CN103341074A - Application of Yixuanning granules in preparation of medicaments for treating insomnia - Google Patents

Application of Yixuanning granules in preparation of medicaments for treating insomnia Download PDF

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Publication number
CN103341074A
CN103341074A CN2013103199900A CN201310319990A CN103341074A CN 103341074 A CN103341074 A CN 103341074A CN 2013103199900 A CN2013103199900 A CN 2013103199900A CN 201310319990 A CN201310319990 A CN 201310319990A CN 103341074 A CN103341074 A CN 103341074A
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yixuanning
insomnia
granules
granule
preparation
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王茂祥
贺天鹏
于静涛
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TONGHUA MAOXIANG PHARMACEUTICAL Co Ltd
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TONGHUA MAOXIANG PHARMACEUTICAL Co Ltd
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Abstract

The invention relates to a new application of a traditional Chinese medicine preparation, namely an application of Yixuanning granules in preparation of medicaments for treating insomnia. The Yixuanning granules have the functions of tranquilizing liver and yang, lowering fire, clearing phlegm, nourishing blood, invigorating spleen, expelling wind and clearing away heat, and can be used for treating hyperactivity of liver yang and qi and blood deficiency type vertigo; and simultaneously, the effect on treating insomnia is also great. The Yixuanning granules are the granules and have the characteristics of convenience in carrying, convenience in administration, good taste, easiness in preservation and stable active pharmaceutical ingredients. The Yixuanning granules are the traditional Chinese medicine preparation, and have the advantages of small side effects in the treatment on insomnia in comparison with western medicines, high sleep quality, no medicament dependence and the like. The clinical observation of 86 patients with insomnia, who take the Yixuanning granules, shows that the total effective rate is above 95.35%.

Description

The application of YIXUANNING granule in preparation Cure for insomnia medicine
Technical field
The present invention relates to a kind of new purposes of Chinese medicine preparation, namely the YIXUANNING granule is as the application of preparation Cure for insomnia medicine.
Background technology
Insomnia is a kind of common disease, also claims to be insomnia or " insomnia ", " must not crouch ", " order does not set ", refers to often can not obtain the disease that ortho sleep is feature.The state of an illness weight of being insomnia differs, and the lighter has difficulty of falling asleep, and sleep but easy to wake is arranged, and has can not sleep after waking up again, the person that also has the sometimes sleeping and sometimes waking, and severe patient then can not be fallen asleep whole night.Insomnia can occur separately, also can with headache, dizzy, cardiopalmus, the forgetful card that waits occurs simultaneously.
The medicine that uses in Cure for insomnia at present is more, in, Western medicine has, curative effect is different, western medicine insomnia all exists untoward reaction, medicine strong according to lazyness, and sleep quality is not high, and motherland's medicine has own original advantage aspect Cure for insomnia, it is little to have side effect, sleep quality height, characteristics such as no drug dependence.
In the prior art, commercially available YIXUANNING granule is produced (the accurate word Z20010023 of traditional Chinese medicines) by the luxuriant auspicious pharmaceutical Co. Ltd in Tonghua, and its prescription is for Arisaema Cum Bile, Fructus Lycii, the pig iron fall, Concha Ostreae (forging), Poria, Flos Chrysanthemi, Fructus Xanthii (stir-fry), the Radix Paeoniae Alba, Caulis Bambusae In Taenia, Radix Scutellariae, Fructus Crataegi, Pericarpium Citri Reticulatae.Rise hardship with the Arisaema Cum Bile suffering in the side and fall, removing heat-phlegm, relieving convulsion fixed dizzy, close the Fructus Lycii nourishing the liver and kidney, one liter of one benefit, one grows one falls, and is monarch drug altogether.With Poria invigorating the spleen and regulating the stomach, mind tranquilizing and the heart calming and the eliminating dampness by diuresis of reducing phlegm, the salty kindization pertinacious phlegm to the greatest extent of Concha Ostreae, nourishing YIN for attracting YANG, tranquillizing and allaying excitement, the Radix Paeoniae Alba yin fluid astringing that nourishes blood, easing the affected liver to relieve pain, the Flos Chrysanthemi wind and heat dispersing, " take the photograph and receive decline; the suppressing the hyperactive liver fire, put out endogenous wind, press down the perverse and unreasonable manner of wood gas, more than five medicines think minister.The pig iron clearing away heat-fire that falls, checking hyperfunction of the liver for relieving convulsion, Fructus Crataegi dissipating blood stasis removing food stagnancy, the Radix Scutellariae heat clearing and damp drying, eliminating fire and detoxication is adjuvant drug altogether.The Fructus Xanthii expelling pathogenic wind and eliminating dampness, saturating brain is up, Pericarpium Citri Reticulatae circulation of qi promoting spleen invigorating, drying dampness to eliminate phlegm draws all medicines and reaches in sick institute and for making medicine.Function is suppressing the hyperactive liver and subsiding YANG, pathogenic fire reducing clearing away phlegm, the spleen invigorating of nourishing blood, expelling wind and clearing away heat with curing mainly.Cure mainly excessive rising of liver-YANG, the QIXUELIANGXU type vertigo, the application in the medicine of preparation insomnia does not appear in the newspapers.
Summary of the invention
The objective of the invention is to provide at above-mentioned deficiency a kind of new purposes of YIXUANNING granule, namely the YIXUANNING granule increases its indication as the application of preparation Cure for insomnia medicine.
Technical solution of the present invention is: the YIXUANNING granule is as the application of preparation Cure for insomnia medicine; Described YIXUANNING granule is made by the crude drug of following weight: Arisaema Cum Bile 75g, Fructus Lycii 100g, the pig iron fall 75g, Concha Ostreae (calcined) 100g, Poria 100g, Flos Chrysanthemi 75g, Fructus Xanthii (parched) 100g, Radix Paeoniae Alba 75g, Caulis Bambusae In Taenia 75g, Radix Scutellariae 75g, Fructus Crataegi 50g, Pericarpium Citri Reticulatae 75g.
More than 12 flavors, it is an amount of to get that the pig iron falls, Concha Ostreae adds water, decocts 2 hours, add Fructus Xanthii, Flos Chrysanthemi, Arisaema Cum Bile, Caulis Bambusae In Taenia, Pericarpium Citri Reticulatae again and continue to decoct three times, be followed successively by 1,1,0.5 hour, gradation filters, it is 1.0~1.2(80~90 ℃ that merging filtrate, filtrate are concentrated into relative density) clear paste.All the other Radix Scutellariaes, the Radix Paeoniae Alba, Poria, Fructus Crataegi, Fructus Lycii etc. decoct with water twice, are followed successively by 1,0.5 hour, and gradation filters, merge filtration, it is 1.1~1.2(50 ℃ that filtrate is concentrated into relative density), the ethanol of adding equivalent, stir, left standstill 24 hours, filter, reclaim ethanol, ethanol extraction and above-mentioned thick paste merge, and add adjuvant, mixing is granulated drying, make 1000g, adorn 100 bags, every bag of heavy 10g of YIXUANNING granule.
Pharmaceutical dosage form is not limited thereto, and the pharmaceutical carrier by commonly used in above-mentioned each medicinal raw material and the pharmacy can be mixed and made into tablet, capsule, powder, pill, liquid preparation or other conventional formulation as excipient or adjuvant.
From traditional Chinese medical science angle, insomnia is five types substantially:
(1) excess syndrome
1. pathogenic fire derived from stagnation of liver-QI primary symptom: insomnia, being irritable and irascible, anorexia, thirst and liking drink, red eyes and bitter taste in the mouth, yellowish or reddish urine, constipation.Red tongue, yellow fur, wiry and frequent pulse.
2. disturb in the expectorant heat: primary symptom: insomnia with heavy sensation of the head, have a dizzy spell, excessive sputum and oppression feeling over the chest, vexed bitter taste is disliked food, nausea and acid regurgitation.Greasy and yellow fur, slippery and rapid pulse.
(2) deficiency syndrome
1. hyperactivity of fire caused by deficiency of YIN: primary symptom: dysphoria and insomnia, dizzy cardiopalmus, soreness of the loins and nocturnal emission, tinnitus, forgetful, dry mouth and lack of saliva, dysphoria with feverish sensation in the chest palms and soles.Red tongue, few tongue, thready and rapid pulse.
2. deficiency of both the heart and spleen: primary symptom: dream is many easily wakes up, and palpitation and amnesia is had a dizzy spell, lassitude of the limbs and mind, and the food of receiving is tasteless, lustreless complexion.Light red tongue, thin fur, thready and weak pulse.
3. the heart and gallbladder deficiency of vital energy
Primary symptom: the dreaminess of being insomnia, be easy to wake up with a start, timidity and palpitation, susceptible to fright when anything crops up, shortness of breath and lassitude, clear urine in large amounts.Light red tongue, stringy and thready pulse.
The YIXUANNING granule has suppressing the hyperactive liver and subsiding YANG, the pathogenic fire reducing clearing away phlegm, and the spleen invigorating of nourishing blood, the function of expelling wind and clearing away heat can be used for the treatment of insomnia.
Insomnia belongs to the Chinese medicine category of being insomnia, and refers to obtain the disease that ortho sleep is feature.The lighter has difficulty falling asleep, has easily to wake up in sleeping, and has can not sleep after sleeping etc. again, and weight person then can not fall asleep whole night.The void of having traced it to its cause has reality.Void person is many because of due to hyperactivity of fire caused by deficiency of YIN, deficiency of both the heart and spleen, the heart and gallbladder deficiency of vital energy; Reality person is many because of pathogenic fire derived from stagnation of liver-QI, due to disturbing in the expectorant heat.
The YIXUANNING granule rises hardship with the Arisaema Cum Bile suffering and falls, and removing heat-phlegm is relieving convulsion fixed dizzy, closes the Fructus Lycii nourishing the liver and kidney, one liter of one benefit, and one grows one falls, and is monarch drug altogether.With Poria invigorating the spleen and regulating the stomach, mind tranquilizing and the heart calming and the eliminating dampness by diuresis of reducing phlegm, the salty kindization pertinacious phlegm to the greatest extent of Concha Ostreae, nourishing YIN for attracting YANG, tranquillizing and allaying excitement, the Radix Paeoniae Alba yin fluid astringing that nourishes blood, easing the affected liver to relieve pain, the Flos Chrysanthemi wind and heat dispersing, " take the photograph and receive decline; the suppressing the hyperactive liver fire, put out endogenous wind, press down the perverse and unreasonable manner of wood gas, more than five medicines think minister.The pig iron clearing away heat-fire that falls, checking hyperfunction of the liver for relieving convulsion, Fructus Crataegi dissipating blood stasis removing food stagnancy, the Radix Scutellariae heat clearing and damp drying, eliminating fire and detoxication is adjuvant drug altogether.The Fructus Xanthii expelling pathogenic wind and eliminating dampness, saturating brain is up, Pericarpium Citri Reticulatae circulation of qi promoting spleen invigorating, drying dampness to eliminate phlegm draws all medicines and reaches in sick institute and for making medicine.
Usage and consumption: oral YIXUANNING granule, one time 1 bag, 3 times on the one, one month is a course for the treatment of, take effect a general course for the treatment of.
Advantage of the present invention is: 1. the YIXUANNING granule has suppressing the hyperactive liver and subsiding YANG, the pathogenic fire reducing clearing away phlegm, and the spleen invigorating of nourishing blood, the function of expelling wind and clearing away heat, the treatment excessive rising of liver-YANG, the QIXUELIANGXU type vertigo while, the Cure for insomnia effect is also fine.2. the YIXUANNING granule is granule, have easy to carry, taking convenience, mouthfeel is good, easily preserves the characteristics that effective ingredient is stable.3. the YIXUANNING granule is Chinese medicine preparation, and it is little that Cure for insomnia has a side effect than Western medicine, sleep quality height, advantages such as no drug dependence.4. through clinical 86 insomniacs are taken observation, total effective rate is more than 95.35%.
Below in conjunction with example the present invention is described in further detail.
The specific embodiment
Embodiment
The YIXUANNING granule is as the application of preparation Cure for insomnia medicine; Described YIXUANNING granule is made by the crude drug of following weight: Arisaema Cum Bile 75g, Fructus Lycii 100g, the pig iron fall 75g, Concha Ostreae (forging) 100g, Poria 100g, Flos Chrysanthemi 75g, Fructus Xanthii (stir-fry) 100g, Radix Paeoniae Alba 75g, Caulis Bambusae In Taenia 75g, Radix Scutellariae 75g, Fructus Crataegi 50g, Pericarpium Citri Reticulatae 75g.More than 12 flavors, it is an amount of to get that the pig iron falls, Concha Ostreae adds water, decocts 2 hours, add Fructus Xanthii, Flos Chrysanthemi, Arisaema Cum Bile, Caulis Bambusae In Taenia, Pericarpium Citri Reticulatae again and continue to decoct three times, be followed successively by 1,1,0.5 hour, gradation filters, it is 1.0~1.2(80~90 ℃ that merging filtrate, filtrate are concentrated into relative density) clear paste.All the other Radix Scutellariaes, the Radix Paeoniae Alba, Poria, Fructus Crataegi, Fructus Lycii etc. decoct with water twice, are followed successively by 1,0.5 hour, and gradation filters, merge filtration, it is 1.1~1.2(50 ℃ that filtrate is concentrated into relative density), the ethanol of adding equivalent, stir, left standstill 24 hours, filter, reclaim ethanol, ethanol extraction and above-mentioned thick paste merge, and add adjuvant, mixing is granulated drying, make 1000g, adorn 100 bags, every bag of heavy 10g of YIXUANNING granule.
Experimental example
Clinical trial
As follows through test that 86 insomniacs (as following table) have been carried out taking medicine:
Figure 2013103199900100002DEST_PATH_IMAGE001
The age-sex
20-30 year 30-40 year 40-50 year More than 50 years old Add up to
The male 3 7 11 23 44
The women 5 6 13 18 42
Add up to 8 13 24 41 86
More than 86 patients all be primary symptom with the insomnia, sleep difficulty or sleep and easily wake up of the lighter people is insomnia after waking up, weight person lies awake all night, the course of disease is all more than 3 weeks, how with diseases such as headache and dizzy, spiritlessness and weakness, palpitation and amnesia, malaise, dreaminess.Male 44 examples wherein, women 42 examples; Age 20-62 year, average 40.3 years old; The course of disease 3 months~6.5 years, average 3.8 years; Informal dress is stabilized person's 24 examples, uses other Chinese medicine person 16 examples.
Instructions of taking: oral YIXUANNING granule, one time 1 bag, 3 times on the one, one month is a course for the treatment of, take effect a general course for the treatment of, the responder obeys 1-2 the course for the treatment of, nonresponder's drug withdrawal according to circumstances again.Other tranquilizers of all stopping using during the treatment.Follow up a case by regular visits to half a year.
Insomnia diagnostic criteria: formulate with reference to State Administration of Traditional Chinese Medicine's " traditional Chinese medical science disease diagnosis criterion of therapeutical effect ".
1 the lighter's difficulty of falling asleep or sleep but easy to wake is insomnia after waking up, and weight person lies awake all night.
2 often with headache, giddy, and cardiopalmus, forgetful, diseases such as dreaminess.
3 is no abnormal through each system and lab testing.
Insomnia clinical development standard:
1 recovery from illness: recover the length of one's sleep normally or reach the length of one's sleep more than 6 hours, the back of waking up is energetic, and simultaneous phenomenon disappears substantially;
2 produce effects: the length of one's sleep, simultaneous phenomenon alleviated about 5 hours every night, and the state of an illness develops to the recovery from illness direction gradually;
3 is effective: the length of one's sleep, simultaneous phenomenon took a turn for the better not obvious between 3-4 hour every night;
4 is invalid: every night the length of one's sleep less than 2 hours, simultaneous phenomenon is not seen and is improved or increase the weight of.
Find that through observing the YIXUANNING granule has suppressing the hyperactive liver and subsiding YANG, the pathogenic fire reducing clearing away phlegm, the spleen invigorating of nourishing blood, the function of expelling wind and clearing away heat namely can be treated the insomnia excess syndrome of fire derived from stagnation of liver-QI type and type of phlegm-heat attacking internally, also can treat the insomnia deficiency syndrome of type of hyperactivity of fire caused by deficiency of YIN, type of deficiency of both the heart and spleen and type of deficiency of heart-QI and gallbladder-QI.
The curative effect of YIXUANNING granule therapy insomnia
Curative effect Recovery from illness Produce effects Effectively Invalid
Number 44 26 12 4
Account for total number of persons % 51.17 30.23 13.95 4.65
The YIXUANNING granule is satisfactory through clinical test results, and this drug side effect is little, the sleep quality height, and advantages such as no drug dependence, total effective rate is more than 95.35%.
Model case
1, Li Hailong, man, 20 years old.Graduating high school graduate in 2010.The patient is introverted usually, and few speech is learnt better in the school at ordinary times.Because college entrance examination in this year is failed in an entrance examination, occur depressed, pessimism.Among the genus reason, so do not add attention.Insomnia appears in the back, and companion's dysphoria is uncomfortable in chest, the time heaviness of the head with dazzle, anorexia arranged, feel sick, disease such as belch acid regurgitation.Once did multiple inspection in hospital, and took medicine treatments such as oryzanol, ranitidine, stable, nourishing blood to tranquillize the mind sheet, SHUGAN HEWEI WAN, but undirected heal million, until lying awake all night at present.Previously check: the unenhanced no abnormality seen of cranium brain CT.Brain electrical activity mapping shows: normal range EEG, BEAM.TCD checks: its internal carotid artery system, vertebra basilar artery blood flow frequency spectrum form and peak value all belong to normally.Hematuria routine, electrocardiogram, Chest X-rays etc. check all no abnormal discoveries.Look into 0 kPa of BP 16. 0/10..Examine its patient's yellowish fur, examine its stringy and rolling pulse.In conjunction with medical history, comprehensive analysis to both pulse manifestation and symptoms is diagnosed as and disturbs institute's induced insomnia in the expectorant heat.The oral YIXUANNING granule of patient, one time 1 bag, 3 times on the one, take effect after the week.After the oral course for the treatment of, all diseases disappear, its sick announcement more.Follow up a case by regular visits to not recurrence again in 6 months.
2, Lin Li, the woman, 49 years old, because of the noisy dispute of family, insomniac 3 months.Slept thorough sleeplessness when heavy, absentminded, pale complexion palpitation and amnesia, soreness of the waist and knees, poor appetite, cisco unity malfunction every night 2 to 3 hours.Look into: thin white fur of tongue, matter secretly have trace speckle, thready and weak pulse.Routine blood test: hemoglobin 90g/L, leukocyte 5.1x10 9/ L.Electrocardiogram: inferior myocardium fatigue.Oral YIXUANNING granule, one time 1 bag, 3 times on the one, after 10 days, symptom is clearly better, and can sleep every night about 5 hours, body of the tongue addiction speckle disappears, and transfers to normal.After taking two courses for the treatment of, all diseases disappear, and sleep can reach 7 to 8 hours.Check routine blood test: hemoglobin 115g/L, leukocyte 6.1x10 9/ L.Electrocardiogram: roughly normal.Resume work, insomnia is accused more.
The YIXUANNING granule is the Cure for insomnia determined curative effect clinically, and side reaction is few, has obtained patient's approval, is worth applying aspect Cure for insomnia.

Claims (1)

1. the YIXUANNING granule is as the application of preparation Cure for insomnia medicine; Described YIXUANNING granule is made by the crude drug of following weight: Arisaema Cum Bile 75g, Fructus Lycii 100g, the pig iron fall 75g, Concha Ostreae (calcined) 100g, Poria 100g, Flos Chrysanthemi 75g, Fructus Xanthii (parched) 100g, Radix Paeoniae Alba 75g, Caulis Bambusae In Taenia 75g, Radix Scutellariae 75g, Fructus Crataegi 50g, Pericarpium Citri Reticulatae 75g.
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104940702A (en) * 2015-07-15 2015-09-30 通化茂祥制药有限公司 Application of suppression dizzy granules in preparation of medicine for curing infantile thermal shock infantile convulsions and convulsions of limbs
CN104997870A (en) * 2015-06-29 2015-10-28 薛红梅 Traditional Chinese medicinal preparation for treating liver depression forming fire type insomnia
CN105106352A (en) * 2015-09-07 2015-12-02 薛红梅 Traditional Chinese medicine preparation for treating insomnia caused by pathogenic fire derived from stagnation of liver-qi
CN106075125A (en) * 2016-07-11 2016-11-09 南京多宝生物科技有限公司 A kind of YIXUANNING JIAONANG and preparation method thereof

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CN102359941A (en) * 2011-10-07 2012-02-22 通化正和药业有限公司 Yixuanning capsule, its identification and content determining method

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CN1593481A (en) * 2004-02-18 2005-03-16 于永生 Chinese patent medicine for treating neurasthenia
CN102359941A (en) * 2011-10-07 2012-02-22 通化正和药业有限公司 Yixuanning capsule, its identification and content determining method

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104997870A (en) * 2015-06-29 2015-10-28 薛红梅 Traditional Chinese medicinal preparation for treating liver depression forming fire type insomnia
CN104940702A (en) * 2015-07-15 2015-09-30 通化茂祥制药有限公司 Application of suppression dizzy granules in preparation of medicine for curing infantile thermal shock infantile convulsions and convulsions of limbs
CN104940702B (en) * 2015-07-15 2018-07-03 通化茂祥制药有限公司 Press down application of the dizzy peaceful particle in preparation treatment children suddenly hot infantile convulsion, tic of limbs drug
CN105106352A (en) * 2015-09-07 2015-12-02 薛红梅 Traditional Chinese medicine preparation for treating insomnia caused by pathogenic fire derived from stagnation of liver-qi
CN106075125A (en) * 2016-07-11 2016-11-09 南京多宝生物科技有限公司 A kind of YIXUANNING JIAONANG and preparation method thereof

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Application publication date: 20131009