CN102198211B - Traditional Chinese medicine composition for treating neurasthenia, and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating neurasthenia, and preparation method thereof Download PDFInfo
- Publication number
- CN102198211B CN102198211B CN201110121752XA CN201110121752A CN102198211B CN 102198211 B CN102198211 B CN 102198211B CN 201110121752X A CN201110121752X A CN 201110121752XA CN 201110121752 A CN201110121752 A CN 201110121752A CN 102198211 B CN102198211 B CN 102198211B
- Authority
- CN
- China
- Prior art keywords
- time
- add
- hours
- amount
- mice
- 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.)
- Active
Links
- 239000003814 drug Substances 0.000 title claims abstract description 62
- 238000002360 preparation method Methods 0.000 title claims abstract description 15
- 239000000203 mixture Substances 0.000 title claims abstract description 14
- 208000007443 Neurasthenia Diseases 0.000 title claims abstract description 10
- 206010003549 asthenia Diseases 0.000 title claims abstract description 10
- 241000208966 Polygala Species 0.000 claims abstract description 10
- 241000405911 Rehmannia glutinosa Species 0.000 claims abstract description 10
- 241000270708 Testudinidae Species 0.000 claims abstract description 8
- 239000002775 capsule Substances 0.000 claims description 50
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 28
- 239000008187 granular material Substances 0.000 claims description 24
- 210000003056 antler Anatomy 0.000 claims description 21
- 239000000706 filtrate Substances 0.000 claims description 21
- 239000000843 powder Substances 0.000 claims description 21
- 238000010992 reflux Methods 0.000 claims description 21
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 19
- 241001247821 Ziziphus Species 0.000 claims description 18
- 239000000341 volatile oil Substances 0.000 claims description 18
- 241000756042 Polygonatum Species 0.000 claims description 9
- 238000000605 extraction Methods 0.000 claims description 8
- 235000019476 oil-water mixture Nutrition 0.000 claims description 8
- 239000007921 spray Substances 0.000 claims description 8
- 235000002789 Panax ginseng Nutrition 0.000 claims description 7
- 235000008599 Poria cocos Nutrition 0.000 claims description 7
- 244000197580 Poria cocos Species 0.000 claims description 7
- 239000012141 concentrate Substances 0.000 claims description 7
- 239000006071 cream Substances 0.000 claims description 7
- -1 dry at 65-75°C Substances 0.000 claims description 7
- 239000000796 flavoring agent Substances 0.000 claims description 7
- 235000019634 flavors Nutrition 0.000 claims description 7
- 229920002472 Starch Polymers 0.000 claims description 5
- 239000008107 starch Substances 0.000 claims description 5
- 235000019698 starch Nutrition 0.000 claims description 5
- 239000002994 raw material Substances 0.000 claims 1
- 230000000694 effects Effects 0.000 abstract description 31
- 230000003285 pharmacodynamic effect Effects 0.000 abstract description 6
- 238000012360 testing method Methods 0.000 abstract description 5
- 231100000331 toxic Toxicity 0.000 abstract description 5
- 230000002588 toxic effect Effects 0.000 abstract description 5
- 206010027175 memory impairment Diseases 0.000 abstract description 4
- 244000248557 Ophiopogon japonicus Species 0.000 abstract description 3
- 238000000034 method Methods 0.000 abstract description 3
- 206010019233 Headaches Diseases 0.000 abstract description 2
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 abstract description 2
- 208000009205 Tinnitus Diseases 0.000 abstract description 2
- 240000008866 Ziziphus nummularia Species 0.000 abstract description 2
- 208000002173 dizziness Diseases 0.000 abstract description 2
- 231100000869 headache Toxicity 0.000 abstract description 2
- 206010022437 insomnia Diseases 0.000 abstract description 2
- 231100000886 tinnitus Toxicity 0.000 abstract description 2
- 230000001914 calming effect Effects 0.000 abstract 2
- 208000005189 Embolism Diseases 0.000 abstract 1
- 240000006079 Schisandra chinensis Species 0.000 abstract 1
- 235000008422 Schisandra chinensis Nutrition 0.000 abstract 1
- 244000067505 Xanthium strumarium Species 0.000 abstract 1
- 210000005036 nerve Anatomy 0.000 abstract 1
- 238000005728 strengthening Methods 0.000 abstract 1
- 229940126680 traditional chinese medicines Drugs 0.000 abstract 1
- 239000003826 tablet Substances 0.000 description 58
- 229940079593 drug Drugs 0.000 description 48
- 241000699670 Mus sp. Species 0.000 description 45
- 238000002474 experimental method Methods 0.000 description 18
- 238000012449 Kunming mouse Methods 0.000 description 13
- 238000005303 weighing Methods 0.000 description 13
- 241001465754 Metazoa Species 0.000 description 11
- 206010021143 Hypoxia Diseases 0.000 description 9
- 241000699666 Mus <mouse, genus> Species 0.000 description 8
- 230000007954 hypoxia Effects 0.000 description 7
- 239000000463 material Substances 0.000 description 7
- 230000008925 spontaneous activity Effects 0.000 description 7
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 6
- 230000002929 anti-fatigue Effects 0.000 description 6
- 239000012153 distilled water Substances 0.000 description 6
- 230000004622 sleep time Effects 0.000 description 5
- 206010010904 Convulsion Diseases 0.000 description 4
- 230000001773 anti-convulsant effect Effects 0.000 description 4
- 230000036461 convulsion Effects 0.000 description 4
- 239000007924 injection Substances 0.000 description 4
- 238000002347 injection Methods 0.000 description 4
- 230000009182 swimming Effects 0.000 description 4
- PCGVPMHGSJFFTI-ZEYGOCRCSA-N (4ar,5as,8ar,13as,15as,15br)-4a,5,5a,7,8,13a,15,15a,15b,16-decahydro-2h-4,6-methanoindolo[3,2,1-ij]oxepino[2,3,4-de]pyrrolo[2,3-h]quinoline-14-one;nitric acid Chemical compound O[N+]([O-])=O.O([C@H]1CC(N([C@H]2[C@H]1[C@H]1C3)C=4C5=CC=CC=4)=O)CC=C1CN1[C@@H]3[C@]25CC1 PCGVPMHGSJFFTI-ZEYGOCRCSA-N 0.000 description 3
- 229930000680 A04AD01 - Scopolamine Natural products 0.000 description 3
- STECJAGHUSJQJN-GAUPFVANSA-N Hyoscine Natural products C1([C@H](CO)C(=O)OC2C[C@@H]3N([C@H](C2)[C@@H]2[C@H]3O2)C)=CC=CC=C1 STECJAGHUSJQJN-GAUPFVANSA-N 0.000 description 3
- STECJAGHUSJQJN-UHFFFAOYSA-N N-Methyl-scopolamin Natural products C1C(C2C3O2)N(C)C3CC1OC(=O)C(CO)C1=CC=CC=C1 STECJAGHUSJQJN-UHFFFAOYSA-N 0.000 description 3
- 230000000147 hypnotic effect Effects 0.000 description 3
- 239000007928 intraperitoneal injection Substances 0.000 description 3
- 230000000144 pharmacologic effect Effects 0.000 description 3
- STECJAGHUSJQJN-FWXGHANASA-N scopolamine Chemical compound C1([C@@H](CO)C(=O)O[C@H]2C[C@@H]3N([C@H](C2)[C@@H]2[C@H]3O2)C)=CC=CC=C1 STECJAGHUSJQJN-FWXGHANASA-N 0.000 description 3
- 229960002646 scopolamine Drugs 0.000 description 3
- 229940059935 strychnine nitrate Drugs 0.000 description 3
- 239000004375 Dextrin Substances 0.000 description 2
- 229920001353 Dextrin Polymers 0.000 description 2
- QGMRQYFBGABWDR-UHFFFAOYSA-M Pentobarbital sodium Chemical compound [Na+].CCCC(C)C1(CC)C(=O)NC(=O)[N-]C1=O QGMRQYFBGABWDR-UHFFFAOYSA-M 0.000 description 2
- 206010039897 Sedation Diseases 0.000 description 2
- 230000002159 abnormal effect Effects 0.000 description 2
- 230000002082 anti-convulsion Effects 0.000 description 2
- 230000037396 body weight Effects 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 235000019425 dextrin Nutrition 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000001146 hypoxic effect Effects 0.000 description 2
- 231100001252 long-term toxicity Toxicity 0.000 description 2
- 230000006993 memory improvement Effects 0.000 description 2
- 229960002275 pentobarbital sodium Drugs 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 230000036280 sedation Effects 0.000 description 2
- 230000001624 sedative effect Effects 0.000 description 2
- HUAUNKAZQWMVFY-UHFFFAOYSA-M sodium;oxocalcium;hydroxide Chemical compound [OH-].[Na+].[Ca]=O HUAUNKAZQWMVFY-UHFFFAOYSA-M 0.000 description 2
- QMGVPVSNSZLJIA-FVWCLLPLSA-N strychnine Chemical compound O([C@H]1CC(N([C@H]2[C@H]1[C@H]1C3)C=4C5=CC=CC=4)=O)CC=C1CN1[C@@H]3[C@]25CC1 QMGVPVSNSZLJIA-FVWCLLPLSA-N 0.000 description 2
- 239000009396 suanzaoren Substances 0.000 description 2
- 230000004083 survival effect Effects 0.000 description 2
- 230000002936 tranquilizing effect Effects 0.000 description 2
- SFLSHLFXELFNJZ-QMMMGPOBSA-N (-)-norepinephrine Chemical compound NC[C@H](O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-QMMMGPOBSA-N 0.000 description 1
- 208000019901 Anxiety disease Diseases 0.000 description 1
- 206010012335 Dependence Diseases 0.000 description 1
- 206010059866 Drug resistance Diseases 0.000 description 1
- 206010022998 Irritability Diseases 0.000 description 1
- 208000019255 Menstrual disease Diseases 0.000 description 1
- 208000019914 Mental Fatigue Diseases 0.000 description 1
- 206010029333 Neurosis Diseases 0.000 description 1
- QMGVPVSNSZLJIA-UHFFFAOYSA-N Nux Vomica Natural products C1C2C3C4N(C=5C6=CC=CC=5)C(=O)CC3OCC=C2CN2C1C46CC2 QMGVPVSNSZLJIA-UHFFFAOYSA-N 0.000 description 1
- 206010033557 Palpitations Diseases 0.000 description 1
- 241001279009 Strychnos toxifera Species 0.000 description 1
- 208000012886 Vertigo Diseases 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 231100000215 acute (single dose) toxicity testing Toxicity 0.000 description 1
- 231100000403 acute toxicity Toxicity 0.000 description 1
- 230000007059 acute toxicity Effects 0.000 description 1
- 238000011047 acute toxicity test Methods 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 230000036506 anxiety Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 230000008034 disappearance Effects 0.000 description 1
- 239000008298 dragée Substances 0.000 description 1
- 230000000517 effect on sleep Effects 0.000 description 1
- 230000002996 emotional effect Effects 0.000 description 1
- 230000029142 excretion Effects 0.000 description 1
- 239000000284 extract Substances 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 235000012631 food intake Nutrition 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 210000002216 heart Anatomy 0.000 description 1
- 201000001881 impotence Diseases 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000011534 incubation Methods 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 208000015238 neurotic disease Diseases 0.000 description 1
- 229960002748 norepinephrine Drugs 0.000 description 1
- SFLSHLFXELFNJZ-UHFFFAOYSA-N norepinephrine Natural products NCC(O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-UHFFFAOYSA-N 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 206010036596 premature ejaculation Diseases 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000033764 rhythmic process Effects 0.000 description 1
- 230000028527 righting reflex Effects 0.000 description 1
- 239000000932 sedative agent Substances 0.000 description 1
- 230000004617 sleep duration Effects 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 210000000952 spleen Anatomy 0.000 description 1
- 238000007619 statistical method Methods 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 229960005453 strychnine Drugs 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000007940 sugar coated tablet Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 210000001541 thymus gland Anatomy 0.000 description 1
- 231100000027 toxicology Toxicity 0.000 description 1
- 229940099259 vaseline Drugs 0.000 description 1
- 231100000889 vertigo Toxicity 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
本发明涉及一种治疗神经衰弱的中药组合物及其制备方法,该中药组合物是由蒸黄精、淫羊藿、枸杞子、鹿茸、鹿角胶、鹿角霜、红参、去核大枣、茯苓、麦冬、龟甲、炒酸枣仁、五味子、制远志、熟地黄、苍耳子共十六味中药制备而成;该药具有滋补强壮,镇静安神的功效;主要用于神经衰弱,头痛,头晕,健忘失眠,耳鸣等症。与现有技术相比,该药的工艺更加合理,其临床药效学试验效果显著提高;生物利用度高,药物稳定性好,且无任何毒副作用。The invention relates to a traditional Chinese medicine composition for treating neurasthenia and a preparation method thereof. , Ophiopogon japonicus, tortoise shell, fried jujube kernel, schisandra, polygala, rehmannia glutinosa, cocklebur, a total of sixteen traditional Chinese medicines; the medicine has the effect of nourishing and strengthening, calming and calming the nerves; it is mainly used for neurasthenia, headache, dizziness , forgetfulness, insomnia, tinnitus embolism. Compared with the prior art, the technique of the medicine is more reasonable, and its clinical pharmacodynamic test effect is significantly improved; the bioavailability is high, the medicine stability is good, and there is no toxic or side effect.
Description
技术领域 technical field
本发明涉及一种治疗神经衰弱的中药组合物及其制备方法,属于制药技术领域。 The invention relates to a traditional Chinese medicine composition for treating neurasthenia and a preparation method thereof, belonging to the technical field of pharmacy. the
技术背景 technical background
神经衰弱是一类以精神容易兴奋和脑力容易疲乏,常有情绪烦恼和心理症状的神经症性障碍疾病。神经衰弱常伴有头昏、头痛、眼花、耳鸣、心悸、易兴奋和激怒,入睡困难,焦虑和抑郁等症,还会出现阳痿、早泄或月经紊乱。 Neurasthenia is a class of neurotic disorders characterized by easy excitement and mental fatigue, emotional troubles and psychological symptoms. Neurasthenia is often accompanied by dizziness, headache, vertigo, tinnitus, palpitations, irritability and irritation, difficulty falling asleep, anxiety and depression, and impotence, premature ejaculation or menstrual disorders. the
随着社会的飞速发展及人们生活节奏的不断加快,人们的生活、学习、工作压力越来越大,很容易患上精神衰弱,严重的影响了人们的健康。 With the rapid development of society and the continuous acceleration of people's life rhythm, people's life, study, and work pressure are increasing, and people are prone to mental weakness, which seriously affects people's health.
目前,西医治疗神经衰弱主要以服用安眠药为主,但临床易产生成瘾及耐药性。中医在治疗神经衰弱方面的中成药很多,但疗效都不够理想。部颁标准《中药成方制剂》第十二册WS3-B-2407-97项下“健脑安神片”是一种纯中药制剂,该药经多年临床应用,在治疗神经衰弱方面取得了一定的疗效,但在临床的应用当中我们发现其疗效还不够理想,存在治愈率低,易复发;为糖衣片,糖尿病病人服用等不可忽视的缺点。 At present, Western medicine mainly treats neurasthenia by taking sleeping pills, but clinical addiction and drug resistance are prone to occur. Traditional Chinese medicine has a lot of Chinese patent medicines in the treatment of neurasthenia, but the curative effect is not ideal enough. "Jiannao Anshen Tablet" under the item WS 3 -B-2407-97 of the twelfth volume of "Prescriptions of Traditional Chinese Medicine" issued by the Ministry of Standards is a pure traditional Chinese medicine preparation. Certain curative effect, but in the middle of clinical application we find that its curative effect is not ideal enough, there is low cure rate, easy to relapse; for sugar-coated tablets, diabetes patients take etc. can not be ignored shortcomings.
酸枣仁中的挥发油有很好的镇静安神作用,但“健脑安神片”制剂工艺提取过程中酸枣仁挥发油未经提取,损失较大,诚为可惜。 The volatile oil in Suanzaoren has a very good sedative and tranquilizing effect, but it is a pity that the volatile oil in Suanzaoren has not been extracted during the extraction process of the preparation process of "Jiannao Anshen Tablets", and the loss is relatively large. the
为解决现有技术所存在的缺陷,在近几年的时间里,我们通过发掘祖国丰富的中医药资源,结合大量的临床药效学研究,我们在原来“健脑安神片”工艺的基础上,通过大量的实验摸索,发现将原工艺中的“酸枣仁破碎与熟地黄、麦冬、黄精、远志、大枣加水煎煮二次,每次4小时”改成“炒酸枣仁破碎与熟地黄、麦冬、蒸黄精、制远志、去核大枣加水煎煮二次,每次4小时,煎煮过程中收集蒸馏的油水混合物分离挥发油;将酸枣仁中的挥发油提取出来,喷入颗粒中,制成片剂、胶囊剂和颗粒剂”后,临床药效学实验效果显著提高,且无任何毒副作用;我们按常规工艺制成了:片剂、胶囊剂和颗粒剂。 In order to solve the defects of the existing technology, in recent years, we have explored the rich resources of traditional Chinese medicine in the motherland, combined with a large number of clinical pharmacodynamic studies, and based on the original "Jiannao Anshen Tablet" technology , Through a large number of experiments and explorations, it was found that in the original process, the "broken wild jujube kernels and cooked rehmannia glutinosa, Ophiopogon japonicus, Polygonatum, Polygala, and jujube were decocted twice, each time for 4 hours" into "fried jujube kernels, broken and cooked rehmannia glutinosa. Huang, Ophiopogon japonicus, Steamed Polygonatum, Polygala, Pitted Jujube Add water and decoct twice, each time for 4 hours, collect the distilled oil-water mixture during the decoction to separate the volatile oil; extract the volatile oil from the jujube seed, and spray it into the granules After being made into tablets, capsules and granules", the effect of the clinical pharmacodynamic experiment was significantly improved without any toxic and side effects; we made it according to the conventional process: tablets, capsules and granules. the
发明内容 Contents of the invention
本发明的目的在于:提供一种治疗神经衰弱的中药组合物及其制备方法。 The object of the present invention is to provide a traditional Chinese medicine composition for treating neurasthenia and a preparation method thereof. the
为达到上述目的,本发明采用的技术方案为: In order to achieve the above object, the technical scheme adopted in the present invention is:
组方配比: Formula ratio:
本发明制备方法为: The preparation method of the present invention is:
1、片剂: 1. Tablets:
以上十六味,红参10g、鹿茸4g、鹿角胶10g、鹿角霜25g和茯苓40g粉碎成细粉,过筛,混匀;五味子155g、苍耳子155g、枸杞子80g破碎与淫羊藿195g加50%乙醇回流提取二次,第一次加13倍量,回流2小时,第二次加11倍量,回流1.5小时,滤过,合并滤液,回收乙醇后,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏;炒酸枣仁40g破碎与熟地黄40g、麦冬40g、蒸黄精235g、制远志80g、去核大枣80g加水煎煮二次,第一次加12倍量,煎煮4小时,第二次加10倍量,煎煮4小时,两次煎煮过程中收集蒸馏的油水混合物分离挥发油,水煎液滤过,合并滤液,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏;龟甲加水煎煮二次,第一次加9倍量,煎煮3小时,第二次加7倍量,煎煮3小时,滤过,合并滤液,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏,残渣干燥后粉碎成细粉,过筛;合并上述稠膏,加入上述细粉及淀粉适量,混匀,制粒,65~75℃干燥,喷入挥发油,压制成1000片,包薄膜衣,即得片剂。 The above sixteen flavors, 10g red ginseng, 4g antler, 10g antler gum, 25g antler cream and 40g poria cocos are crushed into fine powder, sieved and mixed; Add 50% ethanol for reflux extraction twice, add 13 times the amount for the first time, reflux for 2 hours, add 11 times the amount for the second time, reflux for 1.5 hours, filter, combine the filtrates, and recover ethanol, at -0.07~-0.08mpa Thick paste with a relative density of 1.31 to 1.32 when concentrated under reduced pressure to 80°C; 40g of fried jujube kernels, broken, and 40g of Rehmannia glutinosa, 40g of Radix Radix Radix, 235g of steamed Polygonatum, 80g of Polygala, 80g of pitted jujube, and decocted with water For the second time, add 12 times the amount for the first time, decoct for 4 hours, add 10 times the amount for the second time, and decoct for 4 hours, collect the distilled oil-water mixture during the two decoctions to separate the volatile oil, filter the decoction, and combine The filtrate is concentrated under reduced pressure at -0.07~-0.08mpa to a thick paste with a relative density of 1.31~1.32 at 80°C; the tortoise shell is decocted twice, adding 9 times the amount for the first time, decocting for 3 hours, and decocting for the second time. Add 7 times the amount for the second time, decoct for 3 hours, filter, combine the filtrates, concentrate under reduced pressure under the condition of -0.07 ~ -0.08mpa to a thick paste with a relative density of 1.31 ~ 1.32 at 80°C, and the residue is dried and crushed into Fine powder, sieve; combine the above thick paste, add appropriate amount of the above fine powder and starch, mix well, granulate, dry at 65-75°C, spray with volatile oil, press into 1000 tablets, coat with film to obtain tablets. the
2、胶囊剂: 2. Capsules:
以上十六味,红参10g、鹿茸4g、鹿角胶10g、鹿角霜25g和茯苓40g粉碎成细粉,过筛,混匀;五味子155g、苍耳子155g、枸杞子80g破碎与淫羊藿195g加50%乙醇回流提取二次,第一次加13倍量,回流2小时,第二次加11倍量,回流1.5小时,滤过,合并滤液,回收乙醇后,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏;炒酸枣仁40g破碎与熟地黄40g、麦冬40g、蒸黄精235g、制远志80g、去核大枣80g加水煎煮二次,第一次加12倍量,煎煮4小时,第二次加10倍量,煎煮4小时,两次煎煮过程中收集蒸馏的油水混合物分离挥发油,水煎液滤过,合并滤液,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏;龟甲加水煎煮二次,第一次加9倍量,煎煮3小时,第二次加7倍量,煎煮3小时,滤过,合并滤液,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏,残渣干燥后粉碎成细粉,过筛;合并上述稠膏,加入上述细粉及淀粉适量,混匀,制粒,65~75℃干燥,喷入挥发油,制成胶囊1000粒,即得胶囊剂。 The above sixteen flavors, 10g red ginseng, 4g antler, 10g antler gum, 25g antler cream and 40g poria cocos are crushed into fine powder, sieved and mixed; Add 50% ethanol for reflux extraction twice, add 13 times the amount for the first time, reflux for 2 hours, add 11 times the amount for the second time, reflux for 1.5 hours, filter, combine the filtrates, and recover ethanol, at -0.07~-0.08mpa Thick paste with a relative density of 1.31 to 1.32 when concentrated under reduced pressure to 80°C; 40g of fried jujube kernels, broken, and 40g of Rehmannia glutinosa, 40g of Radix Radix Radix, 235g of steamed Polygonatum, 80g of Polygala, 80g of pitted jujube, and decocted with water For the second time, add 12 times the amount for the first time, decoct for 4 hours, add 10 times the amount for the second time, and decoct for 4 hours, collect the distilled oil-water mixture during the two decoctions to separate the volatile oil, filter the decoction, and combine The filtrate is concentrated under reduced pressure at -0.07~-0.08mpa to a thick paste with a relative density of 1.31~1.32 at 80°C; the tortoise shell is decocted twice, adding 9 times the amount for the first time, decocting for 3 hours, and decocting for the second time. Add 7 times the amount for the second time, decoct for 3 hours, filter, combine the filtrates, concentrate under reduced pressure under the condition of -0.07 ~ -0.08mpa to a thick paste with a relative density of 1.31 ~ 1.32 at 80°C, and the residue is dried and crushed into Fine powder, sifted; combine the above thick paste, add appropriate amount of the above fine powder and starch, mix well, granulate, dry at 65-75°C, spray into volatile oil, and make 1000 capsules to obtain capsules. the
3、颗粒剂: 3. Granules:
以上十六味,红参10g、鹿茸4g、鹿角胶10g、鹿角霜25g和茯苓40g粉碎成细粉,过筛,混匀;五味子155g、苍耳子155g、枸杞子80g破碎与淫羊藿195g加50%乙醇回流提取二次,第一次加13倍量,回流2小时,第二次加11倍量,回流1.5小时,滤过,合并滤液,回收乙醇后,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏;炒酸枣仁40g破碎与熟地黄40g、麦冬40g、蒸黄精235g、制远志80g、去核大枣80g加水煎煮二次,第一次加12倍量,煎煮4小时,第二次加10倍量,煎煮4小时,两次煎煮过程中收集蒸馏的油水混合物分离挥发油,水煎液滤过,合并滤液,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏;龟甲加水煎煮二次,第一次加9倍量,煎煮3小时,第二次加7倍量,煎煮3小时,滤过,合并滤液,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏,残渣干燥后粉碎成细粉,过筛;合并上述稠膏,加入上述细粉及糊精适量,混匀,制粒,65~75℃干燥,整粒,喷入挥发油,制成颗粒1000g,即得颗粒剂。 The above sixteen flavors, 10g red ginseng, 4g antler, 10g antler gum, 25g antler cream and 40g poria cocos are crushed into fine powder, sieved and mixed; Add 50% ethanol for reflux extraction twice, add 13 times the amount for the first time, reflux for 2 hours, add 11 times the amount for the second time, reflux for 1.5 hours, filter, combine the filtrates, and recover ethanol, at -0.07~-0.08mpa Thick paste with a relative density of 1.31 to 1.32 when concentrated under reduced pressure to 80°C; 40g of fried jujube kernels, broken, and 40g of Rehmannia glutinosa, 40g of Radix Radix Radix, 235g of steamed Polygonatum, 80g of Polygala, 80g of pitted jujube, and decocted with water For the second time, add 12 times the amount for the first time, decoct for 4 hours, add 10 times the amount for the second time, and decoct for 4 hours, collect the distilled oil-water mixture during the two decoctions to separate the volatile oil, filter the decoction, and combine The filtrate is concentrated under reduced pressure at -0.07~-0.08mpa to a thick paste with a relative density of 1.31~1.32 at 80°C; the tortoise shell is decocted twice, adding 9 times the amount for the first time, decocting for 3 hours, and decocting for the second time. Add 7 times the amount for the second time, decoct for 3 hours, filter, combine the filtrates, concentrate under reduced pressure under the condition of -0.07 ~ -0.08mpa to a thick paste with a relative density of 1.31 ~ 1.32 at 80°C, and the residue is dried and crushed into Fine powder, sieve; combine the above thick paste, add appropriate amount of the above fine powder and dextrin, mix, granulate, dry at 65-75°C, granulate, spray into volatile oil, and make 1000g of granules to obtain granules. the
本发明方案是经过发明人多次反复试验,不断改进调整总结出来的,上述中药组合物药物的制备方法为最佳制备方法,临床药效学实验效果显著提高。 The scheme of the present invention is concluded through repeated experiments by the inventor, continuous improvement and adjustment. The preparation method of the above-mentioned traditional Chinese medicine composition drug is the best preparation method, and the effect of clinical pharmacodynamic experiments is significantly improved. the
下面以本发明制备的胶囊剂对比部颁标准《中药成方制剂》第十二册WS3-B-2407-97项下“健脑安神片”,说明其主要药效学: Below, "Jiannao Anshen Tablet" under the item of the capsule prepared by the present invention is compared with the ministerial standard "Preparation of Traditional Chinese Medicine" twelfth volume WS 3 -B-2407-97, illustrating its main pharmacodynamics:
主要药效学实验 The main pharmacodynamic experiment
实验目的:通过对本发明胶囊和健脑安神片的镇静、催眠、改善记忆力、抗惊厥、耐缺氧、抗疲劳等药理实验研究,将本发明胶囊和健脑安神片进行对比,观察其药理作用的强弱。 Experimental purpose: Through the pharmacological experimental research of the capsules of the present invention and Jiannao Anshen Tablets on sedation, hypnosis, memory improvement, anti-convulsions, hypoxia resistance, anti-fatigue, etc., compare the capsules of the present invention with Jiannao Anshen Tablets, and observe their pharmacological effects strength. the
试验方法:本发明胶囊和健脑安神片对小鼠自发活动的影响;对小鼠睡眠时间的影响;对小鼠记忆力的影响;对小鼠抗惊厥作用的影响;对小鼠耐缺氧作用的影响;对小鼠抗疲劳作用的影响。 Test method: the influence of capsules of the present invention and Jiannao Anshen tablet on the spontaneous activity of mice; the influence of sleep time of mice; the influence of memory of mice; the influence of anticonvulsant effect of mice; The effect of; the effect on the anti-fatigue effect of mice. the
实验材料 Experimental Materials
1.1仪器 1.1 Instruments
XZC一4A型小动物自主活动仪;水迷宫自动控制仪LW一I型。 XZC-4A small animal autonomous activity instrument; water maze automatic control instrument LW-I type. the
1.2试剂 1.2 Reagents
戊巴比妥钠(佛山市化工实验厂);硝酸士的宁注射液(上海天丰药厂) Pentobarbital Sodium (Foshan Chemical Experimental Factory); Strychnine Nitrate Injection (Shanghai Tianfeng Pharmaceutical Factory)
钠石灰(上海五四化学试剂厂);东莨菪碱(北京制药工业研究所) Soda lime (Shanghai Wusi Chemical Reagent Factory); Scopolamine (Beijing Pharmaceutical Industry Research Institute)
1.3动物 1.3 Animals
昆明种小鼠,雌雄兼有,体重18~22g,标准饲料喂养。动物合格证:SCXK(陕)2008-018,由西安交通大学医学院实验动物中心提供。 Kunming mice, both male and female, weighing 18-22g, were fed with standard feed. Animal certificate: SCXK (Shaanxi) 2008-018, provided by the Experimental Animal Center of Xi'an Jiaotong University School of Medicine. the
1.4药物 1.4 Drugs
健脑安神片组:一日2次,一次5片。 Brain-invigorating and tranquilizing tablets group: 5 tablets each time, 2 times a day. the
本发明胶囊大、中、小剂量组:一日2次,一次1粒。 Large, medium and small dosage groups of capsules of the present invention: 1 capsule twice a day. the
含量:日服生药量2.418g/天 Content: daily dose of crude drug 2.418g/day
人的日用量:人日用量为0.035生药/kg(人体重按70kg计) Human daily dosage: Human daily dosage is 0.035 crude drug/kg (body weight is calculated as 70kg)
动物日用量:小鼠的日用量为0.314g生药/kg Daily dosage for animals: the daily dosage for mice is 0.314g crude drug/kg
一、对小鼠自发活动的影响 1. The effect on the spontaneous activity of mice
实验材料 Experimental Materials
1、动物:昆明种小鼠,体重18~22g。 1. Animals: Kunming mice, weighing 18-22 g. the
2、药物:健脑安神片0.2418g生药/片;本发明胶囊大、中、小三个剂量组0.6045g生药/粒。药物在实验前用蒸馏水配置,灌胃给药。 2. Drugs: 0.2418g crude drug/tablet for Jiannao Anshen Tablets; 0.6045g crude drug/granule for the large, medium and small dosage groups of the capsules of the present invention. The drug was prepared with distilled water before the experiment and administered by intragastric administration. the
实验方法 experimental method
昆明种小鼠50只,雌雄各半,体重18~22g,随机分成5组,每组10只。对照组灌胃同体积的生理盐水;本发明胶囊组分别灌胃给药0.8、0.4、0.2g生药/kg;健脑安神片组灌胃给药0.8g生药/kg。连续给药7d,末次给药1h后,将小鼠放入自发活动仪中适应3min后,开始测定小鼠5min内自发活动的次数。 Fifty Kunming mice, half male and half male, weighing 18-22 g, were randomly divided into 5 groups, 10 mice in each group. The control group was gavaged with the same volume of normal saline; the capsule group of the present invention was gavaged with 0.8, 0.4, and 0.2 g crude drug/kg; the Jiannao Anshen tablet group was gavaged with 0.8 g crude drug/kg. The administration was continued for 7 days, and 1 hour after the last administration, the mice were placed in the spontaneous activity instrument for 3 minutes to adapt, and then the number of spontaneous activities of the mice within 5 minutes was measured. the
实验结果:见表1 Experimental results: see Table 1
表1对小鼠自发活动的影响 Table 1 Effects on spontaneous activity in mice
与对照组相比**P<0.01;与健脑安神片组比ΔP<0.05。 Compared with the control group **P<0.01; compared with the Jiannao Anshen tablet group ΔP<0.05. the
结果表明:本发明胶囊组和健脑安神片组能明显减少小鼠的自发活动次数,与对照组相比有极显著性的差异(P<0.01);本发明胶囊大剂量组与健脑安神片组相比较有显著性差异(P<0.05)。可见,本发明胶囊组比健脑安神片组的镇静作用强。 The result shows: the capsule group of the present invention and Jiannao Anshen Tablet group can obviously reduce the number of spontaneous activities of mice, and compared with the matched group, there is a very significant difference (P<0.01); There was a significant difference (P<0.05) compared with the film group. It can be seen that the sedative effect of the capsule group of the present invention is stronger than that of the Jiannao Anshen tablet group. the
二、对小鼠睡民时间的影响 2. Effect on sleep time of mice
实验材料 Experimental Materials
1、动物:昆明种小鼠,体重18~22g。 1. Animals: Kunming mice, weighing 18-22 g. the
2、药物:健脑安神片0.2418g生药/片;本发明胶囊大、中、小三个剂量组0.6045g生药/粒。药物在实验前用蒸馏水配置,灌胃给药。 2. Drugs: 0.2418g crude drug/tablet for Jiannao Anshen Tablets; 0.6045g crude drug/granule for the large, medium and small dosage groups of the capsules of the present invention. The drug was prepared with distilled water before the experiment and administered by intragastric administration. the
实验方法 experimental method
昆明种小鼠50只,雌雄各半,体重18~22g,随机分成5组,每组10只。对照组灌胃同体积的生理盐水;本发明胶囊组分别灌胃给药0.8、0.4、0.2g生药/kg;健脑安神片组灌胃给药0.8g生药/kg。连续给药7d,末次给药1h后,腹腔注射戊巴比妥钠45mg/kg,观察小鼠翻正反射消失和恢复时间,记录睡眠持续时间,共观察2h,睡眠时间超过2h者以2h计算。实验结果:见表2 Fifty Kunming mice, half male and half male, weighing 18-22 g, were randomly divided into 5 groups, 10 mice in each group. The control group was gavaged with the same volume of normal saline; the capsule group of the present invention was gavaged with 0.8, 0.4, and 0.2 g crude drug/kg; the Jiannao Anshen tablet group was gavaged with 0.8 g crude drug/kg. Continuous administration for 7 days, 1 hour after the last administration, intraperitoneal injection of pentobarbital sodium 45mg/kg, observe the disappearance and recovery time of the righting reflex of the mice, record the sleep duration, and observe for a total of 2 hours. If the sleep time exceeds 2 hours, it will be counted as 2 hours. . Experimental results: see Table 2
表2对小鼠睡眠时间的影响 Table 2 Effects on sleep time of mice
与对照组相比**P<0.01;与健脑安神片组比ΔP<0.05。 Compared with the control group **P<0.01; compared with the Jiannao Anshen tablet group ΔP<0.05. the
结果表明:本发明胶囊组和健脑安神片组能明显延长小鼠的睡眠时间,与对照组相比有极显著性的差异(P<0.01);本发明胶囊大剂量组与健脑安神片组相比有显著性差异(P<0.05)。可见,本发明胶囊组比健脑安神片组的催眠作用强。 The result shows: capsule group of the present invention and Jiannao Anshen Tablet group can obviously prolong the sleep time of mouse, compares with matched group and has very significant difference (P<0.01); There was a significant difference between the groups (P<0.05). It can be seen that the hypnotic effect of the capsule group of the present invention is stronger than that of the Jiannao Anshen tablet group. the
三、对小鼠记忆力的影响 3. The effect on the memory of mice
实验材料 Experimental Materials
1、动物:昆明种小鼠,体重18~22g。 1. Animals: Kunming mice, weighing 18-22 g. the
2、药物:健脑安神片0.2418g生药/片;本发明胶囊大、中、小三个剂量组0.6045g生药/粒。药物在实验前用蒸馏水配置,灌胃给药。 2. Drugs: 0.2418g crude drug/tablet for Jiannao Anshen Tablets; 0.6045g crude drug/granule for the large, medium and small dosage groups of the capsules of the present invention. The drug was prepared with distilled water before the experiment and administered by intragastric administration. the
实验方法 experimental method
昆明种小鼠50只,雌雄各半,体重18~22g,随机分成5组,每组10只。对照组灌胃同体积的生理盐水;本发明胶囊组分别灌胃给药0.8、0.4、0.2g生药/kg;健脑安神片组灌胃给药0.8g生药/kg。连续给药7d,木次给药后1h后,腹腔注射东莨菪碱溶液5mg/kg,10min后将小鼠放入水迷宫自动记录仪内,观察小鼠从起点至终点登台的时间,重复4次,每次间隔20s, 取平均值进行统计学分析。 Fifty Kunming mice, half male and half male, weighing 18-22 g, were randomly divided into 5 groups, 10 mice in each group. The control group was gavaged with the same volume of normal saline; the capsule group of the present invention was gavaged with 0.8, 0.4, and 0.2 g crude drug/kg; the Jiannao Anshen tablet group was gavaged with 0.8 g crude drug/kg. Continuous administration for 7 days, 1 hour after the second administration, intraperitoneal injection of 5 mg/kg of scopolamine solution, 10 minutes later, put the mice into the water maze automatic recorder, observe the time for the mice to step on the stage from the starting point to the end point, repeat 4 times, Each interval was 20s, and the average value was taken for statistical analysis. the
实验结果:见表3 Experimental results: see Table 3
表3对小鼠记忆力的影响 Table 3 Effects on the memory of mice
与对照组相比**P<0.01;与健脑安神片组比ΔP<0.05。 Compared with the control group **P<0.01; compared with the Jiannao Anshen tablet group ΔP<0.05. the
结果表明:本发明胶囊组和健脑安神片组对东莨菪碱引起的记忆损伤模型小鼠具有修复记忆的作用,与对照组比较有极显著性差异(P<0.01);本发明胶囊大剂量组与健脑安神片组相比较有显著性差异(P<0.05)。可见,本发明胶囊组比健脑安神片组改善记忆力的作用强。 The result shows: capsule group of the present invention and Jiannao Anshen tablet group have the effect of repairing memory to the memory impairment model mouse that scopolamine causes, compare with matched group and have extremely significant difference (P<0.01); Capsule large dose group of the present invention and Compared with the Jiannao Anshen Tablets group, there was a significant difference (P<0.05). It can be seen that the capsule group of the present invention has a stronger effect on improving memory than the Jiannao Anshen tablet group. the
四、对小鼠抗惊厥作用的影响 4. Effect on anticonvulsant effect in mice
实验材料 Experimental Materials
1、动物:昆明种小鼠,体重18~22g。 1. Animals: Kunming mice, weighing 18-22 g. the
2、药物:健脑安神片0.2418g生药/片;本发明胶囊大、中、小三个剂量组0.6045g生药/粒。药物在实验前用蒸馏水配置,灌胃给药。 2. Drugs: 0.2418g crude drug/tablet for Jiannao Anshen Tablets; 0.6045g crude drug/granule for the large, medium and small dosage groups of the capsules of the present invention. The drug was prepared with distilled water before the experiment and administered by intragastric administration. the
实验方法 experimental method
昆明种小鼠50只,雌雄各半,体重18~22g,随机分成5组,每组10只。对照组灌胃同体积的生理盐水;本发明胶囊组分别灌胃给药0.8、0.4、0.2g生药/kg;健脑安神片组灌胃给药0.8g生药/kg。连续给药7d,末次给药1h后,腹腔注射硝酸士的宁注射液2mg/kg。记录小鼠的惊厥潜伏期(从注射硝酸士的宁至惊厥发生的时间)。 Fifty Kunming mice, half male and half male, weighing 18-22 g, were randomly divided into 5 groups, 10 mice in each group. The control group was gavaged with the same volume of normal saline; the capsule group of the present invention was gavaged with 0.8, 0.4, and 0.2 g crude drug/kg; the Jiannao Anshen tablet group was gavaged with 0.8 g crude drug/kg. Continuous administration for 7 days, 1 hour after the last administration, intraperitoneal injection of strychnine nitrate injection 2mg/kg. The convulsion latency period of the mice (the time from injection of strychnine nitrate to the occurrence of convulsion) was recorded. the
实验结果:见表4 Experimental results: see Table 4
表4对小鼠抗惊厥作用的影响 The impact of table 4 on the anticonvulsant effect of mice
与对照组相比**P<0.01;与健脑安神片组比ΔP<0.05。 Compared with the control group **P<0.01; compared with the Jiannao Anshen tablet group ΔP<0.05. the
结果表明:本发明胶囊组和健脑安神片组均可延长士的宁引起小鼠惊厥发生的潜伏期,与对照组比较有极显著性差异(P<0.01);本发明胶囊大剂量组与健脑安神片组相比较有显著性差异(P<0.05)。可见,本发明胶囊组比健脑安神片组抗惊厥的作用强。 The result shows: capsule group of the present invention and Jiannao Anshen Tablet group all can prolong strychnine and cause the latent period that mouse convulsion takes place, compare with matched group and have extremely significant difference (P<0.01); Compared with the Nao Anshen Tablets group, there was a significant difference (P<0.05). It can be seen that the anticonvulsant effect of the capsule group of the present invention is stronger than that of the Jiannao Anshen tablet group. the
五、对小鼠耐缺氧作用的影响 5. The effect on the hypoxia resistance of mice
实验材料 Experimental Materials
1、动物:昆明种小鼠,体重18~22g。 1. Animals: Kunming mice, weighing 18-22 g. the
2、药物:健脑安神片0.2418g生药/片;本发明胶囊大、中、小三个剂量组0.6045g生药/粒。药物在实验前用蒸馏水配置,灌胃给药。 2. Drugs: 0.2418g crude drug/tablet for Jiannao Anshen Tablets; 0.6045g crude drug/granule for the large, medium and small dosage groups of the capsules of the present invention. The drug was prepared with distilled water before the experiment and administered by intragastric administration. the
实验方法 experimental method
昆明种小鼠50只,雌雄各半,体重18~22g,随机分成5组,每组10只。对照组灌胃同体积的生理盐水;本发明胶囊组分别灌胃给药0.8、0.4、0.2g生药/kg;健脑安神片组灌胃给药0.8g生药/kg。连续给药7d,每日1次,末次给药0.5h后,每只小鼠皮下注射10%去甲肾上腺素0.1ml/只,注射后立即将小鼠放入盛有5g钠石灰的250ml广口瓶里进行耐缺氧实验。将广口瓶口涂上凡士林,每瓶放一只小鼠,加盖封密,立即开始计时。以小鼠呼吸停止为指标,记录小鼠因缺氧而死亡的时间。 Fifty Kunming mice, half male and half male, weighing 18-22 g, were randomly divided into 5 groups, 10 mice in each group. The control group was gavaged with the same volume of normal saline; the capsule group of the present invention was gavaged with 0.8, 0.4, and 0.2 g crude drug/kg; the Jiannao Anshen tablet group was gavaged with 0.8 g crude drug/kg. Continuous administration for 7 days, once a day, 0.5 hours after the last administration, each mouse was subcutaneously injected with 10% norepinephrine 0.1ml/only, and immediately after the injection, the mice were put into a 250ml aquarium filled with 5g of soda lime. The hypoxia resistance test was carried out in the mouth bottle. Coat the mouth of the jar with vaseline, put one mouse in each jar, seal it with a cap, and start timing immediately. The time when the mice died due to hypoxia was recorded by taking the breath stop of the mice as an indicator. the
实验结果:见表5 Experimental results: see Table 5
表5对小鼠耐缺氧作用的影响 Table 5 Effects on Mice's Resistance to Hypoxia
与对照组相比**P<0.01;与健脑安神片组比ΔP<0.05。 Compared with the control group **P<0.01; compared with the Jiannao Anshen tablet group ΔP<0.05. the
结果表明:本发明胶囊组和健脑安神片组能够延长小鼠在缺氧环境中的存活时间,与对照组相比有极显著性差异(P<0.01);本发明胶囊大剂量组与健脑安神片组相比较有显著性差异(P<0.05)。可见,本发明胶囊组比健脑安神片组耐缺氧的作用强。 The result shows: the capsule group of the present invention and the Jiannao Anshen Tablet group can prolong the survival time of mice in the hypoxic environment, and compared with the matched group, there is a very significant difference (P<0.01); Compared with the Nao Anshen Tablets group, there was a significant difference (P<0.05). It can be seen that the capsule group of the present invention has a stronger hypoxia-resistant effect than the Jiannao Anshen tablet group. the
六、对小鼠抗疲劳作用的影响 6. Effect on the anti-fatigue effect of mice
实验材料 Experimental Materials
1、动物:昆明种小鼠,体重18~22g。 1. Animals: Kunming mice, weighing 18-22 g. the
2、药物:健脑安神片0.2418g生药/片;本发明胶囊大、中、小三个剂量组0.6045g生药/粒。药物在实验前用蒸馏水配置,灌胃给药。 2. Drugs: 0.2418g crude drug/tablet for Jiannao Anshen Tablets; 0.6045g crude drug/granule for the large, medium and small dosage groups of the capsules of the present invention. The drug was prepared with distilled water before the experiment and administered by intragastric administration. the
实验方法 experimental method
昆明种小鼠50只,雌雄各半,体重18~22g,随机分成5组,每组10只。对照组灌胃同体积的生理盐水;本发明胶囊组分别灌胃给药0.8、0.4、0.2g生药/kg;健脑安神片组灌胃给药0.8g生药/kg。连续给药7d,每日1次,末次给药1h后,小鼠尾根部束2g的铅,分别将小鼠置于玻璃缸中游泳,水深20cm,水温保持25±0.5℃,记录游泳时间,当小鼠头部沉入水中10s不能浮出水面者即为体力耗竭,即刻计时为小鼠游泳时间。 Fifty Kunming mice, half male and half male, weighing 18-22 g, were randomly divided into 5 groups, 10 mice in each group. The control group was gavaged with the same volume of normal saline; the capsule group of the present invention was gavaged with 0.8, 0.4, and 0.2 g crude drug/kg; the Jiannao Anshen tablet group was gavaged with 0.8 g crude drug/kg. Continuous administration for 7 days, once a day, 1 hour after the last administration, 2 g of lead was bundled at the base of the tail of the mice, and the mice were placed in glass tanks to swim at a water depth of 20 cm and a water temperature of 25±0.5°C, and the swimming time was recorded. When the head of the mouse submerges in the water for 10 seconds and fails to surface, it is considered to be physically exhausted, and the swimming time of the mouse is counted immediately. the
实验结果:见表6 Experimental results: see Table 6
表6对小鼠抗疲劳作用的影响 The influence of table 6 on the anti-fatigue effect of mice
与对照组相比**P<0.01;与健脑安神片组比ΔP<0.05。 Compared with the control group **P<0.01; compared with the Jiannao Anshen tablet group ΔP<0.05. the
结果表明:本发明胶囊组和健脑安神片组可明显延长小鼠的负重游泳时间,与对照组比有极显著性差异(P<0.01);本发明胶囊大剂量组与健脑安神片组相比较有显著性差异(P<0.05)。可见,本发明胶囊组比健脑安神片组抗疲劳的作用强。 The results show that: the capsule group of the present invention and the Jiannao Anshen Tablet group can obviously prolong the weight-bearing swimming time of mice, and there is a very significant difference (P<0.01) compared with the matched group; There was a significant difference (P<0.05). It can be seen that the anti-fatigue effect of the capsule group of the present invention is stronger than that of the Jiannao Anshen tablet group. the
实验结果:本发明胶囊和健脑安神片能明显减少小鼠的自发活动次数;能明显延长小鼠的睡眠时间;对记忆损伤的小鼠具有修复记忆的作用;可延长士的宁引起的小鼠惊厥发生的潜伏期;能够延长小鼠在缺氧环境中的存活时间:可明显延长小鼠的负重游泳时间。 Experimental results: capsules of the present invention and Jiannao Anshen Tablets can significantly reduce the number of spontaneous activities of mice; can obviously prolong the sleep time of mice; have the effect of repairing memory on mice with memory impairment; The incubation period of convulsions in mice; it can prolong the survival time of mice in hypoxic environment: it can significantly prolong the weight-bearing swimming time of mice. the
结论:本发明胶囊比健脑安神片的镇静、催眠、改善记忆力、抗惊厥、耐缺氧、抗疲劳等药理作用强,因此,本发明胶囊比健脑安神片治疗神经衰弱,头痛,头晕,健忘失眠等临床疗效好。 Conclusion: the capsules of the present invention are stronger than Jiannao Anshen Tablets in pharmacological effects such as sedation, hypnosis, memory improvement, anticonvulsion, hypoxia resistance, anti-fatigue, etc. Good clinical curative effect such as forgetfulness and insomnia. the
毒理实验: Toxicology experiment:
急性毒性实验结果表明:将本发明胶囊最大浓度、最大容积灌胃给药,在24h内连续给药 3次,每次间隔4h,累积药物总量达12g生药/kg,相当于人临床拟用量的347倍。给药后7d内,小鼠活动、进食、排泄均正常,生长良好,毛色光亮,其平均体重均随试验时间的延长而增加。第8d处死后解剖每只小鼠肉眼观察心、肝、脾、肺、肾、脑、胸腺、胃、肠等均未发现颜色及形态异常,未能测出LD50。表明本发明胶囊无急性毒性反应。 Acute toxicity test results show that: the maximum concentration and maximum volume of the capsules of the present invention are given by intragastric administration, and the capsules are administered continuously for 3 times within 24 hours, with an interval of 4 hours each time. 347 times. Within 7 days after administration, the mice's activities, food intake, and excretion were all normal, their growth was good, their coat color was bright, and their average body weight increased with the prolongation of the test time. After the 8th day of death, each mouse was dissected to observe the heart, liver, spleen, lung, kidney, brain, thymus, stomach and intestine with naked eyes, and no abnormal color and shape were found, and the LD 50 could not be measured. Show that capsule of the present invention has no acute toxicity reaction.
长期毒性实验结果表明:本发明胶囊组分为低、中、高剂量分别为1、2、4g生药/kg/d,相当于临床剂量的29.0、57.9、115.8倍,灌胃给药12周后,本发明胶囊对动物的一般状况、血液学指标、血液生化指标均无明显的影响,系统解剖、脏器系数及组织病理学检查也未发现异常病理改变。停药2周也未见明显改变。本发明胶囊在长期毒性试验中,未发现明显毒性反应和延迟毒性反应。可见,本发明胶囊无毒性反应,长期用药安全可靠。 Long-term toxicity test results show that: the capsule components of the present invention have low, medium and high doses of 1, 2, and 4 g of crude drug/kg/d, which are equivalent to 29.0, 57.9, and 115.8 times the clinical dose. , the capsule of the present invention has no significant impact on the general condition, hematology index, and blood biochemical index of the animal, and no abnormal pathological changes have been found in system anatomy, organ coefficients, and histopathological examination. There was no significant change after stopping the drug for 2 weeks. In the long-term toxicity test of the capsule of the present invention, no obvious toxic reaction and delayed toxic reaction are found. It can be seen that the capsule of the present invention has no toxic reaction, and the long-term medication is safe and reliable. the
本发明具体实施方式: Specific embodiments of the present invention:
本发明实施例1: Embodiment 1 of the present invention:
组方配比: Formula ratio:
片剂制备方法: Tablet preparation method:
以上十六味,红参10g、鹿茸4g、鹿角胶10g、鹿角霜25g和茯苓40g粉碎成细粉,过筛,混匀;五味子155g、苍耳子155g、枸杞子80g破碎与淫羊藿195g加50%乙醇回流提取二次,第一次加13倍量,回流2小时,第二次加11倍量,回流1.5小时,滤过,合并滤液,回收乙醇后,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏;炒酸枣仁40g破碎与熟地黄40g、麦冬40g、蒸黄精235g、制远志80g、去核大枣80g加水煎煮二次,第一次加12倍量,煎煮4小时,第二次加10倍量,煎煮4小时,两次煎煮过程中收集蒸馏的油水混合物分离挥发油,水煎液滤过,合并滤液,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏;龟甲加水煎煮二次,第一次加9倍量,煎煮3小时,第二次加7倍量,煎煮3小时,滤过,合并滤液,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏,残渣干燥后粉碎成细粉,过筛;合并上述稠膏,加入上述细粉及淀粉适量,混匀,制粒,65~75℃干燥,喷入挥发油,压制成1000片,包薄膜衣,即得片剂。 The above sixteen flavors, 10g red ginseng, 4g antler, 10g antler gum, 25g antler cream and 40g poria cocos are crushed into fine powder, sieved and mixed; Add 50% ethanol for reflux extraction twice, add 13 times the amount for the first time, reflux for 2 hours, add 11 times the amount for the second time, reflux for 1.5 hours, filter, combine the filtrates, and recover ethanol, at -0.07~-0.08mpa Thick paste with a relative density of 1.31 to 1.32 when concentrated under reduced pressure to 80°C; 40g of fried jujube kernels, broken, and 40g of Rehmannia glutinosa, 40g of Radix Radix Radix, 235g of steamed Polygonatum, 80g of Polygala, 80g of pitted jujube, and decocted with water For the second time, add 12 times the amount for the first time, decoct for 4 hours, add 10 times the amount for the second time, and decoct for 4 hours, collect the distilled oil-water mixture during the two decoctions to separate the volatile oil, filter the decoction, and combine The filtrate is concentrated under reduced pressure at -0.07~-0.08mpa to a thick paste with a relative density of 1.31~1.32 at 80°C; the tortoise shell is decocted twice, adding 9 times the amount for the first time, decocting for 3 hours, and decocting for the second time. Add 7 times the amount for the second time, decoct for 3 hours, filter, combine the filtrates, concentrate under reduced pressure under the condition of -0.07 ~ -0.08mpa to a thick paste with a relative density of 1.31 ~ 1.32 at 80°C, and the residue is dried and crushed into Fine powder, sieve; combine the above thick paste, add appropriate amount of the above fine powder and starch, mix well, granulate, dry at 65-75°C, spray with volatile oil, press into 1000 tablets, coat with film to obtain tablets. the
本发明实施例2: Embodiment 2 of the present invention:
组方配比: Formula ratio:
胶囊剂制备方法: Capsule preparation method:
以上十六味,红参10g、鹿茸4g、鹿角胶10g、鹿角霜25g和茯苓40g粉碎成细粉,过筛,混匀;五味子155g、苍耳子155g、枸杞子80g破碎与淫羊藿195g加50%乙醇回流提取二次,第一次加13倍量,回流2小时,第二次加11倍量,回流1.5小时,滤过,合并滤液,回收乙醇后,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏;炒酸枣仁40g破碎与熟地黄40g、麦冬40g、蒸黄精235g、制远志80g、去核大枣80g加水煎煮二次,第一次加12倍量,煎煮4小时,第二次加10倍量,煎煮4小时,两次煎煮过程中收集蒸馏的油水混合物分离挥发油,水煎液滤过,合并滤液,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏;龟甲加水煎煮二次,第一次加9倍量,煎煮3小时,第二次加7倍量,煎煮3小时,滤过,合并滤液,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏,残渣干燥后粉碎成细粉,过筛;合并上述稠膏,加入上述细粉及淀粉适量,混匀,制粒,65~75℃干燥,喷入挥发油,制成胶囊1000粒,即得胶囊剂。 The above sixteen flavors, 10g red ginseng, 4g antler, 10g antler gum, 25g antler cream and 40g poria cocos are crushed into fine powder, sieved and mixed; Add 50% ethanol for reflux extraction twice, add 13 times the amount for the first time, reflux for 2 hours, add 11 times the amount for the second time, reflux for 1.5 hours, filter, combine the filtrates, and recover ethanol, at -0.07~-0.08mpa Thick paste with a relative density of 1.31 to 1.32 when concentrated under reduced pressure to 80°C; 40g of fried jujube kernels, broken, and 40g of Rehmannia glutinosa, 40g of Radix Radix Radix, 235g of steamed Polygonatum, 80g of Polygala, 80g of pitted jujube, and decocted with water For the second time, add 12 times the amount for the first time, decoct for 4 hours, add 10 times the amount for the second time, and decoct for 4 hours, collect the distilled oil-water mixture during the two decoctions to separate the volatile oil, filter the decoction, and combine The filtrate is concentrated under reduced pressure at -0.07~-0.08mpa to a thick paste with a relative density of 1.31~1.32 at 80°C; the tortoise shell is decocted twice, adding 9 times the amount for the first time, decocting for 3 hours, and decocting for the second time. Add 7 times the amount for the second time, decoct for 3 hours, filter, combine the filtrates, concentrate under reduced pressure under the condition of -0.07 ~ -0.08mpa to a thick paste with a relative density of 1.31 ~ 1.32 at 80°C, and the residue is dried and crushed into Fine powder, sifted; combine the above thick paste, add appropriate amount of the above fine powder and starch, mix well, granulate, dry at 65-75°C, spray into volatile oil, and make 1000 capsules to obtain capsules. the
本发明实施例3: Embodiment 3 of the present invention:
组方配比: Formula ratio:
颗粒剂制备方法: Preparation method of granules:
以上十六味,红参10g、鹿茸4g、鹿角胶10g、鹿角霜25g和茯苓40g粉碎成细粉,过 筛,混匀;五味子155g、苍耳子155g、枸杞子80g破碎与淫羊藿195g加50%乙醇回流提取二次,第一次加13倍量,回流2小时,第二次加11倍量,回流1.5小时,滤过,合并滤液,回收乙醇后,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏;炒酸枣仁40g破碎与熟地黄40g、麦冬40g、蒸黄精235g、制远志80g、去核大枣80g加水煎煮二次,第一次加12倍量,煎煮4小时,第二次加10倍量,煎煮4小时,两次煎煮过程中收集蒸馏的油水混合物分离挥发油,水煎液滤过,合并滤液,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏;龟甲加水煎煮二次,第一次加9倍量,煎煮3小时,第二次加7倍量,煎煮3小时,滤过,合并滤液,在-0.07~-0.08mpa的条件下减压浓缩至80℃时相对密度为1.31~1.32的稠膏,残渣干燥后粉碎成细粉,过筛;合并上述稠膏,加入上述细粉及糊精适量,混匀,制粒,65~75℃干燥,整粒,喷入挥发油,制成颗粒1000g,即得颗粒剂。 The above sixteen flavors, 10g red ginseng, 4g antler, 10g antler glue, 25g antler cream and 40g poria cocos are crushed into fine powder, sieved and mixed; Add 50% ethanol for reflux extraction twice, add 13 times the amount for the first time, reflux for 2 hours, add 11 times the amount for the second time, reflux for 1.5 hours, filter, combine the filtrates, and recover ethanol, at -0.07~-0.08mpa Thick paste with a relative density of 1.31 to 1.32 when concentrated under reduced pressure to 80°C; 40g of fried jujube kernels, broken, and 40g of Rehmannia glutinosa, 40g of Radix Radix Radix, 235g of steamed Polygonatum, 80g of Polygala, 80g of pitted jujube, and decocted with water For the second time, add 12 times the amount for the first time, decoct for 4 hours, add 10 times the amount for the second time, and decoct for 4 hours, collect the distilled oil-water mixture during the two decoctions to separate the volatile oil, filter the decoction, and combine The filtrate is concentrated under reduced pressure at -0.07~-0.08mpa to a thick paste with a relative density of 1.31~1.32 at 80°C; the tortoise shell is decocted twice, adding 9 times the amount for the first time, decocting for 3 hours, and decocting for the second time. Add 7 times the amount for the second time, decoct for 3 hours, filter, combine the filtrates, concentrate under reduced pressure under the condition of -0.07 ~ -0.08mpa to a thick paste with a relative density of 1.31 ~ 1.32 at 80°C, and the residue is dried and crushed into Fine powder, sieve; combine the above thick paste, add appropriate amount of the above fine powder and dextrin, mix, granulate, dry at 65-75°C, granulate, spray into volatile oil, and make 1000g of granules to obtain granules. the
Claims (1)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201110121752XA CN102198211B (en) | 2011-05-12 | 2011-05-12 | Traditional Chinese medicine composition for treating neurasthenia, and preparation method thereof |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201110121752XA CN102198211B (en) | 2011-05-12 | 2011-05-12 | Traditional Chinese medicine composition for treating neurasthenia, and preparation method thereof |
Publications (2)
Publication Number | Publication Date |
---|---|
CN102198211A CN102198211A (en) | 2011-09-28 |
CN102198211B true CN102198211B (en) | 2013-04-03 |
Family
ID=44659366
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201110121752XA Active CN102198211B (en) | 2011-05-12 | 2011-05-12 | Traditional Chinese medicine composition for treating neurasthenia, and preparation method thereof |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN102198211B (en) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103083543B (en) * | 2011-11-08 | 2014-07-23 | 陕西方舟制药有限公司 | Chinese medicinal composition for soothing nerves and nourishing brain and preparation method thereof |
CN102526474B (en) * | 2012-03-22 | 2013-06-19 | 王寿江 | Chinese medicine composition for treating neurasthenia |
CN103599270A (en) * | 2013-11-05 | 2014-02-26 | 刘洪英 | Traditional Chinese medicinal composition for treating chronic infantile convulsion |
CN104056045A (en) * | 2014-06-23 | 2014-09-24 | 宋克垣 | Drug for treatment of neurasthenia and preparation method thereof |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1365697A (en) * | 2001-01-15 | 2002-08-28 | 杨孟君 | Nano medicine 'Naoling' and its preparing process |
-
2011
- 2011-05-12 CN CN201110121752XA patent/CN102198211B/en active Active
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1365697A (en) * | 2001-01-15 | 2002-08-28 | 杨孟君 | Nano medicine 'Naoling' and its preparing process |
Non-Patent Citations (7)
Title |
---|
卫生部药典委员会.《健脑安神片》.《卫生部颁药品标准-中药成方制剂第十二册》.1997,157. * |
卫生部药典委员会.《脑灵素片》.《卫生部颁药品标准-中药成方制剂第十六册》.1998,139. * |
卫生部药典委员会.脑灵素胶囊.《卫生部颁药品标准-中药成方制剂第八册》.1993,144. * |
翟丽杰等.《脑灵素胶囊对小鼠中枢神经系统的影响》.《人参研究》.2007,(第1期),5-7. * |
谢海洲.《鹿角霜属缓补之药》.《中医杂志》.2003,第44卷(第5期),331. * |
赖晓明等.《益脑胶囊治疗神经衰弱的临床研究》.《中药新药与临床药理》.2008,第19卷(第4期),314-316. * |
鹿启鹏.《脑灵素片剂颗粒加压灭菌法》.《中成药研究》.1982,(第4期),16. * |
Also Published As
Publication number | Publication date |
---|---|
CN102198211A (en) | 2011-09-28 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN101559168B (en) | Pharmaceutical composition for invigorating Qi, tonifying blood and nourishing liver and kidney as well as preparation method and application thereof | |
CN104825791B (en) | A kind of traditional Chinese medicine health care product with anti-fatigue effect and preparation method thereof | |
KR20100106976A (en) | Pharmaceutical compositions for treating depression and anxiety | |
CN101244244A (en) | A kind of pharmaceutical composition for treating depression and preparation method thereof | |
CN104173493A (en) | Pharmaceutical composition with effect of improving sleep as well as preparation method and application of pharmaceutical composition | |
CN102198211B (en) | Traditional Chinese medicine composition for treating neurasthenia, and preparation method thereof | |
CN107997176A (en) | A kind of stomach strengthening and digestion promoting health food for preventing children's having indigestion apocleisis | |
CN102228617B (en) | Medicinal composition for treating insomnia | |
CN115501304A (en) | Traditional Chinese medicine compound composition for treating insomnia with syndrome of hyperactivity of heart-liver fire as well as preparation method and application thereof | |
CN107569612B (en) | A kind of medicine for improving sleep and preparation method thereof | |
CN101987124A (en) | Traditional Chinese medicine composition for treating dyspepsia and preparation method thereof | |
KR101256210B1 (en) | Pharmaceutical Compositions for Treating Anxiety | |
CN104337920B (en) | Traditional Chinese medicine composition for improving sleep quality | |
CN105999195B (en) | Preparation method of ginseng branch poria cocos preparation | |
CN102106890A (en) | Applications and preparation method of saussurea total sesquiterpene lactone | |
CN100509043C (en) | A kind of traditional Chinese medicine composition for detoxification | |
CN103071080B (en) | Traditional Chinese medicine preparation for treating depressive disorder | |
CN102631492B (en) | Chinese medicinal composition for improving immunity and resisting fatigue | |
CN113842411A (en) | Traditional Chinese medicine composition of lucid ganoderma nerve-soothing capsule and preparation method thereof | |
CN100500171C (en) | Tranquilizing Chinese medicine composition and its preparing method and application | |
CN108404088B (en) | Traditional Chinese medicine for treating type II diabetes and preparation method thereof | |
CN110559354A (en) | Compound rhodiola rosea composition and preparation method thereof | |
CN105168519B (en) | With the composition and its preparation method and application for improving sleep function | |
CN103656161B (en) | A kind of Chinese medicine composition and its production and use | |
CN102631486B (en) | Health care composition |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
TR01 | Transfer of patent right | ||
TR01 | Transfer of patent right |
Effective date of registration: 20220727 Address after: 710304 No. 18, Caotang 4th Road, Caotang science and technology industry base, high tech Zone, Xi'an, Shaanxi Province Patentee after: Shaanxi Hantang Pharmaceutical Co.,Ltd. Address before: 710201 Jinghe Industrial Park, Xi'an Economic and Technological Development Zone, Shaanxi Province Patentee before: XINGBANG PHARMACEUTICAL Co.,Ltd. |
|
PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Preparation method of a traditional Chinese medicine combination for treating neurasthenia Granted publication date: 20130403 Pledgee: Xi'an innovation financing Company limited by guarantee Pledgor: Shaanxi Hantang Pharmaceutical Co.,Ltd. Registration number: Y2024980009262 |
|
PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
PC01 | Cancellation of the registration of the contract for pledge of patent right |
Granted publication date: 20130403 Pledgee: Xi'an innovation financing Company limited by guarantee Pledgor: Shaanxi Hantang Pharmaceutical Co.,Ltd. Registration number: Y2024980009262 |