CN114028323A - 虎眼万年青乳膏剂及其制备方法 - Google Patents
虎眼万年青乳膏剂及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种虎眼万年青乳膏剂及其制备方法,属于中药膏剂技术领域。本发明的虎眼万年青乳膏剂,以20g计,组成为:0.4g虎眼万年青、0.9g吐温‑80、1.4g白凡士林、7.0g二甲基亚砜、1.6g液体石蜡、2.1g甘油、1.2g硬脂酸、0.04g尼泊金乙酯、1.8g单硬脂酸甘油酯、余量为无菌水。本发明还提供该虎眼万年青乳膏剂的制备方法。本发明的虎眼万年青乳膏剂质量较好,消炎性好,且对皮肤无刺激性。
Description
技术领域
本发明属于中药膏剂技术领域,具体涉及一种虎眼万年青乳膏剂及其制备方法。
背景技术
炎症是指具有血管系统的活体组织对损伤因子所发生的防御反应。炎症对身体一般情况是有益的,若身体调节失去了平衡,就会给机体带来损伤,其基本病理变化包括变质、渗出及增生。目前,多以非甾体类药物和糖皮质激素类药物来治疗炎症疾病,但由于此类药物对机体副作用大,而限制了其在临床上的使用。非甾体类药物容易引起的副作用为胃肠道不良反应、心血管不良反应、中枢神经系统不良反应、肾毒性、孕婴不良反应、凝血障碍及瑞夷综合征等;糖皮质激素类药物易引起的副作用为过敏性皮炎、急性扁桃体炎、关节炎、肾上腺皮质机能亢进症、类固醇性溃疡、骨质疏松症等疾病。因此,从天然产物中开发副作用小的抗炎药物成为抗炎药物的发展方向。
虎眼万年青(Ornithogalum caudatumJacq.)别名珍珠草、海葱等,是百合科(Liliaceae)虎眼万年青属多年生草本植物,虎眼万年青原产于南非,在20世纪70年代,虎眼万年青就被引进中国,吉林省长白山地区是其主要产区之一。因当虎眼万年青每长出一片叶子时,在它的鳞茎外皮之上就会长出一个一个小圆球,大小形状就像老虎的眼睛,因此被称作虎眼万年青。虎眼万年青的叶、鳞茎及全草都可入药。其味甘、归肝、脾经、性微寒,具有消坚散结、清热解毒的功效。研究表明,虎眼万年青含皂苷、多糖、黄酮类、挥发油、萜类、生物碱及微量元素等多种化学成分,具有抗肿瘤、抗氧化、抗肝癌、抗炎、提高免疫力等药理作用,其中提高免疫力、抗炎和抗肝癌的作用尤为显著,应用前景十分广泛。虎眼万年青乙醇提取物具有明显的抗炎和镇痛作用,多糖类化合物具有较强调节免疫功能的作用,其皂苷和链激酶的联合作用具有抗癌细胞转移的效果,并且对不同种类的肿瘤细胞株表现出一定的抑制作用。现有技术中,对虎眼万年青的研究集中于化学成分研究、抗肿瘤、药理方面以及多糖对机体免疫调节方面,特别是有关抗肿瘤研究的报道相对较多,而尚未看到对于用虎眼万年青制备成乳膏剂的有关报道。
发明内容
本发明的目的是提供一种虎眼万年青乳膏剂及其制备方法,该虎眼万年青乳膏剂质量好,消炎性好,且对皮肤无刺激性。
为实现上述目的,本发明采用以下技术方案。
本发明提供一种虎眼万年青乳膏剂,以20g计,组成为:
0.4g虎眼万年青、0.9g吐温-80、1.4g白凡士林、7.0g二甲基亚砜、1.6g液体石蜡、2.1g甘油、1.2g硬脂酸、0.04g尼泊金乙酯、1.8g单硬脂酸甘油酯、余量为无菌水。
本发明还提供上述虎眼万年青乳膏剂的制备方法,步骤如下:
步骤一、按组成和配方取各组分;
步骤二、将硬脂酸、单硬脂酸甘油酯、液体石蜡、白凡士林和吐温-80在85℃搅拌溶解,得到油相;
步骤三、将甘油、尼泊金乙酯、二甲基亚砜和无菌水在85℃搅拌溶解,得到水相;
步骤四、将虎眼万年青茎叶捣碎的鲜汁,过滤,滤液在75℃浓缩,得到虎眼万年青浓缩液;
步骤五、将步骤一得到的油相加入到步骤二的水相中,搅拌乳化后,再加入虎眼万年青浓缩液,继续搅拌乳化,至均匀,室温冷却,得到虎眼万年青乳膏剂。
与现有技术相比,本发明的有益效果为:
本发明的虎眼万年青乳膏剂质量好,外观呈乳白色,经离心和耐寒耐热试验,外观没有变化,无酸败、异臭、变色、变硬等变质现象,无油水分离及胀气现象。
本发明的虎眼万年青乳膏剂涂于皮肤后,对皮肤无刺激性,无油水分离、丘疹、瘙痒、酸败、异臭、变色、变硬等现象,易于涂抹、易于洗除、细腻均匀且保湿性好。
本发明的虎眼万年青乳膏剂消炎性好。
附图说明
为了更清楚地说明本发明实施例中的技术方案,下面将对实施例中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其它的附图。
图1为本发明的虎眼万年青乳膏剂的制备方法的工艺流程图。
具体实施方式
为了进一步理解本发明,下面对本发明优选实施方案进行描述,但是应当理解,这些描述只是为进一步说明本发明的特征和优点,而不是对本发明权利要求的限制。
本发明的虎眼万年青乳膏剂,以20g重量份计,组成为:虎眼万年青(0.4g)、吐温-80(0.9g)、白凡士林(1.4g)、二甲基亚砜(7.0g)、液体石蜡(1.6g)、甘油(2.1g)、硬脂酸(1.2g)、尼泊金乙酯(0.04g)、单硬脂酸甘油酯(1.8g)、余量为无菌水。
本发明的虎眼万年青乳膏剂的配方的确定过程为:
1、初步拟定配方为:以20g计,主药:虎眼万年青(0.4g);油相基质:硬脂酸(1.2g)、单硬脂酸甘油酯(1.7g)、液体石蜡(1.8g)、白凡士林(1.2g);透皮促进剂:二甲基亚砜(6.8g);乳化剂:吐温-80(0.9g);防腐剂:尼泊金乙酯(0.04g);水溶性基质:甘油(2.1g)、余量为无菌水。
2、单因素试验
2.1评分标准
基质筛选评分标准如表1所示。以离心试验(A1)、刺激性试验(A2)、耐寒耐热试验(A3)、均匀性(A4)、水洗除性(A5)这五项指标对各配方工艺制得的乳膏剂进行评分,总分=A1+A2+A3+A4+A5,筛选出最佳基质。
离心试验:取5g乳膏剂于离心管中,在6000r/min转速下离心20min,之后观察是否有分层现象,性状是否发生变化。
刺激性试验:取3g虎眼万年青乳膏剂涂抹手臂里侧,30min之后观察是否有红斑、丘疹、瘙痒等症状。
耐寒耐热试验:分别取两份等量乳膏剂,一份放在55℃温箱中6h,一份放在-20℃的冰箱中,24h后观察性状是否发生变化,是否有霉变和油水分离现象。
均匀性:膏体均匀、细腻、光滑,易于涂抹,保湿性好。
水洗除性试验:取5g乳膏剂涂抹于10cm×10cm的玻璃边上,用一块纱布覆盖于玻璃板上,24h之后,在匀速水流下冲洗,观察其是否能够在5min内洗除干净。
表1基质筛选评分标准
2.2硬脂酸的用量的筛选
硬脂酸的量分别为1.1g、1.2g、1.3g、1.4g,其他基质成分均按照初步拟定配方中的量称量,制出四批乳膏,每批乳膏平行做三次,且都要进行离心试验、刺激性试验、耐寒耐热试验、均匀试验、水洗除性试验,然后根据评分标准对其评定,取其平均值。结果见表2。
表2硬脂酸的筛选结果
由表2结果可知,硬脂酸用量的改变对乳膏剂的质量无显著影响,且1.1g与1.4g的评分相同,1.2g与1.3g的评分相同,因此考虑节省辅料,将其用量定为1.2g。
2.3单硬脂酸甘油酯的用量的筛选
单硬脂酸甘油酯的量分别为1.6g、1.7g、1.8g、1.9g,其他基质成分均按照初步拟定配方中的量称量,制出四批乳膏剂,每批乳膏剂平行做三次,且都要进行离心试验、刺激性试验、耐寒耐热试验、均匀试验、水洗除性试验,然后根据评分标准对其评定,取其平均值。结果见表3。
表3单硬脂酸甘油酯的筛选结果
由表3结果可知,单硬脂酸甘油酯的用量对乳膏剂的综合评分影响较大,其中1.8g时乳膏剂综合评价的平均分值最高,1.7g与1.9g的评分次之,综合考虑最终选定1.7g、1.8g、1.9g进行正交试验。
2.4液体石蜡的用量的筛选
液体石蜡的量分别为1.6g、1.7g、1.8g、1.9g,其他基质成分均按照初步拟定配方中的量称量,制出四批乳膏剂,每批乳膏剂平行做三次,且都要进行离心试验、刺激性试验、耐寒耐热试验、均匀试验、水洗除性试验,然后根据评分标准对其评定,取其平均值。结果见表4。
表4液体石蜡的筛选结果
由表4结果可知,液体石蜡的用量对乳膏剂的综合评分影响较大,其中1.8g时乳膏剂综合评价的平均分值最高,1.6g与1.9g评分相同,因此考虑节省辅料,最终选定1.6g、1.7g、1.8g进行正交试验。
2.5白凡士林的用量的筛选
白凡士林的量分别为1.1g、1.2g、1.3g、1.4g,其他基质成分均按照初步拟定配方中的量称量,制出四批乳膏剂,每批乳膏剂平行做三次,且都要进行离心试验、刺激性试验、耐寒耐热试验、均匀试验、水洗除性试验,然后根据评分标准对其评定,取其平均值。结果见表5。
表5白凡士林的筛选结果
由表5结果可知,白凡士林的用量对乳膏剂的综合评分影响较大,其中1.2g时乳膏剂综合评价的平均分值最高,1.3g与1.4g评分次之,因此最终选定1.2g、1.3g、1.4g进行正交试验。
2.6吐温-80的用量的筛选
吐温-80的量分别为0.7g、0.8g、0.9g、1.0g,其他基质成分均按照初步拟定配方中的量称量,制出四批乳膏剂,每批乳膏剂平行做三次,且都要进行离心试验、刺激性试验、耐寒耐热试验、均匀试验、水洗除性试验,然后根据评分标准对其评定,取其平均值。结果见表6。
表6吐温-80的筛选结果
由表6结果可知,温-80的用量对乳膏剂的综合评分影响较大,其中0.9g时乳膏剂综合评价的平均分值最高,0.8g与1.0g评分次之,因此最终选定0.8g、0.9g、1.0g进行正交试验。
2.7二甲基亚砜的用量的筛选
二甲基亚砜的量分别为6.8g、6.9g、7.0g、7.1g,其他基质成分均按照初步拟定配方中的量称量,制出四批乳膏剂,每批乳膏剂平行做三次,且都要进行离心试验、刺激性试验、耐寒耐热试验、均匀试验、水洗除性试验,然后根据评分标准对其评定,取其平均值。结果见表7。
表7二甲基亚砜的筛选结果
由表7结果可知,二甲基亚砜用量的改变对乳膏剂外观及稳定性无显著影响,其中7.0g时乳膏剂综合评价的平均分值最高,因此综合考虑将其用量定为7.0g。
2.8甘油的用量的筛选
甘油的量分别为1.9g、2.0g、2.1g、2.2g,其他基质成分均按照初步拟定配方中的量称量,制出四批乳膏剂,每批乳膏剂平行做三次,且都要进行离心试验、刺激性试验、耐寒耐热试验、均匀试验、水洗除性试验,然后根据评分标准对其评定,取其平均值。结果见表8。
表8甘油的筛选结果
由表8结果可知,甘油的改变对乳膏剂外观及稳定性无显著影响,其中2.1g时乳膏剂综合评价的平均分值最高,因此综合考虑将其用量定为2.1g。
2.9尼泊金乙酯的用量的筛选
尼泊金乙酯的量分别为0.02g、0.03g、0.04g、0.05g,其他基质成分均按照初步拟定配方中的量称量,制出四批乳膏剂,每批乳膏剂平行做三次,且都要进行离心试验、刺激性试验、耐寒耐热试验、均匀试验、水洗除性试验,然后根据评分标准对其评定,取其平均值。结果见表9。
表9尼泊金乙酯的筛选结果
由表9结果可知,硬脂酸用量的改变对乳膏剂外观及稳定性无显著影响,其中0.04g时乳膏剂综合评价的平均分值最高,因此综合考虑将其用量定为0.04g。
3、在单因素试验基础上,选择对乳膏剂外观及稳定性影响显著的4个因素即吐温-80(A)、白凡士林(B)、液体石蜡(C)、单硬脂酸甘油酯(D),将这4个组分作为正交设计的考察因素,每个因素取3个水平,按L9(34)表设计试验方案,组成9个配方,每份总量20g,制备方法与评分标准同上述的单因素试验。
表10因素水平
表11正交试验结果
由以上结果显示,极差最大的是因A,此次是因素D,然后是C,最小的是A,所以四种因素对试验结果影响的的主次顺序为A>D>C>B。由上表中的均值可知,因素A的最大值是K2,因素B的最大值K3,因素C的最大值是K1,因素D的最大值是K2,可得最优组合为A2B1C3D2。
表12方差分析
注:F0.05(2,2)=19.000
由表12可知,FA>F0.05(2,2),所以PA<0.05;FD>F0.05(2,2),所以PD<0.05;FC<F0.05(2,2),所以PC>0.1,因此因素A和D显著,因素C、因素B不显著。四个因素的主次顺序为A>D>C>B,与极差分析结果一样,所以最优组合为A2B3C1D2。
本发明还提供上述虎眼万年青乳膏剂的制备方法,步骤如下:
步骤一、按组成和配方取各组分;
步骤二、将硬脂酸、单硬脂酸甘油酯、液体石蜡、白凡士林和吐温-80在85℃搅拌溶解,得到油相;
步骤三、将甘油、尼泊金乙酯、二甲基亚砜和水在85℃搅拌溶解,得到水相;
步骤四、将虎眼万年青茎叶捣碎的鲜汁,过滤,滤液在75℃浓缩,得到虎眼万年青浓缩液;
步骤五、将步骤一得到的油相加入到步骤二的水相中,搅拌乳化后,再加入虎眼万年青浓缩液,继续搅拌乳化,至均匀,室温冷却,得到虎眼万年青乳膏剂。
上述技术方案中,步骤二、步骤三和步骤四中,搅拌速度和搅拌时间没有特殊限制,达到溶解的技术效果即可。步骤五中,搅拌时间和乳化时间没有特殊限制,达到乳化效果即可。
本发明所有原料,对其来源没有特别限制,在市场上购买的或按照本领域技术人员熟知的常规方法制备即可。本发明所有原料,对其纯度没有特别限制,本发明优先选用分析纯。
在本发明中所使用的术语,一般具有本领域普通技术人员通常理解的含义,除非另有说明。为了使本领域的技术人员更好地理解本发明的技术方案,下面将结合实施例对本发明作进一步的详细介绍。
在以下实施例中,未详细描述的各种过程和方法是本领域中公知的常规方法。下述实施例中所用的材料、试剂、装置、仪器、设备等,如无特殊说明,均可从商业途径获得。
实施例1
虎眼万年青乳膏剂,以20g计,组成为:虎眼万年青(0.4g)、吐温-80(0.9g)、白凡士林(1.4g)、二甲基亚砜(7.0g)、液体石蜡(1.6g)、甘油(2.1g)、硬脂酸(1.2g)尼泊金乙酯(0.04g)、单硬脂酸甘油酯(1.8g)、余量为无菌水。
按上述配方制备3批虎眼万年青乳膏剂。
对实施例1的虎眼万年青乳膏剂的性能进行评价。
1.1取3批虎眼万年青乳膏剂,以离心试验、刺激性试验、耐寒耐热试验、均匀性、水洗除性这五项指标对各乳膏剂进行评分,试验方法与具体实施方式中的相同,评分标准同表1。验证结果如表13。
表13验证试验结果
由表13结果显示平均分为92,符合正交试验结果,所以该三批虎眼万年青乳膏剂无油水分离、丘疹、瘙痒、酸败、异臭、变色、变硬等现象,易于涂抹、易于洗除、细腻均匀且保湿性好。
1.2质量检查
1.2.1性状
取虎眼万年青乳膏剂适量,在皮肤上均匀地涂布,观察其分布效果。
经试验得该乳膏为乳白色,无酸败、异臭、变色、变硬等变质现象,无油水分离及胀气现象。
1.2.2涂布性检查
取虎眼万年青乳膏剂适量,在皮肤上均匀地涂布,观察其分布效果。经试验得该乳膏易于展开,细腻有光泽且无刺激。
1.2.3粒度
取虎眼万年青乳膏剂适量,在载玻片上涂成薄层,薄层面积与盖玻片面积相同,共涂三片,参照显微测定法《中国药典》2020年版四部通则0982第一法测定,均不得检出大于180μm的粒子。经试验,该乳膏并未检出大于180μm的粒子,符合药典规定。
1.3皮肤刺激试验
为了评价虎眼万年青乳膏剂对小鼠皮肤用药的安全性,对4只小鼠腹部两侧对称脱毛2*2cm,然后随机的分为单次给药组和多次给药组。通过单次和多次涂抹虎眼万年青乳膏剂和空白基质进行皮肤刺激性试验,观察皮肤是否出现红斑、水肿、刺激现象。
1.3.1试验的主要评价标准
皮肤刺激性试验参考红斑、水肿、刺激强度进行评价。结果如表14。
表14评价标准
1.3.2单次涂药
分别取虎眼万年青乳膏剂和空白基质各1g,涂抹在小鼠腹部左右脱毛区,24h之后将其用温水洗净,观察是否出现红斑、水肿、刺激现象,连续观察1-72h。结果如表15。
表15单次涂药结果
小鼠进行单次涂药试验,在涂药之后,观察的72h之内小鼠皮肤未曾出现红斑、水肿现象,且刺激强度均在0.5以下,由此可得该乳膏对小鼠皮肤无刺激性。
1.3.3多次涂药
分别取虎眼万年青乳膏剂和空白基质各1g,涂抹在小鼠腹部左右脱毛区,每天涂抹一次,每次都在涂抹6h后将其用温水洗净,连续涂抹一周,最后一次涂抹洗净1h之后观察是否出现红斑、水肿、刺激现象,连续观察一周。结果如表16。
表16多次涂药结果
由试验结果显示,该乳膏剂在单次涂药和多次涂药之后均对小鼠皮肤不产生刺激反应。则说明该乳膏剂使用安全且无刺激性。
显然,上述实施方式仅仅是为清楚地说明所作的举例,而并非对实施例的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有实施例予以穷举。而由此所引申出的显而易见的变化或变动仍处于本发明创造的保护范围之中。
Claims (2)
1.一种虎眼万年青乳膏剂,其特征在于,以20g计,组成为:
0.4g虎眼万年青、0.9g吐温-80、1.4g白凡士林、7.0g二甲基亚砜、1.6g液体石蜡、2.1g甘油、1.2g硬脂酸、0.04g尼泊金乙酯、1.8g单硬脂酸甘油酯、余量为无菌水。
2.根据权利要求1所述的一种虎眼万年青乳膏剂的制备方法,其特征在于,步骤如下:
步骤一、按组成和配方取各组分;
步骤二、将硬脂酸、单硬脂酸甘油酯、液体石蜡、白凡士林和吐温-80在85℃搅拌溶解,得到油相;
步骤三、将甘油、尼泊金乙酯、二甲基亚砜和无菌水在85℃搅拌溶解,得到水相;
步骤四、将虎眼万年青茎叶捣碎的鲜汁,过滤,滤液在75℃浓缩,得到虎眼万年青浓缩液;
步骤五、将步骤一得到的油相加入到步骤二的水相中,搅拌乳化后,再加入虎眼万年青浓缩液,继续搅拌乳化,至均匀,室温冷却,得到虎眼万年青乳膏剂。
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CN1672728A (zh) * | 2004-08-31 | 2005-09-28 | 吕新波 | 虎眼万年青提取物及其制备方法、药物组合物以及用途 |
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CN101972385A (zh) * | 2010-05-20 | 2011-02-16 | 修正药业集团股份有限公司 | 虎眼万年青总黄酮的制备方法及在抗肿瘤和抗炎止痛药物中的应用 |
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