CN104352741A - 一种仙灵骨葆方中药饮片组合制剂及制备方法和应用包装 - Google Patents
一种仙灵骨葆方中药饮片组合制剂及制备方法和应用包装 Download PDFInfo
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- CN104352741A CN104352741A CN201410554522.6A CN201410554522A CN104352741A CN 104352741 A CN104352741 A CN 104352741A CN 201410554522 A CN201410554522 A CN 201410554522A CN 104352741 A CN104352741 A CN 104352741A
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Abstract
本发明公开了一种滋补肝肾,活血通络,强筋壮骨,用于骨质疏松和骨质疏松症,骨折,骨关节炎,骨无菌性坏死等的仙灵骨葆方中药饮片组合制剂及其制备方法和组合包装,该制剂为复方中药饮片制剂,包括质量份数如下的各组分,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份。本发明取自天然成分,为纯中药制剂,并采用现代先进的医药制药技术制备而成,具有本发明所述的治疗骨质疏松的药剂成分简单,疗效显著,经常患骨质疏松者,本发明中药制剂成分安全温和,对人体健康无刺激无危害。
Description
技术领域
本发明涉及一种滋补肝肾,活血通络,强筋壮骨。用于骨质疏松和骨质疏松症,骨折,骨关节炎,骨无菌性坏死等的复合中药饮片,更确切地说是一种仙灵骨葆方中药饮片组合制剂及制备方法和应用包装。
背景技术
现代健康的需要,在中药制剂领域在传承、复兴和发扬中形成众多中医药老字号品牌,如同仁堂(1669)、胡庆余堂(1874)、大生祥(1885)、韩杏堂(1901)、阜通(1644)、杏和堂(1600)、公益大、陈直翁、怀德鹤(1948)、老人和泰、翁长春(1699)、傅济春、雅观斋(明万历年间)、雷允上等以及中医药健康茶老字号品牌如万泰元(1860)、朱乾升、大鹏红日、乾泰聚等,其中万泰元茶號更是荣获1915年万国世界博览会金奖、1926年美国费城世界博览会甲等大奖和1929年首届西湖博览会金奖。
骨质疏松症是一个世界范围的、越来越引起人们重视的健康问题,目前全世界约2亿人患有骨质疏松症,其发病率已跃居常见病、多发病的第七位。最新研究表明,在我国一直被认为是老年人特有疾病的骨质疏松症,实际上在儿童时期就已存在。特别需要强调的是,目前医学上还未有安全而有效的根治方法,帮助已疏松的骨骼恢复原状,因此,正确认识、早期预防显得尤为重要。随着人口老龄化日趋明显,作为中老年多发的退行性疾病一骨质疏松症及其并发症,已成为一个社会性的健康问题而备受老年病学者的关注,并引起了各国政府的高度重视。骨质疏松症的主要危险结果是易致骨折,像高血压病控制不好易致中风一样,骨质疏松症在西方发展国家的妇女中发生率高,在美国约有2500万患者,每年约有150万患者并发骨折,约20%的骨折患者在1年内因并发肺栓塞、肺炎而死亡,在妇女骨质疏松性骨折而致的死亡率超过乳房癌、宫颈癌和子宫体癌的总和,半数髋部骨折的存活者失去独立生活的能力,约20%的患者只能生活在护理院中。骨质疏松性骨折医疗费用耗资巨大,1984年美国估计61亿美元,最近估计达100亿美元,随着人口的不断老龄化和平均期望寿命增长,如果不采取有效的干预,未来的25年,此项医疗引导可能还要成倍增长。
迈入21世纪,我国人口已近13亿,60岁以上的人群达10%,这标志着我国开始进入老龄社会,骨质疏松症病人势必迅猛增加。在我国已经构成一个严重的公众健康问题。
发明内容
由于现有技术的上述缺点,本发明提出一种仙灵骨葆方中药饮片组合制剂,其可以有效解决现有技术的上述缺点。
本发明采用以下技术方案:
一种仙灵骨葆方中药饮片组合制剂,该制剂为复方中药饮片制剂,包括质量份数如下的各组分,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份。
还包括第一复合组分,其包括仙茅、菟丝子、肉苁蓉、三七、肉桂、五加皮、杜仲、赶山鞭、女贞子、制何首乌、鸡血藤、山茱萸、桂枝、防风、乌梅、老鹳草、川牛膝、蜈蚣、甘草、细辛、独活、泽泻、松节、络石藤。
所述第一复合组分与所述续断的质量比为100∶5,所述第一复合组分中各组分的质量份数为仙茅15-25份、菟丝子15-25份、肉苁蓉15-25份、三七15-25份、肉桂15-25份、五加皮15-25份、杜仲15-25份、赶山鞭15-25份、女贞子15-25份、制何首乌15-25份、鸡血藤15-25份、山茱萸10-15份、桂枝10-15份、防风10-15份、乌梅10-15份、老鹳草10-15份、川牛膝10-15份、蜈蚣10-15份、甘草10-15份、细辛10-15份、独活10-15份、泽泻10-15份、松节10-15份、络石藤10-15份。
所述第一复合组分中各组分的质量份数为仙茅17份、菟丝子18份、肉苁蓉17份、三七16份、肉桂18份、五加皮17份、杜仲18份、赶山鞭17份、女贞子18份、制何首乌19份、鸡血藤17份、山茱萸12份、桂枝13份、防风12份、乌梅13份、老鹳草13份、川牛膝13份、蜈蚣12份、甘草12份、细辛12份、独活12份、泽泻12份、松节13份、络石藤13份。
还包括第二复合组分,其包括:牡丹皮、白桂木根、红花、桂枝、香附、香茅、鸡血藤、红母鸡草、吴茱萸、穿山甲粉、白术、枫荷梨、益母草、走马风、鹿角胶、干姜、萝芙木、防已、三棱、大黄、莪术、龙眼肉、双花、王不留行、巴山虎、车前子、岗梅根、连翅、鹿藿、大黄、冬凌草、淫羊藿、罗勒、覆盆子、祖师麻、蒡苈子、游草和三角风。
所述第二复合组分与所述续断的质量比为100∶3,所述第二复合组分中各组分的含量份数为:牡丹皮6-13份、白桂木根6-13份、红花6-13份、桂枝6-13份、香附6-13份、香茅6-13份、鸡血藤6-13份、红母鸡草6-13份、吴茱萸6-13份、穿山甲粉6-13份、白术6-13份、枫荷梨6-13份、益母草7-21份、走马风7-21份、鹿角胶7-21份、干姜7-21份、萝芙木7-21份、防已7-21份、三棱7-21份、大黄7-21份、莪术7-21份、龙眼肉7-21份、双花7-21份、王不留行7-21份、巴山虎7-21份、车前子7-21份、岗梅根7-21份、连翅7-21份、鹿藿7-21份、大黄7-21份、冬凌草6-13份、淫羊藿6-13份、罗勒6-13份、覆盆子6-13份、祖师麻6-13份、蒡苈子6-13份、游草6-13份和三角风6-13份。
所述第二复合组分中各组分的含量为:牡丹皮12份、白桂木根10份、红花9份、桂枝8份、香附10份、香茅10份、鸡血藤8份、红母鸡草7份、吴茱萸8份、穿山甲粉9份、白术8份、枫荷梨8份、益母草8份、走马风15份、鹿角胶16份、干姜17份、萝芙木18份、防已16份、三棱17份、大黄18份、莪术19份、龙眼肉18份、双花17份、王不留行17份、巴山虎16份、车前子18份、岗梅根18份、连翅19份、鹿藿19份、大黄17份、冬凌草9份、淫羊藿10份、罗勒11份、覆盆子8份、祖师麻7份、蒡苈子8份、游草9份和三角风7份。
一种仙灵骨葆方中药饮片组合制剂的制备方法,包括以下步骤:将丹参制成丹参细粉;其余淫羊藿、续断、知母、补骨脂粉碎为粗粉,地黄切成薄片,加水煎煮三次,第一次3小时,第二次2小时,第三次1小时,合并煎液,滤过,滤液浓缩干燥得到活性提取物,将活性提取物粉碎得到活性提取物细粉,将活性提取物细粉与丹参细粉混合即可。
丹参细粉为通过下列方法制备得到,将新鲜的丹参洗净后、切制、炮炙处理;将处理后的丹参粉碎,制成粗粉,再进行灭菌处理;将粗粉放入冻干箱后,启动冻干机,待冻干箱温度降至-30℃~-35℃后,保持1.5-3小时进行冷冻干燥;抽真空至系统绝对压力为60~100Pa,开始加热升温至40℃~50℃,升华干燥15~24小时;将干燥好的粗粉丹参加入超细粉碎机中进行打粉,打粉后所述丹参纯粉的粒径为0.5-2μm。
所述活性提取物细粉为通过下述方法制备得到,将活性提取物放入冻干箱后,启动冻干机,待冻干箱温度降至-40℃~-20℃后,保持1.5-5小时进行冷冻干燥;抽真空至系统绝对压力为20~200Pa,开始加热升温至50℃~80℃,升华干燥11~25小时;将干燥好的活性提取物加入超细粉碎机中进行打粉,打粉后活性提取物细粉的粒径为0.5-2μm。
将丹参细粉及活性提取物细粉按细例包装成袋。
一种仙灵骨葆方中药饮片组合制剂的应用包装,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份按比例包装成袋。
所述包装中还包括辅料,其中淫羊藿、续断、丹参、知母、补骨脂及地黄的总量与辅料的配比为1∶1。
所述辅料为包括崩解剂、润滑剂和填充剂,所述的崩解剂为羧甲基淀粉钠、羟丙纤维素、交联聚乙烯吡咯烷酮和交联羧甲基纤维素钠中的一种或多种;所述的崩解剂的用量为所述的药物活性成分的2-5%;所述的润滑剂为胶态二氧化硅、硬脂酸富马酸钠、滑石粉和硬脂酸镁中的一种或多种;所述的润滑剂的用量为所述的药物活性成分的3-9%;所述的填充剂为乳糖、无水乳糖、甘露醇、微晶纤维素、淀粉、木糖醇、预胶化淀粉和麦芽糖醇中的一种或多种;所述的填充剂的用量为所述的药物活性成分重量的2-5倍。
本发明具有以下优点:本发明取自天然成分,为纯中药制剂,并采用现代先进的医药制药技术制备而成,具有本发明所述的治疗骨质疏松的药剂成分简单,疗效显著,经常患骨质疏松者。本发明中药制剂成分安全温和,对人体健康无刺激无危害。
具体实施方式:
下面结合具体实施方式,详细描述本发明。应理解,这些实施方式仅用于说明本发明而不用于限制本发明的范围。此外应理解,在阅读了本发明讲授的内容之后,本领域技术人员可以对本发明作各种改动或修改,这些等价形式同样落于本申请所附权利要求书所限定的范围。
实施例1
一种仙灵骨葆方中药饮片组合制剂,其特征在于,该制剂为复方中药饮片制剂,包括质量份数如下的各组分,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份。
实施例2
一种仙灵骨葆方中药饮片组合制剂,该制剂为复方中药饮片制剂,包括质量份数如下的各组分,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份。还包括第一复合组分,且所述第一复合组分与所述续断的质量比为100∶5,所述第一复合组分中各组分的质量份数为仙茅15份、菟丝子15份、肉苁蓉15份、三七15份、肉桂15份、五加皮15份、杜仲15份、赶山鞭15份、女贞子15份、制何首乌15份、鸡血藤15份、山茱萸10份、桂枝10份、防风10份、乌梅10份、老鹳草10份、川牛膝10份、蜈蚣10份、甘草10份、细辛10份、独活10份、泽泻10份、松节10份、络石藤10份。
实施例3
一种仙灵骨葆方中药饮片组合制剂,该制剂为复方中药饮片制剂,包括质量份数如下的各组分,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份。还包括第一复合组分,且所述第一复合组分与所述续断的质量比为100∶5,所述第一复合组分中各组分的质量份数为仙茅25份、菟丝子25份、肉苁蓉25份、三七25份、肉桂25份、五加皮25份、杜仲25份、赶山鞭25份、女贞子25份、制何首乌25份、鸡血藤25份、山茱萸15份、桂枝15份、防风15份、乌梅15份、老鹳草15份、川牛膝15份、蜈蚣15份、甘草15份、细辛15份、独活15份、泽泻15份、松节15份、络石藤15份。
实施例4
一种仙灵骨葆方中药饮片组合制剂,该制剂为复方中药饮片制剂,包括质量份数如下的各组分,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份。还包括第一复合组分,且所述第一复合组分与所述续断的质量比为100∶5,所述第一复合组分中各组分的质量份数为仙茅17份、菟丝子18份、肉苁蓉17份、三七16份、肉桂18份、五加皮17份、杜仲18份、赶山鞭17份、女贞子18份、制何首乌19份、鸡血藤17份、山茱萸12份、桂枝13份、防风12份、乌梅13份、老鹳草13份、川牛膝13份、蜈蚣12份、甘草12份、细辛12份、独活12份、泽泻12份、松节13份、络石藤13份。
实施例5
一种仙灵骨葆方中药饮片组合制剂,该制剂为复方中药饮片制剂,包括质量份数如下的各组分,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份。还包括第二复合组分,所述第二复合组分与所述续断的质量比为100∶3,所述第二复合组分中各组分的含量份数为:牡丹皮6份、白桂木根6份、红花6份、桂枝6份、香附6份、香茅6份、鸡血藤6份、红母鸡草6份、吴茱萸6份、穿山甲粉6份、白术6份、枫荷梨6份、益母草7份、走马风7份、鹿角胶7份、干姜7份、萝芙木7份、防已7份、三棱7份、大黄7份、莪术7份、龙眼肉7份、双花7份、王不留行7份、巴山虎7份、车前子7份、岗梅根7份、连翅7份、鹿藿7份、大黄7份、冬凌草6份、淫羊藿6份、罗勒6份、覆盆子6份、祖师麻6份、蒡苈子6份、游草6份和三角风6份。
实施例6
一种仙灵骨葆方中药饮片组合制剂,该制剂为复方中药饮片制剂,包括质量份数如下的各组分,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份。还包括第二复合组分,所述第二复合组分与所述续断的质量比为100∶3,所述第二复合组分中各组分的含量份数为:牡丹皮13份、白桂木根13份、红花13份、桂枝13份、香附13份、香茅13份、鸡血藤13份、红母鸡草13份、吴茱萸13份、穿山甲粉13份、白术13份、枫荷梨13份、益母草21份、走马风21份、鹿角胶21份、干姜21份、萝芙木21份、防已21份、三棱21份、大黄21份、莪术21份、龙眼肉21份、双花21份、王不留行21份、巴山虎21份、车前子21份、岗梅根21份、连翅21份、鹿藿21份、大黄21份、冬凌草13份、淫羊藿13份、罗勒13份、覆盆子13份、祖师麻13份、蒡苈子13份、游草13份和三角风13份。
实施例7
一种仙灵骨葆方中药饮片组合制剂,该制剂为复方中药饮片制剂,包括质量份数如下的各组分,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份。还包括第二复合组分,所述第二复合组分与所述续断的质量比为100∶3,所述第二复合组分中各组分的含量份数为:牡丹皮12份、白桂木根10份、红花9份、桂枝8份、香附10份、香茅10份、鸡血藤8份、红母鸡草7份、吴茱萸8份、穿山甲粉9份、白术8份、枫荷梨8份、益母草8份、走马风15份、鹿角胶16份、干姜17份、萝芙木18份、防已16份、三棱17份、大黄18份、莪术19份、龙眼肉18份、双花17份、王不留行17份、巴山虎16份、车前子18份、岗梅根18份、连翅19份、鹿藿19份、大黄17份、冬凌草9份、淫羊藿10份、罗勒11份、覆盆子8份、祖师麻7份、蒡苈子8份、游草9份和三角风7份。
实施例8
一种仙灵骨葆方中药饮片组合制剂,该制剂为复方中药饮片制剂,包括质量份数如下的各组分,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份。还包括第一复合组分,且所述第一复合组分与所述续断的质量比为100∶5,所述第一复合组分中各组分的质量份数为仙茅15份、菟丝子15份、肉苁蓉15份、三七15份、肉桂15份、五加皮15份、杜仲15份、赶山鞭15份、女贞子15份、制何首乌15份、鸡血藤15份、山茱萸10份、桂枝10份、防风10份、乌梅10份、老鹳草10份、川牛膝10份、蜈蚣10份、甘草10份、细辛10份、独活10份、泽泻10份、松节10份、络石藤10份。还包括第二复合组分,所述第二复合组分与所述续断的质量比为100∶3,所述第二复合组分中各组分的含量份数为:牡丹皮6份、白桂木根6份、红花6份、桂枝6份、香附6份、香茅6份、鸡血藤6份、红母鸡草6份、吴茱萸6份、穿山甲粉6份、白术6份、枫荷梨6份、益母草7份、走马风7份、鹿角胶7份、干姜7份、萝芙木7份、防已7份、三棱7份、大黄7份、莪术7份、龙眼肉7份、双花7份、王不留行7份、巴山虎7份、车前子7份、岗梅根7份、连翅7份、鹿藿7份、大黄7份、冬凌草6份、淫羊藿6份、罗勒6份、覆盆子6份、祖师麻6份、蒡苈子6份、游草6份和三角风6份。
实施例9
一种仙灵骨葆方中药饮片组合制剂,该制剂为复方中药饮片制剂,包括质量份数如下的各组分,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份。还包括第一复合组分,且所述第一复合组分与所述续断的质量比为100∶5,所述第一复合组分中各组分的质量份数为仙茅25份、菟丝子25份、肉苁蓉25份、三七25份、肉桂25份、五加皮25份、杜仲25份、赶山鞭25份、女贞子25份、制何首乌25份、鸡血藤25份、山茱萸15份、桂枝15份、防风15份、乌梅15份、老鹳草15份、川牛膝15份、蜈蚣15份、甘草15份、细辛15份、独活15份、泽泻15份、松节15份、络石藤15份。还包括第二复合组分,所述第二复合组分与所述续断的质量比为100∶3,所述第二复合组分中各组分的含量份数为:牡丹皮13份、白桂木根13份、红花13份、桂枝13份、香附13份、香茅13份、鸡血藤13份、红母鸡草13份、吴茱萸13份、穿山甲粉13份、白术13份、枫荷梨13份、益母草21份、走马风21份、鹿角胶21份、干姜21份、萝芙木21份、防已21份、三棱21份、大黄21份、莪术21份、龙眼肉21份、双花21份、王不留行21份、巴山虎21份、车前子21份、岗梅根21份、连翅21份、鹿藿21份、大黄21份、冬凌草13份、淫羊藿13份、罗勒13份、覆盆子13份、祖师麻13份、蒡苈子13份、游草13份和三角风13份。
实施例10
一种仙灵骨葆方中药饮片组合制剂,该制剂为复方中药饮片制剂,包括质量份数如下的各组分,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份。还包括第一复合组分,且所述第一复合组分与所述续断的质量比为100∶5,所述第一复合组分中各组分的质量份数为仙茅17份、菟丝子18份、肉苁蓉17份、三七16份、肉桂18份、五加皮17份、杜仲18份、赶山鞭17份、女贞子18份、制何首乌19份、鸡血藤17份、山茱萸12份、桂枝13份、防风12份、乌梅13份、老鹳草13份、川牛膝13份、蜈蚣12份、甘草12份、细辛12份、独活12份、泽泻12份、松节13份、络石藤13份。还包括第二复合组分,所述第二复合组分与所述续断的质量比为100∶3,所述第二复合组分中各组分的含量份数为:牡丹皮12份、白桂木根10份、红花9份、桂枝8份、香附10份、香茅10份、鸡血藤8份、红母鸡草7份、吴茱萸8份、穿山甲粉9份、白术8份、枫荷梨8份、益母草8份、走马风15份、鹿角胶16份、干姜17份、萝芙木18份、防已16份、三棱17份、大黄18份、莪术19份、龙眼肉18份、双花17份、王不留行17份、巴山虎16份、车前子18份、岗梅根18份、连翅19份、鹿藿19份、大黄17份、冬凌草9份、淫羊藿10份、罗勒11份、覆盆子8份、祖师麻7份、蒡苈子8份、游草9份和三角风7份。
实施例11
一种仙灵骨葆方中药饮片组合制剂的制备方法,包括以下步骤:将丹参制成丹参细粉;其余淫羊藿、续断、知母、补骨脂粉碎为粗粉,地黄切成薄片,加水煎煮三次,第一次3小时,第二次2小时,第三次1小时,合并煎液,滤过,滤液浓缩干燥得到活性提取物,将活性提取物粉碎得到活性提取物细粉,将活性提取物细粉与丹参细粉混合即可。丹参细粉为通过下列方法制备得到,将新鲜的丹参洗净后、切制、炮炙处理;将处理后的丹参粉碎,制成粗粉,再进行灭菌处理;将粗粉放入冻干箱后,启动冻干机,待冻干箱温度降至-30℃~-35℃后,保持1.5-3小时进行冷冻干燥;抽真空至系统绝对压力为60~100Pa,开始加热升温至40℃~50℃,升华干燥15~24小时;将干燥好的粗粉丹参加入超细粉碎机中进行打粉,打粉后所述丹参纯粉的粒径为0.5-2μm。所述活性提取物细粉为通过下述方法制备得到,将活性提取物放入冻干箱后,启动冻干机,待冻干箱温度降至-40℃~-20℃后,保持1.5-5小时进行冷冻干燥;抽真空至系统绝对压力为20~200Pa,开始加热升温至50℃~80℃,升华干燥11~25小时;将干燥好的活性提取物加入超细粉碎机中进行打粉,打粉后活性提取物细粉的粒径为0.5-2μm。将丹参细粉及活性提取物细粉按细例包装成袋。
实施例12
一种仙灵骨葆方中药饮片组合制剂的制备方法,包括以下步骤:将丹参制成丹参细粉;其余淫羊藿、续断、知母、补骨脂粉碎为粗粉,地黄切成薄片,加水煎煮三次,第一次3小时,第二次2小时,第三次1小时,合并煎液,滤过,滤液浓缩干燥得到活性提取物,将活性提取物粉碎得到活性提取物细粉,将活性提取物细粉与丹参细粉混合即可。丹参细粉为通过下列方法制备得到,将新鲜的丹参洗净后、切制、炮炙处理;将处理后的丹参粉碎,制成粗粉,再进行灭菌处理;将粗粉放入冻干箱后,启动冻干机,待冻干箱温度降至-30℃~-35℃后,保持1.5-3小时进行冷冻干燥;抽真空至系统绝对压力为60~100Pa,开始加热升温至40℃~50℃,升华干燥15~24小时;将干燥好的粗粉丹参加入超细粉碎机中进行打粉,打粉后所述丹参纯粉的粒径为0.5-2μm。所述活性提取物细粉为通过下述方法制备得到,将活性提取物放入冻干箱后,启动冻干机,待冻干箱温度降至-40℃~-20℃后,保持1.5-5小时进行冷冻干燥;抽真空至系统绝对压力为20~200Pa,开始加热升温至50℃~80℃,升华干燥11~25小时;将干燥好的活性提取物加入超细粉碎机中进行打粉,打粉后活性提取物细粉的粒径为0.5-2μm。将第一复合组分进行浸泡、冲洗、干燥、冲击、碰撞、摩擦、剪切、研磨和断裂,制成纳米级1~65nm的超细粉体,其中浸泡的时间为35-40分钟,冲洗的水压为2~12MPa,冲击前先在温度-12℃以下脆化后再进行冲击的,断裂完成后,还进行臭氧灭菌。将丹参细粉及活性提取物细粉及第一复合组分按细例包装成袋。
实施例13
一种仙灵骨葆方中药饮片组合制剂的制备方法,包括以下步骤:将丹参制成丹参细粉;其余淫羊藿、续断、知母、补骨脂粉碎为粗粉,地黄切成薄片,加水煎煮三次,第一次3小时,第二次2小时,第三次1小时,合并煎液,滤过,滤液浓缩干燥得到活性提取物,将活性提取物粉碎得到活性提取物细粉,将活性提取物细粉与丹参细粉混合即可。丹参细粉为通过下列方法制备得到,将新鲜的丹参洗净后、切制、炮炙处理;将处理后的丹参粉碎,制成粗粉,再进行灭菌处理;将粗粉放入冻干箱后,启动冻干机,待冻干箱温度降至-30℃~-35℃后,保持1.5-3小时进行冷冻干燥;抽真空至系统绝对压力为60~100Pa,开始加热升温至40℃~50℃,升华干燥15~24小时;将干燥好的粗粉丹参加入超细粉碎机中进行打粉,打粉后所述丹参纯粉的粒径为0.5-2μm。所述活性提取物细粉为通过下述方法制备得到,将活性提取物放入冻干箱后,启动冻干机,待冻干箱温度降至-40℃~-20℃后,保持1.5-5小时进行冷冻干燥;抽真空至系统绝对压力为20~200Pa,开始加热升温至50℃~80℃,升华干燥11~25小时;将干燥好的活性提取物加入超细粉碎机中进行打粉,打粉后活性提取物细粉的粒径为0.5-2μm。将第二复合组分进行浸泡、冲洗、干燥、冲击、碰撞、摩擦、剪切、研磨和断裂,制成纳米级1~65nm的超细粉体,其中浸泡的时间为35-40分钟,冲洗的水压为2~12MPa,冲击前先在温度-12℃以下脆化后再进行冲击的,断裂完成后,还进行臭氧灭菌。将丹参细粉及活性提取物细粉及第一复合组分按细例包装成袋。
实施例14
一种仙灵骨葆方中药饮片组合制剂的制备方法,包括以下步骤:将丹参制成丹参细粉;其余淫羊藿、续断、知母、补骨脂粉碎为粗粉,地黄切成薄片,加水煎煮三次,第一次3小时,第二次2小时,第三次1小时,合并煎液,滤过,滤液浓缩干燥得到活性提取物,将活性提取物粉碎得到活性提取物细粉,将活性提取物细粉与丹参细粉混合即可。丹参细粉为通过下列方法制备得到,将新鲜的丹参洗净后、切制、炮炙处理;将处理后的丹参粉碎,制成粗粉,再进行灭菌处理;将粗粉放入冻干箱后,启动冻干机,待冻干箱温度降至-30℃~-35℃后,保持1.5-3小时进行冷冻干燥;抽真空至系统绝对压力为60~100Pa,开始加热升温至40℃~50℃,升华干燥15~24小时;将干燥好的粗粉丹参加入超细粉碎机中进行打粉,打粉后所述丹参纯粉的粒径为0.5-2μm。所述活性提取物细粉为通过下述方法制备得到,将活性提取物放入冻干箱后,启动冻干机,待冻干箱温度降至-40℃~-20℃后,保持1.5-5小时进行冷冻干燥;抽真空至系统绝对压力为20~200Pa,开始加热升温至50℃~80℃,升华干燥11~25小时;将干燥好的活性提取物加入超细粉碎机中进行打粉,打粉后活性提取物细粉的粒径为0.5-2μm。将第一复合组分、第二复合组分进行浸泡、冲洗、干燥、冲击、碰撞、摩擦、剪切、研磨和断裂,制成纳米级1~65nm的超细粉体,其中浸泡的时间为35-40分钟,冲洗的水压为2~12MPa,冲击前先在温度-12℃以下脆化后再进行冲击的,断裂完成后,还进行臭氧灭菌。将丹参细粉及活性提取物细粉及第一复合组分和第二复合组分按细例包装成袋。
实施例15
一种仙灵骨葆方中药饮片组合制剂的应用包装,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份、第一复合组分8.35份按比例包装成袋。所述包装中还包括辅料,其中淫羊藿、续断、丹参、知母、补骨脂及地黄的总量与辅料的配比为1∶1。所述辅料为包括崩解剂、润滑剂和填充剂,所述的崩解剂为羧甲基淀粉钠、羟丙纤维素、交联聚乙烯吡咯烷酮和交联羧甲基纤维素钠中的一种或多种;所述的崩解剂的用量为所述的药物活性成分的2-5%;所述的润滑剂为胶态二氧化硅、硬脂酸富马酸钠、滑石粉和硬脂酸镁中的一种或多种;所述的润滑剂的用量为所述的药物活性成分的3-9%;所述的填充剂为乳糖、无水乳糖、甘露醇、微晶纤维素、淀粉、木糖醇、预胶化淀粉和麦芽糖醇中的一种或多种;所述的填充剂的用量为所述的药物活性成分重量的2-5倍。
实施例16
一种仙灵骨葆方中药饮片组合制剂的应用包装,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份、第二复合级分5.01份,按比例包装成袋。所述包装中还包括辅料,其中淫羊藿、续断、丹参、知母、补骨脂及地黄的总量与辅料的配比为1∶1。所述辅料为包括崩解剂、润滑剂和填充剂,所述的崩解剂为羧甲基淀粉钠、羟丙纤维素、交联聚乙烯吡咯烷酮和交联羧甲基纤维素钠中的一种或多种;所述的崩解剂的用量为所述的药物活性成分的2-5%;所述的润滑剂为胶态二氧化硅、硬脂酸富马酸钠、滑石粉和硬脂酸镁中的一种或多种;所述的润滑剂的用量为所述的药物活性成分的3-9%;所述的填充剂为乳糖、无水乳糖、甘露醇、微晶纤维素、淀粉、木糖醇、预胶化淀粉和麦芽糖醇中的一种或多种;所述的填充剂的用量为所述的药物活性成分重量的2-5倍。
实施例17
一种仙灵骨葆方中药饮片组合制剂的应用包装,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份、第一复合组分8.35份、第二复合级分5.01份,按比例包装成袋。所述包装中还包括辅料,其中淫羊藿、续断、丹参、知母、补骨脂及地黄的总量与辅料的配比为1∶1。所述辅料为包括崩解剂、润滑剂和填充剂,所述的崩解剂为羧甲基淀粉钠、羟丙纤维素、交联聚乙烯吡咯烷酮和交联羧甲基纤维素钠中的一种或多种;所述的崩解剂的用量为所述的药物活性成分的2-5%;所述的润滑剂为胶态二氧化硅、硬脂酸富马酸钠、滑石粉和硬脂酸镁中的一种或多种;所述的润滑剂的用量为所述的药物活性成分的3-9%;所述的填充剂为乳糖、无水乳糖、甘露醇、微晶纤维素、淀粉、木糖醇、预胶化淀粉和麦芽糖醇中的一种或多种;所述的填充剂的用量为所述的药物活性成分重量的2-5倍。
实施例18
诊断标准主要症状:骨痛,腰背疼痛,腿膝酸软,易发骨折,可伴有足跟痛,夜间或有排肠肌痉挛。X线表现正常或骨组织密度降低、骨皮质变薄、骨小梁减少变细或有胸腰椎体呈双凹状或前方呈楔形改变。骨密度检测T≥-2.5。
选择符合上述标准的40例骨质疏松患者,男20例、女20例,平均年龄为65岁。使用实施例1中制得的饮片来进行治疗,其中一天2次,,治疗30天为一个疗程。疗效标准(根据郑筱萸.中药新药临床研究指导原则(试行).北京:中国医药科技出版社.2002:357来制定)显效:腰背痛,局部疼痛等症状基本消失,行走腰背痛消失;有效:上述症状基本消除,行走疼痛有所减轻;无效:上述症状无明显改善。
经过有一个疗程的观察,40例患者显效20例,无效5例,有效15例。
实施例19
诊断标准主要症状:骨痛,腰背疼痛,腿膝酸软,易发骨折,可伴有足跟痛,夜间或有排肠肌痉挛。X线表现正常或骨组织密度降低、骨皮质变薄、骨小梁减少变细或有胸腰椎体呈双凹状或前方呈楔形改变。骨密度检测T≥-2.5。
选择符合上述标准的两组40例骨质疏松患者,男20例、女20例,平均年龄为65岁。对照组使用实施例1中制得的饮片来进行治疗,其中一天2次,治疗30天为一个疗程。疗效标准(根据郑筱萸.中药新药临床研究指导原则(试行).北京:中国医药科技出版社.2002:357来制定)显效:腰背痛,局部疼痛等症状基本消失,行走腰背痛消失;有效:上述症状基本消除,行走疼痛有所减轻;无效:上述症状无明显改善。
经过有一个疗程的观察,40例患者显效20例,无效5例,有效15例。
治疗组服用实施例4的制得的饮片来进行治疗,其中一天2次,每次一袋,治疗30天为一个疗程。疗效标准(根据郑筱萸.中药新药临床研究指导原则(试行).北京:中国医药科技出版社.2002:357来制定)显效:腰背痛,局部疼痛等症状基本消失,行走腰背痛消失;有效:上述症状基本消除,行走疼痛有所减轻;无效:上述症状无明显改善。
经过有一个疗程的观察,40例患者显效22例,无效3例,有效15例。
治疗组的总有效率明显高于对照组。
因此第一复合组分相对实施例1中的各组分具有协同的作用,对其作用起来了强化。
实施例20
诊断标准主要症状:骨痛,腰背疼痛,腿膝酸软,易发骨折,可伴有足跟痛,夜间或有排肠肌痉挛。X线表现正常或骨组织密度降低、骨皮质变薄、骨小梁减少变细或有胸腰椎体呈双凹状或前方呈楔形改变。骨密度检测T≥-2.5。
选择符合上述标准的两组40例骨质疏松患者,男20例、女20例,平均年龄为65岁。对照组使用实施例1中制得的饮片来进行治疗,其中一天2次,治疗30天为一个疗程。疗效标准(根据郑筱萸.中药新药临床研究指导原则(试行).北京:中国医药科技出版社.2002:357来制定)显效:腰背痛,局部疼痛等症状基本消失,行走腰背痛消失;有效:上述症状基本消除,行走疼痛有所减轻;无效:上述症状无明显改善。
经过有一个疗程的观察,40例患者显效20例,无效5例,有效15例。
治疗组服用实施例7的制得的饮片来进行治疗,其中一天2次,每次一袋,治疗30天为一个疗程。疗效标准(根据郑筱萸.中药新药临床研究指导原则(试行).北京:中国医药科技出版社.2002:357来制定)显效:腰背痛,局部疼痛等症状基本消失,行走腰背痛消失;有效:上述症状基本消除,行走疼痛有所减轻;无效:上述症状无明显改善。
经过有一个疗程的观察,40例患者显效25例,无效3例,有效12例。
治疗组的总有效率明显高于对照组。
因此第二复合组分相对实施例1中的各组分具有协同的作用,对其作用起来了强化。
实施例21
诊断标准主要症状:骨痛,腰背疼痛,腿膝酸软,易发骨折,可伴有足跟痛,夜间或有排肠肌痉挛。X线表现正常或骨组织密度降低、骨皮质变薄、骨小梁减少变细或有胸腰椎体呈双凹状或前方呈楔形改变。骨密度检测T≥-2.5。
选择符合上述标准的两组40例骨质疏松患者,男20例、女20例,平均年龄为65岁。对照组使用实施例1中制得的饮片来进行治疗,其中一天2次,治疗30天为一个疗程。疗效标准(根据郑筱萸.中药新药临床研究指导原则(试行).北京:中国医药科技出版社.2002:357来制定)显效:腰背痛,局部疼痛等症状基本消失,行走腰背痛消失;有效:上述症状基本消除,行走疼痛有所减轻;无效:上述症状无明显改善。
经过有一个疗程的观察,40例患者显效20例,无效5例,有效15例。
治疗组服用实施例10的制得的饮片来进行治疗,其中一天2次,每次一袋,治疗30天为一个疗程。疗效标准(根据郑筱萸.中药新药临床研究指导原则(试行).北京:中国医药科技出版社.2002:357来制定)显效:腰背痛,局部疼痛等症状基本消失,行走腰背痛消失;有效:上述症状基本消除,行走疼痛有所减轻;无效:上述症状无明显改善。
经过有一个疗程的观察,40例患者显效32例,无效2例,有效6例。
治疗组的总有效率明显高于对照组。
因此第二复合组分和第一复合组分,相对实施例1中的各组分具有协同的作用,对其作用起来了强化。第一复合组分具有治疗肝肾不足的疗效,且第二复合组分具有强筋壮骨的疗效,因此与实施例1合用,效果更明显。
应理解,这些实施方式仅用于说明本发明而不用于限制本发明的范围。此外应理解,在阅读了本发明讲授的内容之后,本领域技术人员可以对本发明的配方作各种改动或修改,这些等价形式同样落于本申请所附权利要求书所限定的范围。
Claims (14)
1.一种仙灵骨葆方中药饮片组合制剂,其特征在于,该制剂为复方中药饮片制剂,包括质量份数如下的各组分,淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份。
2.根据权利要求1所述的仙灵骨葆方中药饮片组合制剂,其特征在于,还包括第一复合组分,其包括仙茅、菟丝子、肉苁蓉、三七、肉桂、五加皮、杜仲、赶山鞭、女贞子、制何首乌、鸡血藤、山茱萸、桂枝、防风、乌梅、老鹳草、川牛膝、蜈蚣、甘草、细辛、独活、泽泻、松节、络石藤。
3.根据权利要求2所述的仙灵骨葆方中药饮片组合制剂,其特征在于,所述第一复合组分与所述续断的质量比为100∶5,所述第一复合组分中各组分的质量份数为仙茅15-25份、菟丝子15-25份、肉苁蓉15-25份、三七15-25份、肉桂15-25份、五加皮15-25份、杜仲15-25份、赶山鞭15-25份、女贞子15-25份、制何首乌15-25份、鸡血藤15-25份、山茱萸10-15份、桂枝10-15份、防风10-15份、乌梅10-15份、老鹳草10-15份、川牛膝10-15份、蜈蚣10-15份、甘草10-15份、细辛10-15份、独活10-15份、泽泻10-15份、松节10-15份、络石藤10-15份。
4.根据权利要求3所述的仙灵骨葆方中药饮片组合制剂,其特征在于,所述第一复合组分中各组分的质量份数为仙茅17份、菟丝子18份、肉苁蓉17份、三七16份、肉桂18份、五加皮17份、杜仲18份、赶山鞭17份、女贞子18份、制何首乌19份、鸡血藤17份、山茱萸12份、桂枝13份、防风12份、乌梅13份、老鹳草13份、川牛膝13份、蜈蚣12份、甘草12份、细辛12份、独活12份、泽泻12份、松节13份、络石藤13份。
5.根据权利要求1至4中任意一项所述的仙灵骨葆方中药饮片组合制剂,其特征在于,还包括第二复合组分,其包括:牡丹皮、白桂木根、红花、桂枝、香附、香茅、鸡血藤、红母鸡草、吴茱萸、穿山甲粉、白术、枫荷梨、益母草、走马风、鹿角胶、干姜、萝芙木、防已、三棱、大黄、莪术、龙眼肉、双花、王不留行、巴山虎、车前子、岗梅根、连翅、鹿藿、大黄、冬凌草、淫羊藿、罗勒、覆盆子、祖师麻、蒡苈子、游草和三角风。
6.根据权利要求5所述的仙灵骨葆方中药饮片组合制剂,其特征在于,所述第二复合组分与所述续断的质量比为100∶3,所述第二复合组分中各组分的含量份数为:牡丹皮6-13份、白桂木根6-13份、红花6-13份、桂枝6-13份、香附6-13份、香茅6-13份、鸡血藤6-13份、红母鸡草6-13份、吴茱萸6-13份、穿山甲粉6-13份、白术6-13份、枫荷梨6-13份、益母草7-21份、走马风7-21份、鹿角胶7-21份、干姜7-21份、萝芙木7-21份、防已7-21份、三棱7-21份、大黄7-21份、莪术7-21份、龙眼肉7-21份、双花7-21份、王不留行7-21份、巴山虎7-21份、车前子7-21份、岗梅根7-21份、连翅7-21份、鹿藿7-21份、大黄7-21份、冬凌草6-13份、淫羊藿6-13份、罗勒6-13份、覆盆子6-13份、祖师麻6-13份、蒡苈子6-13份、游草6-13份和三角风6-13份。
7.根据权利要求6所述的仙灵骨葆方中药饮片组合制剂,其特征在于,所述第二复合组分中各组分的含量为:牡丹皮12份、白桂木根10份、红花9份、桂枝8份、香附10份、香茅10份、鸡血藤8份、红母鸡草7份、吴茱萸8份、穿山甲粉9份、白术8份、枫荷梨8份、益母草8份、走马风15份、鹿角胶16份、干姜17份、萝芙木18份、防已16份、三棱17份、大黄18份、莪术19份、龙眼肉18份、双花17份、王不留行17份、巴山虎16份、车前子18份、岗梅根18份、连翅19份、鹿藿19份、大黄17份、冬凌草9份、淫羊藿10份、罗勒11份、覆盆子8份、祖师麻7份、蒡苈子8份、游草9份和三角风7份。
8.一种仙灵骨葆方中药饮片组合制剂的制备方法,其特征在于,包括以下步骤:将丹参制成丹参细粉;其余淫羊藿、续断、知母、补骨脂粉碎为粗粉,地黄切成薄片,加水煎煮三次,第一次3小时,第二次2小时,第三次1小时,合并煎液,滤过,滤液浓缩干燥得到活性提取物,将活性提取物粉碎得到活性提取物细粉,将活性提取物细粉与丹参细粉混合即可。
9.根据权利要求8所述的仙灵骨葆方中药饮片组合制剂的制备方法,其特征在于,丹参细粉为通过下列方法制备得到,将新鲜的丹参洗净后、切制、炮炙处理;将处理后的丹参粉碎,制成粗粉,再进行灭菌处理;将粗粉放入冻干箱后,启动冻干机,待冻干箱温度降至-30℃~-35℃后,保持1.5-3小时进行冷冻干燥;抽真空至系统绝对压力为60~100Pa,开始加热升温至40℃~50℃,升华干燥15~24小时;将干燥好的粗粉丹参加入超细粉碎机中进行打粉,打粉后所述丹参纯粉的粒径为0.5-2μm。
10.根据权利要求9所述的仙灵骨葆方中药饮片组合制剂的制备方法,其特征在于,所述活性提取物细粉为通过下述方法制备得到,将活性提取物放入冻干箱后,启动冻干机,待冻干箱温度降至-40℃~-20℃后,保持1.5-5小时进行冷冻干燥;抽真空至系统绝对压力为20~200Pa,开始加热升温至50℃~80℃,升华干燥11~25小时;将干燥好的活性提取物加入超细粉碎机中进行打粉,打粉后活性提取物细粉的粒径为0.5-2μm。
11.根据权利要求10所述的仙灵骨葆方中药饮片组合制剂的制备方法,其特征在于,将丹参细粉及活性提取物细粉按细例包装成袋。
12.一种仙灵骨葆方中药饮片组合制剂的应用包装,其特征在于:淫羊藿1167份、续断167份、丹参83份、知母83份、补骨脂83份及地黄83份按比例包装成袋。
13.如权利要求12所述的仙灵骨葆方中药饮片组合制剂的应用包装,其特征在于:所述包装中还包括辅料,其中淫羊藿、续断、丹参、知母、补骨脂及地黄的总量与辅料的配比为1∶1。
14.如权利要求13所述的仙灵骨葆方中药饮片组合制剂的应用包装,其特征在于:所述辅料为包括崩解剂、润滑剂和填充剂,所述的崩解剂为羧甲基淀粉钠、羟丙纤维素、交联聚乙烯吡咯烷酮和交联羧甲基纤维素钠中的一种或多种;所述的崩解剂的用量为所述的药物活性成分的2-5%;所述的润滑剂为胶态二氧化硅、硬脂酸富马酸钠、滑石粉和硬脂酸镁中的一种或多种;所述的润滑剂的用量为所述的药物活性成分的3-9%;所述的填充剂为乳糖、无水乳糖、甘露醇、微晶纤维素、淀粉、木糖醇、预胶化淀粉和麦芽糖醇中的一种或多种;所述的填充剂的用量为所述的药物活性成分重量的2-5倍。
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