CN118141954A - 一种猴耳环可溶性粉剂及其制备方法 - Google Patents
一种猴耳环可溶性粉剂及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种猴耳环可溶性粉剂及其制备方法,属于中兽药制剂领域,它是由猴耳环水提取物与助溶剂β‑环糊精混合后,经过喷雾干燥制备而成,其中,猴耳环水提取物与β‑环糊精的重量配比为:猴耳环水提取物,以猴耳环药材重量计100份,β‑环糊精10‑20份。本发明通过特定的辅料助溶剂选择,既能保证猴耳环水提取物的溶解性,养殖企业使用方便(直接兑入饮用水,不需要单独给药),且静置后不产生沉淀,不会导致养殖场水线堵塞,药品稳定可靠,密封条件下不会出现水解、吸潮、氧化等变质情况,便于运输,满足药典对可溶性粉剂的质量要求,适合工业化大生产,为中兽药的临床使用提供了一种新的方式。
Description
技术领域
本发明涉及一种猴耳环可溶性粉剂及其制备方法,属于中兽药制剂领域。
背景技术
猴耳环Pithecellobium clypearia Benth.为豆科(Leguminosae)猴耳环属Pithecellobium Mart.植物,主要分布在我国的广东、浙江、福建、云南、广西、海南等地。猴耳环始载于明代李时珍所著《本草纲目》,清代赵学敏所著《陆川本草》中也有记载。其干燥带叶茎枝可入药,味微苦、涩,性微寒,归脾、胃、肝经,具有清热解毒、凉血消肿、止泻、去湿敛疮的功效。猴耳环作为传统中药药用历史悠久,其单方制剂猴耳环消炎胶囊、猴耳环消炎片、猴耳环消炎颗粒在临床上主要用于治疗上呼吸道感染、急性咽喉炎、急性扁桃体炎、急性胃肠炎等症。现代研究表明猴耳环主要含有黄酮类、苯丙素类、有机酚酸类、三萜和甾体类化合物,具有抗氧化、抗病毒、抑制T淋巴细胞增殖、抗炎、抗过敏等药理作用。专利申请号:201711404466.8,发明名称:猴耳环或提取物在制备治疗和/或辅助治疗畜禽支气管肺炎的药物中的用途,公开了猴耳环或提取物在制备治疗和/或辅助治疗畜禽支气管肺炎的药物中的用途。
在2020版《中国兽药典》二部附录中,加入了新的剂型可溶性粉剂,可溶性粉剂系指中药材、中药饮片经提取制成的提取物或与适宜的辅料经粉碎、均匀混合制成的可溶于水的干燥粉末状制剂,专用于饮水给药。这类制剂在水中应具有良好的溶解性,便于动物通过饮水摄入药物,从而达到预防或治疗疾病的目的。可溶性粉剂对溶解性的要求较高,在25℃±2℃的溶剂中,上下翻转10次,需全部溶解,静置30分钟,不得有浑浊或沉淀生成。
猴耳环水提取物制备成可溶性粉剂,仍会存在溶解性的问题,尤其是水提取物溶解后静置会有沉淀,不能满足兽药典的要求。
发明内容
本发明的技术方案是提供了一种猴耳环可溶性粉剂,本发明的另一技术方案是提供了该猴耳环可溶性粉剂的制备方法和用途。
本发明提供了一种猴耳环可溶性粉剂,它是由猴耳环水提取物与助溶剂β-环糊精混合后,经过喷雾干燥制备而成,其中,猴耳环水提取物与β-环糊精的重量配比为:
猴耳环水提取物,以猴耳环药材重量计 100份,β-环糊精10-20份。
其中,所述的猴耳环水提取物与β-环糊精的重量配比为:
猴耳环水提取物,以猴耳环药材重量计 100份,β-环糊精20份。
本发明提供了一种所述的可溶性粉剂的制备方法,它包括如下步骤:
a、取猴耳环药材,加水回流提取,得水提取物;
b、将a步骤制备的水提取物中加入β-环糊精,搅拌溶解;
c、在80℃条件下浓缩至稠膏;
d、将稠膏输入喷雾干燥塔干燥;
e、经d步骤喷雾干燥后的产物,再在70℃烘干,即得猴耳环可溶性粉剂。
其中,d步骤所述的干燥参数为进风温度195℃,出风温度90℃,蠕动泵速度25L/小时,喷雾间隙3秒。
β-环糊精是一种环状低聚糖,具有独特的环状中空结构,其外部亲水、内部疏水的特性使其在多个领域有着广泛的应用。β-环糊精可以改善难溶性药物在水性介质中的溶出性质,通过化学修饰进一步提升其增溶能力,β-环糊精与难溶性药物分子形成包合物,提高药物在水中的溶解度(王彦竹,等,β-环糊精及其衍生物在药学中的应用进展,中国药房2014年第25卷第33期)。本申请意外地发现,并非是利用的β-环糊精作为包合物的辅料的作用,而是,先在猴耳环水提取物中加入β-环糊精,溶解后浓缩再干燥,显著改善了猴耳环水提取物的溶解性质。
本发明的有益效果是:
本发明通过特定的辅料助溶剂选择,既能保证猴耳环水提取物的溶解性,养殖企业使用方便(直接兑入饮用水,不需要单独给药),且静置后不产生沉淀,不会导致养殖场水线堵塞,药品稳定可靠,密封条件下不会出现水解、吸潮、氧化等变质情况,便于运输,满足药典对可溶性粉剂的质量要求,适合工业化大生产,为中兽药的临床使用提供了一种新的方式。
具体实施方式
实施例1 本发明猴耳环可溶性粉剂的制备
取猴耳环药材500g,加入20倍量水,回流提取2次,每次1小时,保温2小时,过滤,合并滤液;滤液加入100gβ-环糊精,充分搅拌溶解;在80℃条件下浓缩至相对密度为1.10的稠膏;稠膏输入喷雾干燥塔,干燥参数为:进风温度195℃,出风温度90℃,蠕动泵速度25L/小时,喷雾间隙3秒;得到喷雾干燥粉后,喷雾干燥粉在70℃干燥2h,即得猴耳环可溶性粉1。
其中,喷雾干燥后,喷雾干燥粉中水分含量在10-15%,需进一步烘干。
将猴耳环可溶性粉1按上述质量标准进行含量测定,测定结果显示猴耳环可溶性粉1中没食子酸的含量为236.58mg/g。
实施例2本发明猴耳环可溶性粉剂的制备
取猴耳环药材50kg,加入20倍量水,回流提取2次,每次1小时,保温2小时,过滤,合并滤液;滤液加入5kgβ-环糊精,充分搅拌溶解;在80℃条件下浓缩至相对密度为1.10的稠膏;稠膏输入喷雾干燥塔,干燥参数为:进风温度205℃,出风温度99℃,蠕动泵速度25L/小时,喷雾间隙3秒;得到喷雾干燥粉后,喷雾干燥粉在70℃干燥2h,即得猴耳环可溶性粉2。
将猴耳环可溶性粉2按上述质量标准进行含量测定,测定结果显示猴耳环可溶性粉2中没食子酸的含量为233.69mg/g。
实施例3 猴耳环可溶性粉剂中没食子酸的含量检测方法
对照品溶液的制备:
取没食子酸对照品适量,加甲醇制成100μg/mL的对照品溶液;
样品溶液的制备:
取猴耳环可溶性粉1g,至100mL容量瓶中,加甲醇至刻度,超声15分钟,过滤,取续滤液;
色谱条件:
检测波长为270nm
流动相A为乙腈,流动性B为0.1%磷酸二氢钾溶液,流速为1mL/min
流动梯度如表1:
表1 流动相梯度表
时间(min) | 流动相A(%) | 流动性B(%) |
0-10 | 5-15 | 95-85 |
10-30 | 15-40 | 85-60 |
30-40 | 40-5 | 60-95 |
测定法分别精密吸取对照品溶液与供试品溶液各10μl,注入液相色谱仪,测定,即得。
以下通过药剂学试验证明本发明的有益效果。
试验例1 本发明猴耳环可溶性粉剂辅料及制备工艺条件筛选试验
1试验仪器与设备
高效液相色谱仪(Agilent 1260型,DAD检测器,安捷伦科技(中国)有限公司)
智能节能恒温槽(DC-0530型,宁波新芝生物科技股份有限公司)
旋转蒸发器(RE-5210型,上海亚荣生化仪器厂)
恒温水浴锅(B-220型,上海亚荣生化仪器厂)
鼓风干燥箱(DHG-9075型,上海合恒仪器设备有限公司)
循环水式多用真空泵(SHZ-D(Ⅲ)型,上海锦赋试验仪器设备有限公司)
电子分析天平(BP211D型,德国Sartorius公司)
电子计重称(YHC-31001C型,瑞安市英衡电器有限公司)
数控超声波清洗器(KQ-400DB型,昆山市超声仪器有限公司)
超纯水器(YPR-10T型,北京英普瑞环保设备有限公司)
喷雾干燥机(2500型,昆山仪器设备有限公司)
2试验材料
猴耳环饮片(批号:220923,石家庄柏林药业有限公司)
β-环糊精(批号:2023011201,成都市科龙化工试剂厂)
色谱乙腈(批号:238939,赛默飞世尔科技(中国)有限公司)
色谱甲醇(批号:238937,赛默飞世尔科技(中国)有限公司)
甲醇(批号:2023011201,成都市科龙化工试剂厂)
磷酸二氢钾(批号:2023042601,成都市科龙化工试剂厂)
纯化水(实验室自制)
3辅料筛选实验
猴耳环可溶性粉的制备工艺为水提取,其在水中的溶解性较好,但尚不符合2020版《中国兽药典》二部附录中对可溶性粉的要求,除此以外,在实际使用过程中,更优的溶解性具有使用优势,因此,需要筛选一种能有效增加溶解性且对猴耳环提取物无影响的辅料,且不会对可溶性粉性质产生影响。
3.1辅料品种筛选
药用辅料使用成熟,本发明主要需求为增加猴耳环水提取物的溶解性与溶解效率,主要筛选药用辅料中的表面活性剂,包括脂肪酸山梨坦类、聚山梨酯类、聚氧乙烯脂肪酸酯类等物质,根据本研究需要及相关文献研究,初步筛选出下列辅料:①聚山梨酯80②油酸山梨坦80③聚乙二醇④蔗糖⑤β-环糊精⑥泊洛沙姆188⑦空白组(不添加辅料,直接干燥),并展开相关辅料筛选实验。
取猴耳环提取液6份,各100ml(相当于原生药材100g),分别加入20g质量比例的辅料,充分搅拌,通入喷雾干燥机,收集喷雾干燥粉,以没食子酸含量、喷干粉性状、收率等方面展开评价,实验结果如下:
表2 不同辅料制备的猴耳环可溶性粉剂的溶解性实验
辅料种类 | 没食子酸含量(mg/g) | 性状 | 收率(%) |
聚山梨酯80 | 230.11 | 喷干粉成型后迅速粘成团块,溶解缓慢 | 93.2 |
油酸山梨坦80 | 228.30 | 无法形成喷干粉,内壁黏着膏状物 | 0 |
聚乙二醇 | 231.68 | 无法形成喷干粉,内壁黏着膏状物 | 0 |
蔗糖 | 233.89 | 形成均匀粉末,颜色呈棕褐色,溶解迅速 | 97.3 |
β-环糊精 | 230.29 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 98.1 |
泊洛沙姆188 | 228.57 | 无法形成喷干粉,内壁黏着膏状物 | 0 |
空白 | 223.90 | 形成均匀粉末,溶解后静置有沉淀 | 98.2 |
由上表可知,表面活性剂的加入对猴耳环提取物的指标成分含量物明显影响,但对喷雾干燥粉的影响有显著差异,主要表现为部分辅料作用下最终成品无法成型,判断为辅料本身性质导致,综上所述,初步筛选辅料为蔗糖及β-环糊精。
3.2辅料用量筛选
取猴耳环提取液6份,各100ml(相当于原生药材100g),分别加入15、20、25g质量比例的蔗糖及β-环糊精,分搅拌,通入喷雾干燥机,收集喷雾干燥粉,以没食子酸含量、喷干粉性状、收率等方面展开评价,实验结果如下:
表3 辅料用量筛选结果
辅料用量 | 没食子酸含量(mg/g) | 性状 | 收率(%) |
15%蔗糖 | 233.16 | 形成均匀粉末,颜色呈棕褐色,溶解后有轻微浑浊 | 97.2 |
20%蔗糖 | 237.19 | 形成均匀粉末,颜色呈棕褐色,溶解迅速 | 97.1 |
25%蔗糖 | 235.20 | 形成均匀粉末,颜色呈棕褐色,溶解迅速,溶解后有少量晶体析出 | 96.8 |
15%β-环糊精 | 238.29 | 形成均匀粉末,颜色呈褐色,溶解迅速,溶解后有轻微浑浊 | 97.3 |
20%β-环糊精 | 236.62 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 98.1 |
25%β-环糊精 | 238.83 | 形成粉末,颜色呈浅褐色,颜色不均匀 | 97.8 |
由上表可知,不同浓度的辅料用量也会对最终产品性状产生影响,结合实验结果,最终选择辅料为20%的β-环糊精或蔗糖。
3.3喷雾干燥工艺参数筛选
喷雾干燥作为一种新型干燥工艺,生产效率高,成品性状良好,适用于本项目研究,喷雾干燥机的主要参数包括:进风温度、出风温度、蠕动泵速率、喷雾间隙、风速等,其中,出风温度收到进风温度及蠕动泵速率的直接影响,风速主要影响粉末收集效果,因此出风温度及风速暂不做具体考察,综上,展开对进风温度、蠕动泵速率、喷雾间隙参数的考察。
3.3.1进风温度考察
取猴耳环提取液6份,各100ml,加入辅料混匀,分别在进风温度185℃、195℃、205℃条件下喷雾干燥,收集喷雾干燥粉,以没食子酸含量、喷干粉性状、收率等方面展开评价,实验结果如下:
表4 喷雾干燥进风温度考察结果
条件 | 出风温度(℃) | 过程状态 | 性状 | 收率(%) | 没食子酸含量(mg/g) |
蔗糖-185℃ | 84.3 | 稳定无副产物 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 96.41 | 218.60 |
蔗糖-195℃ | 93.6 | 稳定无副产物 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 97.32 | 216.89 |
蔗糖-205℃ | 105.7 | 出现焦糖色 | 形成均匀粉末,颜色呈深褐色,溶解迅速 | 97.03 | 220.10 |
β-环糊精-185℃ | 85.2 | 稳定无副产物 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 96.59 | 222.20 |
β-环糊精195℃ | 95.1 | 稳定无副产物 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 97.34 | 218.78 |
β-环糊精-205℃ | 106.1 | 稳定无副产物 | 形成均匀粉末,颜色呈深褐色,溶解迅速 | 96.88 | 217.14 |
由实验结果可知,随着进风温度升高,出风温度也随之升高,喷干粉颜色加深,在195℃下出风温度均稳定在95℃左右,粉末收率最高。当温度较高时,干燥塔内壁上出现了焦糖色黏浊物,综合考虑,最终选择进风温度为195℃进行喷雾干燥。
3.3.2蠕动泵速率考察
取猴耳环提取液6份,各100ml,加入辅料混匀,分别在蠕动速率20L/h、25L/h、30L/h条件下喷雾干燥,收集喷雾干燥粉,以没食子酸含量、喷干粉性状、收率等方面展开评价,实验结果如下:
表5 喷雾干燥蠕动泵速率考察结果
条件 | 出风温度(℃) | 过程状态 | 没食子酸含量(mg/g) | 性状 | 收率(%) |
蔗糖-20L/h | 98.7 | 出现焦糖色 | 223.83 | 形成均匀粉末,颜色呈深褐色,溶解迅速 | 97.41 |
蔗糖-25L/h | 95.7 | 稳定无副产物 | 227.70 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 97.46 |
蔗糖-30L/h | 92.4 | 废液管积液 | 225.79 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 96.03 |
β-环糊精-20L/h | 99.5 | 稳定无副产物 | 228.76 | 形成均匀粉末,颜色呈深褐色,溶解迅速 | 97.59 |
β-环糊精-25L/h | 96.3 | 稳定无副产物 | 227.16 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 97.55 |
β-环糊精-30L/h | 93.5 | 废液管积液 | 229.28 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 96.35 |
由实验结果可知,随着蠕动泵流速增加,出风温度略有降低,有效成分含量与收率变化较小,当流速较低时,蔗糖因温度较高,干燥塔内壁上出现了焦糖色黏浊物,综合性状与能效考虑,最终选择25L/h进行喷雾干燥。
3.3.3喷雾间隙考察
取猴耳环提取液6份,各100ml,加入辅料混匀,分别在喷干间隙1s、3s、5s条件下喷雾干燥,收集喷雾干燥粉,以没食子酸含量、喷干粉性状、收率等方面展开评价,实验结果如下:
表6 喷雾干燥喷雾间隙考察结果
条件 | 过程状态 | 没食子酸含量(mg/g) | 性状 | 收率(%) |
蔗糖-1s | 废液管积液 | 253.21 | 形成均匀粉末,颜色呈深褐色,溶解迅速 | 95.27 |
蔗糖-3s | 稳定无副产物 | 257.19 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 97.65 |
蔗糖-5s | 出现焦糖色 | 255.23 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 90.86 |
β-环糊精-1s | 废液管积液 | 258.28 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 94.89 |
β-环糊精-3s | 稳定无副产物 | 256.63 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 97.38 |
β-环糊精-5s | 稳定无副产物 | 258.82 | 形成均匀粉末,颜色呈褐色,溶解迅速 | 91.32 |
由实验结果可知,喷干间隙在3s时收率最高,在1秒时对喷干粉性状有一定影响,由于间隙过低,干燥效果较差,废液管出现了积液,喷干间隙在5s时,经过一定时间运行,易堵塞通针使收率降低,因此,综合考虑,最终选择喷干间隙为3s进行喷雾干燥。
综上研究结果,蔗糖受环境影响较大,对条件偏差较为敏感,不适用于大生产条件,β-环糊精受环境影响低且稳定,最终确定猴耳环可溶性粉的参数如下:
猴耳环提取液加β-环糊精充分溶解,通入喷雾干燥机,干燥参数为:进风温度195℃,出风温度90℃,蠕动泵速度25L/小时,喷雾间隙3秒。
Claims (4)
1.一种猴耳环可溶性粉剂,其特征在于:它是由猴耳环水提取物与助溶剂β-环糊精混合后,经过喷雾干燥制备而成,其中,猴耳环水提取物与β-环糊精的重量配比为:
猴耳环水提取物,以猴耳环药材重量计 100份,β-环糊精10-20份。
2.根据权利要求1所述的猴耳环可溶性粉剂,其特征在于:所述的猴耳环水提取物与β-环糊精的重量配比为:
猴耳环水提取物,以猴耳环药材重量计 100份,β-环糊精20份。
3.一种权利要求1或2所述的可溶性粉剂的制备方法,其特征在于:它包括如下步骤:
a、取猴耳环药材,加水回流提取,得水提取物;
b、将a步骤制备的水提取物中加入β-环糊精,搅拌溶解;
c、在80℃条件下浓缩至稠膏;
d、将稠膏输入喷雾干燥塔干燥;
e、经d步骤喷雾干燥后的产物,再在70℃烘干,即得猴耳环可溶性粉剂。
4.根据权利要求3所述的可溶性粉剂的制备方法,其特征在于:d步骤所述的干燥参数为进风温度195℃,出风温度90℃,蠕动泵速度25L/小时,喷雾间隙3秒。
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