CN114588204A - 一种中药组合物在制备预防心脏破裂药物中的应用 - Google Patents
一种中药组合物在制备预防心脏破裂药物中的应用 Download PDFInfo
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- CN114588204A CN114588204A CN202011402198.8A CN202011402198A CN114588204A CN 114588204 A CN114588204 A CN 114588204A CN 202011402198 A CN202011402198 A CN 202011402198A CN 114588204 A CN114588204 A CN 114588204A
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Abstract
本发明提供了一种中药组合物在制备预防心脏破裂药物中的应用,该中药组合物由人参、水蛭、土鳖虫、制乳香、赤芍等中药组成,临床实验证实该中药组合物对预防心脏破裂具有显著的临床疗效。
Description
技术领域
本发明属于药物应用领域,具体涉及一种中药组合物的用途。
背景技术
心脏破裂多由尖刀锐器、子弹、弹片等穿透胸壁伤及心脏所致,少数则由于暴力撞击前胸引起。在心肌梗死时,心肌软化,在血流冲击下,也可以出现心脏破裂,是心梗的重要并发症之一。以右心室破裂最常见,其次为左心室和右心房,左心房、心包内大血管破裂则少见。急性心肌梗死的发病率随年龄增长而逐渐增高。在男性,发病高峰为51~60岁,女性为61~70岁。在35~55岁之间,男性患心梗的危险性是女性的6倍。在老年,女性的“雌激素保护”已不存在,发病的性别差异消失。有动脉粥样硬化“四大诱因”(即高血压、高胆固醇血症、吸烟和糖尿病)的患者,在青年期即可发生心梗。急性心梗的病死率和致残率相当高,已成为西方发达国家的主要死亡原因。如在美国,每年有近150万人患急性心梗,其中有1/3左右的病人不治而亡。50%的死亡发生在发病后的1h内。我国急性心梗的发病率低于西方国家,但国内北方急性心梗的发病率一般高于南方,城市高于农村。
心脏破裂的临床表现为:心脏出血外溢,心包裂口保持开放畅通者,血液将从前胸伤口涌出或流入胸膜腔。临床上出现低血容量征象:如面色苍白、呼吸浅弱、脉搏细速、血压下降等,病人可快速陷入休克,因大出血死亡。伤员呈现休克,主诉胸痛,呼吸急促,心率快,心音弱,脉率快,脉压差小,血压低,颈静脉怒张,静脉压升高。
近年来,由于经皮冠状动脉介入治疗的广泛应用挽救了大量心梗患者的生命,提高了心梗患者的生存质量,但由于心梗导致的心脏破裂即使在欧美发达国家,其发生率也未见明显降低.随着诊断与治疗性心导管在临床上的普及应用,心血管疾病的诊疗能力得以大幅提高,但一定程度上也增加了心脏破裂的可能性。破裂常发生于初次急性透壁性心肌梗塞。患者既往无明显的心绞痛史和心力衰竭史。因冠状动脉突然血栓形成或严重冠状动脉痉挛,又无足够的侧支循环,常导致贯通性透壁心肌梗塞。这种初次心肌梗塞者,平素无心肌缺血、无陈旧疤痕组织作为支架,而非梗塞区心肌收缩功能又较好,当周围心肌收缩时,对坏死区心肌起着切割作用,故易破裂。
心脏破裂是急性心肌梗死的致死性并发症。充分地认识导致心脏破裂的原因,并积极进行预防,是避免本症的关键。目前在临床尚未有可以预防心脏破裂的方法,可见早期预防心脏破裂是中西医共同的使命。
目前国内外基础研究表明本发明药物组合物预给药3天、3小时和1小时能缩小心肌无再流面积60-70%,减小心梗面积20-30%,并有明确的抗炎、抗氧化、抗凋亡以及防心肌内出血的作用;也有临床研究也显示,本发明药物组合物能够有效防治AMI急诊冠脉介入治疗后心肌无再流,促进心肌再灌注,缩小梗死面积,改善心功能。虽然已有研究证明本发明药物组合物可以缩小STEMI再灌注后心肌无复流面积,但是作用机制与主要信号通路不明。在过去30年中,国际上最突出的进展是在内皮细胞和心肌细胞内发现了一条保护心肌缺血-再灌注损伤的可能共同通路,即再灌注损伤信号(挽救)激酶(Reperfusion InjurySignaling (Salvage) Kinase,RISK)通路,然而保护措施的研究仍无突破,迄今指南尚无推荐治疗方法。
发明内容
本发明的目的是提供一种中药组合物在制备预防心脏破裂药物中的应用。
本发明所采用的技术方案是:
本发明药物组合物在制备预防心脏破裂药物中的应用,该中药组合物由如下重量份的原料药制成:
人参5-9 水蛭5-11 土鳖虫6-9 制乳香2-4 赤芍4-7 降香2-4 檀香2-4 全蝎3-7 蝉蜕6-10 蜈蚣1-3 冰片2-6 炒酸枣仁4-9。
所述应用为该中药组合物在制备治疗急性心梗导致的心脏破裂药物中的作用。
所述应用为该中药组合物在制备心肌修复过程中减轻心肌纤维化、心室重塑药物中的作用。
所述应用该中药组合物在制备治疗未开通冠脉的急性心梗导致的心脏破裂药物中的作用。
作为优选方式,该中药组合物由如下重量份的原料药制成:
人参 5 水蛭 10 土鳖虫9 制乳香 4 赤芍 4 降香 2
檀香 2 全蝎 7 蝉蜕 10 蜈蚣 3 冰片 2 炒酸枣仁4。
或
人参 9 水蛭 5 土鳖虫 6 制乳香 2 赤芍 7 降香 4
檀香 4 全蝎 4 蝉蜕 6 蜈蚣 2 冰片 6 炒酸枣仁9。
或
人参 6 水蛭 11 土鳖虫 7 制乳香2 赤芍 5 降香 2
檀香 2 全蝎 3 蝉蜕 7 蜈蚣 1 冰片 5 炒酸枣仁5。
所述中药组合物的活性成分由下列成分组成:
a 平均粒径小于100 µm的全蝎、水蛭、蜈蚣、土鳖虫、蝉蜕及制乳香药粉;
b 冰片药粉;
c 由降香和檀香提取的挥发油;
d 人参用乙醇提取后的醇提液经浓缩后的醇提浸膏;
e 提取成分c后的降香和檀香药渣的水提液、赤芍和炒酸枣仁加水煎煮后的水提液以及提取成分d后的人参药渣的水提液过滤、混匀后浓缩成的水提浸膏。
为实现上述技术方案,将该中药组合物制为胶囊剂、片剂、颗粒剂、散剂、口服液或丸剂。
所述胶囊剂是由以下步骤制成的:
a) 按照重量份比例称取各原料药;
b) 药材粉碎工艺:
将全蝎、水蛭、蜈蚣、土鳖虫和蝉蜕五种虫药经净选、水洗处理后和净选炮制后的制乳香按处方配料,由粉碎机进行粉碎,药粉细度达到80目以上;粗粉后的药粉经各种超微粉碎技术进行超微粉碎,使药粉平均粒径小于100 µm;待粉碎的药材经清洗烘干灭菌后,配料;
c) 提取浓缩和干燥工艺:
降香和檀香先加水提取挥发油后再用水提取,赤芍和炒酸枣仁加水煎煮,水提液过滤后,待浓缩成浸膏;人参用乙醇提取后,再用水提取,醇提液回收乙醇后,浓缩成醇提浸膏,水提液过滤与所有的水提液混匀后浓缩成水提浸膏;
d) 制剂工艺:
在沸腾制粒干燥机中加入超微粉碎粉,再将步骤c)所得提取浸膏喷入制粒;将制成的颗粒经整粒,加入冰片细粉,喷入由降香和檀香提取的挥发油,混匀后由胶囊充填机充填,制成胶囊。
所述胶囊剂是由以下步骤制成的:
a) 按照重量份比例称取各原料药;
b) 药材粉碎工艺:
将全蝎、水蛭、蜈蚣、土鳖虫和蝉蜕五种虫药经净选、水洗处理后和净选炮制后的制乳香按处方配料,由粉碎机进行粉碎,药粉细度达到80目以上;粗粉后的药粉经各种超微粉碎技术进行超微粉碎,使药粉平均粒径小于100 µm;待粉碎的药材经清洗烘干灭菌后,配料;
c) 提取浓缩和干燥工艺:
降香和檀香先加水提取挥发油后再用水提取,赤芍和炒酸枣仁加水煎煮,水提液过滤后,待浓缩成浸膏;人参用乙醇提取后,再用水提取,醇提液回收乙醇后,浓缩成醇提浸膏,水提液过滤与所有的水提液混匀后浓缩成水提浸膏,将浸膏直接喷雾干燥成喷雾粉;
d) 制剂工艺:
将超微粉碎粉与步骤c)所得喷雾干燥粉一起加到沸腾制粒干燥机中,再喷溶媒制成颗粒;将制成的颗粒经整粒,加入冰片细粉,喷入由降香和檀香提取的挥发油,混匀后由胶囊充填机充填,制成胶囊。
为验证所述中药组合物的效果,做了以下实验,实验研究内容为:
以小鼠急性心梗动物模型,并利用不同用药方案作为干预措施。分别于急性心梗后 3、7、14天心脏取材,通过测量并比较不同干预对于各时间点心脏破裂发生率及蛋白表达的影响,明确急性心梗后心肌早中晚期修复过程中,本发明药物组合物是否有减轻心肌纤维化、心室重塑甚至预防心脏破裂的作用。
材料和方法
1材料
1.1动物C57BL/6J小鼠,320只,雄性,购于北京维通利华实验动物技术有限公司,许可证号:SCXK(京)2016-0006。
1.2药品本发明药物组合物(石家庄以岭药业股份有限公司);尼可地尔片(NiproPharma Corporation Kagamiishi Plant)。
2方法
2.1 实验动物的分组与给药:
动物造模成功后随机分为6组,假手术组(Sham),模型对照组(MI)、尼可地尔组(NCDL)、本发明药物组合物低剂量组(TXL-L)、中剂量组(TXL-M)、高剂量组(TXL-H),50只/组。本发明药物组合物胶囊低、中、高剂量组分别设置为0.5、 1.0、 1.5g/kg/d,尼可地尔组给药剂量为3.0mg/kg/d;假手术组、模型组给予等体积的0.5%CMC-Na溶液,各组给药容积均为10ml/kg体重,造模后开始灌胃给药,连续14天。
2.2 实验步骤:
动物使用戊巴比妥钠(30mg/kg)腹腔注射麻醉后,固定于小鼠手术台上,经气管插管后接入呼吸机,连接小动物心电图检测仪。胸前备皮,碘伏消毒。沿着左胸肋骨第四助间剪开皮肤,钝性分离肌肉,使左心耳充分暴露在视野内,然后用医用手术带线缝合计在左心耳下2毫米处穿针结扎,观察心电图ST段上抬后关胸缝合,心梗制作成功。
术后密切关注小鼠的生存状态;每天至少观察3次,发现动物死亡后迅速剖检,确认是否出现心脏破裂,并详细记录。小鼠取材检测的节点分别为第3天、7天和14天。并到达观察天数后,每组随机取动物,腹腔注射戊巴比妥钠麻醉后腹主动脉采血,3000转离心分离血清备检;将心脏放液氮冻存后冷藏于冰箱中待日后提取蛋白。酶联免疫ELISA检测血清中MMP-2、MMP-9、TNF-α和SOD1的含量,Western Blot检测心肌组织中MMP-2、MMP-9蛋白表达水平。
3结果
3.1生存率:与模型组比较,本发明药物组合物中、高剂量组可以显著降低小鼠心肌梗死后死亡率,p<0.05(见表1)。
3.2 心脏破裂率:与模型组比较,本发明药物组合物高剂量组可以显著降低心梗后心脏破裂发生率,p<0.05(见表2)。
3.3 血清MMP-2、MMP-9:与假手术比较,模型组血中MMP-2、MMP-9含量显著升高;与模型组比较,本发明药物组合物干预后,血中MMP-2、MMP-9含量均下降,呈剂量相关性,中、高剂量组可见统计学差异,p<0.05,p<0.01(见表3、4)。
3.4 心肌组织MMP-2、MMP-9:与假手术比较,心肌组织中MMP-2、MMP-9蛋白表达明显升高;与模型组比较,本发明药物组合物干预后,MMP-2、MMP-9含量均下降,呈剂量相关性,中、高剂量组可见统计学差异,p<0.05,p<0.01(见表5)。
3.5 血清TNF-α:与假手术比较,模型组血清中TNF-α含量显著增高,本发明药物组合物干预后,血中TNF-α含量均下降,呈剂量相关性,中、高剂量组可见统计学差异,p<0.01(见表6)。
3.6 血清中SOD1:与假手术比较,模型组血清中SOD1含量显著降低,本发明药物组合物干预后,血中SOD1含量均上升,呈剂量相关性,其中本发明药物组合物中、高剂量组可见统计学差异,p<0.05,p<0.01(见表7)。
4结论
本发明药物组合物可以显著降低急性心肌梗死后死亡率和心脏破裂发生风险,可最大程度下调梗死区和梗死周边区心肌组织MMP9/MMP2表达水平,可显著降低小鼠心梗后3天和7天血清MMP2/9水平可抑制急性心梗模型小鼠的基质金属蛋白酶过表达,且具有抗炎抗氧化作用,从而保护受损心肌,预防心脏破裂,降低死亡率。
具体实施方式
下面结合具体实施方式对本发明做进一步详细说明:
实施例1:
a) 原料药配方为:
人参39.6g 水蛭72.6g 土鳖虫46.2g 制乳香13.2g 赤芍33g 降香13.2g 檀香13.2g 全蝎19.8g 蝉蜕 46.2g 蜈蚣 6.6g 冰片 33g 炒酸枣仁33g;
b) 药材粉碎工艺:
将全蝎、水蛭、蜈蚣、土鳖虫和蝉蜕五种虫药经净选、水洗处理后和净选炮制后的制乳香按处方配料,由粉碎机进行粉碎,药粉细度达到80目以上;粗粉后的药粉经各种超微粉碎技术进行超微粉碎,使药粉平均粒径小于30 µm;待粉碎的药材经清洗烘干灭菌后,配料;
c) 提取浓缩和干燥工艺:
降香和檀香先加水提取挥发油后再用水提取,赤芍和炒酸枣仁加适量水煎煮二次,每次3小时,合并水提液,过滤后,待浓缩成浸膏;人参用适量70%的乙醇提取二次,每次3小时,合并提取液,回收乙醇至无醇味,再用水提取,醇提液浓缩成60℃测定相对密度为1.05醇提浸膏,水提液过滤与上述所有水提液混匀后浓缩至60℃测定相对密度为1.05的清膏,备用;
d) 制剂工艺:
在沸腾制粒干燥机中加入超微粉碎粉,再将步骤c)所得提取浸膏喷入制粒;将制成的颗粒经整粒,加入冰片细粉,喷入由降香和檀香提取的挥发油,混匀后由胶囊充填机充填,制成1000粒胶囊。
本发明药物的用量,为每次2-4粒,每日服用三次。
实施例2
a) 原料药配方为:
人参 59.4g 水蛭 52.8g 土鳖虫 46.2g 制乳香13.2g
赤芍 33g 降香 13.2g 檀香 13.2g 全蝎 39.6g
蝉蜕 46.2g 蜈蚣 6.6g 冰片 33g 炒酸枣仁33g
b) 药材粉碎工艺:
将全蝎、水蛭、蜈蚣、土鳖虫和蝉蜕五种虫药经净选、水洗处理后和净选炮制后的制乳香按处方配料,由粉碎机进行粉碎,药粉细度达到80目以上;粗粉后的药粉经各种超微粉碎技术进行超微粉碎,使药粉平均粒径小于70 µm;待粉碎的药材经清洗烘干灭菌后,配料;
c) 提取浓缩和干燥工艺:
降香和檀香先加水提取挥发油后再用水提取,赤芍和炒酸枣仁加适量水煎煮二次,每次3小时,合并水提液,过滤后,待浓缩成浸膏;人参用适量70%的乙醇提取二次,每次3小时,合并提取液,回收乙醇至无醇味,再用水提取,醇提液浓缩成相对密度在60℃测定为1.0醇提浸膏,水提液过滤与上述所有水提液混匀后浓缩至60℃测定相对密度为1.0的清膏,备用;
d) 制剂工艺:
在沸腾制粒干燥机中加入超微粉碎粉,再将步骤c)所得提取浸膏喷入制粒;将制成的颗粒经整粒,加入冰片细粉,喷入由降香和檀香提取的挥发油,按常规制剂工艺压制成1000片。
本发明药物的用量,为每次2-4片,每日服用三次。
实施例3:丸剂的制备
a) 原料药配方为:
人参 39.6g 水蛭 66g 土鳖虫 46.2g 制乳香13.2g
赤芍 33g 降香 13.2g 檀香 13.2g 全蝎 46.2g
蝉蜕 46.2g 蜈蚣 6.6g 冰片 33g 炒酸枣仁33g
b) 药材粉碎工艺:
将全蝎、水蛭、蜈蚣、土鳖虫和蝉蜕五种虫药经净选、水洗处理后和净选炮制后的制乳香按处方配料,由粉碎机进行粉碎,药粉细度达到80目以上;粗粉后的药粉经各种超微粉碎技术进行超微粉碎,使药粉平均粒径10µm;待粉碎的药材经清洗烘干灭菌后,配料;
c) 提取浓缩和干燥工艺:
降香和檀香先加水提取挥发油后再用水提取,赤芍和炒酸枣仁加适量水煎煮二次,每次3小时,合并水提液,过滤后,待浓缩成浸膏;人参用适量70%的乙醇提取二次,每次3小时,合并提取液,回收乙醇至无醇味,再用水提取,醇提液浓缩成60℃测定相对密度为1.0醇提浸膏,水提液过滤与上述所有水提液混匀后浓缩至60℃测定相对密度为1.1的清膏,备用;
d) 制剂工艺:
按常规制剂工艺,制成1000粒丸剂。
本发明药物的用量,为每次2-4粒,每日服用三次。
实施例4
a)原料药配方
人参 60g 水蛭 100 g 土鳖虫 90 g 制乳香 40 g 赤芍 40 g 降香 20 g 檀香 20 g 全蝎 70 g 蝉蜕 100g 蜈蚣 30g 冰片 20g 炒酸枣仁40g;
b) 药材粉碎工艺:
将全蝎、水蛭、蜈蚣、土鳖虫和蝉蜕五种虫药经净选、水洗处理后和净选炮制后的制乳香按处方配料,由粉碎机进行粉碎,药粉细度达到80目以上;粗粉后的药粉经各种超微粉碎技术进行超微粉碎,使药粉平均粒径20 µm;待粉碎的药材经清洗烘干灭菌后,配料;
c) 提取浓缩和干燥工艺:
降香和檀香先加水提取挥发油后再用水提取,赤芍和炒酸枣仁加适量水煎煮二次,每次3小时,合并水提液,过滤后,待浓缩成浸膏;人参用适量70%的乙醇提取二次,每次3小时,合并提取液,回收乙醇至无醇味,再用水提取,醇提液浓缩成60℃测定相对密度为1.1醇提浸膏,水提液过滤与上述所有水提液混匀后浓缩至60℃测定相对密度为1.1的清膏,备用;
d) 制剂工艺:
按常规制剂工艺,制成颗粒剂。
实施例5
a)原料药配方
人参 90g 水蛭 50 g 土鳖虫 60 g 制乳香 20 g 赤芍 70 g 降香 40 g 檀香40 g 全蝎 40 g 蝉蜕 60 g 蜈蚣 20 g 冰片 60 g 炒酸枣仁90 g;
b) 药材粉碎工艺:
将全蝎、水蛭、蜈蚣、土鳖虫和蝉蜕五种虫药经净选、水洗处理后和净选炮制后的制乳香按处方配料,由粉碎机进行粉碎,药粉细度达到80目以上;粗粉后的药粉经各种超微粉碎技术进行超微粉碎,使药粉平均粒径50 µm;待粉碎的药材经清洗烘干灭菌后,配料;
c) 提取浓缩和干燥工艺:
降香和檀香先加水提取挥发油后再用水提取,赤芍和炒酸枣仁加适量水煎煮二次,每次3小时,合并水提液,过滤后,待浓缩成浸膏;人参用适量70%的乙醇提取二次,每次3小时,合并提取液,回收乙醇至无醇味,再用水提取,醇提液浓缩成60℃测定相对密度为1.0醇提浸膏,水提液过滤与上述所有水提液混匀后浓缩至60℃测定相对密度为1.0的清膏,备用;
d) 制剂工艺:
按常规制剂工艺,制成散剂。
实施例6
a)原料药配方
人参 60g 水蛭 110 g 土鳖虫 60 g 制乳香 30 g 赤芍 50 g 降香 20 g 檀香 20 g 全蝎 60g 蝉蜕 70 g 蜈蚣 10 g 冰片 50 g 炒酸枣仁50 g;
b) 药材粉碎工艺:
将全蝎、水蛭、蜈蚣、土鳖虫和蝉蜕五种虫药经净选、水洗处理后和净选炮制后的制乳香按处方配料,由粉碎机进行粉碎,药粉细度达到80目以上;粗粉后的药粉经各种超微粉碎技术进行超微粉碎,使药粉平均粒径60 µm;待粉碎的药材经清洗烘干灭菌后,配料;
c) 提取浓缩和干燥工艺:
降香和檀香先加水提取挥发油后再用水提取,赤芍和炒酸枣仁加适量水煎煮二次,每次3小时,合并水提液,过滤后,待浓缩成浸膏;人参用适量70%的乙醇提取二次,每次3小时,合并提取液,回收乙醇至无醇味,再用水提取,醇提液浓缩成60℃测定相对密度为1.0醇提浸膏,水提液过滤与上述所有水提液混匀后浓缩至60℃测定相对密度为1.1的清膏,备用;
d) 制剂工艺:
按常规制剂工艺,制成口服液。
Claims (10)
1.一种中药组合物在制备预防心脏破裂药物中的应用,其特征在于该中药组合物由如下重量份的原料药制成:
人参5-9 水蛭5-11 土鳖虫6-9 制乳香2-4 赤芍4-7 降香2-4 檀香2-4 全蝎3-7 蝉蜕6-10 蜈蚣1-3 冰片2-6 炒酸枣仁4-9。
2.根据权利要求1所述的应用,其特征在于所述应用为该中药组合物在制备治疗急性心梗导致的心脏破裂药物中的作用。
3.根据权利要求1所述的应用,其特征在于所述应用为该中药组合物在制备心肌修复过程中减轻心肌纤维化、心室重塑药物中的作用。
4.根据权利要求2所述的应用,其特征在于所述应用中急性心梗为未开通冠脉的急性心梗。
5.根据权利要求1-3任一项所述的应用,其特征在于该中药组合物由如下重量份的原料药制成:
人参 5 水蛭 10 土鳖虫9 制乳香 4 赤芍 4 降香 2
檀香 2 全蝎 7 蝉蜕 10 蜈蚣 3 冰片 2 炒酸枣仁4。
6.根据权利要求1-3任一项所述的应用,其特征在于该中药组合物由如下重量份的原料药制成:
人参 9 水蛭 5 土鳖虫 6 制乳香 2 赤芍 7 降香 4
檀香 4 全蝎 4 蝉蜕 6 蜈蚣 2 冰片 6 炒酸枣仁9。
7.根据权利要求1-3任一项所述的应用,其特征在于该中药组合物由如下重量份的原料药制成:
人参 6 水蛭 11 土鳖虫 7 制乳香2 赤芍 5 降香 2
檀香 2 全蝎 3 蝉蜕 7 蜈蚣 1 冰片 5 炒酸枣仁5。
8.根据权利要求1-3中任一项所述的应用,其特征在于所述中药组合物的活性成分由下列成分组成:
a 平均粒径小于100 µm的全蝎、水蛭、蜈蚣、土鳖虫、蝉蜕及制乳香药粉;
b 冰片药粉;
c 由降香和檀香提取的挥发油;
d 人参用乙醇提取后的醇提液经浓缩后的醇提浸膏;
e 提取成分c后的降香和檀香药渣的水提液、赤芍和炒酸枣仁加水煎煮后的水提液以及提取成分d后的人参药渣的水提液过滤、混匀后浓缩成的水提浸膏。
9.根据权利要求1-3中任一项所述的应用,其特征在于该中药组合物的制剂剂型为胶囊剂、片剂、颗粒剂、散剂、口服液或丸剂。
10.根据权利要求9所述的应用,其特征在于所述胶囊剂是由以下步骤制成的:
a) 按照重量份比例称取各原料药;
b) 药材粉碎工艺:
将全蝎、水蛭、蜈蚣、土鳖虫和蝉蜕五种虫药经净选、水洗处理后和净选炮制后的制乳香按处方配料,由粉碎机进行粉碎,药粉细度达到80目以上;粗粉后的药粉经各种超微粉碎技术进行超微粉碎,使药粉平均粒径小于100 µm;待粉碎的药材经清洗烘干灭菌后,配料;
c) 提取浓缩和干燥工艺:
降香和檀香先加水提取挥发油后再用水提取,赤芍和炒酸枣仁加水煎煮,水提液过滤后,待浓缩成浸膏;人参用乙醇提取后,再用水提取,醇提液回收乙醇后,浓缩成醇提浸膏,水提液过滤与所有的水提液混匀后浓缩成水提浸膏,将浸膏直接喷雾干燥成喷雾粉;
d) 制剂工艺:
将超微粉碎粉与步骤c)所得喷雾干燥粉一起加到沸腾制粒干燥机中,再喷溶媒制成颗粒;将制成的颗粒经整粒,加入冰片细粉,喷入由降香和檀香提取的挥发油,混匀后由胶囊充填机充填,制成胶囊。
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