CN102309634B - A kind of hypnotic Chinese medicinal preparation of external application - Google Patents
A kind of hypnotic Chinese medicinal preparation of external application Download PDFInfo
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Abstract
The present invention relates to field of traditional Chinese.The invention provides a kind of hypnotic Chinese medicinal preparation of external application, it is made up of main pharmacodynamics composition and auxiliary material, its main pharmacodynamics composition is by following component：Ginseng, the Radix Astragali, Radix Angelicae Sinensis, the fruit of Chinese magnoliavine, grass-leaved sweetflag and polygala.Hypnotic Chinese medicinal preparation provided by the invention is Chinese herbal product, has the characteristics that safe and effective, no dependence relative to Western medicine.Administering mode made by the hypnotic Chinese medicinal preparation is the Chinese herbal product of external application, percutaneous dosing, have the advantages that efficiently, it is less toxic, safely, conveniently.
Description
Technical field
The present invention provides a kind of hypnotic Chinese medicinal preparation of external application, its preparation method and its is preparing diagnosis or treating insomnia
Application in medicine or preparation.
Background technology
Insomnia is a kind of sleep disordered disease, is a variety of bodies, spirit and common clinical table possessed by behavior disease
It is existing.Chronic insomnia can cause the negative results such as quick witted reduction, failure of memory and slow movement, drastically influence people
Physical and mental health, quality of life and operating efficiency.The whole world sleep of the nearest phase announced according to psychiatry branch of Chinese Medical Association
China investigation result shows that China has insomnia crowd and is up to 42.5%, and in rising trend.According to Chinese six cities in 2006
General population's insomnia status investigation statistics：The insomnia illness rate of adult is that the insomnia crowd of 57%, 30-50 year accounts for 51%.
In September, 2007, the Investigation of Sleep State that Shanghai City traditional Chinese medical science insomnia medical collaboration center is adopted international standards find that Shanghai City is had a sleepless night
The incidence of disease is up to 24%.A variety of epidemiology survey data show that the people of western countries about 35.2% has different degrees of insomnia.
According to expert statistics, to the year two thousand twenty whole world insomniac about more than 700,000,000.It can be seen that insomnia is both medical problem, and social concern,
Great attention both domestic and external should be caused.
There are many clinical reports for the treatment of insomnia, but due to a lack of on a large scale to behavior and the research of medicinal treatment, still
Clear and definite treatment guidelines are not formed is applied to clinic.The method for being clinically used for treatment insomnia at present is broadly divided into western medicine, west
Cure non-drug therapy, treatment by Chinese herbs and traditional Chinese medical science non-drug therapy.Western medicine is mainly Benzodiazepines and Non-benzodiazepine
Medicine, but have certain side effect, such as low blood pressure, anxiety, nausea, and drug resistance can be produced over time, it is discontinued
After can produce withrawal symptom；Doctor trained in Western medicine non-drug therapy is mainly controlled including Sleep hygiene education, light exposure treatment, psychology and cognitive behavior
Treat etc., with the advantage such as safety, adverse reaction be small with drug therapy compared with, but numerous studies show the long-term treatment of non-drug therapy
Effect is significantly lower than drug therapy, therefore clinical more and other therapies are used cooperatively.Treatment by Chinese herbs and traditional Chinese medical science non-drug therapy are (predominantly
Acupuncture and moxibustion treatment) there is safe and effective, no dependence, and diagnosis and treatment based on an overall analysis of the illness and the patient's condition and organic conception are extremely emphasized, lost from negative and positive
Adjust, the balance of disorder of qi and blood and function is started with, combine by adjusting to mend, promote body to reach new balance to lose to eliminate
Sleep, therefore have advantageous advantage in terms of insomnia is treated.Have a large amount of clinical research confirmations Chinese medicine and acupuncture at present
Treatment insomnia is evident in efficacy.
Although Chinese medicine and acupuncture and moxibustion therapy insomnia are evident in efficacy, the Chinese medicine of existing treatment insomnia is endo-medicine.
And acupoint has the shortcomings that effect is not lasting enough and has wound in acupuncture and moxibustion therapy.
The content of the invention
The present invention provides a kind of hypnotic Chinese medicinal preparation of external application, its preparation method and its is preparing diagnosis or treating insomnia
Application in medicine or preparation.The hypnotic Chinese medicinal preparation is Chinese herbal product, has safe and effective, no dependence relative to Western medicine
The features such as.Administering mode made by the hypnotic Chinese medicinal preparation is the Chinese herbal product of external application, percutaneous dosing, is had efficient, low
Poison, safely, conveniently the advantages that.
The present invention mentality of designing be：Inventor is on the basis of long campaigns Chinese traditional treatment research work, by repeatedly
Practice, has drawn a kind of recipe ingredient of the hypnotic Chinese medicinal preparation of external application, and by many experiments, demonstrates the peace of the external application
Therapeutic action of the dormancy Chinese medicine preparation to insomniac.
In order to achieve the above object, first aspect present invention discloses a kind of sleeping preparation of external application, by main pharmacodynamics into
Divide and auxiliary material composition, its main pharmacodynamics composition are made up of following component and parts by weight：
Ginseng (Panax ginseng C.A.Mey.) 0.12-0.18；
The Radix Astragali (Astragalus membranaceus (Fisch.) Bunge) 0.12-0.18；
Radix Angelicae Sinensis (Angelica sinensis (Oliv.) Diels) 0.06-0.09；
The fruit of Chinese magnoliavine (Schisandra chinensis (Turcz.) Baill.) 0.06-0.09；
Grass-leaved sweetflag (Acorus tatarinowii Schott) 0.06-0.09；
Polygala (Polygala koi Merr.) 0.06-0.09.
Preferably, the parts by weight composition of the hypnotic Chinese medicinal preparation is as follows：
Main pharmacodynamics composition 2；
Auxiliary material 4.5-5.5.
It is furthermore preferred that the auxiliary material includes the component of following weight percents：
Maltose 60-80wt%；
Alcohol 1-5wt%；
Laurocapram 1-5wt ‰；
Water surplus.
Second aspect of the present invention provides the preparation method of the hypnotic Chinese medicinal preparation of the external application, comprises the following steps：
(1) described main pharmacodynamics composition is separately dried and crushed by weight, sieved and mix；
(2) step 1 gained mixture is mixed with described auxiliary material, mixes stirring；Gained pasty state temper is external application
Hypnotic Chinese medicinal preparation.
The hypnotic Chinese medicinal preparation that this fermentation third aspect provides the external application is preparing the medicine or preparation for the treatment of insomnia
In application.
Fourth aspect present invention provides a kind of Soporific paste, and the Soporific paste includes：Sleeping medicine layer, back sheet and liner
Layer；The composition of the sleeping medicine layer is the hypnotic Chinese medicinal preparation of the external application.
Preferably, the one side of the back sheet is viscose face, and the sleeping medicine layer is located in the viscose face of back sheet
Between.
Preferably, the sleeping medicine layer quality is 1.5-2.5g.
Preferably, the sleeping medicine layer area is the 25%-40% of back sheet area.
Hypnotic Chinese medicinal preparation provided by the present invention is Chinese herbal product, has safe and effective, no dependence relative to Western medicine
The features such as.Administering mode made by the hypnotic Chinese medicinal preparation is the hypnotic Chinese medicinal preparation of external application, percutaneous dosing, has height
Effect, low toxicity, safety without obvious side reaction and it is convenient the advantages that.The hypnotic Chinese medicinal preparation of the external application, in patient body-surface acupoint plaster
Topical application of drug thing, permanent stimulating acupoint, the URIN Treatment disease by medicine to meridional point, be with traditional Chinese medicine characteristic again
A kind of method for the effectively disease preventing and treating for being developed and constantly bringing forth new ideas in practice, is worth pushing away extensively on clinical application
Extensively.
Embodiment
The present invention is expanded on further with reference to embodiment.It should be understood that embodiment is merely to illustrate the present invention, and it is unrestricted
The scope of the present invention.
Embodiment 1：
The dispensing and manufacturing conditions of the hypnotic Chinese medicinal preparation of external application：
The hypnotic Chinese medicinal preparation list of ingredients of table 1
| Composition | Weight (g) | Weight (g) | Weight (g) | Weight (g) |
| It is formulated I | It is formulated II | It is formulated III | It is formulated IV | |
| Ginseng | 12 | 15 | 18 | 15 |
| The Radix Astragali | 18 | 12 | 13.5 | 15 |
| Radix Angelicae Sinensis | 6 | 8 | 9 | 7.5 |
| The fruit of Chinese magnoliavine | 6 | 9 | 7 | 7.5 |
| Grass-leaved sweetflag | 9 | 7.5 | 6 | 7.5 |
| Polygala | 9 | 6 | 9 | 7.5 |
| Quality subtotal | 60 | 57.5 | 62.5 | 60 |
| Maltose | 81 | 100.63 | 137.5 | 120 |
| Alcohol | 4.05 | 1.44 | 8.59 | 3.72 |
| Laurocapram | 0.068 | 0.0719 | 0.0172 | 0.036 |
| Water | 49.88 | 41.61 | 25.77 | 27.44 |
| Quality amounts to | 195 | 201.25 | 234.38 | 211.2 |
The hypnotic Chinese medicinal preparation preparation method of external application：Ginseng, the Radix Astragali, Radix Angelicae Sinensis, the fruit of Chinese magnoliavine, grass-leaved sweetflag and polygala press list of ingredients
Shown weight is separately dried and crushed, and crosses 100 mesh sieves and mixes.By the mixture and maltose, alcohol water blend, bay nitrogen
Tall and erect ketone (aqueous solution for being configured to 3wt%) and water are converted to the weight mixing shown in list of ingredients, mix stirring, and gained pasty state reconciles
Thing is the hypnotic Chinese medicinal preparation of external application.
Embodiment 2：
The making of Soporific paste：
The Soporific paste includes：Sleeping medicine layer, back sheet and inner liner.The one side of the back sheet is viscose face, institute
The centre that sleeping medicine layer is located at the viscose face of the back sheet is stated, the sleeping medicine layer is by being formulated IV's in 2g embodiments 1
External application hypnotic Chinese medicinal preparation is made, and the sleeping medicine layer is included by back sheet and inner liner, the area of the sleeping medicine layer
For the 35% of the back sheet area.
Embodiment 3：
Therapeutic action of the hypnotic Chinese medicinal preparation of the external application to insomniac：
A. tested material：Soporific paste prepared by embodiment 2.
B. negative control medicine：Flour, maltose and 15v% alcohol are mixed by 2: 4: 1 part by weight, addition accounts for flour
The 2wt% Laurocapram aqueous solution (3wt%), mixes stirring, and gained pasty state temper presses obtained pair of the methods described of embodiment 2
According to patch.
C. experimental subjects：Selection meets the sleep-disorder international classification of sleep-disorder federation of the U.S. (ASDA) formulation
(ICSD) about the insomniac 100 for the diagnostic criteria having a sleepless night in, patient is divided into by 2 groups of (Soporific pastes according to table of random number
Group and blank control group), every group 50.
Diagnostic criteria
A) in sleep-disorder state lower body hypofunction；
B) difficulty falling asleep, but it is easily sleepy in the non-sleep time；
C) somatotonia degree improves (such as emotional, muscular tone, vessel retraction enhancing)；
D) Sleep latency extends, and Sleep efficiency reduces, and the times and duration waken up with a start increases；
E) symptoms last more than 4 weeks or less slightly is appealed；
F) part for other non-physical diseases or phrenoblabia symptom；
G) other sleep-disorder can coexist therewith, such as sleep insufficiency, sleep apnea syndrome.
D. research method：
Acupuncture point selects：Shenque, Qihai, Zusanli (double).
Treatment method：The inner liner of patch is thrown off, medicine layer is directed at (double) the progress topical application of drug of SHENQUE acupoint, Qihai, Zusanli；
Topical application of drug time span is 10h, the next day 1 time, 10 times are 1 course for the treatment of, totally 2 courses for the treatment of.
E. experimental result
(1) Pittsburg Sleep Quality Index (Pittsburgh sleep quality index, PSQI) scale：PSQI points
For 7 factors (sleep quality, time for falling asleep, the length of one's sleep, Sleep efficiency, sleep disordered, sleeping medicine, daytime function) and one
Individual total score is compared, and each factor is by 0,1,2,3 integrations, and it is total score to accumulate each factor score, and score is higher, and sleep quality is got over
Difference.
The change of the pretherapy and post-treatment PSQI score values of 2 each experimental group of table is compared with
| Group | Number of cases | Before treatment | After treatment | Before and after treatment relatively |
| Blank control group | 50 | 13.04±1.52 | 12.78±1.47 | P ＞ 0.05 |
| Point application group | 50 | 13.14±1.84 | 8.34±1.11 | P ＜ 0.05 |
| Two groups mutually compare | P ＞ 0.05 | P ＜ 0.05 |
Note：With the conspicuousness of variance P values analysis difference, P ＞ 0.05, both are compared without significant difference；P ＜ 0.05, both
Compared to there were significant differences
As shown in table 2, blank control group before the treatment after there was no significant difference (P ＞ 0.05), the point application of PSQI score values
The PSQI score values of group are remarkably decreased (P ＜ 0.05) before relatively treating after the treatment.Blank control group and point application group are carried out between group
Compare, there was no significant difference (P ＞ 0.05) for PSQI score values before the treatment with point application group for blank control group；Point application group exists
PSQI score values are significantly lower than blank control group (P ＜ 0.05) after treatment.Inventor summarizes to experimental data and drawn, Soporific paste can be bright
The aobvious sleep quality for improving insomniac, reduces PSQI score values, increases Sleep efficiency.
(2) the international uniform Sleep efficiency value quantization modulation standard (calculation formula that the World Health Organization promulgates：Sleep efficiency
(%)=actual time for falling asleep/goes to bed to getting up total time × 100.According to the sleep detection method of the newest promulgations of WHO, by matter of sleeping
Amount is divided into V levels：I levels：Sleep efficiency 71%~80%；II levels：Sleep efficiency 61%~70%；HI levels：Sleep efficiency 51%~
60%；IV levels：Sleep efficiency 41%~50%；V levels：Sleep efficiency 31%~40%.) evaluation sleep quality, Sleep efficiency value
Higher, sleep quality is better.
The change of the pretherapy and post-treatment Sleep efficiency value (%) of 3 each experimental group of table is compared with
| Group | Number of cases | Before treatment | After treatment | Before and after treatment relatively |
| Blank control group | 50 | 49.68±7.10 | 49.76±6.80 | P ＞ 0.05 |
| Point application group | 50 | 51.02±7.28 | 80.89±6.93 | P ＜ 0.05 |
| Two groups mutually compare | P ＞ 0.05 | P ＜ 0.05 |
Note：With the conspicuousness of variance P values analysis difference, P ＞ 0.05, both are compared without significant difference；P ＜ 0.05, both
Compared to there were significant differences
As table 3 can shown in, the pretherapy and post-treatment Sleep efficiency value of blank control group there was no significant difference (P ＞ 0.05), acupuncture point
Sleep efficiency value dramatically increases (P ＜ 0.05) before relatively being treated after the treatment of application group.Blank control group carries out group with point application group
Between compare, blank control group is compared with Soporific paste group before treatment, and there was no significant difference for Sleep efficiency value (P ＞ 0.05)；Acupuncture point is applied
Patch group after the treatment Sleep efficiency value apparently higher than blank control group (P ＜ 0.05).Inventor summarizes to experimental data and drawn, pacifies
Patch of sleeping can obviously improve the sleep quality of insomniac, improve Sleep efficiency value.
Hypnotic Chinese medicinal preparation provided by the present invention remain Chinese medicine safely and effectively, no dependence the features such as while,
Using the method for administration of external application, percutaneous dosing, in patient body-surface point-application medicine, permanent stimulating acupoint, by medicine to warp
The URIN Treatment patient of network acupuncture points on the human body, it is efficient, less toxic, safe without obvious side reaction and convenient to have the advantages that.
Claims (9)
1. a kind of hypnotic Chinese medicinal preparation of external application, is made up of effective component and auxiliary material, its effective component is by following component and weight
Part composition：
Ginseng 0.12-0.18；
Radix Astragali 0.12-0.18；
Radix Angelicae Sinensis 0.06-0.09；
Fruit of Chinese magnoliavine 0.06-0.09；
Grass-leaved sweetflag 0.06-0.09；
Polygala 0.06-0.09；
The auxiliary material is made up of the component of following weight percents：
Maltose 60-80wt%；
Alcohol 1-5wt%；
Laurocapram 1-5wt ‰；
Water surplus；
The parts by weight composition of the hypnotic Chinese medicinal preparation is as follows：
Effective component 2；
Auxiliary material 4.5-5.5；
The preparation method of the hypnotic Chinese medicinal preparation of the external application, comprises the following steps：
(1) effective component is separately dried and crushed by weight, sieved and mix；
(2) step 1 gained mixture is mixed with auxiliary material, mixes stirring；Gained pasty state temper is the sleeping Chinese medicine of external application
Preparation.
2. the preparation method of the hypnotic Chinese medicinal preparation of external application described in claim 1, comprises the following steps：
(1) effective component is separately dried and crushed by weight, sieved and mix；
(2) step 1 gained mixture is mixed with auxiliary material, mixes stirring；Gained pasty state temper is the sleeping Chinese medicine of external application
Preparation.
3. the preparation method of the hypnotic Chinese medicinal preparation of external application as claimed in claim 2, it is characterised in that step (2) described auxiliary material
Component including following weight percents：
Maltose 60-80wt%；
Alcohol 1-5wt%；
Laurocapram 0.1-0.5wt ‰；
Water surplus.
4. the preparation method of the hypnotic Chinese medicinal preparation of external application as claimed in claim 2, it is characterised in that in step (2), step 1
Weight ratio when gained mixture mixes with auxiliary material is：2：(4.5-5.5).
5. purposes of the hypnotic Chinese medicinal preparation of external application described in claim 1 in the medicine or preparation for preparing treatment insomnia.
6. a kind of Soporific paste, it is characterised in that the Soporific paste includes：Sleeping medicine layer, back sheet and inner liner；The sleeping
The composition of medicine layer is the hypnotic Chinese medicinal preparation of external application described in claim 1.
7. Soporific paste as claimed in claim 6, it is characterised in that the one side of the back sheet is viscose face, the hypnotic
Nitride layer is located at the centre in the viscose face of back sheet.
8. Soporific paste as claimed in claim 7, it is characterised in that the sleeping medicine layer quality is 1.5-2.5g.
9. Soporific paste as claimed in claim 8, it is characterised in that the sleeping medicine layer area is back sheet area
25%-40%.
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| CN105878707A (en) * | 2014-10-11 | 2016-08-24 | 王成全 | Wuling Anmian Powder |
| CN106728567B (en) * | 2016-12-14 | 2019-11-12 | 上海中医药大学附属岳阳中西医结合医院 | A kind of external application sleeping cataplasm and its application |
| CN106943459A (en) * | 2017-01-24 | 2017-07-14 | 曹晓宏 | A kind of Chinese medicine composition for treating insomnia and its application |
| CN113491735A (en) * | 2020-04-02 | 2021-10-12 | 常州高新技术产业开发区三维工业技术研究所有限公司 | Anti-insomnia acupoint patch |
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