验动物未出现明显中毒体征。
表2
由表2可以看出,受试物对KM种雌、雄小鼠的经口半数致死剂量(LD50)均大于10000mg/kg.BW,根据《GB 15193.3-2014食品安全国家标准急性经口毒性试验》中的剂量分级标准,该样品属于实际无毒级。
实施例5
对降血糖提高免疫力的复合物制剂进行临床疗效试验:
(1)治疗群体:使用实施例2中制备的降血糖提高免疫力的复合物制剂运用于某医院收治的200名2型糖尿病患者,患者的空腹血糖均超过6.1mmol/L,餐后血糖均超过8.0mmol/L;随机分为两组(常规组和试验组),每组100名患者,在基本信息方面两组患者的差异无统计学意义(P>0.05)。
(2)方法:常规组患者给予格列苯脲(国药准字H14023379)进行治疗,药物剂量为0.25mg,2次/天,餐前30min服用,定期对患者的血糖进行检测,随时调整箱盖血糖参数;
试验组患者给予降血糖提高免疫力的复合物制剂进行治疗,药物剂量为50mg,2次/天,定期对患者的血糖进行检测,随时调整箱盖血糖参数;
(3)观察指标与判断标准:录患者血糖指标控制在标准范围值所应用时间,治疗后的血糖、糖化血红蛋白与甘油三酯等情况,并将常规组合试验组患者的两组数据进行互比。结果如表3所示:
表3
由表3可以看出,试验组患者的指标情况要优于常规组患者。
实施例6
北京某餐饮集团董事长李某某,罹患2型糖尿病6年多,空腹血糖高达18-19mmol/L,胰岛素日注射量16个单位并配二甲双胍片,服用按实施例3方法制得的降血糖提高免疫力的复合物制剂并逐渐减少原用药量和注射量,7个月后,血糖恢复正常,不再打针吃药。多次检测,指标正常,2019年10月的检测显示:空腹血糖为6.23mmol/L。
需要说明的是,在本文中,诸如术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含,从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素,而且还包括没有明确列出的其他要素,或者是还包括为这种过程、方法、物品或者设备所固有的要素。
尽管已经示出和描述了本发明的实施例,对于本领域的普通技术人员而言,可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型,本发明的范围由所附权利要求及其等同物限定。
Claims (6)
1.降血糖提高免疫力的复合物制剂,其特征在于,按质量份计,包括以下原料:
超敏蛋白复合酶2-3份、酵素4-6份和格列苯脲0.05-0.08份;
超敏蛋白复合酶的制备方法为:将中药组合物粉碎脱脂后得到脱脂药粉,对脱脂药粉进行浸提,合并浸提后的上清液,用盐酸溶液调节pH值至5.5,静置30-40min,在4000r/min的条件下冷冻离心20-30min,收集沉淀并用去离子水洗涤至pH值呈中性,得到蛋白提取物;将蛋白提取物、肌醇和微量元素混入发酵液中螯合3-5天,过滤后得到超敏蛋白复合酶。
2.根据权利要求1所述的降血糖提高免疫力的复合物制剂,其特征在于,中药组合物按质量份计包括如下原料:
山药15-20份、红参10-12份、天花粉10-12份、地黄15-20份、枸杞8-10份、黄芪8-10份、山茱萸8-10份、知母10-12份、葛根15-20份、天冬8-10份、茯苓5-6份、五味子8-10份、鸡内金5-6份、桦褐孔菌5-6份。
3.根据权利要求1所述的降血糖提高免疫力的复合物制剂,其特征在于,中药组合物粉碎脱脂的具体方法为:i.将中药组合物清洗、干燥、粉碎后过60-80目筛,得到混合粉末;将混合粉末与3-5倍质量的正己烷混合并搅拌3-4h,静置0.5-1h后将上层含有油脂的黄色液体倒出;ii.再次加入与上一步相同质量的正己烷并搅拌2-3h,静置0.5-1h后倒出上层黄色液体;iii.重复步骤ii,直至上层液体呈无色,取下层沉淀在25-30℃的条件下烘干,粉碎,得到脱脂药粉;收集上层黄色液体并分离出油脂,收集油脂备用。
4.根据权利要求3所述的降血糖提高免疫力的复合物制剂,其特征在于,浸提的具体方法为:将脱脂药粉与去离子水混合搅拌20-30min后得到浆液,向浆液中滴加氢氧化钠溶液,调节浆液的pH值为10后继续搅拌1-1.5h,冷冻离心20-30min,收集上清液;将上一次浸提的残渣与去离子水混合搅拌20-30min后用氢氧化钠溶液调节pH值为10,继续搅拌1-1.5h,冷冻离心20-30min,收集上清液和最后一次浸提的残渣。
5.根据权利要求4所述的降血糖提高免疫力的复合物制剂,其特征在于,发酵液的制备方法为:收集浸提步骤中的上层清液和沉淀的洗涤液,用氢氧化钠溶液调节pH值至中性,得到基液;将粉碎脱脂步骤中获取的油脂和浸提步骤中最后一次浸提的残渣混入基液中,煮沸后降温至微沸状态煎煮1.5-2h,冷却后加入干酵母,在20-30℃的条件下发酵15-20h,过滤去除滤渣得到发酵液,灭菌备用。
6.根据权利要求1所述的降血糖提高免疫力的复合物制剂的制备方法,其特征在于,包括如下步骤:
将超敏蛋白复合酶、酵素和格列苯脲搅拌混合,制粒,得到粉状颗粒,然后用胶囊分装得到降血糖提高免疫力的复合物制剂;每粒胶囊填充粉状颗粒0.4g。
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Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1718233A (zh) * | 2004-07-09 | 2006-01-11 | 北京市圣普华医药科技开发有限公司 | 糖尿乐软胶囊及其制备工艺 |
WO2006122454A1 (fr) * | 2005-05-18 | 2006-11-23 | Guangzhou Zhongyi Pharmaceutical Company Limited | Composition pharmaceutique pour le traitement du diabete et son procede de preparation |
CN101791119A (zh) * | 2010-02-03 | 2010-08-04 | 孟蒙 | 桦褐孔菌营养组合物 |
CN102247526A (zh) * | 2010-05-17 | 2011-11-23 | 李恒勇 | 一种糖尿乐胶囊及制备方法 |
CN104940412A (zh) * | 2015-05-28 | 2015-09-30 | 张军 | 一种中药养生酵素 |
CN109090589A (zh) * | 2018-08-30 | 2018-12-28 | 河南盈哈哈食品有限公司 | 一种山药酵素及其制作方法 |
CN109618944A (zh) * | 2018-12-13 | 2019-04-16 | 哈尔滨森荞生物科技有限公司 | 一种超敏蛋白复合酶制剂及其制备方法与应用 |
CN110074139A (zh) * | 2019-05-13 | 2019-08-02 | 河南地卫士生物科技有限公司 | 一种木霉菌与超敏蛋白复合酶复配的生物农药 |
-
2022
- 2022-08-31 CN CN202211057399.8A patent/CN115282264A/zh active Pending
Patent Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1718233A (zh) * | 2004-07-09 | 2006-01-11 | 北京市圣普华医药科技开发有限公司 | 糖尿乐软胶囊及其制备工艺 |
WO2006122454A1 (fr) * | 2005-05-18 | 2006-11-23 | Guangzhou Zhongyi Pharmaceutical Company Limited | Composition pharmaceutique pour le traitement du diabete et son procede de preparation |
CN101791119A (zh) * | 2010-02-03 | 2010-08-04 | 孟蒙 | 桦褐孔菌营养组合物 |
CN102247526A (zh) * | 2010-05-17 | 2011-11-23 | 李恒勇 | 一种糖尿乐胶囊及制备方法 |
CN104940412A (zh) * | 2015-05-28 | 2015-09-30 | 张军 | 一种中药养生酵素 |
CN109090589A (zh) * | 2018-08-30 | 2018-12-28 | 河南盈哈哈食品有限公司 | 一种山药酵素及其制作方法 |
CN109618944A (zh) * | 2018-12-13 | 2019-04-16 | 哈尔滨森荞生物科技有限公司 | 一种超敏蛋白复合酶制剂及其制备方法与应用 |
CN109906842A (zh) * | 2018-12-13 | 2019-06-21 | 哈尔滨森荞生物科技有限公司 | 超敏蛋白复合酶制剂在防治黄龙病中的应用 |
CN110074139A (zh) * | 2019-05-13 | 2019-08-02 | 河南地卫士生物科技有限公司 | 一种木霉菌与超敏蛋白复合酶复配的生物农药 |
Non-Patent Citations (3)
Title |
---|
牛君等: "中国食用菌降血糖研究进展", 《中国食用菌》 * |
许蓬娟等: "酵素在生物作用中的研究进展", 《食品与发酵科技》 * |
贺紫薇等: "桦褐孔菌研究进展", 《中医药信息》 * |
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