CN107303381A - It is a kind of to treat Chinese medicine composition of overactive bladder and preparation method thereof - Google Patents
It is a kind of to treat Chinese medicine composition of overactive bladder and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9068—Zingiber, e.g. garden ginger
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/26—Aristolochiaceae (Birthwort family), e.g. heartleaf
- A61K36/268—Asarum (wild ginger)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/67—Piperaceae (Pepper family), e.g. Jamaican pepper or kava
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
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Abstract
The invention belongs to the field of Chinese medicines, and in particular to a kind of Chinese medicine composition for treating overactive bladder；In addition, the invention further relates to the preparation method of the Chinese medicine composition.A kind of Chinese medicine composition for treating overactive bladder of the present invention, it is prepared from medicament by the bulk drug of following parts by weight：1.5 10 parts of the root of gansui, 1.5 10 parts of asarum, 3 10 parts of white pepper, 3 15 parts of ginger；Its preparation method is that the present composition passes through extraction, and processing is prepared into transdermal patch, and transdermal patch is made up of back sheet, load medicine hot melt adhesive layer and adherent layer；The load medicine hot melt adhesive layer is located between back sheet and adherent layer, and the load medicine hot melt adhesive layer is containing 10 44 parts of Chinese medicine composition extract medicinal extract, 33 65 parts of thermotropic pressure sensitive glue, 0.3 1 parts of skin penetration enhancers.
Description
Technical field
The invention belongs to the field of Chinese medicines, and in particular to a kind of Chinese medicine composition for treating overactive bladder；In addition, this hair
The bright preparation method for further relating to the Chinese medicine composition.
Background technology
Bladder excessive activities show as detrusor in urodynamics and are overexcited or over-activity, urgent urination, urine caused by it
Frequently, with or without urge incontinence a class syndrome be referred to as overactive bladder (Overactive Bladder,
OAB), include the unstable bladder etc. of the past, it be a variety of paruria diseases (such as sacred disease, FBOO,
Urinary infection etc.) one of final pathology link, be a kind of most common vesical dysfunction, severe patient will also cause kidney,
Hydroureter and kidney function damage.
OAB is without the clear and definite cause of disease, not including the disease caused by the vesicourethral local patholoic change of acute urinary tract infection or other forms
Shape.OAB is common clinical, frequently-occurring disease, and in cumulative year after year trend.The urinary incontinence incidence of disease of Beijing area in 2000 is adjusted
Display is looked into, the OAB incidence of disease is 29.4%, and the incidence of disease is in obvious ascendant trend with age.
Preferred conservative treatment in OAB treatment, but effect is not satisfactory, and such as behaviour therapy long-term effect is biological less than 50%
Feedback treating depends on the compliance of patient, and long-term effect is unclear.Pelvic floor training is primarily used to treatment pressure urine
Incontinence, but it has also been found that play the role of to mitigate unstable bladder.Vaginal irritation is more popular in Europe, and is seldom recognized in North America
Can, China is also rarely employed, the treated effect about 50% of one year.Some women do not feel well to vaginal irritation,
It is difficult to complete；" the built-in sacral nerve root stimulation therapy " of FDA certifications is obtained, due to (about 100,000 yuan of somewhat expensive
RMB or so), it is considerably less that the country carries out this operation, it is impossible to which work objectively compares and analyzed.
In drug therapy, OAB will preferred anticholinergic and anti-spasm medicine, first-line drug such as Tolterodine (Tolterodine)
Deng main by antagonism m receptor, suppress detrusor contractions, improving bladder sensation function etc. improves bladder function, but because of OAB
Etiology unknown, retardance m receptor might not improve symptom, and Organic selection effect and method of administration need to improve to reduce
The side effects such as dry, clinical efficacy also has much room for improvement,
Chinese medicine OAB has long-term clinical practice experience, and acupuncture is as one of traditional treatment method of the traditional Chinese medical science, with pair
Effect less, curative effect it is reliable, applied widely and the features such as facilitate economical；Many scholars enter to acupuncture and moxibustion therapy OAB curative effect
Go research, as a result shown that acupuncture can preferably improve the urination symptom of OAB patient, improve the daily life quality of patient,
Its mechanism is mainly the excess shrinkage for suppressing detrusor, improves the compliance of bladder, maintains normal urination process.But acupuncture
Easily limited by place and time, and some patientss have the psychology of fear to acupuncture, because of the particularity of the disease, also there is part trouble
Person is because of shy psychological escape or delay treatment.
Traditional Chinese medicine acupoint application is that Chinese medicine is made into various formulations to be applied on human acupoint, utilizes stimulation of the medicine to acupuncture point
Pharmacological action with Chinese medicine come treat disease without traumatic pain point stimulating therapy, be the production of the science of acupuncture and moxibustion and the ingenious combination of traditional Chinese medical science prescription
Thing.Have the advantages that safely, effectively, stably, it is good without traumatic pain, simple to operate and patient compliance.But in the market
Treatment overactive bladder Chinese patent drug it is few, external use plaster is more rare.Therefore, people are to the more preferable treatment of curative effect
The Chinese medicine preparation of overactive bladder still suffers from demand.
The content of the invention
One of technical problems to be solved by the invention, which are that proposition is a kind of, can effectively treat the Chinese traditional medicine composition of overactive bladder
Thing.
The two of the technical problems to be solved by the invention are the preparations for the Chinese medicine composition for proposing above-mentioned treatment overactive bladder
Method.
A kind of Chinese medicine composition for treating overactive bladder that the present invention proposes for one of solution above-mentioned technical problem, it
Medicament is prepared from by the bulk drug of following parts by weight：1.5-10 parts of the root of gansui, 1.5-10 parts of asarum, 3-10 parts of white pepper, life
3-15 parts of ginger.
It is preferred that, a kind of Chinese medicine composition for treating overactive bladder, it is prepared from by the bulk drug of following parts by weight
Medicament：10 parts of the root of gansui, 10 parts of asarum, 10 parts of white pepper, 10 parts of ginger.
The Chinese medicine composition for the treatment of overactive bladder of the present invention, the medicament is described in any pharmacy
Formulation, preferably transdermal patch.
The transdermal patch is made up of back sheet, load medicine hot melt adhesive layer and adherent layer；The load medicine hot melt adhesive layer is located at back sheet
Between adherent layer, and the load medicine hot melt adhesive layer is containing 10-44 parts of Chinese medicine composition extract medicinal extract, 33-65 parts of heat molten type pressures
Quick glue, 0.3-1 part skin penetration enhancer.The thermotropic pressure sensitive glue is SIS types, SBS types, SEBS types or epoxidation
One kind in SDS types；Described skin penetration enhancer be selected from pharmaceutically acceptable surfactant, sub- vitriol compound,
The mixture of one or both of Laurocapram class, alcohols and its terpenoid, mushroom alkenes any of the above ratio.
The two of the technical problems to be solved by the invention are the preparations for the Chinese medicine composition for proposing above-mentioned treatment overactive bladder
Method, the preparation method of the Chinese medicine composition transdermal patch, is obtained by the following method：
(1) root of gansui, asarum, white pepper ginger are weighed；
(2) it is that 65%-85% ethanol is heated to reflux with volume fraction by the root of gansui, asarum, white pepper, ginger in step (1)
Extract, ethanol is recovered under reduced pressure in extract solution, and concentrate is vacuum dried, obtains Chinese medicine composition extract medicinal extract of the present invention standby；
(3) thermotropic pressure sensitive glue magnetic agitation is taken to dissolving, then is extracted with skin penetration enhancer and Chinese medicine composition of the present invention
Thing medicinal extract is sufficiently mixed uniformly, obtains coating fluid after ultrasound degassing, the coating fluid is spread evenly across on adherent layer, after drying naturally,
Formed and carry medicine thermotropic pressure sensitive glue-line, finally back sheet is covered on load medicine hot melt adhesive layer, finished product is made in punching.
In the above method, preferred volume fraction is heated to reflux for 75% ethanol, its consumption is 6-8 times of Chinese medicine crude drug quality.
Coating weight of the coating fluid on adherent layer is with the amount of Chinese medicine composition extract medicinal extract of the present invention in 4 × 5c ㎡ small pieces with life
Medicine meter is equivalent to 5g/ pieces.
Embodiment
With reference to embodiment, the invention will be further described.
It is each that the root of gansui, asarum, white pepper, ginger used in the embodiment of the present invention meet one text of China's coastal port
Relevant every regulation under medicinal material.Each medicinal material is by working processes such as net system, cutting, processing, crushing, before feeding intake,
By identification, ingredients material object is consistent with title, and quality meets NF standard, and (specific Med Mat Appreciation method is with reference to pharmacopeia
Standard is performed).
Embodiment 1
(1) weigh
Crude drug is weighed in the ratio of 1.5 parts of the root of gansui, 10 parts of asarum, 10 parts of white pepper, 10 parts of ginger；
(2) extract
With 75% ethanol of 6 times of amounts, ethanol is recovered under reduced pressure in heating and refluxing extraction, extract solution, and concentrate is vacuum dried, obtains
Chinese medicine composition extract medicinal extract of the present invention is standby；
(3) thermotropic pressure sensitive glue prepares (medicinal extract：Glue：Azone=10:33:0.3)
Weigh 330 parts of thermotropic pressure sensitive glue (SIS types), 3 parts of azone, 100 parts of Chinese medicine composition medicinal extract.
Apply cream：Thermotropic pressure sensitive glue is placed in evaporating dish, after being melted with magnetic stirring apparatus, medicinal extract and azone is added, simultaneously
Quick stirring.Back sheet is fixed on coating machine, arrange parameter after zeroing, original position 0cm, coating speed 150mm/s,
Thickness left 1mm, right 1mm.The pastille thermotropic pressure sensitive glue of molten condition is poured on coating machine, start button is pressed, applied
After the completion of cloth, sample 4*10cm2 is obtained, covers and is cut into 4 × 5c ㎡ small pieces.With the matter of Chinese medicine composition extract medicinal extract of the present invention
Amount is calculated as 0.23g/ pieces (equivalent to 5g/ pieces in terms of crude drug).
Embodiment 2
(1) weigh
Crude drug is weighed in the ratio of 10 parts of the root of gansui, 1.5 parts of asarum, 3 parts of white pepper, 15 parts of ginger；
(2) extract
With 80% ethanol of 7 times of amounts, ethanol is recovered under reduced pressure in heating and refluxing extraction, extract solution, and concentrate is vacuum dried, obtains
Chinese medicine composition extract medicinal extract of the present invention is standby；
(3) PUR prepares (medicinal extract：Glue：Azone=34:65:1)
65 parts of thermotropic pressure sensitive glue (SIS types) is weighed, 1 part of azone, Chinese medicine composition soaks 34 parts.
Apply cream：Thermotropic pressure sensitive glue is placed in evaporating dish, after being melted with magnetic stirring apparatus, medicinal extract and azone is added, simultaneously
Quick stirring.Back sheet is fixed on coating machine, arrange parameter after zeroing, original position 0cm, coating speed 150mm/s,
Thickness left 1mm, right 1mm.The pastille thermotropic pressure sensitive glue of molten condition is poured on coating machine, start button is pressed, applied
After the completion of cloth, sample 4*10cm2 is obtained, covers and is cut into 4 × 5c ㎡ fritters.With the matter of Chinese medicine composition extract medicinal extract of the present invention
Amount is calculated as being calculated as 0.29g/ pieces by the quality of Chinese medicine composition extract medicinal extract of the present invention (equivalent to 5g/ pieces in terms of crude drug).
Embodiment 3
(1) weigh
Crude drug is weighed in the ratio of 6 parts of the root of gansui, 8 parts of asarum, 5 parts of white pepper, 8 parts of ginger；
(2) extract
With 85% ethanol of 6 times of amounts, ethanol is recovered under reduced pressure in heating and refluxing extraction, extract solution, and concentrate is vacuum dried, obtains
Chinese medicine composition extract medicinal extract of the present invention is standby；
(3) PUR prepares (medicinal extract：Glue：Azone=27:49:0.65)
Weigh 49 parts of thermotropic pressure sensitive glue (SIS types), 0.65 part of azone, 27 parts of Chinese medicine composition medicinal extract.
Apply cream：Thermotropic pressure sensitive glue is placed in evaporating dish, after being melted with magnetic stirring apparatus, medicinal extract and azone is added, simultaneously
Quick stirring.Back sheet is fixed on coating machine, arrange parameter after zeroing, original position 0cm, coating speed 150mm/s,
Thickness left 1mm, right 1mm.The pastille thermotropic pressure sensitive glue of molten condition is poured on coating machine, start button is pressed, applied
After the completion of cloth, sample 4*10cm2 is obtained, covers and is cut into 4 × 5c ㎡ small pieces.With the matter of Chinese medicine composition extract medicinal extract of the present invention
Amount is calculated as being calculated as 0.32g/ pieces by the quality of Chinese medicine composition extract medicinal extract of the present invention (equivalent to 5g/ pieces in terms of crude drug).
Embodiment 4
(1) weigh
Crude drug is weighed in the ratio of 8 parts of the root of gansui, 4 parts of asarum, 3 parts of white pepper, 12 parts of ginger；
(2) extract
With 85% ethanol of 7 times of amounts, ethanol is recovered under reduced pressure in heating and refluxing extraction, extract solution, and concentrate is vacuum dried, obtains
Chinese medicine composition extract medicinal extract of the present invention is standby；
(3) PUR prepares (medicinal extract：Glue：Azone=44:33:0.83)
Weigh 33 parts of thermotropic pressure sensitive glue (SIS types), 0.83 part of azone, 44 parts of Chinese medicine composition medicinal extract.
Apply cream：Thermotropic pressure sensitive glue is placed in evaporating dish, after being melted with magnetic stirring apparatus, medicinal extract and azone is added, simultaneously
Quick stirring.Back sheet is fixed on coating machine, arrange parameter after zeroing, original position 0cm, coating speed 150mm/s,
Thickness left 1mm, right 1mm.The pastille thermotropic pressure sensitive glue of molten condition is poured on coating machine, start button is pressed, applied
After the completion of cloth, sample 4*10cm2 is obtained, covers and is cut into 4 × 5c ㎡ small pieces.With the matter of Chinese medicine composition extract medicinal extract of the present invention
Amount is calculated as being calculated as 0.27g/ pieces by the quality of Chinese medicine composition extract medicinal extract of the present invention (equivalent to 5g/ pieces in terms of crude drug).
Embodiment 5
(1) weigh
Crude drug is weighed in the ratio of 3 parts of the root of gansui, 6 parts of asarum, 10 parts of white pepper, 9 parts of ginger；
(2) extract
With 65% ethanol of 8 times of amounts, ethanol is recovered under reduced pressure in heating and refluxing extraction, extract solution, and concentrate is vacuum dried, obtains
Chinese medicine composition extract medicinal extract of the present invention is standby；
(3) PUR prepares (medicinal extract：Glue：Azone=10:65:0.48)
Weigh 65 parts of thermotropic pressure sensitive glue (SIS types), 0.48 part of azone, 10 parts of Chinese medicine composition medicinal extract.
Apply cream：Thermotropic pressure sensitive glue is placed in evaporating dish, after being melted with magnetic stirring apparatus, medicinal extract and azone is added, simultaneously
Quick stirring.Back sheet is fixed on coating machine, arrange parameter after zeroing, original position 0cm, coating speed 150mm/s,
Thickness left 1mm, right 1mm.The pastille thermotropic pressure sensitive glue of molten condition is poured on coating machine, start button is pressed, applied
After the completion of cloth, sample 4*10cm2 is obtained, covers and is cut into 4 × 5c ㎡ small pieces.With the matter of Chinese medicine composition extract medicinal extract of the present invention
Amount is calculated as being calculated as 0.30g/ pieces by the quality of Chinese medicine composition extract medicinal extract of the present invention (equivalent to 5g/ pieces in terms of crude drug).
Embodiment 6
(1) weigh
Crude drug is weighed in the ratio of 10 parts of the root of gansui, 10 parts of asarum, 10 parts of white pepper, 10 parts of ginger；
(2) extract
With 75% ethanol of 7 times of amounts, ethanol is recovered under reduced pressure in heating and refluxing extraction, extract solution, and concentrate is vacuum dried, obtains
Chinese medicine composition extract medicinal extract of the present invention is standby；
(3) PUR prepares (medicinal extract：Glue：Azone=10:33:0.48)
Weigh 33 parts of thermotropic pressure sensitive glue (SBS types), 0.48 part of azone, 10 parts of Chinese medicine composition medicinal extract.
Apply cream：Thermotropic pressure sensitive glue is placed in evaporating dish, after being melted with magnetic stirring apparatus, medicinal extract and azone is added, simultaneously
Quick stirring.Back sheet is fixed on coating machine, arrange parameter after zeroing, original position 0cm, coating speed 150mm/s,
Thickness left 1mm, right 1mm.The pastille thermotropic pressure sensitive glue of molten condition is poured on coating machine, start button is pressed, applied
Cloth is completed, and is cut into small pieces.It is calculated as extracting with Chinese medicine composition of the present invention with the quality of Chinese medicine composition extract medicinal extract of the present invention
The quality of thing medicinal extract is calculated as 0.28g/ pieces (equivalent to 5g/ pieces in terms of crude drug).
Embodiment 7
(1) weigh
Crude drug is weighed in the ratio of 6 parts of the root of gansui, 6 parts of asarum, 10 parts of white pepper, 3 parts of ginger；
(2) extract
With 75% ethanol of 7 times of amounts, ethanol is recovered under reduced pressure in heating and refluxing extraction, extract solution, and concentrate is vacuum dried, obtains
Chinese medicine composition extract medicinal extract of the present invention is standby；
(3) PUR prepares (medicinal extract：Glue：Azone=44:65:0.48)
Weigh 65 parts of thermotropic pressure sensitive glue (SEBS types), 0.48 part of azone, 44 parts of Chinese medicine composition medicinal extract.
Apply cream：Thermotropic pressure sensitive glue is placed in evaporating dish, after being melted with magnetic stirring apparatus, medicinal extract and azone is added, simultaneously
Quick stirring.Back sheet is fixed on coating machine, arrange parameter after zeroing, original position 0cm, coating speed 150mm/s,
Thickness left 1mm, right 1mm.The pastille thermotropic pressure sensitive glue of molten condition is poured on coating machine, start button is pressed, applied
Cloth is completed, and is cut into small pieces.It is calculated as extracting with Chinese medicine composition of the present invention with the quality of Chinese medicine composition extract medicinal extract of the present invention
The quality of thing medicinal extract is calculated as 0.20g/ pieces (equivalent to 5g/ pieces in terms of crude drug).
Embodiment 8
(1) weigh
Crude drug is weighed in the ratio of 10 parts of the root of gansui, 8 parts of asarum, 9 parts of white pepper, 15 parts of ginger；
(2) extract
With 70% ethanol of 8 times of amounts, ethanol is recovered under reduced pressure in heating and refluxing extraction, extract solution, and concentrate is vacuum dried, obtains
Chinese medicine composition extract medicinal extract of the present invention is standby；
(3) PUR prepares (medicinal extract：Glue：Azone=18:41:0.48)
Weigh 41 parts of thermotropic pressure sensitive glue (epoxidation SDS types), 0.48 part of azone, 18 parts of Chinese medicine composition medicinal extract.
Apply cream：Thermotropic pressure sensitive glue is placed in evaporating dish, after being melted with magnetic stirring apparatus, medicinal extract and azone is added, simultaneously
Quick stirring.Back sheet is fixed on coating machine, arrange parameter after zeroing, original position 0cm, coating speed 150mm/s,
Thickness left 1mm, right 1mm.The pastille thermotropic pressure sensitive glue of molten condition is poured on coating machine, start button is pressed, applied
Cloth is completed, and is cut into small pieces.It is calculated as extracting with Chinese medicine composition of the present invention with the quality of Chinese medicine composition extract medicinal extract of the present invention
The quality of thing medicinal extract is calculated as 0.29g/ pieces (equivalent to 5g in terms of crude drug).
The beneficial effect of medicine of the present invention is expanded on further below by way of test example, these test examples include the present invention
The clinical research test of medicine (hereinafter referred to as control urine patch).
Test example 1 (clinical research of drug therapy overactive bladder of the present invention)
1 clinical data
1.1 research object
Meet the bladder excessive activities patient 30 of inclusive criteria.
1.2 diagnostic criteria
1.2.1 Western medicine diagnostic criteria：
Formulated with reference to Chinese Urology Surgery association《Chinese urological diseases diagnoses and treatment guide 2011 editions》(people's health
Publishing house, 2011).
(1) screening property inspection
(1) medical history：1) classical symptom：Frequent micturition, urgent urination, urge incontinence etc..2) related symptoms：Dysuria, property
Function, defecation condition etc.；3) related history：Uropoiesis and disease in the male sexual system and treatment history, menstruation, fertility, gynaecology
Disease and treatment history, the nervous system disease and treatment history.
(2) physical examination：1) general physical examination；2) special physical examination：Uropoiesis and reproductive system, nervous system.
(3) laboratory examination：Routine urinalysis, urine culture, blood biochemistry is shown no obvious abnormalities.
(4) Urology Surgery special examined：Urinary flow, urinary system ultrasonic examination (including residual urine is determined).
(2) random inspection
Such as suspect the patient that other lesions are present, should selectivity pathological examination, cytolgical examination, urinary tract plain film, quiet completely
Arteries and veins IVU, urinary system endoscope, CT, MRI and invasive urodynamics test etc..
1.2.2 tcm diagnosis standard：
With reference to national traditional chinese medical science administration's issue《Chinese medical disease Standardization of diagnosis and curative effect stranguria》Nephrasthenia syndrome (publishing house of Nanjing University,
1994).
Primary symptom：Frequent micturition, urgent urination, the urinary incontinence.
Secondary disease：Not to the utmost, underbelly falling inflation, soreness of waist and knee, spiritlessness and weakness, or four limbs owe temperature, aversion to cold and preference for warmth, tongue to dribbling urination
Light, tongue is white, and arteries and veins is thin and delicate.
2. processing method
Pole, Guan Yuan/time Liao, middle Liao acupoint in positioning, conventional alcohol sterilization are respectively spread on acupuncture point with 4cm*4cm control urine patches, seen
30min is examined, after patient is without discomfort reaction, can leave, voluntarily be extractd by patient after often pasting 4 hours with drug paste；If any it is scorching hot,
The discomfort reaction such as itching, shouting pain, can stop application.
The treatment next day, once 6 times were a course for the treatment of, and the course for the treatment of carries out therapeutic evaluation after terminating.
2.3 observation index
2.3.1 urinate symptom assessment
With reference to the international urinary incontinence Advisory Board urinary incontinence questionnaire table abridged table (ICI-Q-SF) criterion evaluation urination.(see attached
Record is 1)
With reference to national traditional chinese medical science administration《Chinese medical disease Standardization of diagnosis and curative effect stranguria》Standard, is commented according to clinical symptoms before and after treatment
Divide evaluation of result therapeutic effect：
Recovery from illness：Clinical cardinal symptom disappears, and general comment is divided into 0 after treatment.
It is effective：Clinical cardinal symptom is disappeared substantially, and more than 2/3 is reduced before overall score is relatively treated after treatment.
Effectively：Clinical cardinal symptom partial disappearance, before overall score is relatively treated after treatment between reduction 1/3-2/3.
It is invalid：Clinical cardinal symptom is present, and less than 1/3 is reduced before overall score is relatively treated after treatment.
2.3.2 daily life quality evaluation (QoL assess table)
Quality of life (WHO, Paris, 1994) is evaluated using the ICS QoL assessments tables recommended.(see annex 2)
2.3.3 urodynamics metrics evaluation
(1) Qmax：Qmax
(2) AFR：Qave
(3) effective bladder capacity：Vv
(4) uroflow time：FT
3. result
Case 30 is included in this research altogether, is all from April, -2011 in October, 2010 attached in Shanghai Univ. of Traditional Chinese Medicine
The medical patient of Yueyang hospitals of traditional Chinese and western medicine urination disorder special outpatient clinic.
The comparison of clinical symptoms before and after 3.1 treatments
3.1.1 the comparison of urination symptom integral
Table 1 shows：There is substantially reduction (P ＜ 0.05) compared with pre-treatment after the urination symptom integral treatment of patient, as a result point out：
Control urine patch point application can substantially reduce the urination symptom integral of patient.
The comparison of urination symptom integral before and after table 1 is treated
| Group (number of cases) | Before treatment | Treatment 6 times |
| Treatment group (30) | 30.07±6.147 | 12.93±5.003※ |
Note：※Represent to compare before and after treating and have significant difference (P ＜ 0.05).
3.1.2 the comparison for main symptom score of urinating
Table 2-3 comments for treatment controlled micturition primary symptom shape " leakage of urine number of times ", " leakage of urine amount ", " urgent urination ", " frequent micturition ", " enuresis nocturna "
Comparison before point being treated and after treating 6 times.The main symptom score of urination after patient treats 6 times is obvious compared with having before treating
Reduce (P ＜ 0.05).Illustrate by course of therapy, the leakage of urine number of times of OAB patient, leakage of urine amount, urgent urination, frequent micturition,
The symptoms such as enuresis nocturna are improved.
Urination primary symptom shape leakage of urine number of times, the comparison of leakage of urine amount scoring before and after table 2 is treated
Note：※Represent to compare before and after treating and have significant difference (P ＜ 0.05).
Urination primary symptom shape frequent micturition, urgent urination, the comparison of enuresis nocturna scoring before and after table 3 is treated
Note：※Represent to compare before and after treating and have significant difference (P ＜ 0.05).
3.1.3QoL the comparison of scoring
Table 4 shows：QoL scorings after patient treats 6 times have substantially reduction (P ＜ 0.05) compared with pre-treatment, as a result point out：
Control urine patch point application can substantially reduce the QoL scorings of patient, and treatment can effectively improve the daily life quality of patient.
Table 4 treats the comparison of front and rear QoL scorings
| Group (number of cases) | Before treatment | Treatment 6 times |
| Treatment group (30) | 5.97±0.183 | 1.20±0.887※ |
Note：※Represent to compare in the front and rear group for the treatment of and have significant difference (P ＜ 0.05).
The comparison of urodynamics change before and after 3.2 treatments
The uroflometry for have 22 to complete before treatment in 30 patients included, to treat 3 times, treating 6 times, originally grinds
The urodynamic data for studying carefully 22 patients by measure is completed carries out statistical analysis.
Table 5 shows：The Q after treating 3 times, treating 6 timesmaxThere is an increase (P ＜ 0.05) before relatively treating, and after treating 6 times
Qmax3 increases are relatively treated to become apparent from (P ＜ 0.05).Illustrate the treatment by a course for the treatment of, control urine patch is to patient's
QmaxThere is improvement result, patient's Qmax has the increased trend with treatment number of times increase.
Table 5 is treated front and rear urinary flow and compared
| Group (number of cases) | Before treatment | Treatment 3 times | Treatment 6 times |
| Treatment group (22) | 16.71±9.690 | 19.70±9.145※ | 26.94±14.096※△ |
Note：※Represent to compare before and after treating and have significant difference (P ＜ 0.05).△Represent treatment has aobvious 6 times with treating to be compared for 3 times
Write sex differernce (P ＜ 0.05).
Table 6 shows：Patient Q after treating 3 times, treating 6 timesaveIt is significantly increased (P ＜ 0.05) before relatively treating；And control
6 times are treated compared with Q when treating 3 timesaveIncrease significantly (P ＜ 0.05).Illustrate the treatment by a course for the treatment of, control urine patch pair
The Q of patientaveThere is improvement result, and the improvement of patient's AFR has the increased trend with the increase for the treatment of number of times.
Table 6QaveCompare before and after treatment
| Group (number of cases) | Before treatment | Treatment 3 times | Treatment 6 times |
| Treatment group (22) | 6.64±4.565 | 8.40±4.052※ | 11.78±5.750※△ |
Note：※Represent to compare in the front and rear group for the treatment of and have significant difference (P ＜ 0.05).△Represent that treat 6 times is compared with treating 3 times
There is significant difference (P ＜ 0.05).
Table 7 shows：Treatment 3 times, treatment 6 times after Vv relatively treat before have increase (P ＜ 0.05)；And 6 relatively treatments for the treatment of
3 Vv increases are significantly (P ＜ 0.05).Illustrate the treatment by a course for the treatment of, control urine patch has improvement to make the Vv of patient
With, and the improvement of the effective bladder capacity of patient has the increased trend with the accumulation for the treatment of number of times.
Compare before and after table 7Vv treatments
| Group (number of cases) | Before treatment | Treatment 3 times | Treatment 6 times |
| Treatment group (22) | 140.59±59.482 | 219.45±73.050※ | 344.09±83.117※△ |
Note：※Represent to compare in the front and rear group for the treatment of and have significant difference (P ＜ 0.05).△Represent that treat 6 times is compared with treating 3 times
There is significant difference (P ＜ 0.05).
Table 7 shows：Before being treated to two groups of patient FT, treatment 3 times, treat the comparison of 6 times：Two groups of treatments 3 times, control
FT has increase (P ＜ 0.05) before relatively treating after treating 6 times；6 relatively 3 increased more apparent (P ＜ of degree for the treatment of of treatment
0.05).Illustrate the treatment by a course for the treatment of, two groups for the treatment of methods have improvement result, and patient's uroflow to the Vv of patient
The improvement of time has the increased trend with the increase for the treatment of number of times.
Compare before and after 7 two groups of FT treatments of table
| Group (number of cases) | Before treatment | Treatment 3 times | Treatment 6 times |
| Treatment group (22) | 22.96±16.183 | 26.34±15.823※ | 29.67±15.371※△ |
Note：※Represent to compare in the front and rear group for the treatment of and have significant difference (P ＜ 0.05).△Represent that treat 6 times is compared with treating 3 times
There is significant difference (P ＜ 0.05).
It can be seen that by table 4-7, control urine patch is to patient's Qmax, AFR, effective bladder capacity, uroflow time
There is improvement result, and this improvement result has the increased trend with the increase for the treatment of number of times.
Claims (10)
1. a kind of Chinese medicine composition for treating overactive bladder, it is characterised in that：It by following parts by weight bulk drug system
It is standby to form medicament：1.5-10 parts of the root of gansui, 1.5-10 parts of asarum, 3-10 parts of white pepper, 3-15 parts of ginger.
2. the Chinese medicine composition for the treatment of overactive bladder according to claim 1, it is characterised in that it is by following heavy
The medicament that the raw material of amount part is prepared from：10 parts of the root of gansui, 10 parts of asarum, 10 parts of white pepper, 10 parts of ginger.
3. the Chinese medicine composition for the treatment of overactive bladder according to claim 1 or 2, it is characterised in that the medicine
Agent is formulation described in any pharmacy.
4. the Chinese medicine composition for the treatment of overactive bladder according to claim 3, it is characterised in that the formulation
For transdermal patch.
5. the Chinese medicine composition transdermal patch of overactive bladder is treated according to claim 4, it is characterised in that described
Transdermal patch is made up of back sheet, load medicine hot melt adhesive layer and adherent layer；The load medicine hot melt adhesive layer is located at back sheet and adherent layer
Between, and the load medicine hot melt adhesive layer containing 10-44 parts of Chinese medicine composition extract medicinal extract, 33-65 parts of thermotropic pressure sensitive glue,
0.3-1 parts of skin penetration enhancers.
6. the transdermal patch of Chinese medicine composition as claimed in claim 5, it is characterised in that the thermotropic pressure sensitive glue is SIS
One kind in type, SBS types, SEBS types or epoxidation SDS types.
7. the transdermal patch of Chinese medicine composition as claimed in claim 5, it is characterised in that described skin penetration enhancer
Selected from pharmaceutically acceptable surfactant, sub- vitriol compound, Laurocapram class, alcohols and its terpenoid,
The mixture of one or both of mushroom alkenes any of the above ratio.
8. a kind of preparation method for the Chinese medicine composition transdermal patch for treating overactive bladder, it is characterised in that be by such as
What lower method was obtained：
(1) root of gansui, asarum, white pepper and ginger are weighed；
(2) it is that 65%-85% ethanol is heated to reflux with volume fraction by the root of gansui, asarum, white pepper, ginger in step (1)
Extract, consumption is 6-8 times of Chinese medicine crude drug quality, and ethanol is recovered under reduced pressure in extract solution, and concentrate is vacuum dried, obtains the present invention
Chinese medicine composition extract medicinal extract is standby；
(3) thermotropic pressure sensitive glue magnetic agitation is taken to dissolving, then is extracted with skin penetration enhancer and Chinese medicine composition of the present invention
Thing medicinal extract is sufficiently mixed uniformly, obtains coating fluid after ultrasound degassing, the coating fluid is spread evenly across on adherent layer, after drying naturally,
Formed and carry medicine thermotropic pressure sensitive glue-line, finally back sheet is covered on load medicine hot melt adhesive layer, finished product is made in punching.
9. the preparation method of Chinese medicine composition transdermal patch as claimed in claim 8, it is characterised in that be heated to reflux preferred body
Fraction is 75% ethanol.
10. the preparation method of Chinese medicine composition transdermal patch as claimed in claim 8, it is characterised in that, the coating fluid is anti-
Coating weight on adhesion coating is with 4 × 5cm2In small pieces the amount of Chinese medicine composition extract medicinal extract of the present invention in terms of crude drug equivalent to 5g/
Piece.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610261494.8A CN107303381A (en) | 2016-04-25 | 2016-04-25 | It is a kind of to treat Chinese medicine composition of overactive bladder and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610261494.8A CN107303381A (en) | 2016-04-25 | 2016-04-25 | It is a kind of to treat Chinese medicine composition of overactive bladder and preparation method thereof |
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ID=60150342
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610261494.8A Pending CN107303381A (en) | 2016-04-25 | 2016-04-25 | It is a kind of to treat Chinese medicine composition of overactive bladder and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN107303381A (en) |
-
2016
- 2016-04-25 CN CN201610261494.8A patent/CN107303381A/en active Pending
Non-Patent Citations (2)
| Title |
|---|
| 刑曼: "针刺配合中药穴位敷贴治疗急迫性尿失禁的临床疗效评价研究", 《MED.WANFANGDATA.COM.CN/PAPER/DETAIL/DEGREEPAPER_Y2019473》 * |
| 罗和古等: "《脐疗巧治病》", 31 October 2008, 中国医药科技出版社 * |
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Application publication date: 20171031 |