CN104857287A - 一种治疗干眼症的中药滴眼液及其制备方法 - Google Patents
一种治疗干眼症的中药滴眼液及其制备方法 Download PDFInfo
- Publication number
- CN104857287A CN104857287A CN201510190375.3A CN201510190375A CN104857287A CN 104857287 A CN104857287 A CN 104857287A CN 201510190375 A CN201510190375 A CN 201510190375A CN 104857287 A CN104857287 A CN 104857287A
- Authority
- CN
- China
- Prior art keywords
- chinese medicine
- traditional chinese
- solomon
- eye
- seal
- 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
Links
- 239000003814 drug Substances 0.000 title claims abstract description 38
- 239000003889 eye drop Substances 0.000 title claims abstract description 28
- 238000002360 preparation method Methods 0.000 title claims abstract description 9
- 229940012356 eye drops Drugs 0.000 claims abstract description 21
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 16
- 239000000243 solution Substances 0.000 claims abstract description 12
- 239000007788 liquid Substances 0.000 claims abstract description 7
- 238000000605 extraction Methods 0.000 claims abstract description 6
- 238000001914 filtration Methods 0.000 claims abstract description 6
- 238000002156 mixing Methods 0.000 claims abstract description 6
- 238000010992 reflux Methods 0.000 claims abstract description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 31
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 15
- 208000005494 xerophthalmia Diseases 0.000 claims description 14
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 13
- UAJTZZNRJCKXJN-UHFFFAOYSA-M sodium;2-dodecoxy-2-oxoethanesulfonate Chemical compound [Na+].CCCCCCCCCCCCOC(=O)CS([O-])(=O)=O UAJTZZNRJCKXJN-UHFFFAOYSA-M 0.000 claims description 13
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 11
- 125000003118 aryl group Chemical group 0.000 claims description 10
- 230000001954 sterilising effect Effects 0.000 claims description 10
- 238000003756 stirring Methods 0.000 claims description 10
- 238000003809 water extraction Methods 0.000 claims description 10
- 238000010438 heat treatment Methods 0.000 claims description 8
- 238000004821 distillation Methods 0.000 claims description 5
- 239000012153 distilled water Substances 0.000 claims description 5
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims description 5
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 claims description 5
- 239000000706 filtrate Substances 0.000 claims description 5
- 239000012467 final product Substances 0.000 claims description 5
- 239000012982 microporous membrane Substances 0.000 claims description 5
- GYCKQBWUSACYIF-UHFFFAOYSA-N o-hydroxybenzoic acid ethyl ester Natural products CCOC(=O)C1=CC=CC=C1O GYCKQBWUSACYIF-UHFFFAOYSA-N 0.000 claims description 5
- 239000002244 precipitate Substances 0.000 claims description 5
- 238000004321 preservation Methods 0.000 claims description 5
- 239000011780 sodium chloride Substances 0.000 claims description 5
- 230000000694 effects Effects 0.000 abstract description 13
- 230000028327 secretion Effects 0.000 abstract description 12
- 241000756042 Polygonatum Species 0.000 abstract description 10
- 208000024891 symptom Diseases 0.000 abstract description 8
- 150000004676 glycans Chemical class 0.000 abstract description 6
- 238000000034 method Methods 0.000 abstract description 6
- 229920001282 polysaccharide Polymers 0.000 abstract description 6
- 239000005017 polysaccharide Substances 0.000 abstract description 6
- 230000003110 anti-inflammatory effect Effects 0.000 abstract description 5
- 230000000840 anti-viral effect Effects 0.000 abstract description 4
- 230000035876 healing Effects 0.000 abstract description 3
- 235000008737 Polygonatum biflorum Nutrition 0.000 abstract 6
- 235000004506 Polygonatum multiflorum Nutrition 0.000 abstract 6
- 241000758769 Houttuynia Species 0.000 abstract 4
- 235000013717 Houttuynia Nutrition 0.000 abstract 4
- 238000004061 bleaching Methods 0.000 abstract 1
- 230000000249 desinfective effect Effects 0.000 abstract 1
- 230000003204 osmotic effect Effects 0.000 abstract 1
- 238000001556 precipitation Methods 0.000 abstract 1
- 210000001508 eye Anatomy 0.000 description 29
- 238000011282 treatment Methods 0.000 description 22
- 238000012360 testing method Methods 0.000 description 11
- 201000010099 disease Diseases 0.000 description 10
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 10
- 241000283973 Oryctolagus cuniculus Species 0.000 description 9
- 210000003734 kidney Anatomy 0.000 description 8
- 210000004185 liver Anatomy 0.000 description 7
- 229910052799 carbon Inorganic materials 0.000 description 6
- 230000007812 deficiency Effects 0.000 description 6
- 229940079593 drug Drugs 0.000 description 6
- 206010011224 Cough Diseases 0.000 description 3
- QBDCOUHKEVYWLO-UHFFFAOYSA-N Decanoyl acetaldehyde Chemical compound CCCCCCCCCC(=O)CC=O QBDCOUHKEVYWLO-UHFFFAOYSA-N 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 3
- 208000007271 Substance Withdrawal Syndrome Diseases 0.000 description 3
- 239000008280 blood Substances 0.000 description 3
- 210000001124 body fluid Anatomy 0.000 description 3
- 239000010839 body fluid Substances 0.000 description 3
- 238000006243 chemical reaction Methods 0.000 description 3
- 210000004087 cornea Anatomy 0.000 description 3
- 238000000703 high-speed centrifugation Methods 0.000 description 3
- 238000001802 infusion Methods 0.000 description 3
- 210000000554 iris Anatomy 0.000 description 3
- 210000004072 lung Anatomy 0.000 description 3
- 210000000952 spleen Anatomy 0.000 description 3
- 208000011580 syndromic disease Diseases 0.000 description 3
- 231100001274 therapeutic index Toxicity 0.000 description 3
- XLYLQUQHYUOPIW-UHFFFAOYSA-N 3-oxo-Tetradecanal Chemical compound CCCCCCCCCCCC(=O)CC=O XLYLQUQHYUOPIW-UHFFFAOYSA-N 0.000 description 2
- 206010007247 Carbuncle Diseases 0.000 description 2
- 206010051625 Conjunctival hyperaemia Diseases 0.000 description 2
- 206010061218 Inflammation Diseases 0.000 description 2
- 208000004880 Polyuria Diseases 0.000 description 2
- 208000033809 Suppuration Diseases 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- 239000000607 artificial tear Substances 0.000 description 2
- UAHWPYUMFXYFJY-UHFFFAOYSA-N beta-myrcene Chemical compound CC(C)=CCCC(=C)C=C UAHWPYUMFXYFJY-UHFFFAOYSA-N 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 208000013116 chronic cough Diseases 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 210000000795 conjunctiva Anatomy 0.000 description 2
- 230000035619 diuresis Effects 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 239000003172 expectorant agent Substances 0.000 description 2
- 230000003419 expectorant effect Effects 0.000 description 2
- 230000036039 immunity Effects 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 230000004054 inflammatory process Effects 0.000 description 2
- 239000002085 irritant Substances 0.000 description 2
- 231100000021 irritant Toxicity 0.000 description 2
- 230000007794 irritation Effects 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 235000016709 nutrition Nutrition 0.000 description 2
- 230000035764 nutrition Effects 0.000 description 2
- 230000008520 organization Effects 0.000 description 2
- 231100000915 pathological change Toxicity 0.000 description 2
- 230000036285 pathological change Effects 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 230000000699 topical effect Effects 0.000 description 2
- 210000001835 viscera Anatomy 0.000 description 2
- 206010010741 Conjunctivitis Diseases 0.000 description 1
- 208000003556 Dry Eye Syndromes Diseases 0.000 description 1
- 206010013774 Dry eye Diseases 0.000 description 1
- 208000000059 Dyspnea Diseases 0.000 description 1
- 206010013975 Dyspnoeas Diseases 0.000 description 1
- 206010015946 Eye irritation Diseases 0.000 description 1
- 208000005100 Herpetic Keratitis Diseases 0.000 description 1
- 208000002720 Malnutrition Diseases 0.000 description 1
- 241000475481 Nebula Species 0.000 description 1
- 206010073938 Ophthalmic herpes simplex Diseases 0.000 description 1
- 206010034960 Photophobia Diseases 0.000 description 1
- LUJAXSNNYBCFEE-UHFFFAOYSA-N Quercetin 3,7-dimethyl ether Natural products C=1C(OC)=CC(O)=C(C(C=2OC)=O)C=1OC=2C1=CC=C(O)C(O)=C1 LUJAXSNNYBCFEE-UHFFFAOYSA-N 0.000 description 1
- PUTDIROJWHRSJW-UHFFFAOYSA-N Quercitrin Natural products CC1OC(Oc2cc(cc(O)c2O)C3=CC(=O)c4c(O)cc(O)cc4O3)C(O)C(O)C1O PUTDIROJWHRSJW-UHFFFAOYSA-N 0.000 description 1
- DWAQJAXMDSEUJJ-UHFFFAOYSA-M Sodium bisulfite Chemical compound [Na+].OS([O-])=O DWAQJAXMDSEUJJ-UHFFFAOYSA-M 0.000 description 1
- 241000191967 Staphylococcus aureus Species 0.000 description 1
- 241000193998 Streptococcus pneumoniae Species 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 208000031971 Yin Deficiency Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- OXGUCUVFOIWWQJ-XIMSSLRFSA-N acanthophorin B Natural products O[C@H]1[C@H](O)[C@H](O)[C@H](C)O[C@H]1OC1=C(C=2C=C(O)C(O)=CC=2)OC2=CC(O)=CC(O)=C2C1=O OXGUCUVFOIWWQJ-XIMSSLRFSA-N 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 239000003732 agents acting on the eye Substances 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 238000003915 air pollution Methods 0.000 description 1
- 229930013930 alkaloid Natural products 0.000 description 1
- 150000003797 alkaloid derivatives Chemical class 0.000 description 1
- VYBREYKSZAROCT-UHFFFAOYSA-N alpha-myrcene Natural products CC(=C)CCCC(=C)C=C VYBREYKSZAROCT-UHFFFAOYSA-N 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- PYKYMHQGRFAEBM-UHFFFAOYSA-N anthraquinone Natural products CCC(=O)c1c(O)c2C(=O)C3C(C=CC=C3O)C(=O)c2cc1CC(=O)OC PYKYMHQGRFAEBM-UHFFFAOYSA-N 0.000 description 1
- 150000004056 anthraquinones Chemical class 0.000 description 1
- 230000003266 anti-allergic effect Effects 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000000845 anti-microbial effect Effects 0.000 description 1
- 230000002421 anti-septic effect Effects 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- 230000002155 anti-virotic effect Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 210000005252 bulbus oculi Anatomy 0.000 description 1
- 229940097217 cardiac glycoside Drugs 0.000 description 1
- 239000002368 cardiac glycoside Substances 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 235000009508 confectionery Nutrition 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000002354 daily effect Effects 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000006735 deficit Effects 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 208000017574 dry cough Diseases 0.000 description 1
- 238000004043 dyeing Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 230000029142 excretion Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 208000030533 eye disease Diseases 0.000 description 1
- 231100000013 eye irritation Toxicity 0.000 description 1
- 210000000720 eyelash Anatomy 0.000 description 1
- 210000000744 eyelid Anatomy 0.000 description 1
- GNBHRKFJIUUOQI-UHFFFAOYSA-N fluorescein Chemical compound O1C(=O)C2=CC=CC=C2C21C1=CC=C(O)C=C1OC1=CC(O)=CC=C21 GNBHRKFJIUUOQI-UHFFFAOYSA-N 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000000745 gonadal hormone Substances 0.000 description 1
- 210000004209 hair Anatomy 0.000 description 1
- 235000008216 herbs Nutrition 0.000 description 1
- 208000008025 hordeolum Diseases 0.000 description 1
- 230000036737 immune function Effects 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000002458 infectious effect Effects 0.000 description 1
- 206010022000 influenza Diseases 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- -1 lauryl aldehydes Chemical class 0.000 description 1
- 210000000265 leukocyte Anatomy 0.000 description 1
- 229920005610 lignin Polymers 0.000 description 1
- 201000003453 lung abscess Diseases 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 230000001071 malnutrition Effects 0.000 description 1
- 235000000824 malnutrition Nutrition 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 238000011587 new zealand white rabbit Methods 0.000 description 1
- 231100000957 no side effect Toxicity 0.000 description 1
- 235000015097 nutrients Nutrition 0.000 description 1
- 208000015380 nutritional deficiency disease Diseases 0.000 description 1
- 229940023490 ophthalmic product Drugs 0.000 description 1
- LPMXVESGRSUGHW-HBYQJFLCSA-N ouabain Chemical compound O[C@@H]1[C@H](O)[C@@H](O)[C@H](C)O[C@H]1O[C@@H]1C[C@@]2(O)CC[C@H]3[C@@]4(O)CC[C@H](C=5COC(=O)C=5)[C@@]4(C)C[C@@H](O)[C@@H]3[C@@]2(CO)[C@H](O)C1 LPMXVESGRSUGHW-HBYQJFLCSA-N 0.000 description 1
- 230000000242 pagocytic effect Effects 0.000 description 1
- 230000008506 pathogenesis Effects 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 230000003285 pharmacodynamic effect Effects 0.000 description 1
- 231100000614 poison Toxicity 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 208000037920 primary disease Diseases 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000001047 pyretic effect Effects 0.000 description 1
- OEKUVLQNKPXSOY-UHFFFAOYSA-N quercetin 3-O-beta-D-glucopyranosyl(1->3)-alpha-L-rhamnopyranosyl(1->6)-beta-d-galactopyranoside Natural products OC1C(O)C(C(O)C)OC1OC1=C(C=2C=C(O)C(O)=CC=2)OC2=CC(O)=CC(O)=C2C1=O OEKUVLQNKPXSOY-UHFFFAOYSA-N 0.000 description 1
- QPHXPNUXTNHJOF-UHFFFAOYSA-N quercetin-7-O-beta-L-rhamnopyranoside Natural products OC1C(O)C(O)C(C)OC1OC1=CC(O)=C2C(=O)C(O)=C(C=3C=C(O)C(O)=CC=3)OC2=C1 QPHXPNUXTNHJOF-UHFFFAOYSA-N 0.000 description 1
- OXGUCUVFOIWWQJ-HQBVPOQASA-N quercitrin Chemical compound O[C@@H]1[C@H](O)[C@@H](O)[C@H](C)O[C@H]1OC1=C(C=2C=C(O)C(O)=CC=2)OC2=CC(O)=CC(O)=C2C1=O OXGUCUVFOIWWQJ-HQBVPOQASA-N 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 230000003716 rejuvenation Effects 0.000 description 1
- 230000033764 rhythmic process Effects 0.000 description 1
- 230000001568 sexual effect Effects 0.000 description 1
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 229930002534 steroid glycoside Natural products 0.000 description 1
- 229930002600 steroidal saponin Natural products 0.000 description 1
- 230000004936 stimulating effect Effects 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000004575 stone Substances 0.000 description 1
- 238000005728 strengthening Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000035922 thirst Effects 0.000 description 1
- 230000017423 tissue regeneration Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 239000003440 toxic substance Substances 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 150000003722 vitamin derivatives Chemical class 0.000 description 1
- 239000000341 volatile oil Substances 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
Landscapes
- Medicines Containing Plant Substances (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
本发明公开了一种治疗干眼症的中药滴眼液,所述中药滴眼液由以下组分按照所示重量份比例范围配制:黄精10-50份,鱼腥草100-200份。本发明还公开了治疗干眼症的中药滴眼液的制备方法,先将黄精加热回流提取、减压浓缩、醇沉、脱色、抽滤后获得黄精溶液,再将鱼腥草蒸馏,得鱼腥草芳香水,再将两混合,调节PH、渗透压等后获得淡黄色澄明液体,再消毒装瓶。本发明的中药滴眼液中的黄精和鱼腥草有抗病毒、抗炎等作用,而且黄精中所含的黄精多糖有增加泪液分泌、促进眼表愈合的作用,将二者结合在改善患者主观症状及增加泪液分泌等方面具有较好的疗效,并且其制备方法简单,价格低,使用方便,易被患者接受。
Description
技术领域
本发明涉及中医药技术领域,具体涉及一种治疗干眼症的中药滴眼液及其制备方法。
背景技术
干眼症,又称角结膜干燥或泪液功能不全综合征,是指泪液质和量异常或动力学异常导致的泪膜稳定性下降,并伴有眼部不适,导致眼表组织病变为特征的疾病总称,是目前最常见的眼科疾病之一。该病以中老年人多见,并严重影响患者的生活质量。随着人类生活节奏的加快,气候干燥、空气污染、人口老龄化等问题日益严重,高科技产品的普及和隐形眼镜的广泛应用,干眼症的发病率在眼科门诊的患病人群中逐年上升,并有逐渐年轻化的趋势。
西医认为足够质量的泪液、正常成分的泪膜和规则的眨眼是构成湿润眼表的先决条件,从而维持正常的视觉功能,使眼表免于干燥。泪膜和眼表组织构成了一个复杂和稳定的系统,如果被眼表炎症、性激素失衡和神经机能障碍等多种因素破坏将导致干眼症的发生。西医治疗方法较多,主要采用人工泪液、佩戴湿房镜和绷带角膜接触镜、抗炎及免疫制剂等,局部治疗的方法虽能在一定程度上减轻患者的主观症状,但是作用时间不长,一旦停药容易复发,很难从根本上解决问题。有些人工泪液因含防腐剂、稳定剂和其他添加剂,长期使用会造成眼表的损害。
中医认为干眼症病机关键在肝肾不足、津液亏虚、目窍失养。《素问·宣明五气论》曰:“五脏化液,肝为泪”。泪由肝精肝血所化,肝开窍于目,泪从目出,泪液的生成与排泄与肝脏有密切关系。《素问·逆调论》曰:“肾者水藏,主津液”。肾主水,肾脏对体内水液的代谢与分布起着重要作用。外感疫邪停留或余邪未尽,日久伤阴耗血,致肝血不足,肾精亏虚,目失濡养;劳瞻竭视、过虑多思、房劳太过均可致肝肾亏虚,精血暗耗,目失濡泽;或劳作太过,体虚气衰,气机衰惫,肝肾之阴精亏虚,不能敷布精微,充泽五脏,上荣于目而致目失濡养。故本病治宜生津润目。
干眼症发病的最关键因素是炎症,目前常规治法是泪液替代法,只能缓解症状,不能针对病因作出根本的治疗;中国医学历史悠久,中医药治疗干眼症具有自身优势,能改善眼表症状,提高机体免疫力,并对患者全身有一定调节作用,中药药源丰富、价格低廉、毒副作用小,但对于干眼症局部治疗的研究比较有限。
发明内容
本发明的目的是提供一种无毒副作用的治疗干眼症的纯中药制剂的滴眼液及其制备方法。
本发明的中药滴眼液由以下组分按照所示重量份比例范围配制:黄精10-50份,鱼腥草100-200份。
本发明的中药滴眼液的制备方法包括以下步骤:
(1)黄精10-50份加水浸泡1h,回流提取2次,第一次10倍量水提取2.5h,第二次8倍量水提取2h,滤过,合并两次滤液,于80℃减压浓缩至相对密度1.08~1.10,浓缩液放至室温,搅拌下加入乙醇使含醇量达到80%,静置24h以上,滤过,取沉淀物,加热溶解,加入适量蒸馏水至100ml,加0.2%(g/ml)一级针用活性炭,煮沸30min,放冷,4℃冷藏静置24小时;
(2)鱼腥草100-200份加10倍量水,蒸馏提取,收集6倍量芳香水,备用;
(3)将静置的黄精药水抽滤,再加入芳香水及氯化钠8.0-8.5g、羟苯乙酯0.1-0.2g,搅匀,加蒸馏水至1000ml,用10%氢氧化钠溶液调pH至7.0,混匀,过0.45μm微孔薄膜,灌封于容器中,105℃灭菌30分钟,备用;
(4)无菌分装于经灭菌的2ml眼药水瓶中,即得。
各原料药药理如下:
黄精甘,平,归脾、肺、肾经。黄精的功效主要是补气养阴,健脾,润发,益肾。主治脾胃虚弱,阴虚肺燥,干咳少痰,肺肾阴虚,劳嗽久咳,内热消渴,肾精亏虚等症。药理学研究证明,黄精具有免疫激发、增强免疫、延缓衰老、抗病毒、抗炎等作用,并有增加泪液分泌、促进眼表愈合的作用。主要含有多糖、甾体皂苷、蒽醌类化合物、生物碱、强心苷、木质素、维生素和多种氨基酸等化合物。其中黄精多糖是其主要药效活性物质。有研究报道黄精多糖对实验性干眼症具有明显疗效。有研究者发现黄精多糖有明显的滋阴作用。
鱼腥草味辛性微寒,归肺经,主要功效有清热解毒、消痈排脓、利尿通淋,主治肺痈吐脓、痰热喘咳、热痢、热淋、痈肿疮毒等病症。现代药理试验证明鱼腥草素具有抗菌、抗病毒、抗炎、抗过敏、抗肿瘤、利尿作用。鱼腥草中含有癸酰乙醛、月桂烯和月桂醛等多种挥发油成分,其中癸酰乙醛是主要的抗菌成分,对金黄色葡萄球菌、肺炎双球菌和流感杆菌等具有明显的抑制作用;含有的槲皮甙等成分则具有明显的抗病毒作用。此外,鱼腥草还具有增强免疫功能、增加白细胞吞噬能力和促进组织再生等方面的作用,而且鱼腥草毒性很低。鱼腥草已被制成不同剂型广泛用于睑腺炎、急性卡他性结膜炎、单疱病毒性角膜炎等感染性眼病的治疗,亦有关于治疗干眼的报道。
本发明的中药滴眼液中的黄精和鱼腥草有抗病毒、抗炎等作用,而且黄精中所含的黄精多糖有增加泪液分泌、促进眼表愈合的作用,将二者结合在改善患者主观症状及增加泪液分泌等方面具有较好的疗效。滴眼液是眼科给药系统中最常用的的剂型,其制备方法简单,价格低,使用方便,易被患者接受。
具体实施方式
以下通过具体实施方式的描述对本发明作进一步说明,但这并非是对本发明的限制,本领域技术人员根据本发明的基本思想,可以做出各种修改或改进,但是只要不脱离本发明的基本思想,均在本发明的范围之内。
实施例1
(1)黄精药10g加水浸泡1h,回流提取2次,第一次10倍量水提取2.5h,第二次8倍量水提取2h,滤过,合并两次滤液,于80℃减压浓缩至相对密度约为1.08~1.10(60℃热测)。浓缩液放至室温,搅拌下加入乙醇使含醇量达到80%,静置24h以上,滤过,取沉淀物,加热溶解,加入适量蒸馏水(至100ml),加0.2%(g/ml)一级针用活性炭(活性炭使用前应在150℃烘箱中干燥4h进行活化),煮沸30min,放冷,4℃冷藏静置24小时;
(2)鱼腥草100g加10倍量水,蒸馏提取,收集6倍量芳香水,备用;
(3)将静置的黄精药水抽滤,再加入芳香水及氯化钠8.0g、羟苯乙酯0.1g(预先用少量水加热溶解),搅匀,加蒸馏水至1000ml,用10%氢氧化钠溶液调pH至7.0,混匀,0.45μm微孔薄膜(或高速离心),灌封于500ml输液瓶中,105℃灭菌30分钟,备用;
(4)无菌分装于经灭菌的2ml眼药水瓶中,即得。
实施例2
(1)黄精药20g加水浸泡1h,回流提取2次,第一次10倍量水提取2.5h,第二次8倍量水提取2h,滤过,合并两次滤液,于80℃减压浓缩至相对密度约为1.08~1.10(60℃热测)。浓缩液放至室温,搅拌下加入乙醇使含醇量达到80%,静置24h以上,滤过,取沉淀物,加热溶解,加入适量蒸馏水(至200ml),加0.2%(g/ml)一级针用活性炭(活性炭使用前应在150℃烘箱中干燥4h进行活化),煮沸30min,放冷,4℃冷藏静置24小时;
(2)鱼腥草150g加10倍量水,蒸馏提取,收集6倍量芳香水,备用;
(3)将静置的黄精药水抽滤,再加入芳香水及氯化钠8.5g、羟苯乙酯0.15g(预先用少量水加热溶解),搅匀,加蒸馏水至1000ml,用10%氢氧化钠溶液调pH至7.0,混匀,0.45μm微孔薄膜(或高速离心),灌封于500ml输液瓶中,105℃灭菌30分钟,备用;
(4)无菌分装于经灭菌的2ml眼药水瓶中,即得。
实施例3
(1)黄精药50g加水浸泡1h,回流提取2次,第一次10倍量水提取2.5h,第二次8倍量水提取2h,滤过,合并两次滤液,于80℃减压浓缩至相对密度约为1.08~1.10(60℃热测)。浓缩液放至室温,搅拌下加入乙醇使含醇量达到80%,静置24h以上,滤过,取沉淀物,加热溶解,加入适量蒸馏水(至400ml),加0.2%(g/ml)一级针用活性炭(活性炭使用前应在150℃烘箱中干燥4h进行活化),煮沸30min,放冷,4℃冷藏静置24小时;
(2)鱼腥草200g加10倍量水,蒸馏提取,收集6倍量芳香水,备用;
(3)将静置的黄精药水抽滤,再加入芳香水及氯化钠8.5g、羟苯乙酯0.2g(预先用少量水加热溶解),搅匀,加蒸馏水至1000ml,用10%氢氧化钠溶液调pH至7.0,混匀,0.45μm微孔薄膜(或高速离心),灌封于500ml输液瓶中,105℃灭菌30分钟,备用;
(4)无菌分装于经灭菌的2ml眼药水瓶中,即得。
采用实施例1制得的中药滴眼液做动物刺激性试验和临床试验。
1、动物刺激性试验
(1)实验方法
采用动物自身左右眼对照法。取12只体重为2.0-2.5Kg的新西兰白兔,雌雄不拘(雌兔无孕),进行编号;给药前检查每只家兔结膜、角膜及虹膜的情况,如有病变者剔除不用;每只家兔右眼滴本发明的中药滴眼液0.1ml,左眼滴0.1ml生理盐水;给药后,使家兔被动闭眼10s,使药物与局部充分接触,每日给药3次;连续给药2周。每天给药前及最后一次给药后6h,24h,48h,72h、4d及7d观察家兔结膜、角膜及虹膜的情况。
(2)刺激性评价标准无刺激性0-3.9分,轻度刺激性4-8.9分,中度刺激性9-12.9分,强度刺激性13-16分。
(3)结果
在给药期间,12只家兔中4只右眼出现结膜充血呈鲜红色,其中3只右眼有少量分泌物,1只右眼分泌物使眼睑和睫毛潮湿或粘着,角膜无混浊,虹膜正常,左眼未见明显异常;根据评分标准右眼共得分9分,平均值0.75分。停止给药后家兔眼表反应见表1。结膜充血在停药后3天消失,分泌物在停药后3天也基本消失。计算出各观察时间的家兔眼刺激反应的综合平均分值分别为0.75(6h)、0.59(24h)、O.26(48h)、0(72h)、0(7d)。
(4)结论 本发明的中药滴眼液对家兔眼睛无刺激性。
表1本发明的中药滴眼液对家兔眼刺激反应
2、临床试验
(1)患者来源 2014年6月至2014年12月湖南中医药大学第一附属医院眼科门诊,共100例,其中,男33例、女67例;年龄20~72岁之间,病程2周~3年。共为2组,分别为A组50例,B组50例。
(2)诊断标准 参照国家中医药管理局颁布的《中医病症诊断疗效标准》。临床表现为眼睛干涩、磨痛、畏光,可伴有口鼻干燥;目珠干燥失却莹润光泽,白睛微红,黑睛生翳,眵多黏稠;泪液分泌试验,多次Schirmer法少于10min/5min或角膜荧光素染色试验阳性。
(3)治疗方法:
A组给予本发明的中药滴眼液,1滴/次,3次/日,连续给药4周。
B组给予新泪然滴眼液,1滴/次,3次/日,连续给药4周。
(4)疗效判定:
①临床痊愈:用药一个疗程后,疗效指数≥90%,泪膜破裂时间恢复正常。②有效:用药一个疗程后,泪液分泌量增加、泪膜破裂时间延长、角膜染色改善三项中满足一项或一项以上者,疗效指数≥30%。③无效:用药一个疗程后,未达到上述标准者。
其中疗效指数=(治疗前症状积分-治疗后症状积分)/治疗前症状积分x 100%。
(5)结果
①经过4周连续用药后,两组临床疗效见表2。
表2临床疗效比较
注:与B组比较P<0.05。
从表2可以看出,采用本发明的中药滴眼液在治疗干眼症方面具有显著的疗效。
②两组治疗后泪液分泌试验和BUT比较见表3。
A组、B组治疗后泪液分泌试验和BUT与治疗前比较差异均有统计学意义(P<O.05),即治疗后各检测指标优均于治疗前,其中A组的泪液分泌试验、泪膜破裂时间改善情况明显优于治疗前。
表3两组治疗前后泪液分泌试验和BUT比较(±S)
注:与同组治疗前比较*P<0.01,**P<0.05。
从表3可以看出,采用本发明的中药滴眼液在改善泪液分泌试验、泪膜破裂时间方面具有明显效果。
显然,本发明的上述实施例仅仅是为清楚地说明本发明所作的举例,而并非是对本发明的实施方式的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无法对所有的实施方式予以穷举。凡是属于本发明的技术方案所引伸出的显而易见的变化或变动仍处于本发明的保护范围之列。
Claims (2)
1.一种治疗干眼症的中药滴眼液,其特征在于:所述中药滴眼液由以下组分按照所示重量份比例范围配制:黄精10-50份,鱼腥草100-200份。
2.根据权利要求1所述的中药滴眼液的制备方法,其特征在于包括以下步骤:
(1)黄精10-50份加水浸泡1h,回流提取2次,第一次10倍量水提取2.5h,第二次8倍量水提取2h,滤过,合并两次滤液,于80℃减压浓缩至相对密度1.08~1.10,浓缩液放至室温,搅拌下加入乙醇使含醇量达到80%,静置24h以上,滤过,取沉淀物,加热溶解,加入适量蒸馏水至100ml,加0.2%(g/ml)一级针用活性炭,煮沸30min,放冷,4℃冷藏静置24小时;
(2)鱼腥草100-200份加10倍量水,蒸馏提取,收集6倍量芳香水,备用;
(3)将静置的黄精药水抽滤,再加入芳香水及氯化钠8.0-8.5g、羟苯乙酯0.1-0.2g,搅匀,加蒸馏水至1000ml,用10%氢氧化钠溶液调pH至7.0,混匀,过0.45μm微孔薄膜,灌封于容器中,105℃灭菌30分钟,备用;
(4)无菌分装于经灭菌的2ml眼药水瓶中,即得。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201510190375.3A CN104857287B (zh) | 2015-04-21 | 2015-04-21 | 一种治疗干眼症的中药滴眼液及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201510190375.3A CN104857287B (zh) | 2015-04-21 | 2015-04-21 | 一种治疗干眼症的中药滴眼液及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN104857287A true CN104857287A (zh) | 2015-08-26 |
CN104857287B CN104857287B (zh) | 2021-05-11 |
Family
ID=53903750
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201510190375.3A Expired - Fee Related CN104857287B (zh) | 2015-04-21 | 2015-04-21 | 一种治疗干眼症的中药滴眼液及其制备方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN104857287B (zh) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110559391A (zh) * | 2019-10-12 | 2019-12-13 | 成都中医药大学 | 一种含有黄精多糖的眼贴 |
CN114028498A (zh) * | 2021-12-10 | 2022-02-11 | 上海泽充生物技术有限公司 | 一种干眼症患者专用眼部清洗液及其制备方法 |
CN114452254A (zh) * | 2022-03-15 | 2022-05-10 | 苏州眼雾医疗科技有限公司 | 一种黄精-鱼腥草滴眼液制备方法 |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20130303557A1 (en) * | 2007-07-11 | 2013-11-14 | Pfizer Inc. | Pharmaceutical compositions and methods of treating dry eye disorders |
-
2015
- 2015-04-21 CN CN201510190375.3A patent/CN104857287B/zh not_active Expired - Fee Related
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20130303557A1 (en) * | 2007-07-11 | 2013-11-14 | Pfizer Inc. | Pharmaceutical compositions and methods of treating dry eye disorders |
Non-Patent Citations (5)
Title |
---|
刘素英: "鱼腥草雾化治疗干眼症68例", 《河南中医学院学报》 * |
孙化萍等: "0.8%黄精多糖滴眼液对干眼症的实验研究", 《中国中医眼科杂志》 * |
李娟娟等: "黄精、枸杞总多糖的提取工艺优选", 《中国医院药学杂志》 * |
杨磊: "鱼腥草滴眼液的制备及临床应用", 《中国药业》 * |
王冬梅等: "鱼精滴眼液的制备及治疗单纯疱疹性角膜炎的临床观察", 《陕西中医学院学报》 * |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110559391A (zh) * | 2019-10-12 | 2019-12-13 | 成都中医药大学 | 一种含有黄精多糖的眼贴 |
CN110559391B (zh) * | 2019-10-12 | 2021-12-21 | 成都中医药大学 | 一种含有黄精多糖的眼贴 |
CN114028498A (zh) * | 2021-12-10 | 2022-02-11 | 上海泽充生物技术有限公司 | 一种干眼症患者专用眼部清洗液及其制备方法 |
CN114452254A (zh) * | 2022-03-15 | 2022-05-10 | 苏州眼雾医疗科技有限公司 | 一种黄精-鱼腥草滴眼液制备方法 |
Also Published As
Publication number | Publication date |
---|---|
CN104857287B (zh) | 2021-05-11 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN101843662B (zh) | 一种预防和治疗视疲劳的中药组合物 | |
CN101716214B (zh) | 含有蒲公英提取物的药物组合物及其制药用途和制备方法 | |
CN103860625A (zh) | 越橘提取物眼用制剂及其制备方法和用途 | |
CN102362924B (zh) | 一种治疗眼科疾病的药物组合物及其制备方法 | |
CN103110810A (zh) | 治疗干眼的中药制剂 | |
CN104857287A (zh) | 一种治疗干眼症的中药滴眼液及其制备方法 | |
CN105106318B (zh) | 一种治疗干眼症的中药组合物及其制备方法 | |
CN103393915B (zh) | 一种治疗干眼症的中药制剂 | |
CN104971304A (zh) | 一种用于治疗干眼症的药物 | |
CN105560891A (zh) | 一种含有冰片的中药滴眼剂及其制备方法 | |
CN104367832A (zh) | 一种治疗干眼症的复方石斛滴眼液及其制备方法 | |
CN106620278A (zh) | 一种抑菌中药眼药水及其制备方法和应用 | |
CN105326954B (zh) | 一种治疗睑缘炎的中药组合物及其制备方法 | |
CN112353883A (zh) | 治疗近视飞蚊症的眼药水的制备方法 | |
CN105902686A (zh) | 一种含有纳米碳晶的原位凝胶眼药水及其制备方法 | |
CN102940753B (zh) | 一种治疗青光眼的药丸及制备方法 | |
CN102920911B (zh) | 用于治疗角结膜干燥症的中药及其制备方法 | |
CN107648397B (zh) | 一种用于治疗肝肾阴虚型的中药组合物及其制备方法和应用 | |
CN105726983A (zh) | 一种治疗干眼症的复方石斛滴眼液及其制备方法 | |
CN100457167C (zh) | 治疗鼻黏膜糜烂及鼻衄的外用中药制剂及其制备方法 | |
CN105943718B (zh) | 一种沉香复方中药组合物及其制备方法、应用 | |
CN104352794A (zh) | 一种治疗肺阴不足型干眼症的中药制剂 | |
CN109200207A (zh) | 一种治疗干眼症的中药组合物 | |
CN107137603A (zh) | 一种缓解视疲劳的中药组合物、制剂及其制备方法 | |
CN103550357B (zh) | 一种防治飞蚊症眼药水及其制备方法和用途 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
GR01 | Patent grant | ||
GR01 | Patent grant | ||
CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20210511 |
|
CF01 | Termination of patent right due to non-payment of annual fee |