CN115487275A - 一种含有三七提取物的中药颗粒及其制备工艺 - Google Patents
一种含有三七提取物的中药颗粒及其制备工艺 Download PDFInfo
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- CN115487275A CN115487275A CN202211310182.3A CN202211310182A CN115487275A CN 115487275 A CN115487275 A CN 115487275A CN 202211310182 A CN202211310182 A CN 202211310182A CN 115487275 A CN115487275 A CN 115487275A
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Abstract
本发明属于中药颗粒领域,公开了一种含有三七提取物的中药颗粒及其制备工艺,所述中药颗粒由以下重量份的原料制成:三七提取物10份、高良姜5‑9份、白芍5‑9份、延胡索5‑9份、白术4‑8份、鸡矢藤4‑8份、大枣4‑8份、吴茱萸3‑6份、细辛3‑6份、鱼腥草3‑6份、路路通2‑5份、丹参2‑5份、白鲜皮2‑4份、蒲公英2‑4份、黄柏1‑3份、地榆1‑3份、知母1‑3份、炙甘草10‑20份;本发明制备的中药颗粒含有浓缩的三七提取物,不含人工成分,和其他的君臣佐使药物配合,对于寒虚型的慢性鼻炎具有较好的疗效,副作用小。
Description
技术领域
本发明属于中药颗粒领域,公开了一种含有三七提取物的中药颗粒及其制备工艺。
背景技术
慢性鼻炎是鼻黏膜及黏膜下层的慢性炎症。其主要特点是炎症持续三个月以上或反复发作,迁延不愈,间歇期亦不能恢复正常,且无明确的致病微生物,伴有不同程度的鼻塞,分泌物增多,鼻黏膜肿胀或增厚等障碍。根据慢性鼻炎的病理和功能紊乱的程度,可分为慢性单纯性鼻炎和慢性肥厚性鼻炎,前者是以鼻黏膜肿胀、分泌物增多为特征的鼻黏膜慢性炎症,后者是以黏膜、黏膜下层甚至骨质的局限性或弥漫性增生肥厚为特点的鼻腔慢性炎症。(1)鼻塞特点为:①间歇性:白天、夏季、劳动或运动时鼻塞减轻,而夜间、静坐或寒冷时鼻塞加重;②交替性:侧卧时下侧鼻腔阻塞,上侧鼻腔通气较好,当转向另一侧卧位时,另一侧鼻腔又出现鼻塞。(2)多为半透明的黏液性鼻涕,继发感染后可有脓涕。鼻涕可向后经后鼻孔流入咽喉部,引起咽喉不适、多“痰”及咳嗽等症状。小儿患者由于鼻涕长期刺激鼻前庭及上唇,可出现鼻前庭炎及湿疹。(3)由于鼻塞,可有间断嗅觉减退、头痛不适及说话时鼻音等。慢性鼻炎使用西药治疗一般只能对症治疗,通常包括减充血剂以及激素类。减充血剂能够迅速缓解鼻塞,但长期使用可能引起药物性鼻炎,因为无明确的致病因素,导致无法治本,从中医角度来看,慢性鼻炎分为实证(风热)和虚证(寒虚)两种,实证的症状较为严重,患者流脓性鼻涕,有异味,鼻腔红肿。而虚证的症状往往是交替性鼻堵、流涕、鼻塞、打喷嚏或头疼。认为慢性鼻炎的治疗应以脾胃为根本,将痰湿浊阴向下疏导,疏通经络。CN200510200531.6公开了一种治疗鼻炎的中药颗粒制剂及其制备方法,由羊耳菊、鱼腥草、绣线菊、大蓟根、路路通、漆姑草、鹅不食草及适量辅料制备而成;本发明的药品具有清热解毒、疏风消肿、利咽通窍的功效,用于风热所致的急慢性鼻炎、鼻窦炎及咽喉炎;本发明采用环糊精包合技术,将提取的挥发油包合在环糊精分子内,并在提取的活性物质中加入可溶性淀粉和乳糖,与现有技术相比,本发明的药品有疗效好、颗粒硬度好、溶出和吸收快,生物利用度高且不易吸潮变质,质量稳定等优点。但是上述鼻炎颗粒主要治疗实证为主,对于虚症的疗效不好。目前并未发现专门用于治疗慢性鼻炎寒虚症的中医颗粒,因此需要在这方面进一步的研究。
发明内容
为了解决上述问题,本发明公开了一种含有三七提取物的中药颗粒及其制备工艺。
本发明的技术方案如下:
一种含有三七提取物的中药颗粒,由以下重量份的原料制成:三七提取物10份、高良姜5-9份、白芍5-9份、延胡索5-9份、白术4-8份、鸡矢藤4-8份、大枣4-8份、吴茱萸3-6份、细辛3-6份、鱼腥草3-6份、路路通2-5份、丹参2-5份、白鲜皮2-4份、蒲公英2-4份、黄柏1-3份、地榆1-3份、知母1-3份、炙甘草10-20份。
进一步的,上述一种含有三七提取物的中药颗粒,所述三七提取物由以下步骤制备:
(1)预处理:以三七的根茎为原料,清洗后晒干,随后投入粉碎机搅拌10-20min,过100-300目筛,得三七粉;
(2)蒸汽处理:将三七粉放入蒸汽处理设备中,在2-3个大气压的高压下,通入110-120℃蒸汽加热30-60min,得三七粉团;
(3)一次酶解:将三七粉团冷却至常温,加入到酶解罐中,加入去离子水的到混合液A,使得固态物占比保持在350-450g/L;投入组合酶A进行搅拌酶解,所述组合酶A包括纤维素酶和果胶酶;搅拌速度50-100rpm,酶解温度为30-40℃,酶解时间为24-48h,得酶解液;
(4)蒸发干燥:对酶解液进行蒸发,干燥至含水量低于20%,得到酶解提取物;
(5)乙醇提取:将酶解提取物投入45~65wt%的乙醇,加热回流24-48h,0.45μm滤膜过滤,弃去滤渣,收集乙醇提取液;
(6)大孔树脂处理:使乙醇提取液通过苯乙烯型大孔树脂柱;并用浓度为55~65wt%的乙醇对所述苯乙烯型大孔树脂柱进行洗脱,收集洗脱液;
(7)真空干燥:将洗脱液放入进行真空干燥,低温干燥,含水量低于10%,得到所述三七提取物。
进一步的,上述一种含有三七提取物的中药颗粒,所述步骤(6)中,苯乙烯型大孔树脂柱的粒径范围为0.3-1.25mm≥95%,比表面积500-600m2/g,平均孔径8-12nm,孔容1.15-1.25mL/g。
进一步的,上述一种含有三七提取物的中药颗粒,所述步骤(7)中,所述真空干燥中,真空压力小于133Pa,温度为55-65℃。
进一步的,上述一种含有三七提取物的中药颗粒,由以下重量份的原料制成:三七提取物10份、高良姜7份、白芍7份、延胡索7份、白术6份、鸡矢藤6份、大枣6份、吴茱萸4份、细辛5份、鱼腥草5份、路路通4份、丹参3份、白鲜皮3份、蒲公英3份、黄柏2份、地榆2份、知母2份、炙甘草15份。
进一步的,上述一种含有三七提取物的中药颗粒的制备方法,包括以下步骤:
1)将除三七提取物外的他原料按配方精密称取,所述原料的形态为干燥中药饮片;
2)将上述饮片混合后,研磨成粉,过100-200目;
3)将上述粉末煎煮釜中,加入原料总质量4~6倍量的去离子水,大火煎煮45~60min,再文火煎煮2~3h,再过滤煎液,收集滤液;
4)在滤液中投入所述三七提取物,继续加热搅拌混合;
5)蒸发浓缩,得到相对密度为1.03-1.14的悬浊液,再加入喷雾干燥辅料至含量为300-400g/L;
6)将上述悬浊液保温状态下泵入喷雾制粒干燥机中,制备得到所述中药颗粒。
进一步的,上述一种含有三七提取物的中药颗粒的制备方法,所述的喷雾干燥辅料为麦芽糊精、蔗糖粉、壳聚糖、阿拉伯胶。
进一步的,上述一种含有三七提取物的中药颗粒的制备方法,按质量百分数计算,所述麦芽糊精占60-70%、蔗糖粉占20-30%、壳聚糖占10-20%、阿拉伯胶占5-10%。
进一步的,上述含有三七提取物的中药颗粒在制备治疗慢性寒虚性鼻炎的药剂中的应用。
进一步的,上述药剂为胶囊剂,含有所述三七提取物的中药颗粒的量为200-400mg。
相比现有技术,本发明具有如下有益效果:本发明公开了一种含有三七提取物的中药颗粒及其制备工艺。所述的三七提取物富含人参皂甙Rb1、Rg1、Rg2以及黄酮甙,化瘀止血,活血通络,和温阳的中药合用为君药,补益类中药为臣药,再配合利湿通窍类中药为佐药,加上炙甘草等使药,共奏温阳补益驱寒通络祛湿通窍之功效,长期服用,对寒虚型慢性鼻炎具有较好的疗效,并且本中药颗粒的有效成分均为纯天然成分,副作用小,长期服用安全有效。
附图说明
图1为实施例临床评分结果。
具体实施方式
一种含有三七提取物的中药颗粒,由以下重量份的原料制成:三七提取物10份、高良姜5-9份、白芍5-9份、延胡索5-9份、白术4-8份、鸡矢藤4-8份、大枣4-8份、吴茱萸3-6份、细辛3-6份、鱼腥草3-6份、路路通2-5份、丹参2-5份、白鲜皮2-4份、蒲公英2-4份、黄柏1-3份、地榆1-3份、知母1-3份、炙甘草10-20份。
所述三七提取物由以下步骤制备:
(1)预处理:以三七的根茎为原料,清洗后晒干,随后投入粉碎机搅拌10-20min,过100-300目筛,得三七粉;
(2)蒸汽处理:将三七粉放入蒸汽处理设备中,在2-3个大气压的高压下,通入110-120℃蒸汽加热30-60min,得三七粉团;
(3)一次酶解:将三七粉团冷却至常温,加入到酶解罐中,加入去离子水的到混合液A,使得固态物占比保持在350-450g/L;投入组合酶A进行搅拌酶解,所述组合酶A包括纤维素酶和果胶酶;搅拌速度50-100rpm,酶解温度为30-40℃,酶解时间为24-48h,得酶解液;
(4)蒸发干燥:对酶解液进行蒸发,干燥至含水量低于20%,得到酶解提取物;
(5)乙醇提取:将酶解提取物投入45~65wt%的乙醇,加热回流24-48h,0.45μm滤膜过滤,弃去滤渣,收集乙醇提取液;
(6)大孔树脂处理:使乙醇提取液通过苯乙烯型大孔树脂柱;并用浓度为55~65wt%的乙醇对所述苯乙烯型大孔树脂柱进行洗脱,收集洗脱液;
(7)真空干燥:将洗脱液放入进行真空干燥,低温干燥,含水量低于10%,得到所述三七提取物。
所述步骤(6)中,苯乙烯型大孔树脂柱的粒径范围为0.3-1.25mm≥95%,比表面积500-600m2/g,平均孔径8-12nm,孔容1.15-1.25mL/g。
所述步骤(7)中,所述真空干燥中,真空压力小于133Pa,温度为55-65℃。
上述含有三七提取物的中药颗粒的制备方法,包括以下步骤:
1)将除三七提取物外的他原料按配方精密称取,所述原料的形态为干燥中药饮片;
2)将上述饮片混合后,研磨成粉,过100-200目;
3)将上述粉末煎煮釜中,加入原料总质量4~6倍量的去离子水,大火煎煮45~60min,再文火煎煮2~3h,再过滤煎液,收集滤液;
4)在滤液中投入所述三七提取物,继续加热搅拌混合;
5)蒸发浓缩,得到相对密度为1.03-1.14的悬浊液,再加入喷雾干燥辅料至含量为300-400g/L;
6)将上述悬浊液保温状态下泵入喷雾制粒干燥机中,制备得到所述中药颗粒。
所述的喷雾干燥辅料为:
按质量百分数计算,所述麦芽糊精占60-70%、蔗糖粉占20-30%、壳聚糖占10-20%、阿拉伯胶占5-10%。
下面对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其它实施例,都属于本发明保护的范围。
本发明实施例中使用的试剂或仪器未注明生产厂商者,均为可以通过市购获得的常规试剂产品。
所述三七采收自云南文山。
实施例1
一种含有三七提取物的中药颗粒,由以下重量份的原料制成:三七提取物10份、高良姜5份、白芍5份、延胡索5份、白术4份、鸡矢藤4份、大枣4份、吴茱萸3份、细辛3份、鱼腥草3份、路路通2份、丹参2份、白鲜皮2份、蒲公英2份、黄柏1份、地榆1份、知母1份、炙甘草10份。
所述三七提取物由以下步骤制备:
(1)预处理:以三七的根茎为原料,清洗后晒干,随后投入粉碎机搅拌10-20min,过100-300目筛,得三七粉;
(2)蒸汽处理:将三七粉放入蒸汽处理设备中,在2-3个大气压的高压下,通入110-120℃蒸汽加热30-60min,得三七粉团;
(3)一次酶解:将三七粉团冷却至常温,加入到酶解罐中,加入去离子水的到混合液A,使得固态物占比保持在350-450g/L;投入组合酶A进行搅拌酶解,所述组合酶A包括纤维素酶和果胶酶质量比1:1,终浓度为2g/L;搅拌速度50-100rpm,酶解温度为30-40℃,酶解时间为24-48h,得酶解液;
(4)蒸发干燥:对酶解液进行蒸发,干燥至含水量低于20%,得到酶解提取物;
(5)乙醇提取:将酶解提取物投入45~65wt%的乙醇,加热回流24-48h,0.45μm滤膜过滤,弃去滤渣,收集乙醇提取液;
(6)大孔树脂处理:使乙醇提取液通过苯乙烯型大孔树脂柱;并用浓度为55~65wt%的乙醇对所述苯乙烯型大孔树脂柱进行洗脱,收集洗脱液;
(7)真空干燥:将洗脱液放入进行真空干燥,低温干燥,含水量低于10%,得到所述三七提取物。
所述步骤(6)中,苯乙烯型大孔树脂柱的粒径范围为0.3-1.25mm≥95%,比表面积500-600m2/g,平均孔径8-12nm,孔容1.15-1.25mL/g。
所述步骤(7)中,所述真空干燥中,真空压力小于133Pa,温度为55-65℃。
上述含有三七提取物的中药颗粒的制备方法,包括以下步骤:
1)将除三七提取物外的他原料按配方精密称取,所述原料的形态为干燥中药饮片;
2)将上述饮片混合后,研磨成粉,过100-200目;
3)将上述粉末煎煮釜中,加入原料总质量4~6倍量的去离子水,大火煎煮45~60min,再文火煎煮2~3h,再过滤煎液,收集滤液;
4)在滤液中投入所述三七提取物,继续加热搅拌混合;
5)蒸发浓缩,得到相对密度为1.03-1.14的悬浊液,再加入喷雾干燥辅料至含量为300-400g/L;
6)将上述悬浊液保温状态下泵入喷雾制粒干燥机中,制备得到所述中药颗粒。
所述的喷雾干燥辅料为:
按质量百分数计算,所述麦芽糊精占60%、蔗糖粉占20%、壳聚糖占10%、阿拉伯胶占10%。
实施例2
一种含有三七提取物的中药颗粒,由以下重量份的原料制成:三七提取物10份、高良姜7份、白芍7份、延胡索7份、白术6份、鸡矢藤6份、大枣6份、吴茱萸4份、细辛5份、鱼腥草5份、路路通4份、丹参3份、白鲜皮3份、蒲公英3份、黄柏2份、地榆2份、知母2份、炙甘草15份。
所述三七提取物由以下步骤制备:
(1)预处理:以三七的根茎为原料,清洗后晒干,随后投入粉碎机搅拌10-20min,过100-300目筛,得三七粉;
(2)蒸汽处理:将三七粉放入蒸汽处理设备中,在2-3个大气压的高压下,通入110-120℃蒸汽加热30-60min,得三七粉团;
(3)一次酶解:将三七粉团冷却至常温,加入到酶解罐中,加入去离子水的到混合液A,使得固态物占比保持在350-450g/L;投入组合酶A进行搅拌酶解,所述组合酶A包括纤维素酶和果胶酶质量比1:1,终浓度为2g/L;搅拌速度50-100rpm,酶解温度为30-40℃,酶解时间为24-48h,得酶解液;
(4)蒸发干燥:对酶解液进行蒸发,干燥至含水量低于20%,得到酶解提取物;
(5)乙醇提取:将酶解提取物投入45~65wt%的乙醇,加热回流24-48h,0.45μm滤膜过滤,弃去滤渣,收集乙醇提取液;
(6)大孔树脂处理:使乙醇提取液通过苯乙烯型大孔树脂柱;并用浓度为55~65wt%的乙醇对所述苯乙烯型大孔树脂柱进行洗脱,收集洗脱液;
(7)真空干燥:将洗脱液放入进行真空干燥,低温干燥,含水量低于10%,得到所述三七提取物。
所述步骤(6)中,苯乙烯型大孔树脂柱的粒径范围为0.3-1.25mm≥95%,比表面积500-600m2/g,平均孔径8-12nm,孔容1.15-1.25mL/g。
所述步骤(7)中,所述真空干燥中,真空压力小于133Pa,温度为55-65℃。
上述含有三七提取物的中药颗粒的制备方法,包括以下步骤:
1)将除三七提取物外的他原料按配方精密称取,所述原料的形态为干燥中药饮片;
2)将上述饮片混合后,研磨成粉,过100-200目;
3)将上述粉末煎煮釜中,加入原料总质量4~6倍量的去离子水,大火煎煮45~60min,再文火煎煮2~3h,再过滤煎液,收集滤液;
4)在滤液中投入所述三七提取物,继续加热搅拌混合;
5)蒸发浓缩,得到相对密度为1.03-1.14的悬浊液,再加入喷雾干燥辅料至含量为300-400g/L;
6)将上述悬浊液保温状态下泵入喷雾制粒干燥机中,制备得到所述中药颗粒。
所述的喷雾干燥辅料为:
按质量百分数计算,所述麦芽糊精占65%、蔗糖粉占20%、壳聚糖占10%、阿拉伯胶占10%。
实施例3
一种含有三七提取物的中药颗粒,由以下重量份的原料制成:三七提取物10份、高良姜9份、白芍9份、延胡索9份、白术8份、鸡矢藤8份、大枣8份、吴茱萸6份、细辛6份、鱼腥草6份、路路通5份、丹参5份、白鲜皮4份、蒲公英4份、黄柏3份、地榆3份、知母3份、炙甘草20份。
所述三七提取物由以下步骤制备:
(1)预处理:以三七的根茎为原料,清洗后晒干,随后投入粉碎机搅拌10-20min,过100-300目筛,得三七粉;
(2)蒸汽处理:将三七粉放入蒸汽处理设备中,在2-3个大气压的高压下,通入110-120℃蒸汽加热30-60min,得三七粉团;
(3)一次酶解:将三七粉团冷却至常温,加入到酶解罐中,加入去离子水的到混合液A,使得固态物占比保持在350-450g/L;投入组合酶A进行搅拌酶解,所述组合酶A包括纤维素酶和果胶酶质量比1:1,终浓度为2g/L;搅拌速度50-100rpm,酶解温度为30-40℃,酶解时间为24-48h,得酶解液;
(4)蒸发干燥:对酶解液进行蒸发,干燥至含水量低于20%,得到酶解提取物;
(5)乙醇提取:将酶解提取物投入45~65wt%的乙醇,加热回流24-48h,0.45μm滤膜过滤,弃去滤渣,收集乙醇提取液;
(6)大孔树脂处理:使乙醇提取液通过苯乙烯型大孔树脂柱;并用浓度为55~65wt%的乙醇对所述苯乙烯型大孔树脂柱进行洗脱,收集洗脱液;
(7)真空干燥:将洗脱液放入进行真空干燥,低温干燥,含水量低于10%,得到所述三七提取物。
所述步骤(6)中,苯乙烯型大孔树脂柱的粒径范围为0.3-1.25mm≥95%,比表面积500-600m2/g,平均孔径8-12nm,孔容1.15-1.25mL/g。
所述步骤(7)中,所述真空干燥中,真空压力小于133Pa,温度为55-65℃。
上述含有三七提取物的中药颗粒的制备方法,包括以下步骤:
1)将除三七提取物外的他原料按配方精密称取,所述原料的形态为干燥中药饮片;
2)将上述饮片混合后,研磨成粉,过100-200目;
3)将上述粉末煎煮釜中,加入原料总质量4~6倍量的去离子水,大火煎煮45~60min,再文火煎煮2~3h,再过滤煎液,收集滤液;
4)在滤液中投入所述三七提取物,继续加热搅拌混合;
5)蒸发浓缩,得到相对密度为1.03-1.14的悬浊液,再加入喷雾干燥辅料至含量为300-400g/L;
6)将上述悬浊液保温状态下泵入喷雾制粒干燥机中,制备得到所述中药颗粒。
所述的喷雾干燥辅料为:
按质量百分数计算,所述麦芽糊精占60%、蔗糖粉占20%、壳聚糖占15%、阿拉伯胶占5%。
对比例
一种中药颗粒,不含有三七提取液,其他同实施例2。
测试例1
将实施例2以及对比例的中药颗粒制备为胶囊制剂,每胶囊含有和200mg和400mg所述中药颗粒。每日早晚各服用1次。
100名被中医诊断为寒虚型慢性鼻炎志愿者,分为5个组,每组20人,分别为:实施例2低剂量、实施例2高剂量、对比例低剂量、对比例高剂量,对照组(不接受上述药物治疗)。
服用上述药物7天,在用药前后分别填写如表1所示的评价表。得分(每人累加)如表2以及图1所示。
表1慢性鼻炎疗效评价表
表2临床评分结果
治疗前指数 | 治疗后指数 | |
实施例2低剂量 | 15 | 42 |
实施例2高剂量 | 16 | 48 |
对比例低剂量 | 14 | 31 |
对比例高剂量 | 15 | 33 |
对照组 | 16 | 21 |
由以上表1和表2的数据可知,;本发明制备的中药颗粒含有浓缩的三七提取物,不含人工成分,和其他的君臣佐使药物配合,对于寒虚型的慢性鼻炎具有较好的疗效,并且呈现出剂量依赖性。而将三七提取物去除之后,整个配方对于寒虚型慢性鼻炎的疗效下降明显。
上述实施例只是本发明的有限几种优选实施方式,其描述较为具体和详细,但并不能因此而理解为对本发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,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)
1.一种含有三七提取物的中药颗粒,其特征在于,由以下重量份的原料制成:三七提取物10份、高良姜5-9份、白芍5-9份、延胡索5-9份、白术4-8份、鸡矢藤4-8份、大枣4-8份、吴茱萸3-6份、细辛3-6份、鱼腥草3-6份、路路通2-5份、丹参2-5份、白鲜皮2-4份、蒲公英2-4份、黄柏1-3份、地榆1-3份、知母1-3份、炙甘草10-20份。
2.根据权利要求1所述的一种含有三七提取物的中药颗粒,其特征在于,所述三七提取物由以下步骤制备:
(1)预处理:以三七的根茎为原料,清洗后晒干,随后投入粉碎机搅拌10-20min,过100-300目筛,得三七粉;
(2)蒸汽处理:将三七粉放入蒸汽处理设备中,在2-3个大气压的高压下,通入110-120℃蒸汽加热30-60min,得三七粉团;
(3)一次酶解:将三七粉团冷却至常温,加入到酶解罐中,加入去离子水的到混合液A,使得固态物占比保持在350-450g/L;投入组合酶A进行搅拌酶解,所述组合酶A包括纤维素酶和果胶酶;搅拌速度50-100rpm,酶解温度为30-40℃,酶解时间为24-48h,得酶解液;
(4)蒸发干燥:对酶解液进行蒸发,干燥至含水量低于20%,得到酶解提取物;
(5)乙醇提取:将酶解提取物投入45~65wt%的乙醇,加热回流24-48h,0.45μm滤膜过滤,弃去滤渣,收集乙醇提取液;
(6)大孔树脂处理:使乙醇提取液通过苯乙烯型大孔树脂柱;并用浓度为55~65wt%的乙醇对所述苯乙烯型大孔树脂柱进行洗脱,收集洗脱液;
(7)真空干燥:将洗脱液放入进行真空干燥,低温干燥,含水量低于10%,得到所述三七提取物。
3.根据权利要求2所述的一种含有三七提取物的中药颗粒,其特征在于,所述步骤(6)中,苯乙烯型大孔树脂柱的粒径范围为0.3-1.25mm≥95%,比表面积500-600m2/g,平均孔径8-12nm,孔容1.15-1.25mL/g。
4.根据权利要求1所述的一种含有三七提取物的中药颗粒,其特征在于,所述步骤(7)中,所述真空干燥中,真空压力小于133Pa,温度为55-65℃。
5.根据权利要求1所述的一种含有三七提取物的中药颗粒,其特征在于,由以下重量份的原料制成:三七提取物10份、高良姜7份、白芍7份、延胡索7份、白术6份、鸡矢藤6份、大枣6份、吴茱萸4份、细辛5份、鱼腥草5份、路路通4份、丹参3份、白鲜皮3份、蒲公英3份、黄柏2份、地榆2份、知母2份、炙甘草15份。
6.如权利要求1所述的一种含有三七提取物的中药颗粒的制备方法,其特征在于,包括以下步骤:
1)将除三七提取物外的他原料按配方精密称取,所述原料的形态为干燥中药饮片;
2)将上述饮片混合后,研磨成粉,过100-200目;
3)将上述粉末煎煮釜中,加入原料总质量4~6倍量的去离子水,大火煎煮45~60min,再文火煎煮2~3h,再过滤煎液,收集滤液;
4)在滤液中投入所述三七提取物,继续加热搅拌混合;
5)蒸发浓缩,得到相对密度为1.03-1.14的悬浊液,再加入喷雾干燥辅料至含量为300-400g/L;
6)将上述悬浊液保温状态下泵入喷雾制粒干燥机中,制备得到所述中药颗粒。
7.根据权利要求1-6任一项所述的含有三七提取物的中药颗粒的制备方法,其特征在于,所述步骤6)中,所述的喷雾干燥辅料为麦芽糊精、蔗糖粉、壳聚糖、阿拉伯胶。
8.根据权利要求7所述的含有三七提取物的中药颗粒的制备方法,其特征在于,按质量百分数计算,所述麦芽糊精占60-70%、蔗糖粉占20-30%、壳聚糖占10-20%、阿拉伯胶占5-10%。
9.如权利要求1-6任一项所述的含有三七提取物的中药颗粒在制备治疗慢性寒虚性鼻炎的药剂中的应用。
10.根据权利要求9所述的应用,其特征在于,所述药剂为胶囊剂,含有所述三七提取物的中药颗粒的量为200-400mg。
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