CN1284548C - 补益类胶囊的制备工艺 - Google Patents
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Abstract
本发明公开了一种补益类胶囊的制备工艺，它是取女贞子、黄芪加水煎煮3次，合并煎液，再进行超滤，滤液浓缩，干燥后制成颗粒，再干燥，装胶囊即得。本发明具有补益效果好，服用量少，药效佳等优点。其服用量可较传统的药物减少1/3。用于久病虚损，气阴不足；配合手术、放射治疗、化学治疗，促进正常功能的恢复。
Description
技术领域：
本发明涉及一种用中草药制备胶囊的工艺。
技术背景：
传统的补益类中草药制备胶囊工艺中过滤方法一般都是用200目筛网过滤，不能除去药液中的胶质、鞣质、蛋白质等大分子杂质，造成药效不佳，服用量大，且引湿性强。
发明内容：
本发明的目的在于：提供一种用超滤的方法来制取中草药胶囊，它能起到分离、纯化、浓缩的作用，以提高药效，减少服用量。
本发明是这样实现的：取女贞子、黄芪提取3次，合并提取液，再进行超滤，滤液浓缩至相对密度1.07～1.09的清膏，干燥后制成颗粒，再干燥，装胶囊即得。
本发明与现有技术相比，具有补益效果好，服用量少，药效佳等优点。其服用量可较传统的药物减少1/3。用于久病虚损，气阴不足；配合手术、放射治疗、化学治疗，促进正常功能的恢复。具体临床试验小结如下：
1材料与方法
1.1一般资料：全部病例中住院患者132例，门诊患者18例；观察组比例中，男52例，女48例，对照组男27例，女23例；年龄在38～69岁之间。恶性肿瘤病例全部明确诊断，预计生存期3个月以上，卡氏平分≥60分，病种情况见表1。
表1 病种分布
| 肿瘤 | 例数 | 百分率(％) | 慢性病 | 例数 | 百分率(％) |
| 肺癌肝癌 | 366 | 41.46.8 | 糖尿病肝硬化 | 1816 | 28.525.4 |
| 妇癌鼻咽癌恶淋乳腺癌 | 241247 | 27.413.84.68.0 | 萎缩性胃炎慢支炎慢性结肠炎其它 | 14843 | 22.312.76.34.8 |
| 小计 | 87 | 100 | 63 | 100 |
1.2方法
150例患者采用单育法随机分组，观察组100例用本发明5粒，1日3次口服，对照组用香菇多糖片，5片，1日3次口服，疗程6周。观察过程中停用其它相关药物，但放化疗继续进行。
1.3观察指标
1.3.1临床症候评分，根据中医症状分级者评分，治疗前后各记录一次。
表2 中医症状分级表
| 症状 | 0分 | 1分 | 2分 | 3分 | 4分 |
| 神疲呕恶纳呆发热 | 无无无无 | 略感疲劳，能坚持工作偶有恶心饮食无味，食量未减＜38℃，＜2d | 易疲劳，不能坚持工作恶心明显，呕吐1-2次/日食量较平时减少1/3＜38℃，＞2d，或38°～40℃，＜2d | 易疲劳，需别人帮助进食呕吐3～5次/d食量较平时减少1/238°～40℃，＞2d或40℃以上，＜1d | 极疲劳，需医疗护理呕吐5次以上/d，难控制食量较平时减少2/3以上40℃以上，＞2d，或38°～40℃持续1周或＜38℃持续1月 |
中医症状疗效评定标准：临床治疗：治疗后所有症状消失，症状积分降至0；显效：症状多数消失，治疗后积分比治疗前积分降低2/3以上；有效：症状好转，积分降低1/3以上，无效：症状无明显改善，积分与治疗前相等，或降低不足1/3。
1.3.2外周血WBC及Hb疗效标准：显效：WBC、Hb治疗后比治疗前分别上升1.0×109/L、30g/L，有效：WBC及Hb上升不足1.0×109/L、30g/L，或维持在4.0×109/L、90g/L以上；无效：治疗后WBC及Hb无变化或分别降至4.0×109/L及90g/L以下。
1.3.3提高免疫指标疗效标准：以给药前后免疫指标测定值均值经统计学处理判定。
1.3.4生存质量评分：以卡氏评分标准，治疗前后分别给予计分，治疗前后计分提高10分应为提高，减少10分应为降低，增高或减少小于10分应为稳定。
2结果
2.1临床症状疗效：观察组100例，显效80例(80％)，有效14例(14％)，无效6例(6％)，总有效率94％，对照组50例，显效10例(20％)，有效20例(40％)，无效20例(40％)，总有效率60％。
结果提示：两组相比差异有非常显著性，P＜0.01。
2.2外周血WBC及Hb的升高效果，见表3
表3 外周血WBC及Hb升高效果
| 指标 | 组别 | 例数 | 显效(％) | 有效(％) | 无效(％) | 总有效率％ |
| WBCHb | 观察组对照组P＜0.01观察组对照组P＜0.01 | 80428042 | 54(67.5)8(19.00)65(81.2)5(11.9) | 22(27.5)12(28.6)7(8.8)20(47.6) | 4(5)22(52.4)8(10)17(40.5) | 95.047.69059.5 |
结果提示：观察组与对照组相比统计学分析有非常显著化差异(P＜0.01＝。
2.3治疗前后免疫指标T淋巴细胞亚群的变化，以两组肿瘤患者治疗前后6周内TH、TS、TH/TS的均值进行统计学处理，结果见表4。
表4 两组内肿瘤患者治疗前后T淋巴细胞变化(X±S)
| 组别 | 例数 | TH(％) | TS(％) | TH/TS(％) | ||||||
| 观察组对照组 | 6027 | 疗前 | 疗后 | P | 疗前 | 疗后 | P | 疗前 | 疗后 | P |
| 34.8±6.235.9±7.6 | 41.2±7.137.0±6.9 | ＜0.01＞0.05 | 41.6±5.139.9±7.4 | 33.8±7.640.1±6.6 | ＜0.01＞0.05 | 0.91±0.320.98±0.49 | 0.96±0.400.97±0.44 | ＜0.01＞0.05 | ||
上表结果显示，观察组TH及TH/TS比值上升明显(P＜0.01)，TS下降明显，对照组治疗前后无明显变化(P＞0.05)，说明本发明有提高细胞免疫功能的疗效。
2.4生活质量评价，见表5
表5
| 100例治疗前后生活质量变化 | ||
| 效果 | 例数 | 比例 |
| 提高稳定降低无效 | 4239514 | 4239514 |
3结论
本发明对100例恶性肿瘤及慢性虚损性疾病患者治疗6周后的结果说明：该药能显著改善患者的神疲乏力，呕恶、发热、纳呆等症状，提高患者外周血WBC、Hb的测定值，明显的增加机体的细胞免疫功能，生活质量得到显著提高，其扶正固本的功效在多方面得到体现，不失为治疗恶性肿瘤及其它虚损性慢性疾病的有效药物。
具体实施方式：
本发明的实施例：以制取1000粒为例，取女贞子467g，黄芪933g粉碎，加水煎煮3次(第1次10倍量水，第2、3次分别加8倍量水)，第1次2小时，第2、3次各1小时，合并煎液，用200目筛网过滤，再用截流分子量为50000的中空纤维超滤膜进行超滤，滤液浓缩至相对密度1.07～1.09(50℃)的清膏，干燥后制成颗粒，再干燥，装1000粒胶囊即得。
Claims (1)
1.一种补益类胶囊的制备工艺，其特征在于：取女贞子467g、黄芪933g，加水煎煮3次，第1次2小时，第2、3次各1小时，合并煎液，用截留分子量为50000的中空纤维超滤膜进行超滤，滤液浓缩至相对密度1.07-1.09的清膏，干燥后制成颗粒，再干燥，装胶囊即得。
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN100489076C (zh) * | 2002-06-25 | 2009-05-20 | 日本札幌啤酒株式会社 | 啤酒样酒精饮料及其制造方法 |
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| CN101805413A (zh) * | 2010-04-01 | 2010-08-18 | 苏州宝泽堂医药科技有限公司 | 一种女贞子多糖的制备方法 |
| CN105267308A (zh) * | 2014-06-27 | 2016-01-27 | 北京海吉星医疗科技有限公司 | 一种具有抗肿瘤活性的中药组合物 |
| CN105311116A (zh) * | 2014-06-27 | 2016-02-10 | 北京海吉星医疗科技有限公司 | 一种治疗虚损的药物组合物 |
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Effective date of registration: 20181214 Address after: 550018 6th Floor, Kekaiyuan, Koujie Road Estuary, Wudang District, Guiyang City, Guizhou Province Patentee after: GUIZHOU XINBANG PHARMACEUTICAL Co.,Ltd. Address before: 550003 No. 75 Ruijin North Road, Guiyang City, Guizhou Province Patentee before: XINBANG YUANDONG PHARMACEUTICA |
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Date of cancellation: 20210420 Granted publication date: 20061115 Pledgee: Agricultural Bank of China Limited by Share Ltd. Luodian branch Pledgor: GUIZHOU XINBANG PHARMACEUTICAL Co.,Ltd. Registration number: 2017520000004 |
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Granted publication date: 20061115 |
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