CN1872186A - Compound capsule of Chinese date kernel, and preparation method - Google Patents
Compound capsule of Chinese date kernel, and preparation method Download PDFInfo
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- CN1872186A CN1872186A CN 200610078947 CN200610078947A CN1872186A CN 1872186 A CN1872186 A CN 1872186A CN 200610078947 CN200610078947 CN 200610078947 CN 200610078947 A CN200610078947 A CN 200610078947A CN 1872186 A CN1872186 A CN 1872186A
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Abstract
A medicine in the form of capsule for treating insomnia is prepared from wild jujube and levo-corydalis B through breaking wild jujube, decocting, filtering concentrating, depositing in alcohol, taking supernatant, recovering alcohol, concentrating, drying, pulverizing, adding levo-corydalis B and starch, mixing and loading in capsules.
Description
Technical field
The present invention relates to a kind of Chinese medicine of calming the nerves and preparation method thereof, be specifically related to a kind of FUFANG ZAOREN JIAONANG and preparation method thereof.
Background technology
Insomnia belongs to motherland's medical science category of " being insomnia ", the mechanism of its morbidity crucial for the heart become homeless foster, irritability, so tranquilizing by nourishing the heart is the common method of Cure for insomnia.Traditional Chinese medical science ancient books thinks that Semen Ziziphi Spinosae " obeys settling five organs; make light of one's life by commiting suicide and prolong life " " control insomnia due to insufficiency of the gallbladder-qi " for a long time, Gu the Chinese medicine of Cure for insomnia is many to be principal agent with the Semen Ziziphi Spinosae, discloses a kind of sedative jujube kernel capsule as China Patent No. CN1435206A, it is to be made by Semen Ziziphi Spinosae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis three flavor medicines; China Patent No. CN1406624A discloses a kind of pharmaceutical composition with the sedation of reposing, and this choice of drug Semen Ziziphi Spinosae, Radix Polygalae, Plumula Nelumbinis, Margarita are that primary raw material is made.These two kinds of patent drugs all are to be that crude drug is made by Chinese herbal medicine, exist shortcomings such as the crude drug consumption is big, curative effect is not remarkable.And the Western medicine of symptoms such as the multiple treatment headache that occurs on the market, cardiopalmus, insomnia also exists action time short, the shortcoming that disease can not be effected a radical cure.Therefore, the medicine that needs a kind of rapid-action, safety, Cure for insomnia that untoward reaction is few.
Summary of the invention
The object of the present invention is to provide a kind of FUFANG ZAOREN JIAONANG and preparation method thereof, be mainly used in irritability, insomnia, dreaminess, symptoms such as palpitation with fear reach the purpose of feeling at ease to repose.
Principal agent Semen Ziziphi Spinosae of the present invention can significantly strengthen the hypnotic effect of tetrahydropalmatine, and strengthens with the increase of Semen Ziziphi Spinosae dosage, and toleration can appear in tetrahydropalmatine, but Semen Ziziphi Spinosae does not have toleration, and the two 5 usefulness can be offset the generation of tetrahydropalmatine toleration.
" the active ingredient of autonomic drug handbook was carried in 1986, and the raceme tetrahydropalmatine has significant analgesia, hypnosis, calmness and hypotensive activity, and the pain relieving of rotundine and syngignoscism are strong than the raceme tetrahydropalmatine.
The present invention is made by following materials of weight proportions medicine: 5000～7500 parts of Semen Ziziphi Spinosaes, 45～70 parts of rotundines, 50～75 parts of starch.
The present invention can also be made by following materials of weight proportions medicine: 5500～7000 parts of Semen Ziziphi Spinosaes, 50～65 parts of rotundines, 55～70 parts of starch.
The optimum weight proportioning that the present invention forms is: 6000 parts of Semen Ziziphi Spinosaes, 60 parts of rotundines, 60 parts of starch.
The capsular preparation method of the present invention is: spiny jujuba seed powder is broken into coarse powder, crosses 24～65 mesh sieves, at 90 ℃ to boiling temperature, decoct with water 2 times, add 4～8 times of water gagings of Semen Ziziphi Spinosae gross weight the 1st time, add 3～5 times of water gagings of Semen Ziziphi Spinosae gross weight the 2nd time, each 1～3 hour, filter, filtrate is concentrated into 5000～7000ml, add equivalent ethanol, stir, left standstill the leaching supernatant 8～16 hours, reclaim ethanol to there not being the alcohol flavor, be condensed into thick paste, drying is ground into fine powder, cross 80～100 mesh sieves, add rotundine and starch, mixing is pulverized, cross 60～90 mesh sieves, incapsulate.
Weight portion of the present invention is corresponding with gram, and used crude drug rotundine is commercially available prod (Xieli Pharmaceutical Co., Ltd., Sichuan's production).
Usage and dosage: oral, one time 1, the preceding clothes of sleeping.
Specification: every dress 0.4g (containing rotundine 60mg)
Pharmacodynamic test of active extract result of the present invention shows: the length of one's sleep of FUFANG ZAOREN JIAONANG energy significant prolongation penthiobarbital, pentobarbital sodium, and can make the pentobarbital sodium of sub-threshold dose sleeping, show that this product has tangible sedative-hypnotic effect.In addition, FUFANG ZAOREN JIAONANG also has certain analgesia and anti-frightened effect, can be used for accompanying the insomniac of pain discomfort.The sedative-hypnotic effect effective dose of FUFANG ZAOREN JIAONANG is about 0.034～0.067g/kg body weight, and its LD50＞8.10g/kg body weight, shows that FUFANG ZAOREN JIAONANG is a Chinese patent medicine safely and effectively.
The present invention shows that through the checking of hospital clinicals such as the attached First Academy of Medical University Of Chongqing this product is used for the insomnia, and total effective rate is 84.15%, and reference substance Cinnabar Sedative Pill total effective rate is 67.06%, and the methaqualone total effective rate is 81.61%.Do further to observe in conjunction with hospital application this product Cure for insomnia diseases such as hospitals through the Chongqing traditional Chinese medical science in addition, the result shows that its total effective rate is 84.5%.
The clinical research report of FUFANG ZAOREN JIAONANG:
The present invention has been carried out 147 routine insomnias' clinical research, and result of study shows: 106 examples are organized in treatment, and clinical cure-remarkable-effectiveness rate is 55.5%, and total effective rate is 84.5%; Matched group 41 examples, clinical cure-remarkable-effectiveness rate are 34.5%, and total effective rate is 69.0%.In the clinical observation process, do not find untoward reaction.Now be reported as follows:
1. clinical data
1.1 physical data
This data totally 147 examples 1.1.1 case is originated, wherein: clinic case 122 examples, inpatient's 25 examples.Be divided into three groups in order at random, wherein merge into the treatment group for two groups, one group is matched group.
1.1.2 among the routine patient of ages 147, under 18 years old, oldest 59 years old, the age distribution situation saw Table 1.
Table 1. liang group age distribution
| Group | The example number | Below 30 years old | 30-50 year | More than 51 years old | U | P |
| Treatment group matched group | 106 41 | 24 11 | 57 26 | 25 4 | 0.170 | ＞0.05 |
Table 1 shows, two groups of case age distribution there was no significant differences.
1.1.3 among the sex 147 routine patients, male's 61 examples, women's 86 examples.Two groups of sex ratio situations see Table 2.
Table 2. liang group sex ratio
| Group | The example number | The man | The woman | X 2 | P |
| Treatment group matched group | 106 41 | 39 22 | 67 19 | 2.804 | ＞0.05 |
Table 2 shows, two groups of case sex there was no significant differences.
1.1.4 among the course of disease 147 routine patients, the shortest about 1 month of the course of disease, the longest about 15 years, two groups of course of disease distribution situations saw Table 3.
Table 3. a liang group course of disease distributes
| Group | The example number | ～1 year | 1～5 year | 5～10 years | 10 years～ | U | P |
| Treatment group matched group | 106 41 | 24 11 | 57 26 | 25 4 | 7 2 | 0.387 | ＞0.05 |
Table 3 shows, two groups of case course of disease distribution there was no significant differences.
1.1.5 state of an illness weight 147 routine patients divide by the clinical observation scheme, state of an illness weight distribution situation sees Table 4.
Table 4. a liang group state of an illness weight distributes
| Group | The example number | Slightly | Moderate | Severe | U | P |
| Treatment group matched group | 106 41 | 29 14 | 63 19 | 14 8 | 0.441 | ＞0.05 |
Table 4 shows, two groups of case state of an illness weight distribution there was no significant differences.
1.1.6 Chinese medical discrimination 147 routine patients, dialectical by the clinical observation scheme, disease type distribution situation sees Table 5.
Table 5. a liang group disease type distributes
| Group | The example number | Hyperactivity of fire caused by deficiency of YIN | Deficiency of both the heart and spleen | The heart and gallbladder deficiency of vital energy |
| Treatment group matched group | 106 41 | 25 11 | 64 12 | 17 18 |
Table 5 statistics shows two groups of case disease type distribution there was no significant differences.
By above statistics as seen, treatment group and matched group clinical research have comparability.
1.2 diagnostic criteria
The tcm diagnosis standard
(1) classical symptom of insomnia is arranged: difficulty falling asleep, awakening often, sleep and unstable or wake up after can not sleep again; Wake up morning too early, can not fall asleep night, daytime lethargic and drowsy state; Do not have enough sleep 5 hours.
(2) history of repeated attack is arranged
Chinese medical discrimination
(1) hyperactivity of fire caused by deficiency of YIN disease
Dysphoria and insomnia or dreaming often and waking easily, dizziness and tinnitus, dry mouth and throat is not in the mood for dysphoria with smothery sensation, and the cardiopalmus sweating is forgetful, or soreness of the waist and knees is arranged, seminal emission, menoxenia, red tongue, thready and rapid pulse.
(2) deficiency of both the heart and spleen disease
Insomnia and dreamful sleep, palpitation and amnesia, physical fatigue and lassitude of spirit, the food poor appetite is few, or abdominal distention after meal, lustreless complexion, pale tongue, corpulent tongue, white and thin fur, thready and weak pulse.
(3) heart and gallbladder deficiency of vital energy disease
Insomnia and dreamful sleep, in time, easily wake up with a start, timid fearness sound, cardiopalmus, sensation of oppression over the chest with shortness of breath, corpulent tongue, white and thin fur, thready and weak pulse or stringy and thready pulse.
Insomnia weight grade scale
(1) slight: sleep is awakened often or is slept and unstable, and it is too early to wake up morning, but does not influence work.
(2) moderate: do not have enough sleep 4 hours, but still can adhere to work.
(3) severe: lie awake all night, be difficult to adhere to operate as normal.
1.2.2 case standard
Include the case standard in
Have the insomnia classical symptom, continue to meet Chinese medical discrimination standard person, can include the test case in more than 1 month.
Get rid of case standard (comprising inadaptation or rejecting standard)
(1) every systemic disease such as pain, heating, cough, operation etc., and external environmental interference factor causer.
(2) gestation or women breast-feeding their children are to this medicine allergy sufferers below 18 one full year of life or 65 above persons the age.
(3) be associated with serious primary disease person such as cardiovascular, lung, liver, kidney and hemopoietic system, psychotic.
(4) all standards of including in that do not meet, not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment and safety judgement person.
1.3 observation index
Safety observation
(1) general health check-up project
(2) blood, urine routine test
(3) liver, kidney function test.
Health giving quality observation
(1) length of one's sleep and sleep awakening degree.
(2) mental status after the awakening.
(3) person of having ready conditions can do the sleep electroencephalogram inspection.
1.4 curative effect determinate standard
(1) clinical recovery: recover the length of one's sleep normal or the nighttime sleep time more than 6 hours, sleep is dull, 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.
2. Therapeutic Method
2.1 treatment group: FUFANG ZAOREN JIAONANG (Chongqing Xi Eran Pharmaceutical is produced and provided) is provided, each 1-2 grain, obey half an hour before sleeping, and a course of treatment 2 Mondays, observes 1～2 course of treatment.
2.2 matched group: (the luxuriant auspicious pharmaceutical Co. Ltd in Tonghua produces lot number: 991001), take according to the medicine operation instructions, a course of treatment 2 Mondays, observe 1～2 course of treatment to take ANSHEN JIAONANG.
3. therapeutic outcome
3.1 two groups of curative effects relatively: see Table 6～7.
Table 6. liang group curative effect relatively
| Group | The example number | Clinical recovery | Produce effects | Effectively | Invalid | Obvious effective rate (%) | Total effective rate (%) |
| Treatment group matched group | 106 41 | 24 11 | 57 26 | 25 4 | 7 2 | 0.387 | ＞0.05 |
Table 6 result adds up demonstration, there was no significant difference between two groups of obvious effective rates and the total effective rate
Table 7. disease type curative effect relatively
| n | Clinical recovery | Produce effects | Effectively | Invalid | Obvious effective rate (%) | Total effective rate (%) | ||
| Hyperactivity of fire caused by deficiency of YIN | Treatment group matched group | 25 11 | 2 0 | 7 4 | 10 5 | 6 2 | 36.0 36.4 | 76.0 81.8 |
| Deficiency of both the heart and spleen | Treatment group matched group | 64 12 | 8 3 | 20 6 | 23 2 | 13 1 | 43.8 75.0 | 79.7 91.7 |
| The heart and gallbladder deficiency of vital energy | Treatment group matched group | 17 18 | 9 0 | 6 1 | 2 8 | 0 9 | 88.2 * 5.6 * | 100 * 50.0 |
Annotate: X
2Check,
*P＜0.01
4. untoward reaction
Two groups of totally 147 routine object of study are not seen obvious adverse reaction at viewing duration.Minority matched group patient states capsule and causes the stomach discomfort sense, and the treatment group is less because of dosing, and this reaction is not arranged.Treatment is organized in the 106 routine object of study, has made liver, kidney function test before and after the 32 example treatments, through more no abnormal.
Brief summary:
FUFANG ZAOREN JIAONANG of the present invention is made up of tetrahydropalmatine, Semen Ziziphi Spinosae etc., refines through science and makes capsule, has tranquilizing by nourishing the heart, the abirritative effect.Have clinically rapid-action, safety, characteristics such as untoward reaction is few are the Chinese patent medicines preferably of Cure for insomnia disease.By the clinical research observation of 106 examples, show: FUFANG ZAOREN JIAONANG is 49.1% to insomnia's obvious effective rate, and total effective rate is 82.1%; With contrast medicine there was no significant difference, but in onset speed, aspects such as dosage obviously are better than ANSHEN JIAONANG on obvious effective rate, total effective rate.
The specific embodiment
The present invention will be further described below in conjunction with embodiment:
Embodiment 1
FUFANG ZAOREN JIAONANG composition weight proportioning of the present invention is 5000 parts of Semen Ziziphi Spinosaes, 45 parts of rotundines, 50 parts of starch, its preparation method is that spiny jujuba seed powder is broken into coarse powder, crosses 24 mesh sieves, under 90 ℃ of temperature, decoct with water 2 times, add 4 times of water gagings of Semen Ziziphi Spinosae gross weight the 1st time, 3 times of water gagings that add the Semen Ziziphi Spinosae gross weight for the 2nd time each 1 hour, filter, filtrate is concentrated into 5000ml, adds equivalent ethanol, stirs, left standstill 14 hours, the leaching supernatant reclaims ethanol to there not being the alcohol flavor, is condensed into thick paste, dry, be ground into fine powder, cross 80 mesh sieves, add rotundine and starch, mixing, pulverize, cross 60 mesh sieves, incapsulate.
Embodiment 2
FUFANG ZAOREN JIAONANG composition weight proportioning of the present invention is 5500 parts of Semen Ziziphi Spinosaes, 50 parts of rotundines, 60 parts of starch, its preparation method spiny jujuba seed powder is broken into coarse powder, crosses 65 mesh sieves, in temperature is under 98 ℃, decocts with water 2 times, adds 6 times of water gagings of Semen Ziziphi Spinosae gross weight the 1st time, 4 times of water gagings that add the Semen Ziziphi Spinosae gross weight for the 2nd time each 3 hours, filter, filtrate is concentrated into 7000ml, adds equivalent ethanol, stirs, left standstill 10 hours, the leaching supernatant reclaims ethanol to there not being the alcohol flavor, is condensed into thick paste, dry, be ground into fine powder, cross 90 mesh sieves, add rotundine and starch, mixing, pulverize, cross 60 mesh sieves, incapsulate.
Embodiment 3
FUFANG ZAOREN JIAONANG composition weight proportioning of the present invention is 7000 parts of Semen Ziziphi Spinosaes, 65 parts of rotundines, 70 parts of starch, its preparation method spiny jujuba seed powder is broken into coarse powder, crosses 45 mesh sieves, add water boil 2 times, add 8 times of water gagings of Semen Ziziphi Spinosae gross weight the 1st time, add 5 times of water gagings of Semen Ziziphi Spinosae gross weight the 2nd time, each 3 hours, filter, filtrate is concentrated into 7000ml, add equivalent ethanol, stir, left standstill the leaching supernatant 8 hours, reclaim ethanol to there not being the alcohol flavor, be condensed into thick paste, drying is ground into fine powder, cross 100 mesh sieves, add rotundine and starch, mixing is pulverized, cross 70 mesh sieves, incapsulate.
Embodiment 4
FUFANG ZAOREN JIAONANG composition weight proportioning of the present invention is 6000 parts of Semen Ziziphi Spinosaes, 60 parts of rotundines, 55 parts of starch, its preparation method spiny jujuba seed powder is broken into coarse powder, crosses 55 mesh sieves, under 95 ℃ of temperature, decoct with water 2 times, add 5 times of water gagings of Semen Ziziphi Spinosae gross weight the 1st time, 4 times of water gagings that add the Semen Ziziphi Spinosae gross weight for the 2nd time each 1.5 hours, filter, filtrate is concentrated into 6000ml, adds equivalent ethanol, stirs, left standstill 12 hours, the leaching supernatant reclaims ethanol to there not being the alcohol flavor, is condensed into thick paste, dry, be ground into fine powder, cross 90 mesh sieves, add rotundine and starch, mixing, pulverize, cross 80 mesh sieves, incapsulate.
Embodiment 5
FUFANG ZAOREN JIAONANG composition weight proportioning of the present invention is 7500 parts of Semen Ziziphi Spinosaes, 70 parts of rotundines, 75 parts of starch, its preparation method spiny jujuba seed powder is broken into coarse powder, crosses 65 mesh sieves, add water boil 2 times, add 7 times of water gagings of Semen Ziziphi Spinosae gross weight the 1st time, add 3 times of water gagings of Semen Ziziphi Spinosae gross weight the 2nd time, each 2 hours, filter, filtrate is concentrated into 5000ml, add equivalent ethanol, stir, left standstill the leaching supernatant 16 hours, reclaim ethanol to there not being the alcohol flavor, be condensed into thick paste, drying is ground into fine powder, cross 95 mesh sieves, add rotundine and starch, mixing is pulverized, cross 90 mesh sieves, incapsulate.
Claims (4)
1, a kind of FUFANG ZAOREN JIAONANG is characterized in that this capsule is to be made by following materials of weight proportions medicine: 5000～7500 parts of Semen Ziziphi Spinosaes, 45～70 parts of rotundines, 50～75 parts of starch.
2, FUFANG ZAOREN JIAONANG according to claim 1 is characterized in that this capsular preferred weight proportioning is: 5500～7000 parts of Semen Ziziphi Spinosaes, 50～65 parts of rotundines, 55～70 parts of starch.
3, FUFANG ZAOREN JIAONANG according to claim 1 is characterized in that this capsular optimum weight proportioning is: 6000 parts of Semen Ziziphi Spinosaes, 60 parts of rotundines, 60 parts of starch.
4, a kind of preparation method of FUFANG ZAOREN JIAONANG is: Semen Ziziphi Spinosae is pulverized, and crosses 24～65 mesh sieves, at 90 ℃ to boiling temperature, decoct with water 2 times, add 4～8 times of water gagings of Semen Ziziphi Spinosae gross weight the 1st time, add 3～5 times of water gagings of Semen Ziziphi Spinosae gross weight the 2nd time, each 1～3 hour, filter, filtrate is concentrated into 5000～7000ml, add equivalent ethanol, stir, left standstill the leaching supernatant 8～16 hours, reclaim ethanol to there not being the alcohol flavor, be condensed into thick paste, drying is pulverized, cross 80～100 mesh sieves, add rotundine and starch, mixing is pulverized, cross 60～90 mesh sieves, incapsulate.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB200610078947XA CN100457144C (en) | 2006-04-28 | 2006-04-28 | Compound capsule of Chinese date kernel, and preparation method |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB200610078947XA CN100457144C (en) | 2006-04-28 | 2006-04-28 | Compound capsule of Chinese date kernel, and preparation method |
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| CN100457144C CN100457144C (en) | 2009-02-04 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104257790A (en) * | 2014-09-29 | 2015-01-07 | 北京亚东生物制药有限公司 | Novel application of compound jujube kernel capsule |
| CN110478348A (en) * | 2019-08-16 | 2019-11-22 | 上海长海医院 | Application of the rotundine in preparation prevention or treatment Postmenopausal Osteoporosis drug |
| CN113893280A (en) * | 2021-10-27 | 2022-01-07 | 重庆希尔安药业有限公司 | Combined medicine for treating insomnia and preparation method thereof |
-
2006
- 2006-04-28 CN CNB200610078947XA patent/CN100457144C/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104257790A (en) * | 2014-09-29 | 2015-01-07 | 北京亚东生物制药有限公司 | Novel application of compound jujube kernel capsule |
| CN104257790B (en) * | 2014-09-29 | 2016-09-21 | 北京亚东生物制药有限公司 | A kind of new application of FUFANG ZAOREN JIAONANG |
| CN110478348A (en) * | 2019-08-16 | 2019-11-22 | 上海长海医院 | Application of the rotundine in preparation prevention or treatment Postmenopausal Osteoporosis drug |
| CN113893280A (en) * | 2021-10-27 | 2022-01-07 | 重庆希尔安药业有限公司 | Combined medicine for treating insomnia and preparation method thereof |
| CN113893280B (en) * | 2021-10-27 | 2022-11-22 | 重庆希尔安药业有限公司 | Combined medicine for treating insomnia and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100457144C (en) | 2009-02-04 |
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Address after: Hilan road in Chongqing city of Hechuan Industrial Park Patentee after: Chongqing Hilan Pharmaceutical Co., Ltd. Address before: Floor 8, building B, hung Cheng Building, No. 33 Jianxin East Road, Jiangbei District, Chongqing Patentee before: Chongqing Hilan Pharmaceutical Co., Ltd. |