CN110237132B - 补肾降脂药物、其制备方法及其应用 - Google Patents
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Abstract
本发明属于中药技术领域,具体涉及一种补肾降脂药物,其有效成分包括以下重量份的原料药:女贞子15‑20份、杜仲15‑30份、葛根20‑30份、山楂10‑30份、丹参10‑20份、陈皮10‑15份。本发明还提供了补肾降脂药物的制备方法及其应用。本发明所公开的补肾降脂药物,以补肾祛瘀,化痰降脂为主的治法来治疗更年期女性血脂异常问题,不仅可以改善患者的血脂水平,而且还可以通过调节促卵泡生成激素及其受体和改善血管内皮祖细胞功能以防治更年期女性血脂异常,治疗效果好、安全性可靠。
Description
技术领域
本发明属于中药技术领域,具体涉及一种补肾降脂药物、其制备方法及其应用。
背景技术
对于更年期女性血脂异常的治疗,张晓丹等(宁神合剂治疗绝经期妇女血脂异常临床观察[J].上海中医药杂质,2015,49(9):46-48.)采用女贞子、桑葚子、丹参、夜交藤、景天三七、香附、香橼来治疗绝经期妇女血脂异常,方中女贞子与桑葚子合用为君药,滋补肝肾、益阴养血;丹参、夜交藤、景天三七为臣药,宁心安神、活血化瘀通络;香附、香橼为佐使之药,可疏肝理气、宽中化痰;全方以补益肝肾为本,兼有活血化痰之效。该方通过提高雌激素水平以改善血脂代谢,见效快,一旦停药,容易复发,疗效很难稳定巩固。
专利CN106039228A公开一种降脂中药组合物,组分为:葛根、金银花、山楂、郁金、白芍和陈皮。方中葛根活血化瘀、降低血脂、补血生血,降低血液粘稠度、消除血管壁脂肪沉积,为君药;金银花清解火热毒邪,山楂消食健胃、行气散瘀,共为臣药;郁金散肝郁、行气,白芍平抑肝阳、养血敛阴、收胃气、和血脉,共为佐药;陈皮调味、行气、健脾运,为使药;以上诸药合用,共奏清利湿热,化瘀通络之效。该方主要针对脾气虚弱,利用护肝、行气以增健脾、除湿浊之效,若用于治疗绝经期妇女血脂异常,该方虽能活血化瘀、肝脾胃同补却忽视滋肾阴补肾气,治标不治本。
专利CN1628786A公开一种治疗高血脂症的药物,由女贞子、大蓟、白术、丹参、杜仲和佛手组成,方中女贞子滋养肝肾之阴,强筋骨、降脂,为君药;大蓟凉血止血、祛瘀消肿解毒,助女贞子补肝肾、祛瘀解毒降脂;白术益气健脾、燥湿利水,与女贞子相配则脾肾双补,与大蓟共为臣药;佛手疏肝理气、燥湿化痰,与白术相配,理气化痰祛湿之效尤著;丹参活血祛瘀、养血安神,与佛手共为佐药;杜仲补益肝肾之阳,与女贞子相配,肝肾之阴阳双补,使补益肝肾之效尤著而无滋腻或助火之虞,为使药。全方共奏健脾益肾、理气化痰、祛瘀解毒之功。该方主要是治疗一般性的高血脂症,而对更年期女性血脂异常的情况没有针对性,疗效不佳。
研究表明,绝经后血脂异常其本在于肾气不足,其标在于痰瘀阻滞。上述现有专利技术虽然均使用中医治疗血脂异常,但并不是针对更年期血脂异常,女性更年期女性血脂异常实为更年期合并高脂血症,研究表明肾气亏虚是更年期妇女的根本病理特点,上述现有技术未从病之根本“肾气亏虚”出发,使得治而不全,降低病征整体治疗效果。因此针对更年期血脂异常仍需要在配方上深入研究以使得药效更佳、更可靠,达到标本兼治的效果。
发明内容
本发明的目的在于提供一种补肾降脂药物及其制备方法和应用,以解决上述问题中的一个或几个。
根据本发明的一个方面,本发明提供了一种补肾降脂药物,其有效成分包括以下重量份的原料药:女贞子15-20份、杜仲15-30份、葛根20-30 份、山楂10-30份、丹参10-20份、陈皮10-15份。
在一些实施方式中,上述药物的比例关系可以优选为:女贞子15份、杜仲15份、葛根20份、山楂10份、丹参10份克、陈皮10份。
研究表明,更年期女性血脂异常根据中医辨证属肝肾阴虚夹痰湿,其本在于肾气不足,其标在于痰瘀阻滞;表现为腰酸膝软,眩晕耳鸣,五心烦热,口干,健忘,失眠;舌脉:舌质红,少苔,脉细数。
因此,基于绝经后血脂异常其本在于肾气不足、其标在于痰瘀阻滞,本发明治法予以补肾降脂,祛瘀化痰为主。方中以女贞子、杜仲补肝肾,强腰膝,补肾气为君药;葛根健脾升阳,升清化浊为臣药;山楂消食积,散瘀血,具有降血脂、血压作用;丹参活血祛瘀,对心血管疾病有良好的治疗作用为佐药;陈皮理气调中,燥湿化痰为使药;全方药仅六味,组方严谨,补虚祛实,补肾祛瘀,化痰降脂,升清降浊;补肾兼顾肾阴肾气,补后天兼顾先天,祛瘀化痰并用。
具体地,女贞子性甘、苦、凉,具有降血脂、抗动脉硬化、增强体液免疫的作用;杜仲性甘、温,具有补肝肾、强筋骨、降血压的功效;此方中,女贞子、杜仲配伍使用能够补肝肾、强腰膝,同为君药。
葛根性甘、辛、凉,能够健脾升阳、升清化浊、解肌退热,其中的黄酮成分能增加脑及冠状血管血流量,对心血管疾病有益处,为臣药。
山楂性酸、甘、微温,能消食积、散瘀血,具有降血脂、调血压作用;丹参性苦、微寒,能够活血祛瘀、对心血管疾病有良好的治疗作用,两者同为佐药。
陈皮性苦、辛、温,理气调中,燥湿化痰,能增加冠脉血流量,为使药。
本发明所公开的补肾降脂药物,以补肾气祛瘀,化痰降脂为主的治法来治疗更年期女性血脂异常问题,不仅可以改善患者的血脂水平,而且还可以通过调节促卵泡生成激素及其受体和改善血管内皮细胞功能来防治更年期女性血脂异常,治疗效果好、安全性可靠。
在一些实施方式中,上述药物还包括医药学上可接受的载体或赋形剂,以便制成患者所需的不同剂型,便于使用、保存和运输,满足临床和市场需求;其中,所用载体或赋形剂均为现有技术中的常用剂。
在一些实施方式中,上述药物可以为丸剂、片剂、胶囊剂、颗粒剂或汤剂,优选地,以颗粒剂为宜,患者易接受、便于服用和携带。
根据本发明的另一个方面,本发明还提供了补肾降脂药物的制备方法,当补肾降脂药物为颗粒剂时,其制备方法包括以下步骤:
(1)按比例取原料药,加水煎煮1-2次,所得煎液过滤去除药渣后留滤液备用;
(2)将步骤(1)所得滤液减压浓缩得清膏;
(3)向步骤(2)所得清膏中加麦芽糊精,喷雾干燥,得干膏粉;
(4)向步骤(3)所得干膏粉中加麦芽糊精,得混合粉末;
(5)向步骤(4)所得混合粉末中加入体积分数为90%的乙醇-水溶液制软材,将软材过筛,得湿颗粒。
本发明通过湿法制粒制备得到颗粒剂药物,操作简单易行,适用于工业化大规模成批量生产。
在一些实施方式中,步骤(1)中加水煎煮1-2次的操作步骤如下:第一次,加相当于原料药总质量的8~12倍水,加热至沸,保持微沸1~2小时,分离后得第一煎液和药渣;第二次,取第一次煎煮后所得的药渣,加相当于原料药总质量的6~10倍水,加热至沸,保持微沸1~2小时,分离后得第二煎液和药渣;合并第一煎液和第二煎液。
在一些实施方式中,步骤(2)中减压浓缩的条件为:真空度-0.08Mpa,温度60℃~80℃。
在一些实施方式中,步骤(2)所得清膏在60℃时相对密度为1.10~1.16,将清膏密度控制在此范围内,有利于清膏与辅料麦芽糊精搅拌均匀,便于后续制粒。
在一些实施方式中,步骤(3)中麦芽糊精的添加量为原料药总质量的 8~12%,以便于赋形。
在一些实施方式中,步骤(3)喷雾干燥工艺参数为:进风温度160-180℃;出风温度:95-105℃。
在一些实施方式中,步骤(4)中干膏粉中添加麦芽糊精后,可用混合机混合30分钟使干膏粉和麦芽糊精混合均匀。
在一些实施方式中,还包括步骤(6):将步骤(5)所得的湿颗制粒后在60 ~70℃环境下干燥,以使得颗粒剂能硬化固形,增加颗粒强度。
根据本发明的另一个方面,提供了上述补肾降脂药物在制备治疗更年期女性血脂异常药物方面的应用,其治疗效果在具体实施方式中具体说明。
附图说明
图1为三组小鼠肝脏组织形态对比图;其中(a)为正常组,(b)为模型组, (c)为中医治疗组;
图2为三组小鼠肝组织切片形态对比图;其中(a)为正常组,(b)为模型组,(c)为中医治疗组。
具体实施方式
下面结合具体实施方式对本发明作进一步详细的说明。若无特殊说明,以下化学试剂均为市购。
本发明所提供的药物主要针对更年期女性血脂异常的患者,下面列举了本发明实施例1~5的组分和重量,其中1份可以为1克或1千克。
实施例1
一种补肾降脂的颗粒剂药物,由如下方法制备得到:
(1)按重量份取原料药女贞子15份、杜仲15份、葛根20份、山楂10 份、丹参10份、陈皮10份;
(2)将上述原料药加水煎煮2次:第一次,加相当于原料药总质量的10 倍水,加热至沸,保持微沸1.5小时,分离后得第一煎液和药渣;第二次,取第一次煎煮后所得的药渣,加相当于原料药总质量的8倍水,加热至沸,保持微沸1.5小时,分离后得第二煎液和药渣;合并第一煎液和第二煎液,过滤得滤液;
(3)将步骤(2)所得滤液减压浓缩(真空度-0.08Mpa,温度70℃)至相对密度为1.15(60℃)的清膏;
(4)向步骤(3)所得清膏中添加原料药总质量10%的麦芽糊精后喷雾干燥,得干膏粉,其中喷雾干燥工艺参数为:进风温度170℃,出风温度100℃;
(5)向步骤(4)所得干膏粉中按经验添加适量麦芽糊精,用混合机混合30 分钟使其均匀,得混合粉末;
(6)向步骤(5)所得的混合粉末中加入体积分数为90%的乙醇-水溶液制软材,将软材过12目筛制粒,即湿颗粒;
(7)将步骤(6)所得湿颗粒经65℃干燥,即得。
若将上述湿颗粒通过压片法压片则可得到用于补肾降脂的片剂药物;此外,上述药物按照原料配比除制备成颗粒剂、片剂外,还可以按现有剂型制备方法分别做成丸剂、胶囊剂或口服液等剂型。
实施例2
一种补肾降脂药物,其有效成分包括以下重量份的原料药:女贞子20 份、杜仲15份、葛根15份、山楂15份、丹参10份、陈皮10份。
本实施例可以按照实施例1的制备方法制备成颗粒剂,也可以根据现有相应剂型常用的制备方法制成其他剂型,如:片剂、胶囊剂、口服液等。
实施例3
一种补肾降脂药物,其有效成分包括以下重量份的原料药:女贞子10 份、杜仲15份、葛根15份、山楂15份、丹参10份、陈皮5份。
本实施例可以按照实施例1的制备方法制备成颗粒剂,也可以根据现有相应剂型常用的制备方法制成其他剂型,如:片剂、胶囊剂、口服液等。
实施例4
一种补肾降脂药物,其有效成分包括以下重量份的原料药:女贞子15 份、杜仲20份、葛根30份、山楂10份、丹参15份、陈皮10份。
本实施例可以按照实施例1的制备方法制备成颗粒剂,也可以根据现有相应剂型常用的制备方法制成其他剂型,如:片剂、胶囊剂、口服液等。
实施例5
一种补肾降脂药物,其有效成分包括以下重量份的原料药:女贞子20 份、杜仲30份、葛根25份、山楂10份、丹参20份、陈皮10份。
本实施例可以按照实施例1的制备方法制备成颗粒剂,也可以根据现有相应剂型常用的制备方法制成其他剂型,如:片剂、胶囊剂、口服液等。
为了验证本发明药物用于治疗更年期女性血脂异常的效果,进行如下一系列试验进行评价。
试验1:补肾降脂药物疗效与安全性评价研究
1、试验对象 (1)纳入标准:
①年龄41-60岁自然绝经一年以上的女性患者;
②符合血脂异常西医诊断标准,且属于原发性高脂血症患者。
③血脂水平控制范围:血清总胆固醇(TC)5.18mmol/L-6.19mmol/L; LDL-C3.37mnol/L-4.12mmol/L;甘油三脂(TG)1.70mnol/L-2.25mmol/L;
④10年心血管风险<10%患者(ASCVD风险评估);
⑤中医辨证属于肝肾阴虚证;
⑥近4周内未用其他降脂药物;未使用过激素治疗、选择性雌激素受体调节剂、芳香化酶抑制剂、大豆提取物或草药。
(2)排除标准:
①继发性血脂异常及家族性高胆固醇血症患者;
②不稳定型心绞痛、急性心肌梗死、冠脉支架植入术后或冠脉搭桥术后等属冠心病高危患者;
③糖尿病史>10年,并合并肾病或其他心血管疾病危险因素的1型糖尿病患者;
④合并颈动脉狭窄、短暂性脑缺血发作、急性脑卒中、外周血管疾病患者;
⑤严重肝、肾功能不全者、造血系统、恶性肿瘤等严重原发性疾病;
⑥精神病患者(精神分裂症、躁狂症、偏执性精神病及有明显自杀倾向的抑郁症患者);
⑦嗜酒或者相关产品者;
⑧过敏体质患者;
⑨有肌肉关节疾病妨碍进行中等强度运动(例如:骨关节炎、类风湿性关节炎、滑膜炎)者。
采用随机对照盲选法,参照上述标准,选取合格受试者104例,分为中医治疗组53例,和对照组51例。
2、试验方法
基础治疗:治疗性生活方式改变(therapeutic life-style change,TLC):
制定详细的生活方式改变指导手册,具体包括:减少饱和脂肪酸和胆固醇的摄入(如高温煎炸、烘烤的食品及人造黄油及其制品)。选择能够降低 LDL-C的食物(如可溶性纤维素及含纤维素高的食品,如全谷类、蔬菜、水果、各种豆类),为有效调控食物,制定膳食评价表,登记每周进食的肉类、蛋类、煎炸及奶制食品的量化评分表以便更有效的指导患者下一步饮食干预方案;减轻体重;增加有规律的体力活动;取针对其他心血管病危险因素的措施如戒烟、限盐以降低血压等。在TLC基础上:
(1)中医治疗组:按实施例1配方所制备的补肾降脂颗粒剂,每次一包,每天一次,一包6g,共治疗6个月。
(2)对照组:给予补肾降脂方中药免煎颗粒的安慰剂,安慰剂外形、颜色、包装、服法与中药免煎颗粒一致。每次一包,每天一次,共治疗6个月。
3、疗效评价结果 (1)血脂疗效比较
①采用配对秩和/t检验,中医治疗组对于血脂六项中甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋白(LDL-C)、载脂蛋白A(LAPO-A)和载脂蛋白 B(LAPO-B)均有改善,差异有统计学意义(P<0.05),对照组对于APO-b有改善,但对于高密度脂蛋白胆固醇(HDL-C)有降低,差异有统计学意义 (P<0.05),见表1。
②采用独立样本t检验/秩和检验,对于血脂治疗前后差值进行组间比较,结果显示,治疗后,中医治疗组较对照组能改善患者的总胆固醇(TC)、低密度脂蛋白(LDL-C)、载脂蛋白B(LAPO-B),差异有统计学意义(P<0.05),其余差异无统计学意义(P>0.05),见表2:
表2血脂治疗前后差值的组间比较
(2)心血管疾病其他高危因素的效果分析
①采用配对秩和/t检验,中医治疗组对于胰岛素、瘦素、血管内皮生长因子(VEGF)治疗前后均有改善,对照组对于胰岛素、脂联素治疗前后有改善,差异有统计学意义(P<0.05)。两组对于血糖、同型半胱氨酸(HCY)、C 反应蛋白(CRP)、内皮素改善差异无统计学意义(P>0.05),见表3。
②采用独立样本t检验/秩和检验,对于治疗前后差值进行组间比较, ITT分析结果显示,治疗后,中医治疗组较对照组能改善患者的瘦素和内皮素,差异有统计学意义(P<0.05),其余差异无统计学意义(P>0.05),见表4。
表4其他相关指标治疗前后差值的组间比较(ITT)
注:#表示秩和检验的结果。
(3)体格检查指标的效果分析
①采用配对秩和/t检验,中医治疗组对于体重、腰围、臀围、肩胛部皮下脂肪、腹部皮下脂肪、髂部皮下脂肪具有改善(ITT分析)(P<0.05),在PP 数据分析集中,对于臂部皮下脂肪改善治疗前后也有意义(P<0.05)。对照组对于臀围治疗前后改善差异有统计学意义(P<0.05)(ITT分析),在PP数据分析集中,对于腰围的改善治疗前后也有统计学意义(P<0.05),见表5。
②采用独立样本t检验/秩和检验,对于治疗前后差值进行组间比较, ITT分析结果显示,治疗后,对于体重、腰围、臀围、皮下脂肪(肩胛部、腹部、髂部)两组间差异有统计学意义(P<0.05),但对于臂部皮下脂肪的改善差异无统计学意义(P>0.05),见表6。
表6体格检查指标治疗前后差值的组间比较
4、安全性评价结果
两组各发生一例转氨酶升高,其中,中医治疗组的患者有饮酒史,对照组的患者曾服用大量感冒药,但经复查后均好转,临床专家考虑与干预措施无关。两组其余的实验室安全性检查指标未见明显异常。
总体不良反应和不良事件发生率低,且多为轻度不良反应,均未退出临床研究,继续治疗或者暂停后继续用药。
以上的研究结果显示,本研究的中药补肾降脂颗粒临床疗效显著且安全性好。
试验2:补肾降脂药物对去势大鼠促卵泡生成激素(FSH)及其受体和改善血管内皮祖细胞(EPCs)功能的实验研究
1、试验模型及方法
选取45只雌性SD大鼠,随机分为三组:正常组10只、中医治疗组 10只、对照组10只;其中:
正常组:育龄期未去势,无高热量饮食;
中医治疗组:利用去势+高热量饮食建立绝经后糖脂代谢紊乱SD大鼠模型,给予实施例1所制备的补肾降脂颗粒连续服用三个月;
对照组:去势+高脂喂养+不给药物。
去势动物造模方法:
水合氯醛0.33mL/100g给予腹腔注射进行全身麻醉,然后进行手术。手术方式采取背部切口进行卵巢摘除,背部备皮(剃毛,两侧均要备皮,安尔碘常规消毒。先于背部正中切开皮肤,切口约1-2cm,用圆头剪插入皮肤和肌肉之间,一边扩张一边钝性分离,用皮镊子夹住从创口看到的肌层,在离脊柱1cm肋下剪开腰肌,长约1cm切口,立即可见两侧包绕卵巢的游离的白色水样透明的脂肪组织及紧密相连的子宫角,用眼科镊轻轻夹住脂肪组织将其拉出口创口,将卵巢周围的脂肪组织及血管分离,然后在子宫角上部及下部的输卵管的部位做两个结扎,结扎后用眼科剪切断子宫角,摘除卵巢,术后检查有无出血,无出血再把脂肪组织推回腹腔内(若有出血,先止血,可用明胶海绵或丝线结扎血管,假手术组仅切除卵巢周围的脂肪组织,然后将腹膜与肌层一起缝合。手术中注意右侧的卵巢要稍高于左侧,寻找卵巢时动作轻柔,不可过用猛力。术后予以肌肉注射青霉素抗感染,每只给予0.5mL的肌肉注射,连续2天抗感染治疗。术后的缝合伤口涂以红霉素眼膏,预防伤口感染并促进伤口的愈合。
2、疗效评价结果
①血脂及血糖相关指标的组间比较
正常组与中医治疗组的血糖及血脂相关指标对比如表7所示,三组大鼠的TC、LDL-C及血糖检测指标的组间比较,差异均有统计学意义(P< 0.05);三组TG的检测指标差异无统计学意义(P>0.05),但治疗组较对照组降低,接近正常组,提示补肾降脂颗粒能有效改善SD模型大鼠的糖脂代谢紊乱,血糖及血脂相关指标。
表7正常组与中医治疗组血脂及血糖相关指标对比
②对心血管疾病其他高危因素影响的组间比较
同时对于心血管疾病的其他高危因素如同性半胱氨酸,中药治疗组具有改善作用,效果优于对照组,差异有统计学意义,(P<0.05);C反应蛋三组比较虽差异无统计学意义(P>0.05),但中药治疗组与对照组比较,具有下调趋势,接近正常组。提示补肾降脂颗粒能有效改善SD模型大鼠的糖脂代谢紊乱和心血管疾病高危因素相关指标,见表8。
表8正常组与中医治疗组C反应蛋白及同性半胱氨酸指标对比
指标 | 正常组 | 对照组 | 中医治疗组 | F | P |
C反应蛋白 | 1.12±1.17 | 3.53±2.11 | 2.12±1.15 | 1.476 | 0.256 |
同性半胱氨酸 | 7.53±1.24 | 26.20±5.38 | 15.52±3.06 | 14.73 | 0.00 |
③在肝脏组织形态方面的组间比较
a.如图1所示,正常组大鼠肝脏肝呈深红色,柔软,体积适中;而模型组肝脏呈淡粉色,有油腻感,体积偏大;中医治疗组肝脏体积较正常组略微大,但其颜色(深红色)、质地(质软)与正常组差别不明显。
b.如图2所示,肝组织切片示模型组肝细胞肿大,胞质内含有较多大小不一的脂滴或脂肪空泡;中医治疗组的脂滴和脂肪空泡较模型组明显减少,但与正常大鼠比较,仍见散在脂肪空泡和脂滴。
上述研究结果表明,补肾降脂颗粒有助于恢复SD模型大鼠的糖脂代谢紊乱和肝脏形态学改变。
以上所述的仅是本发明的一些实施方式。对于本领域的普通技术人员来说,在不脱离本发明创造构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。
Claims (10)
1.一种治疗更年期女性血脂异常的药物,其特征在于,其有效成分由以下重量份的原料药制成:女贞子15-20份、杜仲15-30份、葛根20-30份、山楂10-30份、丹参10-20份、陈皮10-15份。
2.根据权利要求1所述的药物,其特征在于,其有效成分由以下重量份的原料药制成:女贞子15份、杜仲15份、葛根20份、山楂10份、丹参10份、陈皮10份。
3.根据权利要求2所述的药物,其特征在于,所述药物还包括医药学上可接受的载体或赋形剂。
4.根据权利要求2所述的药物,其特征在于,所述的药物为丸剂、片剂、胶囊剂、颗粒剂、口服液或汤剂。
5.权利要求4所述的药物的制备方法,其特征在于,所述药物为颗粒剂时,其制备方法包括以下步骤:
(1)按比例取原料药,加水煎煮1-2次,所得煎液过滤去除药渣后留滤液备用;
(2)将步骤(1)所得滤液减压浓缩得清膏;
(3)向步骤(2)所得清膏中加麦芽糊精,喷雾干燥,得干膏粉;
(4)向步骤(3)所得干膏粉中加麦芽糊精,得混合粉末;
(5)向步骤(4)所得混合粉末中加入体积分数为90%的乙醇-水溶液制软材,将软材过筛,得湿颗粒。
6.根据权利要求5所述的制备方法,其特征在于,步骤(1)中加水煎煮1-2次的操作步骤如下:
第一次,加相当于原料药总质量的8-12倍水,加热至沸,保持微沸1-2小时,分离后得第一煎液和药渣;第二次,取第一次煎煮后所得的药渣,加相当于原料药总质量的6-10倍水,加热至沸,保持微沸1-2小时,分离后得第二煎液和药渣;合并第一煎液和第二煎液。
7.根据权利要求5所述的制备方法,其特征在于,步骤(2)中减压浓缩的条件为:真空度-0.08Mpa,温度60-80℃。
8.根据权利要求5所述的制备方法,其特征在于,步骤(3)中麦芽糊精的添加量为原料药总质量的8-12%,且喷雾干燥工艺参数为:进风温度160-180℃;出风温度:95-105℃。
9.根据权利要求5所述的制备方法,其特征在于,还包括步骤(6):将步骤(5)所得的湿颗粒在60-70℃环境下干燥。
10.权利要求1-4任一项所述的药物在制备治疗更年期女性血脂异常药物方面的应用。
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