CN114947124A - 具有缓解痛风作用的固体组合物及其制备方法 - Google Patents
具有缓解痛风作用的固体组合物及其制备方法 Download PDFInfo
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- CN114947124A CN114947124A CN202210433057.5A CN202210433057A CN114947124A CN 114947124 A CN114947124 A CN 114947124A CN 202210433057 A CN202210433057 A CN 202210433057A CN 114947124 A CN114947124 A CN 114947124A
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Abstract
本发明提供具有缓解痛风作用的固体组合物及其制备方法,所述固体组合物在稳定性、口感、降低尿酸、缓解疼痛方面具有良好的综合效果。
Description
技术领域
本发明涉及具有缓解痛风作用的固体组合物及其制备方法,可应用于食品、保健食品、药品等各领域。
背景技术
痛风(Gout)是一种常见的关节炎类型的疾病,各个年龄段均可能罹患本病,男性发病率高于女性。痛风患者经常会在夜晚出现突然性的关节疼,发病急,关节部位出现疼痛、水肿、红肿和炎症,疼痛感慢慢减轻直至消失,持续几天或几周不等。已知痛风发作与体内尿酸浓度有关,尿酸会在关节腔等处形成尿酸盐沉积,进而引发急性关节疼痛。现有技术中虽然已有一些具有缓解痛风作用的药物以及食品,但有的口感较差患者顺应性不好,有的效果过于剧烈或过于轻微,并不理想。综合考虑患者的口感、降低尿酸的效果、降低疼痛的效果、产品稳定性等,仍期待有更好的产品来满足患者的需求。
发明内容
为解决上述问题,本发明的发明人进行了长期锐意地研究。发明人发现,对于痛风患者而言,为了缓解痛风症状并减少痛风的复发,需要兼顾尿酸生成、尿酸排出、酸碱平衡,同时,为了减缓疼痛感受,需要配合消炎剂。基于这样的发现和发明构思,发明人发现了下述固体组合物,其在口感、降低尿酸的效果、降低疼痛的效果、产品稳定性等方面,具有综合的优势,并由此完成了本发明。本发明的固体组合物包含降尿酸剂、促排剂、调解排出剂、消炎剂、矫味剂、以及助流剂,优选还含有包合剂。本发明的固体组合物优选含有山竹果粉作为消炎剂与其他成分组合使用,用于降低尿酸、缓解痛风症状以及降低由于上述原因引起的肝肾功能异常风险。
本发明还提供所述固体组合物的制备方法,该方法包括以喷雾制粒的形式,对吸湿性强的成分用包合剂进行包覆,将得到的颗粒干燥,然后与剩余成分进行混合,以制备得到稳定性良好的固体组合物。
具体而言,本发明例如包括以下内容。
[1]一种具有缓解痛风作用的固体组合物,其包含:降尿酸剂、促排剂、调解排出剂、消炎剂、矫味剂、和助流剂。
[2]上述[1]所述的固体组合物,其中,降尿酸剂由向日葵花粉、葵花盘低聚肽粉、葵花盘提取物以及海洋鱼低聚肽粉中三种或三种以上成分组成。
[3]上述[1]-[2]中任一项所述的固体组合物,其中,促排剂是薏苡仁粉、茯苓粉这两种与选自山楂粉、淡竹叶粉、白茅根粉、芹菜籽粉、栀子粉中的两种的组合。
[4]上述[1]-[3]中任一项所述的固体组合物,其中,调解排出剂选自柠檬酸、柠檬果汁粉、酸樱桃粉、酸樱桃浓缩果汁粉中的一种或者两种以上。
[5]上述[1]-[4]中任一项所述的固体组合物,其中,消炎剂是山竹果粉、鱼腥草粉和杜仲雄花粉中的一种或者两种以上。
[6]上述[1]-[5]中任一项所述的固体组合物,其中,矫味剂是山梨糖醇和甜菊糖苷这两种的组合。
[7]上述[1]-[6]中任一项所述的固体组合物,其中,所述固体组合物还含有包合剂,包合剂是麦芽糊精。
[8]上述[1]-7]中任一项所述的固体组合物,其中,助流剂是二氧化硅。
[9]上述[1]-[8]中任一项所述的固体组合物,其中,各成分的含量以重量份计:降尿酸剂25-40份;促排剂8-1 8份;调解排出剂8-1 5份;消炎剂4-8份;矫味剂30-35份;助流剂0.5-2.5份;优选还含有包合剂0.5-2.5份。
[10]上述[1]-[9]中任一项所述的固体组合物,其中,各成分的含量以重量份计:葵花盘提取物12-20份;海洋鱼低聚肽粉2-3份;葵花盘低聚肽粉4-10份;薏苡仁粉2-6份;茯苓粉2-6份;山楂粉2-4份;淡竹叶粉2-5份;山竹果粉2-5份;鱼腥草粉1-5份;柠檬酸6-12份;柠檬果汁粉2-4份;山梨糖醇25-35份;甜菊糖苷0.8-1.2份;二氧化硅1-2份;麦芽糊精0.8-1.2份。
[11]制备上述[1]-[10]中任一项所述的固体组合物的方法,该方法包括:
(1)用喷雾制粒方法,将包合剂溶液喷雾至部分或全部的吸湿性成分的混合物,进行制粒,
(2)将所得颗粒干燥至水分≤2%,
(3)整粒,
(4)整粒后的颗粒与剩余物料混合。
[12]上述[11]所述的制备方法,其中,吸湿性成分为葵花盘提取物、薏苡仁粉、茯苓粉、山楂粉、淡竹叶粉、鱼腥草粉、山梨糖醇。
具体实施方式
本发明的固体组合物包含:降尿酸剂、促排剂、调解排出剂、消炎剂、矫味剂、和助流剂,优选还含有包合剂。本发明的固体组合物可以为仅由上述这些成分组成。
所述的降尿酸剂是指具有抑制尿酸合成作用的成分,例如,可选自:向日葵花粉、葵花盘低聚肽粉、葵花盘提取物以及海洋鱼低聚肽粉中的一种、两种、三种或四种。例如,降尿酸剂由日葵花粉以及海洋鱼低聚肽粉组成。例如,由葵花盘低聚肽粉以及海洋鱼低聚肽粉组成。优选地,降尿酸剂由葵花盘提取物、葵花盘低聚肽粉、以及海洋鱼低聚肽粉这三种成分组成。例如由日葵花粉、葵花盘低聚肽粉、以及海洋鱼低聚肽粉这三种成分组成。
所述的促排剂是指具有促进尿酸排泄作用的成分,例如,可选自药食同源成分中的四种以上,例如选自:薏苡仁粉、茯苓粉、山楂粉、淡竹叶粉、白茅根粉、芹菜籽粉、栀子粉中的四种或四种以上的组合。例如,可以是薏苡仁粉、茯苓粉这两种与选自山楂粉、淡竹叶粉、白茅根粉、芹菜籽粉、栀子粉中的两种或者三种的组合。例如,可以是薏苡仁粉、茯苓粉、山楂粉、淡竹叶粉这四种的组合。
所述的调解排出剂是指具有pH调解功能的成分,可以缓解尿酸过度排出所致的酸碱失衡,例如可选自酸性添加剂,例如:柠檬酸、酒石酸、苹果酸、柠檬果汁粉、苹果粉、蓝莓果粉、酸樱桃粉、酸樱桃浓缩果汁粉中的一种或者两种以上。例如,可选自柠檬酸、柠檬果汁粉、酸樱桃粉、酸樱桃浓缩果汁粉中的一种或者两种以上。例如,可以是自柠檬酸和柠檬果汁粉这两种的组合。
所述的消炎剂是指具有消除或缓解炎性症状功能的成分,例如可选自:山竹果粉、鱼腥草粉和杜仲雄花粉中的一种或者两种以上。例如,山竹果粉和鱼腥草粉这两种的组合。优选消炎剂含有山竹果粉。
所述的矫味剂是指具有甜味作用的辅料,可以选自山梨糖醇、木糖醇、异麦芽酮糖醇、三氯蔗糖、甜菊糖苷中的一种或者两种以上。例如,山梨糖醇和甜菊糖苷这两种的组合。
所述助流剂例如二氧化硅等。
所述包合剂为例如糊精等,例如麦芽糊精、环糊精等。优选麦芽糊精作为包合剂。
本发明的固体组合物优选含有山竹果粉作为消炎剂与其他成分组合使用,用于缓解痛风。
优选地,本发明固体组合物包含:葵花盘提取物、葵花盘低聚肽粉、以及海洋鱼低聚肽粉这三种作为降尿酸剂;薏苡仁粉、茯苓粉、山楂粉、淡竹叶粉这四种药食同源成分作为促排剂;柠檬酸、柠檬果汁粉这两种酸性物质作为调解排出剂;山竹果粉和鱼腥草粉这两种作为消炎剂;山梨糖醇和甜菊糖苷这两种作为矫味剂;以及二氧化硅作为助流剂;优选还含有麦芽糊精作为包合剂。本发明的固体组合物可以为仅由上述这些成分组成。
本发明中所述的各种成分,均为市售的已知成分,可以在市场上购买获得。例如,向日葵花粉、葵花盘提取物、葵花盘低聚肽粉、海洋鱼低聚肽粉、薏苡仁粉、茯苓粉、山楂粉、淡竹叶粉、白茅根粉、芹菜籽粉、栀子粉、山竹果粉、鱼腥草粉、杜仲雄花粉等均为市售的已知产品,符合本领域已知的质量标准。例如,山竹果粉可以购自上海楷达生物科技有限公司。
本发明优选以下固体组合物:
本发明中所述的固体组合物包含以下成分或者仅由这些成分组成,以重量份计:降尿酸剂25-40份;促排剂8-18份;调解排出剂8-15份;消炎剂4-8份;矫味剂30-35份;助流剂0.5-2.5份;优选还含有包合剂0.5-2.5份;
其中,所述的降尿酸剂25-40份,可以为25-35份,25-30份,28.6份,其成分可以由向日葵花粉、葵花盘提取物、海洋鱼低聚肽粉、葵花盘低聚肽粉中的一种或两种以上组成,优选由葵花盘提取物、海洋鱼低聚肽粉、葵花盘低聚肽粉这三种组成;
所述的促排剂8-18份,可以为12-18份,16.4份,其成分可以由选自以下药食同源成分薏苡仁粉、茯苓粉、山楂粉、淡竹叶粉、白茅根粉、芹菜籽粉、栀子粉中的四种或四种以上的组合组成,例如,可以是薏苡仁粉、茯苓粉这两种与选自山楂粉、淡竹叶粉、白茅根粉、芹菜籽粉、栀子粉中的两种或者三种的组合,例如是薏苡仁粉、茯苓粉、山楂粉、淡竹叶粉这四种药食同源成分的组合;
所述的调解排出剂8-15份,可以为10-14份,10.8份,其成分可以由柠檬酸、酒石酸、苹果酸、柠檬果汁粉、苹果粉、蓝莓果粉、酸樱桃粉、酸樱桃浓缩果汁粉中的一种或者两种以上的酸性物质组成,例如,可以是选自柠檬酸、柠檬果汁粉、酸樱桃粉、酸樱桃浓缩果汁粉中的一种或者两种以上,可以是自柠檬酸和柠檬果汁粉这两种的组合;
所述的消炎剂3-8份,可以为5-8份,7.2份,其成分可以是由竹果粉、鱼腥草粉和杜仲雄花粉中的一种或者两种以上组成,可以是山竹果粉和鱼腥草粉这两种的组合;优选含有山竹果粉;
所述的矫味剂30-35份,可以为32-35份,34.8份,其成分可以是由山梨糖醇、木糖醇、异麦芽酮糖醇、三氯蔗糖、甜菊糖苷中的一种或者两种以上组成,可以是山梨糖醇和甜菊糖苷这两种的组合;
所述的助流剂0.5-2.5份,可以为0.5-1.5份,1.4份,其成分可以为二氧化硅
所述的包合剂0.5-2.5份,可以为0.5-1.5份,0.8份,其成分可以为麦芽糊精。
进一步地,本发明优选以下固体组合物:
本发明的固体组合物包含以下成分或者仅由这些成分组成,以重量份计:降尿酸剂25-30份;促排剂10-18份;调解排出剂10-14份;消炎剂4-8份;矫味剂32-35份;助流剂0.5-1.5份;包合剂0.5-1.5份;
例如,本发明的固体组合物包含以下成分或者仅由这些成分组成,以重量份计:降尿酸剂28.6份;促排剂16.4份;调解排出剂10.8份;消炎剂7.2份;矫味剂34.8份;助流剂1.4份;包合剂0.8份;
其中,所述的降尿酸剂由向日葵花粉、葵花盘提取物、海洋鱼低聚肽粉、葵花盘低聚肽粉中三种或三种以上成分组成,例如是葵花盘提取物、海洋鱼低聚肽粉、葵花盘低聚肽粉这三种的组合;
所述的促排剂是药食同源成分薏苡仁粉、茯苓粉这两种与选自山楂粉、淡竹叶粉、白茅根粉、芹菜籽粉、栀子粉中的两种或者三种的组合,例如是薏苡仁粉、茯苓粉、山楂粉、淡竹叶粉这四种的组合;
所述的调解排出剂是选自柠檬酸、柠檬果汁粉、酸樱桃粉、酸樱桃浓缩果汁粉中的一种或者两种以上,或者是自柠檬酸和柠檬果汁粉这两种的组合;
所述的消炎剂是由山竹果粉、鱼腥草粉和杜仲雄花粉中的一种或者两种以上组成,或者是山竹果粉和鱼腥草粉这两种的组合;优选含有山竹果粉;
所述的矫味剂是山梨糖醇和三氯蔗糖这两种的组合;
二氧化硅是助流剂,麦芽糊精是包合剂。
进一步地,本发明优选以下固体组合物:
本发明的固体组合物包含以下成分或者仅由这些成分组成,以重量份计:葵花盘提取物12-20份;海洋鱼低聚肽粉2-3份;葵花盘低聚肽粉4-10份;薏苡仁粉2-6份;茯苓粉2-6份;山楂粉2-4份;淡竹叶粉2-5份;山竹果粉2-5份;鱼腥草粉1-5份;柠檬酸6-12份;柠檬果汁粉2-4份;山梨糖醇25-35份;甜菊糖苷0.8-1.2份;二氧化硅1-2份;麦芽糊精0.8-1.2份。
进一步地,本发明优选以下固体组合物:
本发明的固体组合物包含以下成分或者仅由这些成分组成,以重量份计:葵花盘提取物16-20份;海洋鱼低聚肽粉2-3份;葵花盘低聚肽粉6-8份;薏苡仁粉4-5份;茯苓粉4-5份;山楂粉3-4份;淡竹叶粉4-5份;山竹果粉3-4份;鱼腥草粉4-5份;柠檬酸8-10份;柠檬果汁粉2-3份;山梨糖醇32-34份;甜菊糖苷0.8-1.0份;二氧化硅1-1.4份;麦芽糊精0.8-1份。
例如,本发明的固体组合物包含以下成分或者仅由这些成分组成,以重量份计:葵花盘提取物20份;海洋鱼低聚肽粉2.6份;葵花盘低聚肽粉6份;薏苡仁粉4.6份;茯苓粉4.6份;山楂粉3份;淡竹叶粉4.2份;山竹果粉3份;鱼腥草粉4.2份;柠檬酸8份;柠檬果汁粉2.8份;山梨糖醇34份;甜菊糖苷0.8份;二氧化硅1.4份;麦芽糊精0.8份。
本发明的固体组合物,可以通过将各成分混合均匀而制备得到,也可以以湿法制粒的方式,制备软材然后整粒,再与剩余成分混合而制备得到。
此外,本发明的发明人尤其注意到,本发明的固体组合物优选以喷雾制粒的方式制备,以包合剂(例如环糊精、麦芽糊精)喷雾至全部或部分的吸湿性强的成分的混合物进行制粒,可以起到抗吸湿作用,可以显著增加所得固体组合物的稳定性。
例如,本发明提供所述固体组合物的制备方法,其包括:
(1)用喷雾制粒方法,将包合剂溶液喷雾至全部或部分的吸湿性成分的混合物,进行制粒,
(2)将所得颗粒干燥至水分≤2%,
(3)整粒,
(4)整粒后的颗粒与剩余物料混合。
具体地,可以利用沸腾干燥制粒机进行喷雾制粒。将吸湿性强的成分(例如山梨糖醇、葵花盘提取物、薏苡仁粉、茯苓粉、山楂粉、淡竹叶粉、鱼腥草粉等),投料至沸腾干燥一步制粒机,混合均匀后喷入由包合剂(例如麦芽糊精)制备的水溶液(例如麦芽糊精浆溶液)(浓度10-20%左右,例如16%),控制进风温度(大约60-80℃,例如75℃)以及蠕动泵的压力(0.4-0.6Mpa,)和转速(100-120rpm),保持≤20kg/h的速度喷完,使各成分被糊精均匀包裹,然后烘干至水分≤2%。随后,与其他成分进行混合,混合均匀后,分装,例如每袋5g。
在上述方法中,可以将全部或部分量的山梨糖醇用于喷雾制粒,优选将部分量(例如40-90%,70%左右,或者更多些或更少些)的山梨糖醇进行上述喷雾制粒,剩余量的山梨糖醇在制粒后,与其他剩余成分混合。所述的麦芽糊精浆溶液为将麦芽糊精溶解于热水得到浆液然后再用水稀释至规定浓度而制备。
本发明的固体组合物优选是水分含量≤2%。
本发明的固体组合物可以是饮料、保健食品、药品等。本发明的固体组合物优选是颗粒的形式,以袋来分装,根据需要设定每袋的重量,优选每袋3-8g,例如5g。消费者或者患者在服用时,用温开水冲泡而服用。用量可以根据需要进行调整,例如每日一次,每次两袋。本发明的固体组合物在口感、稳定性、降低尿酸、缓解疼痛方面,均具有良好的效果。优选地,本发明的固体组合物作为固体饮料。
实施例
以下通过实施例对本发明进行进一步解释和说明,但本发明并不限定于实施例。
实施例中用到的各个成分,均为市售产品,符合相关质量标准。
实施例1
根据表1中的成分及其用量,将各成分以固体形式直接混合,混合均匀后,得到固体组合物,分装,每袋5g。
表1:
成分名称 | 千袋用量(g) | 重量份 |
山梨糖醇 | 1740 | 34.8 |
葵花盘提取物 | 1000 | 20 |
柠檬酸 | 400 | 8 |
葵花盘低聚肽粉 | 300 | 6 |
薏苡仁粉 | 230 | 4.6 |
茯苓粉 | 230 | 4.6 |
淡竹叶粉 | 210 | 4.2 |
鱼腥草粉 | 210 | 4.2 |
山竹果粉 | 150 | 3 |
山楂粉 | 150 | 3 |
柠檬果汁粉 | 140 | 2.8 |
海洋鱼低聚肽粉 | 130 | 2.6 |
二氧化硅 | 70 | 1.4 |
甜菊糖苷 | 40 | 0.8 |
实施例2
采用湿法制粒。将表1中用量的葵花盘提取物、薏苡仁粉、茯苓粉、山楂粉、淡竹叶粉、鱼腥草粉、以及表1中的70%用量的山梨糖醇混合,用纯化水制得软材,制粒,经沸腾干燥设备烘干至水分≤2%,然后与表1中剩余的成分进行混合,混合均匀,得到固体组合物,分装,每袋5g。
实施例3
采用麦芽糊精喷雾制粒。将表2中用量的葵花盘提取物、薏苡仁粉、茯苓粉、山楂粉、淡竹叶粉、鱼腥草粉、以及表2中的70%用量的山梨糖醇投料至沸腾干燥一步制粒机,混合均匀后喷入由表2中用量的麦芽糊精制备的麦芽糊精浆溶液(浓度16%),控制进风温度(75℃)以及蠕动泵的压力(0.4-0.6Mpa,)和转速(100-120rpm),保持≤20kg/h的速度喷完,使各成分被麦芽糊精均匀包裹,然后烘干至水分≤2%。随后,与表2中的剩余成分进行混合,混合均匀,得到固体组合物,分装,每袋5g。
表2:
实施例4
根据表3中的成分,按照与实施例3类似的方法制备固体组合物。将表3中用量的葵花盘提取物、薏苡仁粉、茯苓粉、山楂粉、淡竹叶粉、鱼腥草粉以及表3中的70%用量的山梨糖醇投料至一步制粒机,混合均匀后喷入由表3中用量的麦芽糊精制备的麦芽糊精浆溶液(浓度16%),控制进风温度(75℃)以及蠕动泵的压力(0.4-0.6Mpa,)和转速(100-120rpm),保持≤20kg/h的速度喷完,使各成分被糊精均匀包裹,然后烘干至水分≤2%。随后,与表4中的剩余成分进行混合,混合均匀,得到固体组合物,分装,每袋5g。
表3:
实施例5
根据表4中的成分,按照与实施例3类似的方法制备固体组合物。将表4中用量的葵花盘提取物、白茅根粉、栀子粉、山楂粉、淡竹叶粉、鱼腥草粉以及表4中的70%用量的山梨糖醇投料至一步制粒机,混合均匀后喷入由表4中用量的麦芽糊精制备的麦芽糊精浆溶液(浓度16%),控制进风温度(75℃)以及蠕动泵的压力(0.4-0.6Mpa,)和转速(100-120rpm),保持≤20kg/h的速度喷完,使各成分被糊精均匀包裹,然后烘干至水分≤2%。随后,与表4中的剩余成分进行混合,混合均匀,得到固体组合物,分装,每袋5g。
表4:
对比例1
根据表5中的成分,按照与实施例3类似的方法制备固体组合物。将表5中用量的葵花盘提取物、薏苡仁粉、茯苓粉、山楂粉以及表5中的70%用量的山梨糖醇投料至一步制粒机,混合均匀后喷入由表3中用量的麦芽糊精制备的麦芽糊精浆溶液(浓度16%),控制进风温度(75℃)以及蠕动泵的压力(0.4-0.6Mpa,)和转速(100-120rpm),保持≤20kg/h的速度喷完,使各成分被糊精均匀包裹,然后烘干至水分≤2%。随后,与表5中的剩余成分进行混合,混合均匀,得到固体组合物,分装,每袋5g。
表5:
成分名称 | 千袋用量(g) | 重量份 |
山梨糖醇 | 1800 | 36 |
葵花盘提取物 | 1250 | 25 |
柠檬酸 | 400 | 8 |
葵花盘低聚肽粉 | 300 | 6 |
薏苡仁粉 | 230 | 4.6 |
茯苓粉 | 230 | 4.6 |
山楂粉 | 220 | 4.4 |
柠檬果汁粉 | 220 | 4.4 |
海洋鱼低聚肽粉 | 200 | 4 |
二氧化硅 | 70 | 1.4 |
麦芽糊精 | 40 | 0.8 |
甜菊糖苷 | 40 | 0.8 |
实验例1稳定性实验
将实施例1-3中制备得到的模拟上市包装产品,一式十份样品,放置于恒温恒湿箱,在37±2℃,相对湿度75%±5%的加速试验条件下保存3个月,考察产品是否有结块现象,以评价稳定性。
表6
实施例1 | 实施例2 | 实施例3 | |
是否结块 | 7个样品有结块 | 3个样品有结块 | 均无结块 |
由表6可知,实施例3得到的固体组合物产品,稳定性明显优于实施例1和实施例2。
本发明的发明人注意到,本发明的一些成分具有较强的吸湿性,采用实施例1中所述的将各成分直接混合分装生产工艺时,制得的产品在加速稳定性实验中有结块。当采用实施例2中所述的湿法制粒时,在加速稳定性实验中结块现象有较大好转,但仍然不够理想;而当采用实施例3中所述的以麦芽糊精浆溶液进行喷雾包覆的工艺,则产品的稳定性显著提高。这提示,以麦芽糊精等包合剂预先对吸湿成分进行包合,例如采用喷雾制粒的方式,然后再与剩余成分混合,对于提高本发明的固体组合物的稳定性具有重要的作用。
实验例2缓解痛风效果实验
对103名痛风成年患者(主诉尿酸高,有关节疼痛等痛风症状,年龄:38-72岁,男女:80:23),将患者按照尿酸值和痛风症状进行均衡分组,按照每日以温水冲服,口服一次,每次1袋(5g/袋)的方法,服用实施例3(41人)、实施例4(30人)、对比例1(32人)的产品,服用一个月。以服用一个月后的尿酸值、疼痛的缓解情况为指标,对各产品的缓解痛风效果进行了评价。
实验结果:实施例3:患者按照规定的服用方法服用一个月后尿酸值实现了较为平稳的下降(13.22%),没有痛风发作,且绝大多数(95.12%)有关节疼痛的患者,在服用2-5天后疼痛感都显著减弱;实施例4:按照规定的服用方法服用一个月后尿酸值均有较明显的降低(12.95%),但仍有部分患者(36.67%)关节疼痛症状改善较慢;对比例1:该配方的降尿酸效果显著(26.50%),但是约25%的患者在服用一周左右出现痛风发作。由上述结果可知,实施例3的产品对于患者尿酸值降低、痛风复发情况、疼痛的缓解的综合方面,效果更好。
实验结果分析
对比例1中的约25%的患者在服用一周左右出现痛风发作,这可能是由于尿酸降低过快,血液中pH值变化过大,诱发了关节中尿酸盐的活动,导致痛风发作。这提示,降尿酸剂、促排剂、调解排出剂的用量配比具有较为重要的影响。
实施例4与对比例1相比,患者尿酸值降低较为温和,整体效果有很大进步。这提示,通过增加消炎剂(例如鱼腥草粉),调整降尿酸剂、促排剂、调解排出剂的用量配比(减少降尿酸剂的用量,例如葵花盘提取物、葵花盘低聚肽粉、海洋鱼低聚肽粉;平衡促排剂的组分,例如在薏苡仁粉、茯苓粉、山楂粉这三种的基础上增加淡竹叶粉从而变成四种),可以使得缓解痛风效果得到提高,药食同源成分由三种变为四种具有良好的平衡效果。同时,考虑到实施例4中炎症效果有好转但也仍存在有少数患者关节疼痛症状改善较慢的情况,这提示消炎剂的应用和选择具有较为重要的影响。
实施例3与实施例4相比,添加了山竹果粉作为消炎剂,实验结果显示尿酸值也是实现了平稳的下降,且绝大多数有关节疼痛的患者,在服用2-5天后疼痛感都显著减弱,实现了更好的缓解痛风效果。这提示,应用山竹果粉作为消炎剂与其他组分组合,具有较为重要的影响。
实验例3口感实验
作为口感实验,由实验例2中的60名患者,对在以温水冲服2袋口服实施例3、实施例4、对比例1(各20人)时的口感给出评价,评分标准:较差6分,一般7分,较好8分,很好9分,具体结果示于表7(表中的数值是20人打分的平均值)如下:
如表7中所示,实施例3和实施例4的固体组合物在溶解性和味道方面,相比于对比例1具有优势,实施例3的效果更好。
综上所述,本发明的固体组合物具有良好的口感、稳定性、降低尿酸和缓解疼痛的作用,取得了良好的技术效果。
本发明如上所述进行了描述。当然本发明在其范围中包含各种方式的变化,这些变化并不偏离本发明的范围。此外,对于对本领域技术人员而言明显是本发明的变形的改变,都包括在权利要求的范围内。
Claims (10)
1.一种具有缓解痛风作用的固体组合物,其包含:降尿酸剂、促排剂、调解排出剂、消炎剂、矫味剂、和助流剂。
2.所述的固体组合物,其中,降尿酸剂由向日葵花粉、葵花盘低聚肽粉、葵花盘提取物以及海洋鱼低聚肽粉中的三种或三种以上成分组成。
3.权利要求1-2中任一项所述的固体组合物,其中,促排剂是选自薏苡仁粉、茯苓粉、山楂粉、淡竹叶粉、白茅根粉、芹菜籽粉、栀子粉中的四种或四种以上的药食同源成分的组合。
4.权利要求1-3中任一项所述的固体组合物,其中,调解排出剂选自柠檬酸、酒石酸、苹果酸、柠檬果汁粉、苹果粉、蓝莓果粉、酸樱桃粉、酸樱桃浓缩果汁粉中的一种或者两种以上的酸性成分。
5.权利要求1-4中任一项所述的固体组合物,其中,消炎剂是选自山竹果粉、鱼腥草粉和杜仲雄花粉中的一种或者两种以上。
6.权利要求1-5中任一项所述的固体组合物,其中,矫味剂是选自山梨糖醇、木糖醇、异麦芽酮糖醇、三氯蔗糖、甜菊糖苷中的一种或者两种以上。
7.权利要求1-6中任一项所述的固体组合物,其中,所述固体组合物还含有包合剂,包合剂选自环糊精、麦芽糊精。
8.权利要求1-7中任一项所述的固体组合物,其中,助流剂是二氧化硅。
9.权利要求1-8中任一项所述的固体组合物,其中,各成分的含量以重量份计:降尿酸剂25-40份;促排剂8-18份;调解排出剂8-15份;消炎剂4-8份;矫味剂30-35份;助流剂0.5-2.5份;优选还含有包合剂0.5-2.5份。
10.制备权利要求7-9中任一项所述的固体组合物的方法,该方法包括:
(1)用喷雾制粒方法,将包合剂溶液喷雾至吸湿性成分的混合物,进行制粒,
(2)将所得颗粒干燥至水分≤2%,
(3)整粒,
(4)整粒后的颗粒与剩余物料混合。
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