CN104491721A - 一种治疗脾肾阳虚型子宫颈癌的中药及制备方法 - Google Patents
一种治疗脾肾阳虚型子宫颈癌的中药及制备方法 Download PDFInfo
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Abstract
本发明提供了一种治疗脾肾阳虚型子宫颈癌的中药及制备方法，中药各原料药材包括：腹水草、千年不烂心、墓头回、莪术、黄独零余子、附子、白花蛇舌草、仙鹤草、艾实、海马、紫河车、枇杷芋、柑核、石花、牛奶浆根、木豆、小一把抓、白九股牛、都拉、刺五加、黄珠子草、香茶菜和铧头草。本发明的有益效果：本发明中药，根据中医辨证施治原则，对脾肾阳虚型子宫颈癌的针对性强，有确切疗效，见效快，毒副作用小且复发率低。
Description
技术领域
本发明涉及含有来源于植物、动物或矿物组份的医用配制品，尤其涉及一种治疗脾肾阳虚型子宫颈癌的中药及制备方法。
背景技术
子宫颈癌的是指发生在子宫阴道部及宫颈管的恶性肿瘤。宫颈癌的转移，可向邻近组织和器官直接蔓延，向下至阴道穹窿及阴道壁，向上可侵犯子宫体，向两侧可侵犯盆腔组织，向前可侵犯膀胱，向后可侵犯直肠。也可通过淋巴管转移至宫颈旁、髂内、髂外、腹股沟淋巴结，晚期甚至可转移到锁骨上及全身其他淋巴结。血行转移比较少见，常见的转移部位是肺、肝及骨。子宫颈癌是妇科最常见的恶性肿瘤之一。
极早期患者可无明显症状，仅在普查或其他原因作妇科检查时偶然发现。一旦出现症状，则多表现为：
(一)子宫出血：绝经期前后的不规则阴道出血是子宫内膜癌的主要症状，常为少量至中等量出血，很少为大量出血。不仅较年轻或近绝经期患者易误认为月经不调，不及时就诊，即使医生亦往往疏忽。个别也有月经周期延迟者，但表现不规律。在绝经后患者多表现为持续或间断性阴道出血。子宫内膜癌患者一般无接触性出血。晚期出血中可杂有烂肉样组织。
(二)阴道排液：因腺癌生长于宫腔内，感染机会较宫颈癌少，故在初期可能仅有少量血性白带，但后斯发生感染、坏死，则有大量恶臭的脓血样液体排出。有时排液可夹杂癌组织的小碎片。倘若宫颈腔积脓，引起发烧、腹痛、白细胞增多。一般情况也迅速恶化。
(三)疼痛：由于癌肿及其出血与排液的瘀积，刺激子宫不规则收缩而引起阵发性疼痛，约占10～46％。这种症状多半发生在晚期。如癌组织穿透浆膜或侵蚀宫旁结缔组织、膀胱、直或压迫其他组织也可引起疼痛，往往呈顽固性和进行性加重；且多从腰骶部、下腹向大腿及膝放射。
(四)其他：晚期患者自己可触及下腹部增大的子宫或及邻近组织器官可致该侧下肢肿痛，或压迫输尿管引起该侧肾盂输尿管积水或致肾脏萎缩；或出现贫血、消瘦、发热、恶液质等全身衰竭表现。
子宫内膜癌发生年龄较晚，合并妊娠似不可能，但文献曾有个别合并妊娠或输卵管妊娠的病例报道。不规则阴道出血，出血可于任何时间出现，行激素治疗者除外。如果行激素替代治疗的绝经后妇女出现阴道出血，类似于月经，则预示着子宫颈癌的可能。因此，若有任何不正常的阴道出血或出血量多，应及早到医院诊治。阴道分沁物，呈粉色、褐色、水样或粘稠状，有异味。经盆腔检查发现子宫增大。体重下降，虚弱，下腹、背部及腿部疼痛。这种情况发生在癌肿转移或扩散时。
大量临床实践证明，对中晚期病人进行大剂量放、化疗，或对产生耐药的患者再次进行化疗只能导致虚弱的生命更加垂危，加速了患者死亡。临床常常可以见到，患者死因不是因为癌症本身造成，而是由于不科学、不恰当的杀伤性治疗所致。如肝癌多次介入后出现腹水、黄疸等肝功衰竭而致死；肺癌胸水化疗后导致呼吸衰竭而死亡；胃癌、肠癌化疗后恶心、呕吐，患者更加衰竭而死亡；白血球下降，患者感染而死亡等。对晚期癌症的治疗更重要的是减轻痛苦，提高生活质量，控制病情，"稳中求进"，以便获得"长期带瘤生存"。
目前在子宫颈癌的治疗中，手术以及放疗和化疗是最常用的治疗方式，虽然对治疗子宫颈癌有较好的疗效，但也具有较多的副作用和不良反应，以及复发率高等缺陷。化疗是近年来在肿瘤治疗中最常用的治疗方法之一。但是化疗药物常“是非不清”、“敌我不分”，在杀伤肿瘤细胞的同时，也杀伤了人体正常细胞。因此，化疗可能出现如下的毒性作用和不良反应：
1、静脉注射化疗药物时，操作不慎药液外漏可引起局部组织坏死和栓塞性静脉炎。因此，医护人员必须十分仔细，认真加以预防。
2、抑制骨髓造血系统，主要是白细胞和血小板下降。在每次化疗前，都应该做血象检查，如果白细胞的数目若低于(2.5～3)×109/升、血小板(50～80)×109/升，应该暂时停止化疗，遵照医生的医嘱使用升高血细胞药。除原有的鲨肝醇、利血生、核苷酸和维生素B6以及益气补血的中药治疗外，近年来由基因重组工程生产的一些集落刺激因子，具有明显的促进血细胞增生的功能。只在在化疗后及时用上这些药物，白细胞就不会明显下降。
3、可不同程度的损害肝脏细胞，出现谷丙转氨酶增高、胆红素上升、肝肿大、肝区疼痛、黄疸等，严重的会引起肝硬化、凝血机制障碍等，所以在用药前和用药过程中，要检查肝功能，及时发现问题，及时解决，必要时停止化疗。
4、有些化疗药物对心血管系统有毒性作用，严重的可发生心力衰竭。所以用药前及用药中应检查心电图，发现异常立即停药，及时治疗。对有心脏病变的病人，应避免使用对心脏有毒性作用的化疗药物。
5、对呼吸系统有毒性作用和不良反应的化疗药物可引起急性化学性肺炎和慢性肺纤维化，甚至出现呼吸衰竭。因此用肺毒性药物(即对呼吸系统有毒性的化疗药物)，如争光霉素等，应在用药期间定期检查肺部情况，停药后还要注意随访。发现肺部毒性反应，立即停止化疗并用激素治疗。
6、泌尿系统的毒性作用和不良反应表现有蛋白尿，少尿或无尿，有的发生血尿。为了能够清楚了解肾脏功能，在用药前和用药过程中均要定期检查，发现问题，及时治疗。使每天尿量在2000～3000毫升。经验证明，这样可减少泌尿系统的毒性作用和不良反应。
7、某些药物可影响生育，导致畸胎。在化疗期间，男性病人应节育，女性病人如有妊娠应中止或避免化疗一般停药后生育功能可恢复。
8、脱发和皮肤反应并不是所有的病人都会出现，即使出现也不必过分担忧，因为一般病人停药后，脱掉的头发会重新长出，皮肤的红斑、皮疹和色素沉着也会好转或消失。
9、在化疗的全身反应中，要数消化系统的毒性作用和不良反应最令患者烦恼，如恶心、呕吐、食欲不振、腹痛、腹泻，以及口腔黏膜溃疡、咽喉炎等。
发明内容
本发明所要解决的技术问题在于，提供一种治疗脾肾阳虚型子宫颈癌的中药及制备方法，本发明中药对脾肾阳虚型子宫颈癌的有确切疗效，针对性强、见效快、毒副作用小且复发率低。
为了解决上述技术问题，本发明提供了一种治疗脾肾阳虚型子宫颈癌的中药，所述中药各原料药材包括：腹水草、千年不烂心、墓头回、莪术、黄独零余子、附子、白花蛇舌草、仙鹤草、艾实、海马、紫河车、枇杷芋、柑核、石花、牛奶浆根、木豆、小一把抓、白九股牛、都拉、刺五加、黄珠子草、香茶菜和铧头草。
其中，所述中药各原料药材的重量份数比可以优选如下：腹水草40～50份、千年不烂心20～30份、墓头回30～40份、莪术30～40份、黄独零余子10～20份、附子10～20份、白花蛇舌草20～30份、仙鹤草15～25份、艾实10～20份、海马20～30份、紫河车5～15份、枇杷芋10～20份、柑核20～30份、石花5～15份、牛奶浆根25～35份、木豆10～20份、小一把抓20～30份、白九股牛10～20份、都拉15～25份、刺五加20～30份、黄珠子草10～20份、香茶菜20～30份和铧头草15～25份。
其中，所述中药各原料药材的重量份数比可以优选如下：腹水草40～45份、千年不烂心25～30份、墓头回35～40份、莪术30～35份、黄独零余子15～20份、附子10～15份、白花蛇舌草20～25份、仙鹤草15～20份、艾实10～15份、海马25～30份、紫河车5～10份、枇杷芋15～20份、柑核25～30份、石花10～15份、牛奶浆根30～35份、木豆10～15份、小一把抓20～25份、白九股牛15～20份、都拉20～25份、刺五加25～30份、黄珠子草10～15份、香茶菜20～25份和铧头草15～20份。
其中，所述中药各原料药材的重量份数比可以优选如下：腹水草45份、千年不烂心26份、墓头回37份、莪术33份、黄独零余子17份、附子13份、白花蛇舌草22份、仙鹤草16份、艾实11份、海马27份、紫河车6份、枇杷芋16份、柑核25份、石花12份、牛奶浆根31份、木豆12份、小一把抓23份、白九股牛17份、都拉22份、刺五加28份、黄珠子草13份、香茶菜24份和铧头草18份。
其中，所述中药各原料药材的重量份数比可以优选如下：腹水草42份、千年不烂心28份、墓头回40份、莪术32份、黄独零余子19份、附子11份、白花蛇舌草24份、仙鹤草18份、艾实12份、海马29份、紫河车8份、枇杷芋19份、柑核28份、石花14份、牛奶浆根33份、木豆15份、小一把抓21份、白九股牛16份、都拉24份、刺五加25份、黄珠子草11份、香茶菜23份和铧头草17份。
当上述任意一种所述中药的剂型为胶囊剂，其制备方法包括以下步骤：
第一步，将腹水草、千年不烂心、墓头回、莪术、黄独零余子、附子和白花蛇舌草按所述比例混合，加相对于混合物4～6倍的水提取挥发油，将获得的挥发油用β-环糊精包合，挥发油与β-环糊精的比例为1∶3～6，搅拌60分钟～90分钟，温度30℃～50℃，得挥发油包合物，备用；另将水提取液浓缩至60℃时相对密度为1.15～1.17的清膏；
第二步，将木豆、小一把抓、白九股牛、都拉、刺五加、黄珠子草、香茶菜和铧头草按所述比例混合，加相对于混合物5～8倍量醇浓度为75％～90％的乙醇回流提取3～5次，每次2～3小时，分别过滤，各次滤液合并，回收乙醇，浓缩至60℃时相对密度为1.20～1.22的清膏，备用；
第三步，将剩余所述原料药材按所述比例混合，加相对于混合物8～10倍量水，煮沸6～8小时，过滤，浓缩至60℃时相对密度为1.28～1.30的清膏；
第四步，将第一步、第二步、第三步的清膏混合，60℃～70℃减压真空干燥，得干膏粉；
第五步，将第一步所述挥发油包合物和第四步所述干膏粉充分混合，随后相对于100重量份所述挥发油包合物和干膏粉的混合物，加入5～7重量份羧甲基淀粉钠、5～50重量份淀粉混合均匀，然后加入150～200重量份醇浓度为80％～90％乙醇制粒，干燥，整粒，最后相对于100重量份所述挥发油包合物和干膏粉的混合物，加入3～5重量份硬脂酸镁，然后装入明胶胶囊中。
当上述任意一种所述中药的剂型为葡萄糖注射液时，其制备方法包括以下步骤：
第一步，将所述原料药材按比例混合，放入超微粉碎机中粉碎成0.1～10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料，所述混合粉料的得粉率至少为95％；
第二步，在第一步获得的混合粉料中加入相对于所述混合粉料的质量3～5倍的醇浓度为85％～95％的乙醇，搅拌溶解获得乙醇溶液，将乙醇溶液在5℃～10℃的条件下静置24～36小时，采用渗漉法以每分钟1～2ml的速度缓缓渗漉，收集渗漉液，浓缩并干燥，并在此放入超微粉碎机中粉碎40～60分钟，获得0.1～10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料，所述混合粉料的得粉率至少为95％；
第三步，取第二步获得的混合粉料30g～50g，加入丙二醇50g～100g，加400ml注射用水，搅拌使其溶解，进一步加注射用水至1000ml，再加入3g～5g针用活性炭，充分搅拌50～120分钟；脱炭过滤；用0.22～0.24μm微孔滤膜过滤；冷冻干燥得无菌粉末，分装灌封。
本发明的有益效果：本发明中药，根据中医辨证施治原则，对脾肾阳虚型子宫颈癌的针对性强，有确切疗效，见效快，毒副作用小且复发率低。
具体实施方式
本发明提供了一种治疗脾肾阳虚型子宫颈癌的中药，其原料药材包括：腹水草、千年不烂心、墓头回、莪术、黄独零余子、附子、白花蛇舌草、仙鹤草、艾实、海马、紫河车、枇杷芋、柑核、石花、牛奶浆根、木豆、小一把抓、白九股牛、都拉、刺五加、黄珠子草、香茶菜和铧头草。
所述中药中各原料药材的药理如下：
腹水草：为玄参科植物爬红岩或毛叶腹水草的全草。拉丁植物动物矿物名：1.Veronicastrum axillare(Sieb.Et Zucc.)Yamazaki[Paederotaaxillaris Sieb.Et Zucc.]2.Veronicastrum uillosulum(Miq.)Yamazaki[Paederota uillosula Miq.]。味苦；性微寒。归肝；脾；肾经。行水；消肿；散瘀；解毒。主肝硬化腹水；肾炎水肿；跌打损伤；疮肿疔毒；烫伤；毒蛇咬伤。《中华本草》
千年不烂心：为茄科植物毛年不烂心的全草。拉丁植物动物矿物名：Solanum cathayanum C.Y.Wuet S.C.Huang[S.dulcamara L.var.chinenseDunal]。味甘；苦；性寒。清热解毒；息风定惊。主小儿发热惊风；黄疸；肺热咳嗽；风火牙痛；瘰疬；妇女崩漏、带下、盆腔炎。《中华本草》
墓头回：为败酱科植物糙叶败酱或异叶几酱的根。拉丁植物动物矿物名：1.Patrinia rupestris(Pall.)Juss.subsp.scabra(Bunge)H.J.Wang[Patriniascabra Bunge]2.Patrinia heterophylla Bunge。味苦；微酸涩；性凉。归心；肝经。燥湿止带；收敛止血；清热解毒。主赤白带下；崩漏；泄泻痢疾；黄疸；疟疾；肠痈；疮疡肿毒；跌打损伤；子宫颈癌；胃癌。《中华本草》
莪术：为姜科植物莪术Curcuma phaeocaulis Val.、广西莪术CurcumaKwangsiensis S.G.Lee et C.F.Liang或温郁金Curcuma wenyujin Y.H.Chenet C.Ling的干燥根茎。辛、苦，温。归肝、脾经。行气破血，消积止痛。用于燀瘕痞块，瘀血经闭，食积胀痛；早期宫颈癌。《中国药典》
黄独零余子：为薯蓣科植物黄独叶腋内生长的紫褐色珠芽。拉丁植物动物矿物名：Dioscorea bulbifera L.。苦；辛；寒；有小毒。清热化痰；止咳平喘；散结解毒。主痰热咳喘；百日咳；咽喉肿痛；瘿瘤；瘰疬；疮疡肿毒；蛇犬蛟伤。《中华本草》
附子：为毛茛科植物乌头Aconitum carmichaeli Debx.的子根的加工品。辛、甘，大热；有毒。归心、肾、脾经。回阳救逆，补火助阳，逐风寒湿邪。用于亡阳虚脱，肢冷脉微，阳萎，宫冷，心腹冷痛，虚寒吐泻，阴寒水肿，阳虚外感，寒湿痹痛。《中国药典》
白花蛇舌草：为茜草科耳草属植物白花蛇舌草Hedyotis diffusaWilld.[Oldenlandia diffusa(Willd.)Roxb.]的全草。甘、淡，凉。入胃、大肠、小肠经。清热解毒，利尿消肿，活血止痛。用于肠痈(阑尾炎)，疮疖肿毒，湿热黄疸，小便不利等症；外用治疮疖痈肿，毒蛇咬伤。《中国药典》
仙鹤草：为蔷薇科植物龙芽草的地上部分。拉丁植物动物矿物名：Agrimonia pilosa Ledeb.味苦、涩，性平。归肺；肝；脾经。收敛止血，止痢，杀虫。主咯血；吐血；尿血；便血；赤白痢疾；崩漏带下；劳伤脱力；痈肿；跌打；创伤出血。《中华本草》
艾实：为菊科植物艾的果实。拉丁植物动物矿物名：Artemisia argyiLevl.et Vant.味苦；辛；性温。温肾壮阳。主肾虚腰酸；阳虚内寒。《中华本草》
海马：为海龙科动物线纹海马Hippocampus kelloggi Jordan etSnyder、刺海马Hippocampus histrix Kaup、大海马Hippocampus kudaBleeker、三斑海马Hippocampus trimaculatus Leach或小海马(海蛆)Hippocampus japonicus Kaup的干燥体。甘，温。归肝、肾经。温肾壮阳，散结消肿。用于阳痿，遗尿，肾虚作喘，症瘕积聚，跌扑损伤；外治痈肿疔疮。《中国药典》
紫河车：为健康人的干燥胎盘。甘、咸，温。归心、肺、肾经。温肾补精，益气养血。用于虚劳羸瘦，骨蒸盗汗，咳嗽气喘，食少气短，阳痿遗精，不孕少乳。《中国药典》
枇杷芋：为列当科植物丁座草的块茎。拉丁植物动物矿物名：Boschniakiahimalaica Hook.f.et Thomas[Xylanche himalaica(Hook.f.et Thomas)]。味辛；微苦；性温；小毒。温肾除湿；理气活血；杀虫解毒。主肾虚腰膝酸痛；风痹痛；脘腹胀痛；疝气；跌打损伤；月经不调；劳伤咳嗽；血吸虫病；疮痈溃疡；咽喉肿痛；肋腺炎。《中华本草》
柑核：为芸香科植物茶枝柑Citrus chachiensis Hort.等多种柑类的种子。拉丁植物动物矿物名：Citrus chachiensis Hort.苦；辛；温。归心；肝经。温肾止痛；行气散结。主腰痛；膀胱气痛；小肠疝气；睾丸偏坠肿痛。《中华本草》
石花：为梅衣科植物石梅衣的地衣体。拉丁植物动物矿物名：Parmeliasaxatilis(L.)Ach.[Lichen saxatilis L.]。甘；性平。归肝；肾经。补肾益肾；明目；止血，利湿解毒。主视物模糊；腰膝疼痛；吐血；崩漏黄疸，疮癣。《中华本草》
牛奶浆根：为桑科植物天仙果的根。拉丁植物动物矿物名：Ficus erectaThumb.var.beecheyana(Hook.et Arn.)King[F.beecheyana Hook.et Arn.]。甘；辛；性温。归肺；脾；肾经。益气健脾；活血通络；祛风除湿。主劳倦乏力；食少；乳汁不下；脾虚白带；脱肛；月经不调；头风疼痛；跌打损伤；风湿性关节痛。《中华本草》
木豆：为豆科植物木豆的种子。拉丁植物动物矿物名：Cajanuscajan(L.)Millisp.[Cytisus cajan L.]。辛、涩；平；无毒。归肝；脾经。利湿，消肿，散瘀，止血。主风湿痹痛，跌打损伤，衄血，便血，疮疖肿毒，产后恶露不尽，水肿，黄疸型肝炎。《中华本草》
小一把抓：为中国蕨科植物毛叶粉背蕨的全草。拉丁植物动物矿物名：Aleuritopteris squamosa(Hope et C.H.Wright)Ching[Pellaea squamosaHope.et C.H.Wright]。甘；温。健脾益气。主脾胃虚弱；小儿疳积。《中华本草》
白九股牛：为五加科植物丛枝楤木的根。味辛；微甘；性平。补中益气；托毒消肿。主气虚头晕；耳鸣；慢性淋巴腺炎；疮痈久不溃；慢性化脓性骨髓炎。《中华本草》
都拉：为川续断科植物西南囊苞花的根。拉丁植物动物矿物名：Triplostegia glandulifera Wall.ex DC。味甘；微苦；性微温。归肺；脾；肾经。温肾益气；活血止血。主体虚头昏；虚劳久咳；脾虚食积；肾虚腰痛；带下；阳痿；不孕；风湿性心脏病；外伤出血。《中华本草》
刺五加：为五加科植物刺五加Acanthopanax senticosus(Rupr.etMaxim.)Harms的干燥、根及根茎或茎。辛、微苦，温。归脾、肾、心经。益气健脾，补肾安神。用于脾肾阳虚，体虚乏力，食欲不振，腰膝酸痛，失眠多梦。《中国药典》
黄珠子草：为大戟科植物黄珠子草的全草。甘苦；平。归脾经。健脾消积；利尿通淋；清热解毒。主疳积；痢疾；淋病；乳痈；牙疳；毒蛇咬伤。《中华本草》
香茶菜：为唇形科植物香茶菜的地上部分。味辛；苦；性凉。归肝；肾经。清热利湿；活血散瘀；解毒消肿。主湿热黄疸；淋证；水肿；咽喉肿痛；关节痹痛；闭经；乳痈；痔疮；发背；跌打损伤；毒蛇咬伤。《中华本草》
铧头草：为堇菜植物戟叶堇菜的全草。味微苦；辛；性寒。归大肠；心；肝经。清热解毒；散瘀消肿。主疮疡肿毒；喉痛；乳痈；肠痈；黄疸；目赤肿痛；跌打损伤；刀伤出血。《中华本草》
其中，所述中药各原料药材的重量份数比可以优选如下：腹水草40～50份、千年不烂心20～30份、墓头回30～40份、莪术30～40份、黄独零余子10～20份、附子10～20份、白花蛇舌草20～30份、仙鹤草15～25份、艾实10～20份、海马20～30份、紫河车5～15份、枇杷芋10～20份、柑核20～30份、石花5～15份、牛奶浆根25～35份、木豆10～20份、小一把抓20～30份、白九股牛10～20份、都拉15～25份、刺五加20～30份、黄珠子草10～20份、香茶菜20～30份和铧头草15～25份。
其中，所述中药各原料药材的重量份数比可以优选如下：腹水草40～45份、千年不烂心25～30份、墓头回35～40份、莪术30～35份、黄独零余子15～20份、附子10～15份、白花蛇舌草20～25份、仙鹤草15～20份、艾实10～15份、海马25～30份、紫河车5～10份、枇杷芋15～20份、柑核25～30份、石花10～15份、牛奶浆根30～35份、木豆10～15份、小一把抓20～25份、白九股牛15～20份、都拉20～25份、刺五加25～30份、黄珠子草10～15份、香茶菜20～25份和铧头草15～20份。
其中，所述中药各原料药材的重量份数比可以优选如下：腹水草45份、千年不烂心26份、墓头回37份、莪术33份、黄独零余子17份、附子13份、白花蛇舌草22份、仙鹤草16份、艾实11份、海马27份、紫河车6份、枇杷芋16份、柑核25份、石花12份、牛奶浆根31份、木豆12份、小一把抓23份、白九股牛17份、都拉22份、刺五加28份、黄珠子草13份、香茶菜24份和铧头草18份。
其中，所述中药各原料药材的重量份数比可以优选如下：腹水草42份、千年不烂心28份、墓头回40份、莪术32份、黄独零余子19份、附子11份、白花蛇舌草24份、仙鹤草18份、艾实12份、海马29份、紫河车8份、枇杷芋19份、柑核28份、石花14份、牛奶浆根33份、木豆15份、小一把抓21份、白九股牛16份、都拉24份、刺五加25份、黄珠子草11份、香茶菜23份和铧头草17份。
当上述任意一种所述中药的剂型为胶囊剂，其制备方法包括以下步骤：
第一步，将腹水草、千年不烂心、墓头回、莪术、黄独零余子、附子和白花蛇舌草按所述比例混合，加相对于混合物4～6倍的水提取挥发油，将获得的挥发油用β-环糊精包合，挥发油与β-环糊精的比例为1∶3～6，搅拌60分钟～90分钟，温度30℃～50℃，得挥发油包合物，备用；另将水提取液浓缩至60℃时相对密度为1.15～1.17的清膏；
第二步，将木豆、小一把抓、白九股牛、都拉、刺五加、黄珠子草、香茶菜和铧头草按所述比例混合，加相对于混合物5～8倍量醇浓度为75％～90％的乙醇回流提取3～5次，每次2～3小时，分别过滤，各次滤液合并，回收乙醇，浓缩至60℃时相对密度为1.20～1.22的清膏，备用；
第三步，将剩余所述原料药材按所述比例混合，加相对于混合物8～10倍量水，煮沸6～8小时，过滤，浓缩至60℃时相对密度为1.28～1.30的清膏；
第四步，将第一步、第二步、第三步的清膏混合，60℃～70℃减压真空干燥，得干膏粉；
第五步，将第一步所述挥发油包合物和第四步所述干膏粉充分混合，随后相对于100重量份所述挥发油包合物和干膏粉的混合物，加入5～7重量份羧甲基淀粉钠、5～50重量份淀粉混合均匀，然后加入150～200重量份醇浓度为80％～90％乙醇制粒，干燥，整粒，最后相对于100重量份所述挥发油包合物和干膏粉的混合物，加入3～5重量份硬脂酸镁，然后装入明胶胶囊中。
当上述任意一种所述中药的剂型为葡萄糖注射液时，其制备方法包括以下步骤：
第一步，将所述原料药材按比例混合，放入超微粉碎机中粉碎成0.1～10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料，所述混合粉料的得粉率至少为95％；
第二步，在第一步获得的混合粉料中加入相对于所述混合粉料的质量3～5倍的醇浓度为85％～95％的乙醇，搅拌溶解获得乙醇溶液，将乙醇溶液在5℃～10℃的条件下静置24～36小时，采用渗漉法以每分钟1～2ml的速度缓缓渗漉，收集渗漉液，浓缩并干燥，并在此放入超微粉碎机中粉碎40～60分钟，获得0.1～10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料，所述混合粉料的得粉率至少为95％；
第三步，取第二步获得的混合粉料30g～50g，加入丙二醇50g～100g，加400ml注射用水，搅拌使其溶解，进一步加注射用水至1000ml，再加入3g～5g针用活性炭，充分搅拌50～120分钟；脱炭过滤；用0.22～0.24μm微孔滤膜过滤；冷冻干燥得无菌粉末，分装灌封。
以下采用实施例来详细说明本发明的实施方式，借此充分理解本发明如何应用技术手段来解决技术问题，达成技术效果并据以实施。
实施例1：胶囊剂
取腹水草420g、千年不烂心280g、墓头回400g、莪术320g、黄独零余子190g、附子110g、白花蛇舌草240g、仙鹤草180g、艾实120g、海马290g、紫河车80g、枇杷芋190g、柑核280g、石花140g、牛奶浆根330g、木豆150g、小一把抓210g、白九股牛160g、都拉240g、刺五加250g、黄珠子草110g、香茶菜230g和铧头草170g；
其制备方法包括以下步骤：
第一步，将腹水草、千年不烂心、墓头回、莪术、黄独零余子、附子和白花蛇舌草按所述比例混合，加相对于混合物5倍的水提取挥发油，将获得的挥发油用β-环糊精包合，挥发油与β-环糊精的比例为1∶5，搅拌80分钟，温度45℃，得挥发油包合物，备用；另将水提取液浓缩至60℃时相对密度为1.16的清膏；
第二步，将木豆、小一把抓、白九股牛、都拉、刺五加、黄珠子草、香茶菜和铧头草按所述比例混合，加相对于混合物7倍量醇浓度为85％的乙醇回流提取4次，每次2小时，分别过滤，各次滤液合并，回收乙醇，浓缩至60℃时相对密度为1.22的清膏，备用；
第三步，将剩余所述原料药材按所述比例混合，加相对于混合物8倍量水，煮沸6小时，过滤，浓缩至60℃时相对密度为1.29的清膏；
第四步，将第一步、第二步、第三步的清膏混合，70℃减压真空干燥，得干膏粉；
第五步，将第一步所述挥发油包合物和第四步所述干膏粉充分混合，随后相对于100重量份所述挥发油包合物和干膏粉的混合物，加入6重量份羧甲基淀粉钠、35重量份淀粉混合均匀，然后加入170重量份醇浓度为90％乙醇制粒，干燥，整粒，最后相对于100重量份所述挥发油包合物和干膏粉的混合物，加入5重量份硬脂酸镁，然后装入明胶胶囊中。
实施例2：葡萄糖注射液剂
取腹水草450g、千年不烂心260g、墓头回370g、莪术330g、黄独零余子170g、附子130g、白花蛇舌草220g、仙鹤草160g、艾实110g、海马270g、紫河车60g、枇杷芋160g、柑核250g、石花120g、牛奶浆根310g、木豆120g、小一把抓230g、白九股牛170g、都拉220g、刺五加280g、黄珠子草130g、香茶菜240g和铧头草180g；
其制备方法包括以下步骤：
第一步，将所述原料药材按比例混合，放入超微粉碎机中粉碎成3μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料，所述混合粉料的得粉率至少为95％；
第二步，在第一步获得的混合粉料中加入相对于所述混合粉料的质量5倍的醇浓度为95％的乙醇，搅拌溶解获得乙醇溶液，将乙醇溶液在7℃的条件下静置30小时，采用渗漉法以每分钟1ml的速度缓缓渗漉，收集渗漉液，浓缩并干燥，并在此放入超微粉碎机中粉碎60分钟，获得0.5μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料，所述混合粉料的得粉率至少为95％；
第三步，取第二步获得的混合粉料40g，加入丙二醇80g，加400ml注射用水，搅拌使其溶解，进一步加注射用水至1000ml，再加入4.5g针用活性炭，充分搅拌90分钟；脱炭过滤；用0.22μm微孔滤膜过滤；冷冻干燥得无菌粉末，分装灌封。
毒性实验：
急性毒性实验：应用小鼠80只，雌雄各半，体重24～30g，进行急性毒性试验。小鼠随机分为两组，即对照组和给药组，实验前禁食12小时，将本发明的实施例1制备的中药胶囊剂溶解在水中，(浓度为7.30g生药/ml，最高浓度)灌胃，灌胃容积为5ml/kg(即单次给药剂量为36.5生药/kg)，对照组给予等量生理盐水，一天给药2次，给药间隔时间6小时，给药后连续观察14天，并记录小鼠的毒性反应及死亡数。实验结果表明：与对照组比较，给药后小鼠未见明显差异，实验连续观察14天，小鼠全身状况、饮食、饮水、体重增长均正常。小鼠口服灌胃本发明的药片即LD50>36.5生药/kg，每日最大给药量为73.0生药/kg/日。本发明的中药临床用药量为6.4g生药/日/人，成人体重以60KG计，平均用药剂量为0.107g生药/kg/日。按体重计：小鼠(平均体重以27g计)口服灌胃本发明的中药的耐受量为临床用量的682倍。因此本发明的中药急性毒性极低，临床用药安全。
长期毒性实验：本发明中药实施例1胶囊剂对小鼠按13.12、19.03和37.45g生药/kg连续用药15周(1.0ml/100g体重，每天2次)及停药3周后，结果表明：本发明中药对小鼠的毛发、行为、大小便、体重、脏器重量、血象、肝肾功能、血糖、血脂等指标均无明显影响，脏器肉眼没有发现异样变化和组织学检查结果表明，用药15周及停药3周后，小鼠各脏器均无明显改变。说明本发明中药对小鼠长期用药后毒性小，停药后也没有异样反应，应用安全。
抑瘤作用试验：
试验对象：ICR小鼠100只，体重19—24g，雄性。
试验接种内容：将小鼠子宫颈癌的细胞(U14)接种于小鼠的背侧腋窝皮下，等瘤体长至1-1.5cm时，选择良好的瘤组织，制备成单细胞悬液(癌细胞数为1×106个/ml)。
取ICR小鼠，于背侧腋窝皮下常规接种U14癌细胞悬液0.2ml(癌细胞数为1×106个细胞/m1)，次日随机分成5组。治疗组分为三个组，分别为高剂量组、中剂量组和低剂量组，采用本发明实施例1的胶囊剂，粉碎后蒸馏水溶解，每日分别灌胃给药1.2ml、0.8m1和0.4m1，连续10天；对照组分为两个组，分别为生理盐水组和CTX组，生理盐水组每日胃饲0.4m1生理盐水，连续10天；CTX组给药环磷酰胺，每日给药0.2g，蒸馏水溶解后灌胃给药，连续10天；5组均为停药后次日处死动物，剥瘤称重，计算抑瘤率，抑瘤率公式为：抑瘤率(％)＝(生理盐水对照组平均瘤重-用药组平均瘤重)/生理盐水对照组平均瘤重×100％，结果显示，本发明的药物对U14生长有抑制作用，其抑瘤率随剂量增加而递增，与对照组相比有显著性差异P<0.05。对U14的抑制作用及抑瘤效果见表1。
表1：对U14的抑制作用及抑瘤效果
| 组别 | 平均瘤重(g) | 小鼠平均体重变化(g) | 抑瘤率(％) |
| 高剂量组 | 1.31±0.48 | +3.79 | 59.82 |
| 中剂量组 | 1.46±0.52 | +4.31 | 55.21 |
| 低剂量组 | 1.55±0.39 | +4.72 | 52.45 |
| CTX组 | 1.53±0.64 | -1.58 | 53.07 |
| 生理盐水组 | 3.26±0.53 | +5.25 | 0 |
通过表1可知：采用本发明中药制剂的治疗组，与生理盐水组比较，能够抑制瘤体生长，且抑瘤率随剂量的增加而递增，有显著性差异P<0.05，(n＝10，X±SD)；采用本发明中药制剂的治疗组，与CTX组比较，治疗组的小鼠的体重有增加，而CTX组的小鼠体重减轻，两者相比较有显著性差异P<0.05，(n＝10，X±SD)。
另外通过流体细胞仪测量，结果显示，本发明的中药制剂阻止了肿瘤细胞由S→G2进程，同时也影响了G1→S的进行，使S和G1期的细胞明显增加，G2和M期的细胞相对较低，干扰了肿瘤细胞的增殖活动，达到抗肿瘤的作用。
上述实验结果显示，本发明中药对子宫颈癌的动物模型的肿瘤具有明显的抑制作用，进而可以推知本发明的中药对子宫颈癌的具有有效的治疗作用。
临床资料：
病例选择：全部90例病例均为我院门诊或住院患者，其中20～30岁女子20例，31～40岁女子26例，41～50岁女子37例，50岁以上女子7例。随机分为治疗组和对照组，其中治疗组45人，其中20～30岁女子10例，31～40岁女子13例，41～50岁女子18例，50岁以上女子4例。对照组45人，其中20～30岁女子10例，31～40岁女子13例，41～50岁女子19例，50岁以上女子3例。两组年龄、病变部位、临床表现及病情严重程度比较差异均无统计学意义(p>0.05)。
诊断标准：参照卫生部2011年卫生部发布的《子宫颈癌诊断》中的子宫颈癌的诊断标准和中医辨证诊断标准。
中医辨证标准：脾肾阳虚型：神疲乏力，腰膝冷痛，带下量多，质稀薄，或有阴道流血，量多，小腹坠胀，纳差，便溏或先干后溏，舌体胖，边有齿印，苔薄白，脉沉细无力。
治疗方法：
治疗组：给予本发明实施例1胶囊剂每日3次，每次6粒。1个月为1疗程,根据患者所患子宫颈癌时间长短，一年以内连续服用2～3个疗程，一年到两年连续服用4～5个疗程，两年以上5～6个疗程；
对照组：给予手术治疗和同步放化疗治疗。放射治疗：采用体外照射与腔内后装相结合。体外照射用6MV-x线直线加速器，采用前后两大野对穿照射(上界相当于第4～5腰椎水平，下界为耻骨联合上缘下4～5cm)，每周5次，DT1.8～2.0Gy/d，先照射10～12次，全盆照射DT20～25Gy，再前后野中线用挡铅照射10～12次，DT20～25Gy，，DT1.8～2.0Gy/d，每周5次，总量45Gy。在此期间腔内治疗用铱192后装治疗，每周一次，每次A点剂量达到4～6Gy,总剂量36～41Gy，疗程6～7周。腔内治疗当日不行体外照射，每日配合进行阴道冲洗。化疗方案：化疗药物与放射治疗同步进行。DDP(顺氯氨铂)40mg，每日一次连用3d，5-FU 1.0g，每日一次连用3d，BLM(博来酶素)15mg，每日一次，均连用3d，排除化疗禁忌证后，每例患者在放疗前、放疗中、放疗后各1个疗程，共3个疗程。
疗效观察：两组患者每周行妇科检查，记录宫颈肿瘤退缩情况，记录胃肠道反应，阴道流血，流液，腹痛及下腹不适等改善情况。每周2次查血常规，治疗结束后定期门诊复查。
疗效判断标准：完全缓解(CR)：肿瘤消失，临床症状消失，时间不少于4周；部分缓解(PR)：肿瘤体积缩小1/2以上，临床症状基本消失，时间不少于4周；无效(MR)：肿瘤体积缩小1/2以下，临床症状有所好转，并在治疗期间无新的肿瘤病灶出现；进展(PD)：肿瘤体积增大和/或有新的肿瘤病灶出现。CR加PR为有效。
治疗结果：两组分别治疗2～6个疗程后，统计结果参见表1。从表1可以看出，采用本发明的中药治疗脾肾阳虚型子宫颈癌的，相对于西药在治疗效果上，具有显著的改进。
表1两组分别治疗2～6个月后两组疗效比较(例)：
| 组别 | n | CR | PR | MR | PD | 总有效 |
| 治疗组 | 45 | 34 | 8 | 3 | 0 | 42(93.33％) |
| 对照组 | 45 | 24 | 13 | 4 | 4 | 37(82.22％) |
生存率统计：对所有患者跟踪随访5年并定期复查，并分别计算1、3、5年生存率，统计结果见表2。由表2统计数据可知，治疗组和对照组1年生存率差别不大，而3年和5年的生存率方面，治疗组明显优于对照组，即本发明的中药能够明显延长子宫颈癌患者的生存时间。
表2两组分别追踪5年生存率统计结果
| 组别 | 1年 | 3年 | 5年 |
| 治疗组 | 39(86.67％) | 36(80％) | 29(64.44％) |
| 对照组 | 35(77.78％) | 27(60％) | 17(37.78％) |
同时，在跟踪随访和定期复查过程中，观察到：治疗组34CR患者中，无复发及转移，8例PR患者中，病情加重1例，总复发率为2.4％(1/42)；对照组24例CR患者中，复发6人，13例PR患者中，病情加重或转移6例，总复发率32.43％(12/37)。
不良反应：治疗组45例患者中，有7例出现轻微恶心、呕吐等症状，2～3d恢复正常；对照组，45例患者中，37例出现恶心、呕吐、22例食欲减退，9例出现骨髓抑制伴尿急、尿频和尿痛，38例出现不同程度的脱发等。
具体病例：薛某，女性，49岁。因阴道流血和腰痛入院求诊。经CT及其他检查，确诊为子宫颈癌。进一步根据患者的症状：神疲乏力，腰膝冷痛，带下量多，质稀薄，有阴道流血，量多，便溏，舌体胖，边有齿印，苔薄白，脉沉细无力，中医辨证分型为脾肾阳虚型子宫颈癌。给予本发明中药实施例1胶囊剂每天3次，每次6粒，治疗4个月痊愈，随访5年未复发。
以上所述，仅是本发明的较佳实施例而已，并非是对本发明作其它形式的限制，任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为等同变化的等效实施例。但是凡是未脱离本发明技术方案内容，依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改型，仍属于本发明技术方案的保护范围。
Claims (9)
1.一种治疗脾肾阳虚型子宫颈癌的中药，其特征在于，所述中药各原料药材包括：腹水草、千年不烂心、墓头回、莪术、黄独零余子、附子、白花蛇舌草、仙鹤草、艾实、海马、紫河车、枇杷芋、柑核、石花、牛奶浆根、木豆、小一把抓、白九股牛、都拉、刺五加、黄珠子草、香茶菜和铧头草。
2.如权利要求1所述的中药，其特征在于，所述中药各原料药材的重量份数比如下：腹水草40～50份、千年不烂心20～30份、墓头回30～40份、莪术30～40份、黄独零余子10～20份、附子10～20份、白花蛇舌草20～30份、仙鹤草15～25份、艾实10～20份、海马20～30份、紫河车5～15份、枇杷芋10～20份、柑核20～30份、石花5～15份、牛奶浆根25～35份、木豆10～20份、小一把抓20～30份、白九股牛10～20份、都拉15～25份、刺五加20～30份、黄珠子草10～20份、香茶菜20～30份和铧头草15～25份。
3.如权利要求1或2所述的中药，其特征在于，所述中药各原料药材的重量份数比如下：腹水草40～45份、千年不烂心25～30份、墓头回35～40份、莪术30～35份、黄独零余子15～20份、附子10～15份、白花蛇舌草20～25份、仙鹤草15～20份、艾实10～15份、海马25～30份、紫河车5～10份、枇杷芋15～20份、柑核25～30份、石花10～15份、牛奶浆根30～35份、木豆10～15份、小一把抓20～25份、白九股牛15～20份、都拉20～25份、刺五加25～30份、黄珠子草10～15份、香茶菜20～25份和铧头草15～20份。
4.如权利要求1至3所述的中药，其特征在于，所述中药各原料药材的重量份数比如下：腹水草45份、千年不烂心26份、墓头回37份、莪术33份、黄独零余子17份、附子13份、白花蛇舌草22份、仙鹤草16份、艾实11份、海马27份、紫河车6份、枇杷芋16份、柑核25份、石花12份、牛奶浆根31份、木豆12份、小一把抓23份、白九股牛17份、都拉22份、刺五加28份、黄珠子草13份、香茶菜24份和铧头草18份。
5.如权利要求1至3所述的中药，其特征在于，所述中药各原料药材的重量份数比如下：腹水草42份、千年不烂心28份、墓头回40份、莪术32份、黄独零余子19份、附子11份、白花蛇舌草24份、仙鹤草18份、艾实12份、海马29份、紫河车8份、枇杷芋19份、柑核28份、石花14份、牛奶浆根33份、木豆15份、小一把抓21份、白九股牛16份、都拉24份、刺五加25份、黄珠子草11份、香茶菜23份和铧头草17份。
6.如权利要求1至5所述的中药，其特征在于，所述中药的剂型为胶囊剂，其制备方法包括以下步骤：
第一步，将腹水草、千年不烂心、墓头回、莪术、黄独零余子、附子和白花蛇舌草按所述比例混合，加相对于混合物4～6倍的水提取挥发油，将获得的挥发油用β-环糊精包合，挥发油与β-环糊精的比例为1∶3～6，搅拌60分钟～90分钟，温度30℃～50℃，得挥发油包合物，备用；另将水提取液浓缩至60℃时相对密度为1.15～1.17的清膏；
第二步，将木豆、小一把抓、白九股牛、都拉、刺五加、黄珠子草、香茶菜和铧头草按所述比例混合，加相对于混合物5～8倍量醇浓度为75％～90％的乙醇回流提取3～5次，每次2～3小时，分别过滤，各次滤液合并，回收乙醇，浓缩至60℃时相对密度为1.20～1.22的清膏，备用；
第三步，将剩余所述原料药材按所述比例混合，加相对于混合物8～10倍量水，煮沸6～8小时，过滤，浓缩至60℃时相对密度为1.28～1.30的清膏；
第四步，将第一步、第二步、第三步的清膏混合，60℃～70℃减压真空干燥，得干膏粉；
第五步，将第一步所述挥发油包合物和第四步所述干膏粉充分混合，随后相对于100重量份所述挥发油包合物和干膏粉的混合物，加入5～7重量份羧甲基淀粉钠、5～50重量份淀粉混合均匀，然后加入150～200重量份醇浓度为80％～90％乙醇制粒，干燥，整粒，最后相对于100重量份所述挥发油包合物和干膏粉的混合物，加入3～5重量份硬脂酸镁，然后装入明胶胶囊中。
7.如权利要求1至5所述的中药，其特征在于，所述中药的剂型为葡萄糖注射液时，其制备方法包括以下步骤：
第一步，将所述原料药材按比例混合，放入超微粉碎机中粉碎成0.1～10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料，所述混合粉料的得粉率至少为95％；
第二步，在第一步获得的混合粉料中加入相对于所述混合粉料的质量3～5倍的醇浓度为85％～95％的乙醇，搅拌溶解获得乙醇溶液，将乙醇溶液在5℃～10℃的条件下静置24～36小时，采用渗漉法以每分钟1～2ml的速度缓缓渗漉，收集渗漉液，浓缩并干燥，并在此放入超微粉碎机中粉碎40～60分钟，获得0.1～10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料，所述混合粉料的得粉率至少为95％；
第三步，取第二步获得的混合粉料30g～50g，加入丙二醇50g～100g，加400ml注射用水，搅拌使其溶解，进一步加注射用水至1000ml，再加入3g～5g针用活性炭，充分搅拌50～120分钟；脱炭过滤；用0.22～0.24μm微孔滤膜过滤；冷冻干燥得无菌粉末，分装灌封。
8.一种权利要求1至5所述中药的制备方法，其特征在于，所述中药的剂型为胶囊剂，其制备方法包括以下步骤：
第一步，将腹水草、千年不烂心、墓头回、莪术、黄独零余子、附子和白花蛇舌草按所述比例混合，加相对于混合物4～6倍的水提取挥发油，将获得的挥发油用β-环糊精包合，挥发油与β-环糊精的比例为1∶3～6，搅拌60分钟～90分钟，温度30℃～50℃，得挥发油包合物，备用；另将水提取液浓缩至60℃时相对密度为1.15～1.17的清膏；
第二步，将木豆、小一把抓、白九股牛、都拉、刺五加、黄珠子草、香茶菜和铧头草按所述比例混合，加相对于混合物5～8倍量醇浓度为75％～90％的乙醇回流提取3～5次，每次2～3小时，分别过滤，各次滤液合并，回收乙醇，浓缩至60℃时相对密度为1.20～1.22的清膏，备用；
第三步，将剩余所述原料药材按所述比例混合，加相对于混合物8～10倍量水，煮沸6～8小时，过滤，浓缩至60℃时相对密度为1.28～1.30的清膏；
第四步，将第一步、第二步、第三步的清膏混合，60℃～70℃减压真空干燥，得干膏粉；
第五步，将第一步所述挥发油包合物和第四步所述干膏粉充分混合，随后相对于100重量份所述挥发油包合物和干膏粉的混合物，加入5～7重量份羧甲基淀粉钠、5～50重量份淀粉混合均匀，然后加入150～200重量份醇浓度为80％～90％乙醇制粒，干燥，整粒，最后相对于100重量份所述挥发油包合物和干膏粉的混合物，加入3～5重量份硬脂酸镁，然后装入明胶胶囊中。
9.一种权利要求1至5所述中药的制备方法，其特征在于，所述中药的剂型为葡萄糖注射液，其制备方法包括以下步骤：
第一步，将所述原料药材按比例混合，放入超微粉碎机中粉碎成0.1～10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料，所述混合粉料的得粉率至少为95％；
第二步，在第一步获得的混合粉料中加入相对于所述混合粉料的质量3～5倍的醇浓度为85％～95％的乙醇，搅拌溶解获得乙醇溶液，将乙醇溶液在5℃～10℃的条件下静置24～36小时，采用渗漉法以每分钟1～2ml的速度缓缓渗漉，收集渗漉液，浓缩并干燥，并在此放入超微粉碎机中粉碎40～60分钟，获得0.1～10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料，所述混合粉料的得粉率至少为95％；
第三步，取第二步获得的混合粉料30g～50g，加入丙二醇50g～100g，加400ml注射用水，搅拌使其溶解，进一步加注射用水至1000ml，再加入3g～5g针用活性炭，充分搅拌50～120分钟；脱炭过滤；用0.22～0.24μm微孔滤膜过滤；冷冻干燥得无菌粉末，分装灌封。
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| CN105434670A (zh) * | 2016-01-10 | 2016-03-30 | 姜达志 | 一种治疗肋软骨炎的中药制剂及其制备方法 |
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| CN103520651A (zh) * | 2013-10-25 | 2014-01-22 | 刘瑾 | 一种治疗宫颈癌的中药组合物 |
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| CN105434670A (zh) * | 2016-01-10 | 2016-03-30 | 姜达志 | 一种治疗肋软骨炎的中药制剂及其制备方法 |
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