CN104800286B - Load medicine acupuncture needle and its application of blood circulation invigorating efficacies can be strengthened - Google Patents

Load medicine acupuncture needle and its application of blood circulation invigorating efficacies can be strengthened Download PDF

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Publication number
CN104800286B
CN104800286B CN201510222584.1A CN201510222584A CN104800286B CN 104800286 B CN104800286 B CN 104800286B CN 201510222584 A CN201510222584 A CN 201510222584A CN 104800286 B CN104800286 B CN 104800286B
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acupuncture needle
plga
radix salviae
salviae miltiorrhizae
medicine acupuncture
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CN104800286A (en
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张春雁
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Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of TCM
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Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of TCM
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Abstract

The present invention relates to load medicine acupuncture needle and its application of blood circulation invigorating efficacies can be strengthened, its preparation method is:A) take Radix Salviae Miltiorrhizae appropriate, volume fraction 80 95% alcohol reflux of addition 5 10 times amount 14 times, 0.5 3 hours every time, united extraction liquid, concentrate, be dried, obtain Radix Salviae Miltiorrhizae extract;B) take PLGA appropriate, add chloroform dissolving, make the solution that PLGA mass concentration is 1 3%, it is subsequently adding Radix Salviae Miltiorrhizae extract prepared by step a), stirring and dissolving, using nebulization by this solution spraying in the needle body surface of acupuncture needle, then is vacuum dried 8 20 hours.The load medicine acupuncture needle of present invention preparation contains the significant Radix Salviae Miltiorrhizae extract of the effect ofactivating blood circulation to dissipate blood stasis, its can with macromolecular material PLGA stable bond, in human body can quick release, increase the medicine amount of penetrating, clinical trial obtains good therapeutic effect.

Description

Load medicine acupuncture needle and its application of blood circulation invigorating efficacies can be strengthened
【Technical field】
The present invention relates to pharmaceutical technology field, specifically, be related to strengthen the load medicine acupuncture needle of blood circulation invigorating efficacies and Its application.
【Background technology】
With the reinforcement of health of people health care consciousness, traditional non-drug therapy presents the development trend become better and better, its In the most prominent with this traditional means of acupuncture.But, simple dependence acupuncture means remain in many shortcomings, such as acupuncture and moxibustion therapy model Enclose narrower, slower to part disease therapeuticing effect or weaker, therefore pharmacotherapy and acupuncture and moxibustion treatment are combined into a kind of new Therapeutic Method.
Have some patent applications about load medicine acupuncture needle at present, such as:Yin Zhiheng, horse yu-kin. a kind of acupuncture of load medicine Pin. Chinese patent, patent No. ZL 200320112401.3, day for announcing 2014.11.17, described load medicine acupuncture needle includes pin Body, needle handle, the outer surface coating medicine layer of needle body, medicine layer is oil preparation medicine or emulsifying agent medicine or water preparation medicine or alcohol agent medicine is applied to needle body The medicament film layer being formed, it passes through to apply medicine during acupuncture, and then reaches the purpose improving therapeutic effect of acupuncture and moxibustion. Impact carries the many factors of medicine acupuncture needle therapeutic effect, including the drug effect of the concrete composition of medicine layer, medicine rate of release in vivo Deng.
Motherland's medical science thinks, congestion is to block in arteries and veins because blood operation is not smooth, or overflows outside arteries and veins, condenses in a certain office Portion and the pathological product that formed, and the congestion after producing can affect blood normal operation and become some diseases pathogenic because Element, leads to many new diseases.Blood circulation promoting and blood stasis dispelling is most important theories and the Therapeutic Principle of China's medical science,《Interior warp》Record " promoting circulation of QI-blood, make its tune reach ", it has also become the basis of the later age blood circulation promoting and blood stasis dispelling rule for the treatment of.With deeply grinding to blood-activating and stasis-removing Study carefully, find its have improve hemodynamics, improve hemorheology, to improve microcirculation disturbance, antithrombotic, anti-atherogenic hard Change and the effect such as myocardial ischemia, suppression tissue abnormalities hypertrophy, suppression inflammation, suppression tumor.
Have not yet to see and the effective ingredient in Chinese or composition with blood circulation invigorating efficacies are supported on acupuncture wire surface, be used for The report for the treatment of syndrome of blood stasis relevant disease.
【Content of the invention】
The purpose of the present invention is for deficiency of the prior art, provides a kind of load medicine pin strengthening blood circulation invigorating efficacies Acupuncture needle.
Another purpose of the present invention is to provide the purposes of described load medicine acupuncture needle.
For achieving the above object, the present invention adopts the technical scheme that:
A kind of load medicine acupuncture needle strengthening blood circulation invigorating efficacies, it is prepared by the following method and obtains:
A) take Radix Salviae Miltiorrhizae appropriate, the volume fraction 80-95% alcohol reflux of addition 5-10 times amount 1-4 time, each 0.5-3 Hour, united extraction liquid, concentrate, be dried, obtain Radix Salviae Miltiorrhizae extract;
B) take PLGA appropriate, add chloroform dissolving, make the solution that PLGA mass concentration is 1-3%, be subsequently adding step A) Radix Salviae Miltiorrhizae extract prepared, stirring and dissolving, using nebulization by this solution spraying in the needle body surface of acupuncture needle, then vacuum is done Dry 8-20 hour.
Its Acetic acid, hydroxy-, bimol. cyclic ester of described PLGA, the ratio of lactide are (40-60):(60-40).
Its Acetic acid, hydroxy-, bimol. cyclic ester of described PLGA, the ratio of lactide are 50:50.
In step b), the amount of the Radix Salviae Miltiorrhizae extract of addition is equivalent to 0.3-0.5 times of 1-3%PLGA solution weight.
In step b), described nebulization is specially:Injection rate is 0.3-0.8m/s, and spray date is 15-30min.
For realizing above-mentioned second purpose, the present invention adopts the technical scheme that:
As above arbitrary described medicine acupuncture needle that carries promotes the application in the medical apparatus and instruments of blood circulation invigorating efficacies in preparation.
As above arbitrary described load application in preparing the medical apparatus and instruments of cure scapulohumeral periarthritis or lumbar muscle strain for the medicine acupuncture needle.
The invention has the advantages that:
The present invention extracts the effective ingredient obtaining blood circulation promoting and blood stasis dispelling from Radix Salviae Miltiorrhizae, with suitable macromolecular material PLGA as bone Frame, forms, in acupuncture wire surface, the film layer containing activating blood circulation to dissipate blood stasis effective ingredient by nebulization, for carrying the macromolecular material energy of medicine With active ingredient of Chinese herbs stable bond, energy quick release in human body, increase the medicine amount of penetrating, clinical trial obtains good Therapeutic effect.
【Specific embodiment】
The specific embodiment below present invention being provided elaborates.
Embodiment 1 present invention carries the preparation () of medicine acupuncture needle
(1) extraction of the composition such as tanshinone in salvia miltiorrhiza bunge IIa
Using ethanol extraction process, that is, take Radix Salviae Miltiorrhizae appropriate, volume fraction 95% alcohol reflux of addition 8 times amount 2 times, 2 hours every time, united extraction liquid, concentrate, be dried, obtain final product.
(2) carry the preparation of medicine acupuncture needle
Take polyglycolic-lactic acid (PLGA;Acetic acid, hydroxy-, bimol. cyclic ester, the ratio of lactide are 50:50) appropriate, add chlorine Imitative dissolving, makes the solution that PLGA mass concentration is 2%, is subsequently adding the Radix Salviae Miltiorrhizae being equivalent to 2%PLGA solution weight 0.4 times amount Extract, stirring and dissolving, using nebulization by this solution spraying in the needle body surface of acupuncture needle, injection rate is 0.5m/s, spray The medicine time is 20min, then is vacuum dried 12 hours, obtains final product.
Embodiment 2 present invention carries the preparation (two) of medicine acupuncture needle
(1) extraction of the composition such as tanshinone in salvia miltiorrhiza bunge IIa
Using ethanol extraction process, that is, take Radix Salviae Miltiorrhizae appropriate, volume fraction 95% alcohol reflux of addition 5 times amount 1 time, 3 hours every time, concentrate, be dried, obtain final product.
(2) carry the preparation of medicine acupuncture needle
(Acetic acid, hydroxy-, bimol. cyclic ester, the ratio of lactide are 40 to take PLGA:60) appropriate, add chloroform dissolving, make PLGA mass concentration Solution for 1%, is subsequently adding the Radix Salviae Miltiorrhizae extract being equivalent to 1%PLGA solution weight 0.3 times amount, stirring and dissolving, using spray By this solution spraying in the needle body surface of acupuncture needle, injection rate is 0.8m/s to mist method, and spray date is 30min, then vacuum is done Dry 20 hours, obtain final product.
Embodiment 3 present invention carries the preparation (three) of medicine acupuncture needle
(1) extraction of the composition such as tanshinone in salvia miltiorrhiza bunge IIa
Using ethanol extraction process, that is, take Radix Salviae Miltiorrhizae appropriate, add volume fraction 80% alcohol reflux 4 of 10 times amount Secondary, 0.5 hour every time, united extraction liquid, concentrate, be dried, obtain final product.
(2) carry the preparation of medicine acupuncture needle
(Acetic acid, hydroxy-, bimol. cyclic ester, the ratio of lactide are 60 to take PLGA:40) appropriate, add chloroform dissolving, make PLGA mass concentration Solution for 3%, is subsequently adding the Radix Salviae Miltiorrhizae extract being equivalent to 3%PLGA solution weight 0.5 times amount, stirring and dissolving, using spray By this solution spraying in the needle body surface of acupuncture needle, injection rate is 0.3m/s to mist method, and spray date is 15min, then vacuum is done Dry 8 hours, obtain final product.
Comparative example 1
(1) extraction of the composition such as tanshinone in salvia miltiorrhiza bunge IIa
Using ethanol extraction process, that is, take Radix Salviae Miltiorrhizae appropriate, volume fraction 95% alcohol reflux of addition 8 times amount 2 times, 2 hours every time, united extraction liquid, concentrate, be dried, obtain final product.
(2) carry the preparation of medicine acupuncture needle
Taking polyethylene glycol/polyvinyl alcohol graft copolymerized copolymer Kollicoat IR is appropriate, adds chloroform dissolving, makes quality dense Spend the solution for 2%, be subsequently adding and be equivalent to 2% Polyethylene Glycol/polyvinyl alcohol graft copolymerized copolymer Kollicoat IR solution weight Measure the Radix Salviae Miltiorrhizae extract of 0.4 times amount, stirring and dissolving, using nebulization by this solution spraying in the needle body surface of acupuncture needle, spray Speed is 0.5m/s, and spray date is 20min, then is vacuum dried 12 hours, obtains final product.
Comparative example 2
(1) extraction of the composition such as tanshinone in salvia miltiorrhiza bunge IIa
Using ethanol extraction process, that is, take Radix Salviae Miltiorrhizae appropriate, volume fraction 95% alcohol reflux of addition 5 times amount 1 time, 3 hours every time, concentrate, be dried, obtain final product.
(2) carry the preparation of medicine acupuncture needle
(Acetic acid, hydroxy-, bimol. cyclic ester, the ratio of lactide are 30 to take PLGA:70) appropriate, add chloroform dissolving, make PLGA mass concentration Solution for 1%, is subsequently adding the Radix Salviae Miltiorrhizae extract being equivalent to 1%PLGA solution weight 0.3 times amount, stirring and dissolving, using spray By this solution spraying in the needle body surface of acupuncture needle, injection rate is 0.8m/s to mist method, and spray date is 30min, then vacuum is done Dry 20 hours, obtain final product.
Embodiment 4 present invention carries the clinical trial of medicine acupuncture needle
First, the clinical trial of cure scapulohumeral periarthritis
1. clinical data
Select clinical diagnosises clear and definite scapulohumeral periarthritis patient, diagnostic criteria meets《Chinese medical disease Standardization of diagnosis and curative effect》, doctor trained in Western medicine Diagnostic criteria is:1) onset concealment, no obvious trauma history, Chang Yin lifts, arms sideward lift causes pain to begin to be noted;2) local is pressed Pain spot is in subacromial bursa, caput longum musculi bicipitis brachii, processus coracoideus, supraspinatuss attachment point or intertubercular sulcus etc.;4) shoulder mobility is subject to Limit or stiff, with abduction outward turning, after to stretch obstacle the most notable;5) exclusion anemia of pregnant woman, tumor.X-ray film discharges shoulder joint pathological changes etc..Altogether 120, man 58, female 62,51 years old mean age, medical history is the shortest 1 month, the longest a year and a half.Patient is randomly divided into four groups: Treatment group, matched group one, matched group two, simple matched group, each group 30, each group Gender, age, course of disease etc. are through statistics Process has comparability.
2. Therapeutic Method
The load medicine acupuncture that treatment group, matched group one, matched group two are prepared using embodiment 1, comparative example 1, comparative example 2 respectively Pin gives to treat, and simple matched group gives to treat using the acupuncture needle not carrying medicine.
Specifically Therapeutic Method is:Take shoulder three pin of JIN TRI-POINTS, shoulder I pin (in subacromial depression), shoulder II pin are (in shoulder I pin The each side of front and rear direction open at about 2 cun), take sky ancestor, Quchi, Wai Guan, Ashi point.Patient takes seat or lateral position, routine disinfection Afterwards, take acupuncture needle acupuncture on above acupuncture point, after bringing about the desired sensation, let the acupuncture needle remain at a certain point 15 minutes, and one time a day, 5 times is 1 course for the treatment of, opens after having three days off Begin the 2nd course for the treatment of, treats 2 courses for the treatment of altogether.Clinical symptoms, sign before and after observation and treatment.Statistical method is counted with SPSS19.0 Learn software analysis, measurement data represents, carry out t inspection, enumeration data carries out X2 inspection, P using mean ± standard deviation<When 0.05 For difference, there is statistical significance.
3. curative effect determinate standard
Effective:Shoulder pain disappears or alleviates substantially, and shoulder mobility scope is recovered normal or improved substantially;Effectively:Shoulder Portion's pain is alleviated substantially, and shoulder mobility range section improves;Invalid:Symptom is no improved.
4. result
Statistical result is shown in Table 1.Statistical analysis show, treatment group, matched group one, matched group two respectively with simple matched group Total effective rate is compared, and is respectively provided with statistical significance (P<0.05);Treatment group and the total effective rate difference of matched group one, matched group two Relatively, also it is respectively provided with statistical significance (P<0.05).Show that the load medicine acupuncture needle cure scapulohumeral periarthritis effect is significant of the present invention is better than Simple points acupuncture treatment, the load medicine acupuncture needle that effect is better than comparative example 1 simultaneously, prepared by comparative example 2.
Table 1 scapulohumeral periarthritis curative effect counts
Effective Effectively Invalid Total effective rate
Treatment group 16 13 1 96.67%
Matched group one 8 12 10 66.67%
Matched group two 9 13 8 73.33%
Simple matched group 4 11 15 50%
The effect of the follow-up load medicine acupuncture needle to the preparation of embodiment 2-3 has carried out clinical trial testing, and concrete grammar is ibid. Result shows, the total effective rate of the load medicine acupuncture needle cure scapulohumeral periarthritis of embodiment 2-3 preparation is 90%.
2nd, treat the clinical trial of lumbar muscle strain
1. clinical data
Select clinical diagnosises clear and definite lumbar muscle strain patient, diagnostic criteria is:Patients clinical symptom display waist once had Cross wound or have in daily life habitually to bend over, sore waist and aching in the waist and the back often occurs, always feel tired and relatively In the case of cold, disease can increase, by certain time rest or take Insulation can play the work of relief of symptoms With.Find patient's dorsiflexion muscle tonus in health check-up, and can not be anteflexion restricted, patient's musculus sacrospinalis outside left is pressed, disease The obvious feels pain of people.Totally 160, man 72, female 88,56 years old mean age, the shortest course of disease 1.5 years, the longest course of disease 13 years. Patient is randomly divided into four groups:Treatment group, matched group one, matched group two, simple matched group, each group 40, each group Gender, Age, course of disease etc. are statistically analyzed with comparability.
2. Therapeutic Method
Patient is allowed to choose ventricumbent position or to choose lateral position, basic acupuncture point:Acupoint Dachangshu, chooses double acupuncture points;Weizhong point, choosing Take double acupuncture points.First take skin surface disinfectant measure, after Protective Erfect of Acupuncture, maintain 10 minutes, acupuncture depth is probably at 2 centimetres Left and right, skin at acupuncture point for the needle handle position, between 0.5 centimetre to 1 centimetre, carries out seance daily, is for 5 times 1 treatment Journey, rest started the 2nd course for the treatment of after 2 days, treated 3 courses for the treatment of altogether.Clinical symptoms, sign before and after observation and treatment.
3. curative effect determinate standard
Effective:Principle of Pain symptom eliminates or be significantly improved, other related symptoms eliminate or are significantly improved;Have Effect:Principle of Pain symptom has improvement, and other related symptoms have some improvement;Invalid:Principle of Pain symptom do not improve or Exacerbation of symptoms.
4. statistical method
Application SPSS19.0 statistics software carries out the analysis of data to above-mentioned treatment, and measurement data adopts mean ± standard Difference represents, carries out t inspection, enumeration data carries out X2 inspection, P<For difference, there is statistical significance when 0.05.
5. result
Statistical result is shown in Table 2.Statistical analysis show, treatment group, matched group one, matched group two respectively with simple matched group Total effective rate is compared, and is respectively provided with statistical significance (P<0.05);Treatment group and the total effective rate difference of matched group one, matched group two Relatively, also it is respectively provided with statistical significance (P<0.05).Show that the load medicine acupuncture needle therapeutic lumbar muscle strain effect is significant of the present invention is excellent In simple points acupuncture treatment, the load medicine acupuncture needle that effect is better than comparative example 1, prepared by comparative example 2 simultaneously.
Table 2 lumbar muscle strain curative effect counts
Effective Effectively Invalid Total effective rate
Treatment group 23 15 2 95%
Matched group one 8 19 13 67.5%
Matched group two 11 18 11 72.5%
Simple matched group 5 14 21 47.5%
The effect of the follow-up load medicine acupuncture needle to the preparation of embodiment 2-3 has carried out clinical trial testing, and concrete grammar is ibid. Result shows, the total effective rate of the load medicine acupuncture needle therapeutic lumbar muscle strain of embodiment 2-3 preparation is respectively 90%, 92.5%.
The above is only the preferred embodiment of the present invention it is noted that ordinary skill people for the art Member, on the premise of without departing from the inventive method, can also make some improvement and supplement, these improve and supplement also should be regarded as Protection scope of the present invention.

Claims (7)

1. a kind of load medicine acupuncture needle strengthening blood circulation invigorating efficacies is it is characterised in that it is to be prepared by the following method to obtain 's:
A) take Radix Salviae Miltiorrhizae appropriate, the volume fraction 80-95% alcohol reflux of addition 5-10 times amount 1-4 time, each 0.5-3 is little When, united extraction liquid, concentrate, be dried, obtain Radix Salviae Miltiorrhizae extract;
B) take PLGA appropriate, add chloroform dissolving, make PLGA quality Concentration is the solution of 1-3%, is subsequently adding Radix Salviae Miltiorrhizae extract prepared by step a), stirring and dissolving, using nebulization by this solution It is sprayed at the needle body surface of acupuncture needle, then be vacuum dried 8-20 hour.
2. according to claim 1 carry medicine acupuncture needle it is characterised in that described PLGA its Acetic acid, hydroxy-, bimol. cyclic ester, the ratio of lactide are (40-60):(60-40).
3. according to claim 2 carry medicine acupuncture needle it is characterised in that described PLGA its Acetic acid, hydroxy-, bimol. cyclic ester, the ratio of lactide are 50:50.
4. load medicine acupuncture needle according to claim 1 is it is characterised in that in step b), the amount of the Radix Salviae Miltiorrhizae extract of addition Be equivalent to 0.3-0.5 times of 1-3% PLGA solution weight.
5. load medicine acupuncture needle according to claim 1 is it is characterised in that in step b), described nebulization is specially:Spray Firing rate rate is 0.3-0.8m/s, and spray date is 15-30min.
6. the arbitrary described medicine acupuncture needle that carries of claim 1-5 promotes answering in the medical apparatus and instruments of blood circulation invigorating efficacies in preparation With.
7. the arbitrary described load medicine acupuncture needle of claim 1-5 is in preparing the medical apparatus and instruments of cure scapulohumeral periarthritis or lumbar muscle strain Application.
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CN112121079A (en) * 2020-09-24 2020-12-25 长春中医药大学 Acupuncture needle capable of enhancing pain relieving efficacy and preparation method and application thereof

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CN2655888Y (en) * 2003-11-26 2004-11-17 尹志恒 Acupuncture needle with medicine
CN2774504Y (en) * 2004-12-12 2006-04-26 任志云 Acupuncture needle coated with medicinal membrane layer
CN101278920B (en) * 2008-04-25 2011-05-04 广东药学院 Salvianolic acid controlled porosity osmotic pump tablets and method of preparing the same
CN102579691B (en) * 2012-03-05 2013-09-25 黄荣 Medicinal oil for acupuncture and preparation method thereof

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