CN101011489A - 鱼腥草滴眼液及其制备方法 - Google Patents
鱼腥草滴眼液及其制备方法 Download PDFInfo
- Publication number
- CN101011489A CN101011489A CN 200610021199 CN200610021199A CN101011489A CN 101011489 A CN101011489 A CN 101011489A CN 200610021199 CN200610021199 CN 200610021199 CN 200610021199 A CN200610021199 A CN 200610021199A CN 101011489 A CN101011489 A CN 101011489A
- Authority
- CN
- China
- Prior art keywords
- eye drops
- cordate houttuynia
- herba houttuyniae
- thickening agent
- houttuynia eye
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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- 239000003889 eye drop Substances 0.000 title claims abstract description 147
- 229940012356 eye drops Drugs 0.000 title claims abstract description 131
- 238000002360 preparation method Methods 0.000 title claims abstract description 36
- 235000013717 Houttuynia Nutrition 0.000 title claims description 110
- 240000000691 Houttuynia cordata Species 0.000 title abstract 4
- 241000758769 Houttuynia Species 0.000 claims description 109
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 96
- UAJTZZNRJCKXJN-UHFFFAOYSA-M sodium;2-dodecoxy-2-oxoethanesulfonate Chemical compound [Na+].CCCCCCCCCCCCOC(=O)CS([O-])(=O)=O UAJTZZNRJCKXJN-UHFFFAOYSA-M 0.000 claims description 76
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 63
- 239000000284 extract Substances 0.000 claims description 48
- 239000011780 sodium chloride Substances 0.000 claims description 48
- 239000002562 thickening agent Substances 0.000 claims description 44
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 claims description 37
- 238000003756 stirring Methods 0.000 claims description 30
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- XJLDYKIEURAVBW-UHFFFAOYSA-N 3-decanone Chemical compound CCCCCCCC(=O)CC XJLDYKIEURAVBW-UHFFFAOYSA-N 0.000 claims description 22
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims description 22
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 claims description 22
- GYCKQBWUSACYIF-UHFFFAOYSA-N o-hydroxybenzoic acid ethyl ester Natural products CCOC(=O)C1=CC=CC=C1O GYCKQBWUSACYIF-UHFFFAOYSA-N 0.000 claims description 22
- 239000002994 raw material Substances 0.000 claims description 22
- 229960000686 benzalkonium chloride Drugs 0.000 claims description 17
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims description 17
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- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 claims description 16
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- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims description 2
- HHAGWXCTPQVPJV-UHFFFAOYSA-N N.[Br] Chemical compound N.[Br] HHAGWXCTPQVPJV-UHFFFAOYSA-N 0.000 claims description 2
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- 239000003814 drug Substances 0.000 abstract description 44
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- 235000013719 Houttuynia cordata Nutrition 0.000 abstract 3
- 239000006001 Methyl nonyl ketone Substances 0.000 abstract 2
- KMPQYAYAQWNLME-UHFFFAOYSA-N Undecanal Natural products CCCCCCCCCCC=O KMPQYAYAQWNLME-UHFFFAOYSA-N 0.000 abstract 2
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- KHSLHYAUZSPBIU-UHFFFAOYSA-M benzododecinium bromide Chemical compound [Br-].CCCCCCCCCCCC[N+](C)(C)CC1=CC=CC=C1 KHSLHYAUZSPBIU-UHFFFAOYSA-M 0.000 description 7
- 210000000744 eyelid Anatomy 0.000 description 7
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- LWZFANDGMFTDAV-BURFUSLBSA-N [(2r)-2-[(2r,3r,4s)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl] dodecanoate Chemical compound CCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O LWZFANDGMFTDAV-BURFUSLBSA-N 0.000 description 2
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Landscapes
- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
增稠剂 | 溶解条件 | 结果 |
壳聚糖 | 取本品0.3g加入100ml注射用水中 | 无色透明澄清液体 |
羟丙甲纤维素 | 取本品0.3g加入100ml注射用水中 | 2~3天完全溶胀,为无色澄明液体 |
玻璃酸钠 | 取本品0.3g加入100ml注射用水中 | 无色透明澄清溶液 |
卡波姆 | 取本品0.3g加入100ml约40℃的注射用水中 | 2~3天完全溶胀,为几乎澄明的液体 |
聚乙烯醇 | 取本品0.3g加入100ml注射用水中 | 无色透明澄清液体 |
浓度(%) | 黏度(mpa.s) | 峰时(min) | 持续时间(min) | AUC(cm2) |
- | 0.0 | 15 | 113 | 25 |
0.1 | 32.4 | 15 | 150 | 67 |
0.2 | 85.6 | 15 | 300 | 103 |
0.3 | 200.8 | 15 | 400 | 117 |
组别 | 受试物 | 给药浓度(mg/ml) | 给药体积(μl/ml) | 给药剂量(mg/kg) | |
正常对照组 | 鱼腥草滴眼液 | --- | 200 | --- | |
模型组 | 空白对照液 | --- | 200 | --- | |
不含增稠剂 | 鱼腥草滴眼液(3.0μg) | 鱼腥草滴眼液(3.0μg) | 3.0μg/ml | 200 | 0.4 |
含增稠剂玻璃酸钠 | 鱼腥草滴眼液(6.0μg) | 鱼腥草滴眼液(6.0μg) | 6.0μg/ml | 200 | 0.4 |
鱼腥草滴眼液(5.0μg) | 鱼腥草滴眼液(5.0μg) | 5.0μg/ml | 200 | 0.4 | |
鱼腥草滴眼液(2.0μg) | 鱼腥草滴眼液(2.0μg) | 2.0μg/ml | 200 | 0.4 | |
鱼腥草滴眼液(1.0μg) | 鱼腥草滴眼液(1.0μg) | 1.0μg/ml | 200 | 0.4 | |
含增稠剂壳聚糖 | 鱼腥草滴眼液(6.0μg) | 鱼腥草滴眼液(6.0μg) | 6.0μg/ml | 200 | 0.4 |
鱼腥草滴眼液(5.0μg) | 鱼腥草滴眼液(5.0μg) | 5.0μg/ml | 200 | 0.4 | |
鱼腥草滴眼液(2.0μg) | 鱼腥草滴眼液(2.0μg) | 2.0μg/ml | 200 | 0.4 | |
鱼腥草滴眼液(1.0μg) | 鱼腥草滴眼液(1.0μg) | 1.0μg/ml | 200 | 0.4 | |
含增稠剂羟丙甲纤维素 | 鱼腥草滴眼液(6.0μg) | 鱼腥草滴眼液(6.0μg) | 6.0μg/ml | 200 | 0.4 |
鱼腥草滴眼液(5.0μg) | 鱼腥草滴眼液(5.0μg) | 5.0μg/ml | 200 | 0.4 | |
鱼腥草滴眼液(2.0μg) | 鱼腥草滴眼液(2.0μg) | 2.0μg/ml | 200 | 0.4 | |
鱼腥草滴眼液(1.0μg) | 鱼腥草滴眼液(1.0μg) | 1.0μg/ml | 200 | 0.4 | |
含增稠剂卡波姆 | 鱼腥草滴眼液(6.0μg) | 鱼腥草滴眼液(6.0μg) | 6.0μg/ml | 200 | 0.4 |
鱼腥草滴眼液(5.0μg) | 鱼腥草滴眼液(5.0μg) | 5.0μg/ml | 200 | 0.4 | |
鱼腥草滴眼液(2.0μg) | 鱼腥草滴眼液(2.0μg) | 2.0μg/ml | 200 | 0.4 | |
鱼腥草滴眼液(1.0μg) | 鱼腥草滴眼液(1.0μg) | 1.0μg/ml | 200 | 0.4 | |
含增稠剂聚乙烯醇 | 鱼腥草滴眼液(6.0μg) | 鱼腥草滴眼液(6.0μg) | 6.0μg/ml | 200 | 0.4 |
鱼腥草滴眼液(5.0μg) | 鱼腥草滴眼液(5.0μg) | 5.0μg/ml | 200 | 0.4 | |
鱼腥草滴眼液(2.0μg) | 鱼腥草滴眼液(2.0μg) | 2.0μg/ml | 200 | 0.4 | |
鱼腥草滴眼液(1.0μg) | 鱼腥草滴眼液(1.0μg) | 1.0μg/ml | 200 | 0.4 |
组别 | 剂量(g/kg) | 兔数(只) | 眼数(只) | 家兔大耳兔双眼结膜炎症病变总情况(分值,X±SD) | |||||||
造模24h后 | 给药1天后 | 给药2天后 | 给药3天后 | 给药4天后 | 给药5天后 | 给药6天后 | |||||
正常对照组 | - | 8 | 16 | 0.00±0.00 | 0.00±0.00 | 0.00±0.00 | 0.00±0.00 | 0.00±0.00 | 0.00±0.00 | 0.00±0.00 | |
模型组 | - | 8 | 16 | 8.91±2.31 | 9.50±3.08 | 9.74±2.05 | 9.36±2.61 | 6.72±2.59 | 5.341±1.89 | 4.64±1.09 | |
未添加增稠剂 | 鱼腥草滴眼液(3.0μg) | - | 8 | 16 | 9.81±2.11 | 8.59±2.38 | 7.84±1.83 | 6.55±1.58 | 5.21±2.18 | 4.34±1.87* | 3.82±2.43* |
加入玻璃酸钠 | 鱼腥草滴眼液(6.0μg) | 0.4 | 8 | 16 | 9.74±1.54 | 8.93±1.29 | 6.14±1.37 | 5.57±2.38 | 4.76±2.81 | 3.81±1.46* | 2.95±1.85* |
鱼腥草滴眼液(5.0μg) | 0.4 | 8 | 16 | 9.70±1.74 | 7.92±3.22 | 6.14±2.91 | 5.00±2.72* | 4.01±3.43** | 3.24±2.48** | 2.24±1.47** | |
鱼腥草滴眼液(2.0μg) | 0.4 | 8 | 16 | 9.79±1.62 | 8.01±1.52 | 6.21±1.07 | 5.12±0.79 | 4.24±0.37* | 3.59±0.71** | 2.59±0.81** | |
鱼腥草滴眼液(1.0μg) | 0.4 | 8 | 16 | 9.88±1.61 | 8.71±1.99 | 6.64±1.81 | 5.61±2.95 | 4.69±2.01 | 3.88±1.54* | 2.87±1.24* | |
加入壳聚糖 | 鱼腥草滴眼液(6.0μg) | 0.4 | 8 | 16 | 9.16±1.87 | 8.78±1.37 | 7.75±2.71 | 6.82±1.46 | 4.82±2.53 | 3.38±2.75* | 3.19±2.80* |
鱼腥草滴眼液(5.0μg) | 0.4 | 8 | 16 | 9.69±1.48 | 8.92±1.15 | 7.42±1.90 | 5.51±1.36* | 4.21±1.01* | 3.62±0.97** | 3.00±1.18** | |
鱼腥草滴眼液(2.0μg) | 0.4 | 8 | 16 | 9.61±2.10 | 8.86±1.24 | 7.93±2.08 | 5.82±2.38 | 4.33±2.17* | 3.67±2.13** | 3.27±1.47** | |
鱼腥草滴眼液(1.0μg) | 0.4 | 8 | 16 | 9.74±1.79 | 8.82±1.42 | 7.90±2.84 | 6.10±1.45 | 4.52±2.57 | 3.73±2.84* | 3.55±2.34* |
加入羟丙甲纤维素 | 鱼腥草滴眼液(6.0μg)鱼腥草滴眼液(5.0μg)鱼腥草滴眼液(2.0μg)鱼腥草滴眼液(1.0μg) | 0.40.40.40.4 | 8888 | 16161616 | 9.72±1.829.68±2.029.79±2.589.82±1.48 | 8.46±1.858.88±3.128.34±1.858.44±1.92 | 7.68±1.727.56±1.497.49±2.917.67±1.82 | 6.19±2.305.55±2.58*5.77±3.016.04±2.11 | 4.76±2.634.19±2.34*4.62±1.42*4.67±2.38 | 4.41±3.13*3.69±1.48**3.95±2.61*4.29±3.00* | 3.85±2.22*3.18±2.19*3.57±2.13**3.61±2.07* |
加入卡波姆 | 鱼腥草滴眼液(6.0μg)鱼腥草滴眼液(5.0μg)鱼腥草滴眼液(2.0μg)鱼腥草滴眼液(1.0μg) | 0.40.40.40.4 | 8888 | 16161616 | 9.85±1.619.67±1.439.73±2.129.70±1.46 | 9.26±1.438.76±1.299.01±1.969.11±1.28 | 8.26±2.667.81±2.498.04±1.188.11±2.51 | 5.28±2.435.41±3.02*5.49±2.085.69±2.46 | 4.90±1.184.56±2.14*4.73±3.15*4.88±1.06 | 4.34±2.08*3.70±2.53**3.92±2.00**4.08±2.73* | 3.43±2.50*3.23±1.27**3.40±1.90**3.55±2.61* |
加入羧乙烯醇 | 鱼腥草滴眼液(6.0μg)鱼腥草滴眼液(5.0μg)鱼腥草滴眼液(2.0μg)鱼腥草滴眼液(1.0μg) | 0.40.40.40.4 | 8888 | 16161616 | 9.77±2.099.85±1.769.89±3.019.80±2.00 | 9.23±2.168.67±1.428.69±2.899.11±2.03 | 7.83±1.497.73±2.817.82±2.647.94±1.99 | 5.73±2.355.79±2.91*5.73±2.295.90±2.46 | 5.22±2.434.69±2.82**5.02±1.34*5.06±2.31 | 4.48±1.87*4.37±2.50**4.36±3.29*4.53±1.97* | 3.72±2.43*3.16±2.24**3.44±1.34*3.69±2.55* |
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