WO2016150377A1 - 一种含有水飞蓟宾、ve和左旋肉碱的药物组合物 - Google Patents
一种含有水飞蓟宾、ve和左旋肉碱的药物组合物 Download PDFInfo
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- WO2016150377A1 WO2016150377A1 PCT/CN2016/077036 CN2016077036W WO2016150377A1 WO 2016150377 A1 WO2016150377 A1 WO 2016150377A1 CN 2016077036 W CN2016077036 W CN 2016077036W WO 2016150377 A1 WO2016150377 A1 WO 2016150377A1
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- the Pu'er tea extract is commercially available, preferably in the form of Dibao Pu'er tea. It can also be prepared according to the prior art. In order to better exert the therapeutic effect of the present invention, it is preferred that the Pu'er tea or Pu'er tea extract is prepared according to Patent Publication Nos. CN101961061A, CN101961061B, CN101961425A, CN101961425B, CN101961060A, CN101961059A, CN101961059B.
- the vitamin E is any one of vitamin E, vitamin E acetate and vitamin E succinate which are commercially available for dietary supplement or medicinal use.
- the L-carnitine is any one of L-carnitine and L-carnitine tartrate which are commercially available for dietary supplementation or medicinal use.
- the traditional Chinese medicine composition or preparation of the present invention determines the usage amount according to the condition of the patient at the time of use.
- the pharmaceutical composition preparation of the present invention such as a tablet, a capsule, a granule, etc.
- a dissolution condition a slurry method, a rotation speed of 100 rpm, a temperature of 37 ° C, and a release medium of 1000 ml of a hydrochloric acid solution having a pH of 1.2.
- Amount 1 capsule / 1 tablet / 1 bag of granules.
- the cumulative dissolution in vitro for 2h is not less than 60%, and the dissolution at 30min is greater than or equal to 15%.
- a method for preparing a pharmaceutical composition of the present invention comprises the following steps:
- the pharmaceutical composition is obtained by mixing in an ascending manner.
- a pharmaceutical preparation and a pharmaceutically acceptable carrier are prepared into a conventional preparation.
- mice The body weight of each group of mice was weighed once a week during the experiment.
- the serum TC, LDL, ALT, AST, and insulin resistance indexes of the nonalcoholic fatty liver model mice were significantly increased (P ⁇ 0.05); the silybin phospholipid complexes were abnormal. There was no significant improvement in the elevated index (P>0.05). There were no significant improvements in serum ALT except for composition 4 in different proportions of silybin phosphate complex, Pu'er tea extract, VE and L-carnitine. Outside (P>0.05), all other compositions can significantly reduce TC, LDL-C, ALT, AST and insulin resistance index (P ⁇ 0.05), and the effect is better than that of silybin phospholipid complex alone.
- the prescribed amount of vitamin E and L-carnitine are uniformly mixed, and then the mixture of the two is mixed with the particles prepared in step 2 in an equal amount, and bagged to make 1000 bags of particles.
- silybin complex liquid Preparation of silybin complex liquid: Weigh the prescribed amount of silybin and soybean phospholipid into absolute ethanol, heat and reflux to clarify the solution, continue heating for 0.5 hours, and concentrate and recover ethanol to 5% of original volume under reduced pressure. ,spare;
- a bag of pellets of 26.25 g, 195 g of phospholipid, 75 g of Pu'er tea extract, 120 g of vitamin E, and 180 g of L-carnitine were prepared according to the method of Example 1 to prepare 1000 bags of granules.
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Abstract
Description
组别 | 体重(g) | 肝湿重(g) | 肝指数% |
正常 | 27.71±1.94 | 1.03±0.11 | 3.73±0.30 |
模型 | 62.23±2.77 | 4.22±0.34 | 6.79±0.59 |
水飞蓟宾磷脂复合物 | 62.30±4.79 | 3.88±0.39* | 6.28±0.96 |
组合1 | 53.97±2.07** | 2.54±0.30** | 4.70±0.54** |
组合2 | 58.64±3.20* | 2.96±0.40** | 5.07±0.79** |
组合3 | 56.02±2.28** | 2.73±0.43** | 4.88±0.88** |
组合4 | 52.07±1.90** | 2.31±0.21** | 4.44±0.54** |
组合5 | 54.67±1.90** | 2.65±0.25** | 4.84±0.47** |
组别 | TC | LDL-C | ALT | AST | 胰岛素抵抗指数 |
正常 | 3.03±0.27 | 0.28±0.05 | 60.89±34.55 | 127.78±50.91 | 0.577±0.117 |
模型 | 10.27±1.20 | 2.21±0.54 | 411.67±95.45 | 200.89±26.13 | 1.172±0.228 |
水飞蓟宾磷脂复合物 | 10.29±1.16 | 2.26±0.32 | 356.24±17.67 | 176.49±23.30 | 1.008±0.385 |
组合1 | 6.86±1.05** | 1.07±0.14** | 229.51±90.05** | 118.41±20.01** | 0.661±0.081** |
组合2 | 9.12±0.88* | 1.71±0.28* | 179.51±44.62** | 171.74±34.80* | 0.841±0.262** |
组合3 | 7.85±1.09** | 1.36±0.17** | 291.69±110.33* | 158.66±35.36* | 0.773±0.135** |
组合4 | 5.76±1.29** | 0.97±0.17** | 326.03±85.10 | 110.63±27.18** | 0.625±0.089** |
组合5 | 7.06±1.04** | 1.10±0.10** | 239.51±86.62** | 123.97±22.06** | 0.753±0.207** |
组别 | 油红O染色病理评分 |
正常 | 0.000±0.000 |
模型 | 2.900±0.316 |
水飞蓟宾磷脂复合物 | 2.556±0.726 |
普洱茶提取物 | 2.444±0.726 |
组合1 | 2.222±0.667* |
组合2 | 2.400±0.516* |
组合3 | 2.222±0.833* |
组合4 | 1.778±0.833** |
组合5 | 2.100±0.738** |
Claims (11)
- 如权利要求1-3任意一项所述的药物组合物,其特征在于,所述维生素E可以用维生素E醋酸酯或维生素E琥珀酸酯代替。
- 如权利要求1-3任意一项所述的药物组合物,其特征在于,所述左旋肉碱还可以是左旋肉碱酒石酸盐。
- 一种药物制剂,其特征在于,包括如权利要求1-3任意一项所述的药物组合物,和药学上可接受的载体;优选药学上可接受的载体以重量计可以是制剂总重量的0.1-99.9%;优选药学上可接受的载体以重量计可以是制剂总重量的40-70%。
- 如权利要求6所述的制剂,其特征在于,所述的载体包括甘露醇、山梨醇、山梨酸或钾盐、焦亚硫酸钠、亚硫酸氢钠、硫代硫酸钠、盐酸半胱氨酸、巯基乙酸、蛋氨酸、维生素A、维生素C、维生素E、维生素D、氮酮、EDTA二钠、EDTA钙钠,一价碱金属的碳酸盐、醋酸盐、 磷酸盐或其水溶液、盐酸、醋酸、硫酸、磷酸、氨基酸、氯化钠、氯化钾、乳酸钠、木糖醇、麦芽糖、葡萄糖、果糖、右旋糖苷、甘氨酸、淀粉、蔗糖、乳糖、甘露糖醇、硅衍生物、纤维素及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、丙二醇、乙醇、土温60-80、司班-80、蜂蜡、羊毛脂、液体石蜡、十六醇、没食子酸酯类、琼脂、三乙醇胺、碱性氨基酸、尿素、尿囊素、碳酸钙、碳酸氢钙、表面活性剂、聚乙二醇、环糊精、β-环糊精、磷脂类材料、高岭土、滑石粉、硬脂酸钙、硬脂酸镁、微晶中一种或以上;优选所述的载体为微晶纤维素、乳糖、淀粉、羧甲基纤维素钠、低取代羟丙基纤维素、滑石粉中一种或以上。
- 如权利要求7所述的制剂,其特征在于,所述的制剂为片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、丸剂、散剂、膏剂、丹剂、混悬剂、溶液剂、注射剂、栓剂、软膏剂、硬膏剂、霜剂、喷雾剂、贴剂任意一种;优选所述的制剂为胶囊剂、颗粒剂或片剂。
- 如权利要求6所述制剂的制备方法,其特征在于:包括如下步骤:①取处方量的原料备用;②水飞蓟宾复合液的制备:称取处方量水飞蓟宾、磷脂溶解到无水乙醇中,加热回流使溶液澄清后再继续加热一定时间,再将澄清溶液减压浓缩至一定体积,得到水飞蓟宾复合液,备用;③制粒:称取处方量普洱茶提取物作为底料,以②中制备得水飞蓟宾复合液为料液,以流化床流化喷液方式制颗粒,待液态复合物全部喷入后,干燥,备用;④总混:先将维生素E、左旋肉碱与步骤③颗粒混合均匀即得药物组合物;⑤制剂:取药物组合物与药学上可接受的载体制成常规制剂。
- 权利要求9的方法,其特征在于,步骤②中所述的加热时间为0.5~1.5小时;所述的浓缩的体积为原体积的5%~20%,减压浓缩温度为60~80℃;步骤③中流化床的参数为:物料温度40~65℃,制粒过程调节风机频率,进风温度和输液频率等参数,保持物料良好流化状态;制粒完成后,干燥10-60分钟,干燥温度为55~65℃。
- 权利要求1-3任意一项所述的药物组合物或权利要求6所述制剂在制备治疗非酒精性脂肪肝和/或减肥降脂、美容养颜药物中的应用。
Priority Applications (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP16767754.1A EP3275454B1 (en) | 2015-03-23 | 2016-03-22 | Pharmaceutical composition containing silybin, ve and l-carnitine |
RU2017137012A RU2700793C2 (ru) | 2015-03-23 | 2016-03-22 | Фармацевтическая композиция, содержащая силибин, витамин е и l-карнитин |
KR1020177030489A KR102579754B1 (ko) | 2015-03-23 | 2016-03-22 | 실리빈, ve 및 카르니틴 함유 약학 조성물 |
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