CN101940770A - Medicament for treating insomnia and preparation method thereof - Google Patents

Medicament for treating insomnia and preparation method thereof Download PDF

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CN101940770A
CN101940770A CN2010102762374A CN201010276237A CN101940770A CN 101940770 A CN101940770 A CN 101940770A CN 2010102762374 A CN2010102762374 A CN 2010102762374A CN 201010276237 A CN201010276237 A CN 201010276237A CN 101940770 A CN101940770 A CN 101940770A
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insomnia
liver
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medicine
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丰广魁
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Abstract

The invention discloses a medicament for treating insomnia. The medicament comprises the following raw materials: Chinese thorowax, scutellaria root, pro formula pinellia rhizome, mix-fried licorice, dragon bone, oyster shell, campanumaea pilosula, nacre, ginger and jujube. The treatment for the insomnia is from liver; the traditional Chinese medicine theory is that sleeping equals to that yang enters yin; a plurality of disease causes can cause that the yang does not enter the yin and mental disturbance is one of main disease causes. The medicament soothes liver-qi stagnation and tranquilizes and allays the spirit, which is more accordant with insomnia pathogenesis; through years of clinical treatment cases, the medicament has remarkable treatment effect, achieves a total cure rate of over 90 percent and is used for symptoms such as tense, anxiety, disquieted heart spirit, unquiet sleep at night, heart vexation testiness and the like which are caused by the liver-Qi stagnation and phlegm-heat and spirit harassing.

Description

Medicine of a kind of Cure for insomnia and preparation method thereof
Technical field
The present invention relates to a kind of is the medicine of the Chinese patent medicine of feedstock production, particularly a kind of Cure for insomnia with the Chinese herbal medicine.The invention still further relates to a kind of preparation method of this medicine.
Background technology
Insomnia (insomnia) is modal a kind of sleep disordered disease, it is the common clinical manifestation that multiple body, spirit and behavior disease are had, the traditional Chinese medical science is referred to as " being insomnia ", " insomnia ", " insomnia ", " must not crouch ", " unable to close the eyes " etc., along with work, rhythm of life are accelerated, it is all multifactor that inter personal contact anxiety, operating pressure are big etc., the sickness rate of insomnia rises, and raises wages according to stream and expects to show that the people of western countries about 35.2% has insomnia in various degree; China's insomnia rate is also up to 10%~20%.It is also very wide to involve scope, no matter the men and women, whether health, and old man youth all can be taken place, and therefore, insomnia becomes an important killer who threatens human health just day by day.The Chinese patent medicine of existing commercially available Cure for insomnia is the agent of kidney invigorating and YANG supporting as ANSHEN BUNAO YE, sweet dreams oral liquid etc., and informal dress has the suspicion of getting angry; Tianwang Buxin Dan, blood-nourishing and brain-refreshing granules are the agent of nourishing YIN and clearing away fire, and the worry of the impairment of the spleen is arranged.
Summary of the invention
The technical problem to be solved in the present invention is at the deficiencies in the prior art, has proposed a kind of medicine with Cure for insomnia of soothing liver-QI for relieving depression, effects of tranquilizing and allaying excitement.Another technical problem that will solve of the present invention has provided a kind of preparation method of this medicine.
The technical problem to be solved in the present invention is achieved through the following technical solutions, and a kind of medicine of Cure for insomnia is characterized in that it is the medicament of being made by the following weight proportion raw material:
Radix Bupleuri 3~24g, Radix Scutellariae 3~24g,
Rhizoma Pinelliae Preparatum 3~12g, Radix Glycyrrhizae Preparata 3~15g,
Os Draconis 9~60g, Concha Ostreae 9~60g,
Radix Codonopsis 9~30g, Concha Margaritifera 9~60g,
Rhizoma Zingiberis Recens 3~30g, Fructus Jujubae 6~30g.
Another technical problem that will solve of the present invention is achieved through the following technical solutions, the preparation method of the medicine of above-mentioned Cure for insomnia, be characterized in: (1) with Radix Bupleuri Radix Scutellariae, Rhizoma Pinelliae Preparatum, Radix Codonopsis according to " appended Chinese crude drug concocting method of Chinese pharmacopoeia version in 2005 is concocted processing in accordance with the law, 80 ℃ of dryings, pulverizing, cross 100 mesh sieves, get the medical material fine powder, standby; (2) Radix Glycyrrhizae Preparata, Os Draconis, Concha Ostreae, Concha Margaritifera, Rhizoma Zingiberis Recens, Fructus Jujubae are added 8~10 times of water gagings immersions respectively and decoct after 1~3 hour, the elimination residue, concentrating filter liquor gets extractum, and is standby; (3) above-mentioned fine powder and extractum mixing, pill, 80 ℃ of dryings, polishing, packings get final product.
The present invention can soothing liver-QI for relieving depression, tranquillizing and allaying excitement.Be used for because of depression of liver-QI, expectorant heat is disturbed diseases such as anxiety, anxiety, irritability, night restlessness due to the god slept, susceptible to lose temper due to restlessness.
Treatment advantage of the present invention: Cure for insomnia of the present invention is to control from the liver opinion, theory of Chinese medical science thinks that sun goes into sleeping of the moon meaning, Different types of etiopathogenises all can cause sun not go into Yu Yin, and disorder of emotion is one of important cause of disease, dispersing the stagnated live-QI to relieve the stagnation of QI of the present invention, the tranquillizing and allaying excitement pathogenesis of pressing close to have a sleepless night the most is from clinical treatment case for many years, evident in efficacy, total effective rate reaches more than 90%.
The specific embodiment
A kind of medicine of Cure for insomnia, it is the medicament of being made by the following weight proportion raw material:
Radix Bupleuri 3~24g, Radix Scutellariae 3~24g,
Rhizoma Pinelliae Preparatum 3~12g, Radix Glycyrrhizae Preparata 3~15g,
Os Draconis 9~60g, Concha Ostreae 9~60g,
Radix Codonopsis 9~30g, Concha Margaritifera 9~60g,
Rhizoma Zingiberis Recens 3~30g, Fructus Jujubae 6~30g.
The preparation method of the medicine of above-mentioned Cure for insomnia, (1) with Radix Bupleuri Radix Scutellariae, Rhizoma Pinelliae Preparatum, Radix Codonopsis according to " appended Chinese crude drug concocting method of Chinese pharmacopoeia version in 2005 is concocted processing, and 100 mesh sieves are crossed in 80 ℃ of dryings, pulverizing in accordance with the law, get the medical material fine powder, standby; (2) Radix Glycyrrhizae Preparata, Os Draconis, Concha Ostreae, Concha Margaritifera, Rhizoma Zingiberis Recens, Fructus Jujubae are added 8~10 times of water gagings immersions respectively and decoct after 1~3 hour, the elimination residue, filtrate is concentrated into relative density about 1.30, gets extractum, and is standby; (3) above-mentioned fine powder and extractum mixing, pill, 80 ℃ of dryings, polishing, packings get final product.
Said preparation is according to the difference of formula proportion, and every gram is equivalent to crude drug 3~8 grams, and is oral, a 6g, 3 times on the one.Be used for because of depression of liver-QI, expectorant heat is disturbed diseases such as anxiety, anxiety, irritability, night restlessness due to the god slept, susceptible to lose temper due to restlessness.
In addition, according to prescription of the present invention, can also be processed as other dosage forms such as capsule, tablet, granule according to conventional method.
One, the pharmacodynamics of Cure for insomnia of the present invention and acute toxicity testing
Purpose: observe sedative-hypnotic effect and the acute toxicity testing of the present invention to mice.
Method: observe the mice autonomic activities, to the influence and the health status of hypnosis and the effect of subliminal hypnosis dosage pentobarbital sodium.
The result: the present invention can reduce mice and walk about and lift number of times on time and the mice forelimb, shortens pentobarbital and causes the sleeping latent time of mice, prolongs sleep time, increases the sleeping rate of subliminal hypnosis dosage pentobarbital sodium mice.Conclusion: the present invention has sedative-hypnotic effect.
By clinical observation, Cure for insomnia of the present invention is obtained curative effect preferably, and this experiment is investigated the pharmacodynamics and the acute toxicity testing of its Cure for insomnia.
1, experiment material the present invention (contains crude drug amount 3.809g/g, provides lot number 20080119 by the Drug Manufacturing Room of Lianyungang institute of traditional Chinese medicine.Grind to form 0.4g/ml with purified water before the experiment, be equivalent to contain crude drug amount 1.524g/ml.) Alprazolamum, Xuzhou grace China Pharmaceutical Group Co.,Ltd produces, and is made into suspension 0.006mg/ml with distilled water before the experiment.Pentobarbital sodium: Shanghai chemical reagent purchasing and supply station chemical reagent work; Kunming mouse, body weight 18g~22g, female, male dual-purpose.
2, method and result
2.1, to the influence of mice autonomic activities
60 of mices are divided 5 groups at random, and the grouping situation sees Table 1, and gastric infusion is irritated the long-pending 0.2ml/10g body weight that is of body of stomach.Mice dropped in the active box before the administration and adapt to 5 minutes, 60min after the administration, walk about time and forelimb of the animal of writing down 2min by the same method upwards praised number of times.The results are shown in Table 1.
Table 1 the present invention to the influence of mice autonomic activities (
Figure BSA00000262182000041
N=12)
Figure BSA00000262182000042
Table 1 as seen, with the blank group relatively, mice of the present invention is walked about, and the parity number average has significant difference on time and the forelimb.
2.2, to the influence of HD pentobarbital sodium mouse sleep time
Animal divides into groups and handles the same.After the administration 60 minutes, difference lumbar injection pentobarbital sodium 40mg/kg, observed and recorded time for falling asleep (righting reflex loss time) and sleep time (righting reflex loss is to the time of recovering).The results are shown in Table 2.
Table 2 the present invention to the influence of HD pentobarbital sodium mouse sleep time (± s, n=12)
By table 2 as seen, compare with matched group, the present invention can shorten the sleeping latent time of mice, prolongs the mice sleep persistent period.
2.3, to the influence of sub-threshold dose pentobarbital sodium effect
Mice is handled the same.After the administration 60 minutes, lumbar injection pentobarbital sodium 30mg/kg respectively observes righting reflex loss in 15 minutes and reaches number of mice more than 1 minute.The results are shown in Table 3.
Table 3 the present invention to the effect of subliminal hypnosis dosage pentobarbital sodium mice (± s, n=12)
Figure BSA00000262182000052
Compare with the blank group, the present invention can significantly strengthen the sleeping rate of mice.
Among above description of test the present invention, heavy dose of group has synergism with barbital sodium, illustrates that the present invention has obvious sedative-hypnotic effect.
2.4, acute toxicity testing
40 of mices are divided into 2 groups, (are equivalent to contain crude drug amount 1.524g/ml with the present invention.), respectively on an empty stomach gastric infusion 1 time (0.5ml/ only, 1.0ml/ only) was observed 7 days continuously, did not see untoward reaction, and all healthy active, it is dead not have 1 example.Its maximum tolerated dose>20g/kg is equivalent to 3.3 times of the each oral dose of clinical adult (6g).
Two, clinical data
1.1 physical data 106 examples are outpatient service prescription on individual diagnosis patient, male's 49 examples wherein, women's 57 examples; 25 years old~63 years old age, average (45 ± 4) year; The course of disease 3 months~18 years, average (49 ± 13) moon; Show as difficulty falling asleep person's 49 examples, Yi Xingzhe or early awakening person 38 examples, the person's of lying awake all night 1 example, the non-person's of sleeping 18 examples of seemingly sleeping.
1.2 the diagnostic criteria Western medicine diagnose is with reference to the diagnostic criteria [1] of relevant insomnia in " Chinese mental disorder classification and diagnostic criteria ", tcm diagnosis with reference in State Administration of Traditional Chinese Medicine's " traditional Chinese medical science disease diagnosis criterion of therapeutical effect " [2] about the diagnostic criteria and the dialectical standard of " being insomnia ": 1. the lighter's difficulty falling asleep and easily waking up, be difficult to again sleeping after waking up, more than continuous 2 weeks, weight person lies awake all night; 2. often with diseases such as dizziness, headache, cardiopalmus, forgetful dreaminess; 3. no abnormal through each system and lab testing.The Chinese medical discrimination typing is a liver qi stagnation type, and disease is seen:
2 Therapeutic Method
Adopt the present invention, each 6 grams, three times on the one, treated altogether 2 months, the present invention is by Radix Bupleuri, Radix Scutellariae, the Rhizoma Pinelliae, Radix Codonopsis, Radix Glycyrrhizae, Os Draconis, Concha Ostreae, Concha Margaritifera, Rhizoma Zingiberis Recens, Fructus Jujubae is formed, every bottle 60 gram dress.
3 criterions of therapeutical effect
Criterion of therapeutical effect evaluation with reference to " the clinical research guideline of new Chinese medicine Cure for insomnia " in " the new Chinese medicine clinical research guideline " of Ministry of Public Health formulation in 1993.
1. clinical recovery: recover the length of one's sleep normal or the nighttime sleep time increased to more than 6 hours, sleep is dull, and the back of waking up is hale and hearty; 2. produce effects: sleep is clearly better, and increases the length of one's sleep more than 3 hours, and Depth of sleep increases; 3. effective: sx, the length of one's sleep, more preceding increase less than was 3 hours; 4. invalid: sleep does not have obviously improvement or the anti-person of increasing the weight of.
4 therapeutic outcomes
Among the 106 routine insomnia of depression of liver-QI type patients, clinical recovery 28 examples; Produce effects 36 examples; Effective 32 examples; Invalid 10 examples.Total effective rate 90.56%.
5 discuss
Insomnia, Chinese medicine is called is insomnia, and the lighter shows as difficulty falling asleep, sleeps and then easily wakes up, and weight person is insomnia all night, is clinically commonly encountered diseases, frequently-occurring disease, has a strong impact on patient's work and quality of life.Says among the Zhang Jiebin " Jing Yue's complete work is insomnia ": " lid this moon of sleeping, refreshing its master also, Shen Anze sleeps, refreshing uneasiness then is insomnia ".The five internal organs all have is insomnia, and in close relations with liver, it is multiple that the cause of disease of being insomnia has, and how relevant with disorder of emotion, Zhou Shi reports (3), and 30 examples wherein belong to caused by hepatic stagnation qi stagnation 22 examples, type of deficiency of both the heart and spleen 3 examples, type of hyperactivity of fire caused by deficiency of YIN 2 examples, liver-energy depressing and liver-yin deficiency syndrome 2 examples in maintaining secrecy.Caused by hepatic stagnation qi stagnation example number is maximum, and 24 examples are arranged, and accounts for this group 80%.
It is in close relations with liver to be insomnia, and this is because of liver controlling conveyance and dispersion, blood stored in the liver, and harmonizing the functional activities of vital QI, harmonizing emotions, the liver controlling conveyance and dispersion function is normal, and then QI and blood is in harmonious proportion, and five will peacefulnesses, feelings will also with smooth, are slept awake freely; If the liver failing to maintain the normal flow of QI, the unusual of feelings will such as insomnia and dreamful sleep then can appear.Otherwise, extraneous direct stimulation, particularly disgruntled, cause the catharsis malfunction of liver, depression of liver-QI appears, and harmonizing emotions is become estranged and is seen dysphoria and insomnia, irritability or joyless.Say when Song's Xu Shuwei is discussed the cause of disease of being insomnia in " general Ji ability side volume one ": " the normal person liver is not subjected to heresy, and soul belongs to liver so crouch then, and god is quiet and must sleep.Modern liver has heresy, and soul must not be returned, and is to raise if exsomatize also with then soul for sleeping in." this meaning just, therefore, treatment is insomnia, and should control from the liver opinion; and the soothing the liver routine treatment the most of the method resolving depression for the treatment of the liver, and the easiest gram of liver cuts down spleen soil, and the method for spleen for " know that liver violate spleen, tonifying the spleen in the ban " protected in ridging; the easiest excited and superinverse of irritability, and to fall the contrary suppressing the hyperactive liver in town high but Jie's class is dived, and also is the key medicine for the treatment of the liver.
Bavin Long Xieyudan adds Os Draconis by Herba Sidae Rhombifoliae soup, Concha Ostreae, Concha Margaritifera forms, Herba Sidae Rhombifoliae soup is few positive Liver Channel first party, aim at treating SHAO YANG disease by mediation and establish, have dispersing the stagnated live-QI to relieve the stagnation of QI, the power of stomach function regulating spleen invigorating, and its effect has YIN and YANG balance regulating, the effect of harmonizing emotions, the little hardship of Radix Bupleuri is slightly cold in the side, goes into Liver Channel, and dispersing the stagnated live-QI to relieve the stagnation of QI is monarch, Radix Scutellariae bitter in the mouth light weight liver heat removing gallbladder, the heat of the part of the body cavity above the diaphragm housing the heart and lungs, the Rhizoma Pinelliae relieving accumulation of pathogens that reduces phlegm also is the key medicine of calming the nerves, Os Draconis, Concha Ostreae, the latent town that falls of Concha Margaritifera is contrary, tranquillization with heavy prescription is a minister, the product impairment of the spleen of the gas of Radix Codonopsis invigorating the heart and spleen and anti-heavily bobs is for helping, Radix Glycyrrhizae Preparata help the Radix Codonopsis QI invigorating with in, and coordinating the actions of various ingredients in a prescription is for making, Rhizoma Zingiberis Recens, Fructus Jujubae protects the spleen stomach function regulating and also is messenger drug, all medicines are long memorial liver resolving depression altogether, the merit of tranquillizing and allaying excitement is used for because of depression of liver-QI, and expectorant heat is disturbed being insomnia due to the god.
Three, list of references
[1] Chinese Medical Association's psychiatric department branch. Chinese mental disorder classification and diagnostic criteria [S]. the third edition. Jinan: Shandong science tech publishing house, 2001:118-119.
[2] State Administration of Traditional Chinese Medicine. traditional Chinese medical science disease diagnosis criterion of therapeutical effect [S]. Nanjing: publishing house of Nanjing University,
1994:19-20.
[3] all exhibitions, red being permitted very, Jiang Youqian, Zhang Min is insomnia and controls from the liver opinion: journal of shanghai Chinese medicine 1994,10.

Claims (2)

1. the medicine of a Cure for insomnia is characterized in that it is the medicament of being made by the following weight proportion raw material:
Radix Bupleuri 3~24g, Radix Scutellariae 3~24g,
Rhizoma Pinelliae Preparatum 3~12g, Radix Glycyrrhizae Preparata 3~15g,
Os Draconis 9~60g, Concha Ostreae 9~60g,
Radix Codonopsis 9~30g, Concha Margaritifera 9~60g,
Rhizoma Zingiberis Recens 3~30g, Fructus Jujubae 6~30g.
2. the preparation method of the medicine of the described Cure for insomnia of claim 1, it is characterized in that: (1) concocts processing with Radix Bupleuri Radix Scutellariae, Rhizoma Pinelliae Preparatum, Radix Codonopsis, 100 mesh sieves are crossed in 80 ℃ of dryings, pulverizing, the medical material fine powder, standby; (2) Radix Glycyrrhizae Preparata, Os Draconis, Concha Ostreae, Concha Margaritifera, Rhizoma Zingiberis Recens, Fructus Jujubae are added 8~10 times of water gagings immersions respectively and decoct after 1~3 hour, the elimination residue, concentrating filter liquor gets extractum, and is standby; (3) above-mentioned fine powder and extractum mixing, pill, 80 ℃ of dryings, polishing, packings get final product.
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103977188A (en) * 2014-04-18 2014-08-13 姜晓红 Traditional Chinese medicine composition for treating insomnia
CN104138592A (en) * 2014-08-06 2014-11-12 绍兴市第七人民医院 Traditional Chinese medicine for universality anxiety disorder curing
CN108159382A (en) * 2018-02-12 2018-06-15 山西省中医药研究院 A kind of medicine of insomnia with anxiety-depression
CN114470146A (en) * 2022-01-26 2022-05-13 河南中医药大学 Traditional Chinese medicine composition for treating phlegm-heat internal disturbance type insomnia and preparation method thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
《中医经典著作选读》 19930228 戴锡孟 《中医经典著作选读》 中国医药科技出版社 第95,97页 1-2 , 第1版 1 *
《中药学》 20030228 高学敏 《中药学》 中国中医药出版社 第452,465,466页 1-2 , 第1版 1 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103977188A (en) * 2014-04-18 2014-08-13 姜晓红 Traditional Chinese medicine composition for treating insomnia
CN104138592A (en) * 2014-08-06 2014-11-12 绍兴市第七人民医院 Traditional Chinese medicine for universality anxiety disorder curing
CN108159382A (en) * 2018-02-12 2018-06-15 山西省中医药研究院 A kind of medicine of insomnia with anxiety-depression
CN108159382B (en) * 2018-02-12 2020-10-27 山西省中医药研究院(山西省中医院) Medicine for treating insomnia accompanied with anxiety and depression
CN114470146A (en) * 2022-01-26 2022-05-13 河南中医药大学 Traditional Chinese medicine composition for treating phlegm-heat internal disturbance type insomnia and preparation method thereof

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