CN104367940B - A kind of microneedle cutaneous system of compound Chinese medicinal preparation - Google Patents
A kind of microneedle cutaneous system of compound Chinese medicinal preparation Download PDFInfo
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- CN104367940B CN104367940B CN201410589652.3A CN201410589652A CN104367940B CN 104367940 B CN104367940 B CN 104367940B CN 201410589652 A CN201410589652 A CN 201410589652A CN 104367940 B CN104367940 B CN 104367940B
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Abstract
The present invention relates to a kind of microneedle cutaneous system of compound Chinese medicinal preparation, cataplasm and micropin medicine-feeding technology are combined, using traditional medicine volatile oil and borneol as medicine material, cataplasm is prepared into；Again by microneedle cutaneous.
Description
Technical field
The invention mainly relates to pharmaceutical technology field, and in particular to a kind of microneedle cutaneous system of compound Chinese medicinal preparation
Preparation method.
Technical background
Traditional Chinese medicine " Angong Niuhuang Wan " its main component has Moschus, borneol and root tuber of aromatic turmeric, cape jasmine, stops convulsion with inducing resuscitation, clearly
Hot cool blood, the promoting flow of qi and blood circulation, the effect for analgesic of detoxifying.It is clinically used for treating cerebrovas-cularaccident, encephalitis B, central nervous system togetherness
Contaminate, angina pectoris, disturbance of consciousness etc. caused by alcohol or drug poisoning etc..The curative effect composition of the compound Chinese medicinal preparation is to original
Volatile essential oil for obtaining after material is distilled, also known as volatile oil, be come out with steam distillation in Chinese medicine and with water not
The general name of miscible volatility oily composition.Volatile oil is mixture, and its component is complex, generally oil-based liquid, makes
Its curative effect can be influenceed in Clinical practice by obtaining medicine, so needing a kind of method of administration more easily and effectively.
Percutaneous dosing is got the attention in recent years because having the advantages that convenience, safely and without liver first-pass effect, but
Due to the barrier action of keratoderma, the infiltration rate and infiltration capacity of most of medicine are very low, are unable to reach treatment and require, are
The development that this transdermal rush oozes technology has become the key of percutaneous dosing.What is occurred in recent years is microneedle cutaneous, is exactly a kind of
Promote the new technique of drug transdermal infiltration, its core is micro-needle array chip, i.e., in several square millimeters of single crystal silicon material table
Face produces the array being made up of up to a hundred micropins.The array can pierce through the skin keratin that barrier action is played to drug diffusion
Layer, while up to a hundred administration channels are opened, so as to improve the percutaneous penetration of multi-medicament.Due to skin elasticity and itself is micro-
Small size, the depth that micropin enters skin is not typically achieved skin corium, will not also form obvious pain, be a kind of nothing
Pain promotees to ooze technology.
Microneedle cutaneous system is compared with traditional delivery system, and it is mainly characterized by：
1st, micropin is carefully sharp, and general paracentesis depth does not stimulate nerve endings only in cuticula, and pain is not caused,
It is a kind of painless, undamaged percutaneous dosing mode.
2nd, by carrying out painless pore processing to skin, small-molecule drug, macromolecular substances and hydrophilic can be significantly improved
The percutaneous permeation of property medicine, and skin is not damaged, it is easy to use.
3rd, micropin causes real passage on cuticula, and this passage more than with electro-ionic osmosis, ultrasound, pressure wave,
" fuzzy " channel function that the modes such as electroporation, penetrating agent are caused is powerful and unrelated with keratin structure.Its transport resistance is smaller,
And permeability increase.
4th, the transdermal penetration rates of medicine are improved, the skin hold-up of medicine is reduced, extend medicine effective acting time.
5th, the degraded of first pass effect and intestines and stomach without liver, utilization ratio of drug is high.
6th, micropin administration is accurate, and quickly, small volume is easy to carry.And promote infiltration methods with others not conflict, can be with
It is used in combination to improve transdermal delivery rates.
Microneedle cutaneous research has been carried out in medical research field in succession abroad at present, but apply on traditional Chinese medicine research compared with
It is few, and the research of traditional Chinese medicine monomer is focused primarily upon, and for the compound Chinese medicinal preparation containing a variety of volatile oil and solid drugs
Microneedle cutaneous application study temporarily have no report.So in order to supplement in the microneedle cutaneous research of traditional medicine volatile oil
Hold, the applicant sets up the preparation method of above-mentioned microneedle cutaneous system by experimental exploring.
The content of the invention
The present invention mainly overcomes the limitation of prior art, and cataplasm and micropin medicine-feeding technology are combined, waved a variety of
Cataplasm is made in the compound medicine of hair oil and solid drugs composition, then by microneedle cutaneous.Its central scope is as follows：By medicine
After material extract, medicinal material or chemicals are mixed with suitable hydrophilic matrix, the cataplasm being made on back lining materials is coated on,
The basic structure of cataplasm includes:Support layer, also known as ground or is mounted by the main carrier function for playing lotion, typically from artificial
Cotton, non-woven fabrics, flannel etc.；Paste layer, i.e. matrix and main ingredient part, appropriate adhesion is produced in sticking and is allowed to and skin
Skin close contact, to reach the purpose for the treatment of.During cutaneous penetration, hindered due to being limited to the outermost barrier of skin
Cause most drug molecule can not by and dosage very little, and excessively slow rate of release be extremely difficult to treatment mesh
, taken for this and micropin is first pierced into skin, be detained certain time, micropin is extracted quickly after producing small hole；It will carry again
On the skin of drug paste agent patch micropin processing, by destroying cuticula to strengthen permeability of the skin to medicine, promote drug absorption,
Improve bioavilability.
Therefore the present invention provides a kind of microneedle cutaneous system of compound Chinese medicinal preparation, it is characterised in that including in
Medicine is cataplasm and microneedle patch prepared by bulk drug.
Wherein described cataplasm is the cataplasm prepared using traditional medicine volatile oil and borneol as medicine material.
Described microneedle cutaneous system, is a kind of assembly packaging for being packaged together cataplasm and microneedle patch, makes
Used time needs to use cataplasm and microneedle patch.
Described microneedle cutaneous system, is with 1 by cataplasm and microneedle patch:1 ratio is packaged together.
The traditional medicine volatile oil is the mixture of cape jasmine volatile oil, Radix Curcumae volatile oil and Moschus volatile oil, the ratio of volatile oil
Example is calculated as with crude drug：The parts by weight of cape jasmine 300, the parts by weight of root tuber of aromatic turmeric 300,75 parts of Moschus weight.Both traditional medicine volatile oil and borneol
Part by weight is 30：1.
The cataplasm is made up of support layer, lotion, anti-mucous membrane, and support layer is selected from：Cotton, non-woven fabrics, flannel, poly- second
Alkene film, glassine paper, lotion contain matrix and medicine, and matrix is selected from：Adhesive agent, filler, NMF, crosslinking agent, transdermal rush
Enter agent, PH conditioning agents, anti-mucous membrane to be selected from：Separate paper, polyethylene film.
Wherein described cataplasm, preparation process is as follows：
1) take mixture of volatile oil, distilled water, with adhesive agent in container, heating water bath stirring and dissolving.
2) 1 is added after mixing appropriate filler, NMF, crosslinking agent, is mixed with magnetic stirring apparatus, makes dissolving.
3) transdermal enhancer and borneol are mixed, 2 is added after being ground with homogenizer.
4) PH conditioning agents are eventually adding, are stirred and evenly mixed, lotion is obtained.
5) lotion is spread evenly across on non-woven fabrics, dries, cover polyethylene film, cut into suitable size, produce.
Wherein described microneedle patch, preparation process is as follows：Sprayed with plating mode on polymer film or on micro-silicon mould micro-
Pin, micropin is made of metal or alloy material.
Described microneedle cutaneous system is preparing the application in treating angina pectoris, alcoholism, hyperpyretic convulsion disease.
The extraction of volatile oil of the present invention can be obtained by supercritical extraction, and it is 20-45MP, extraction to control extracting pressure
40 DEG C -60 DEG C of temperature, parses pressure 10-30MP, 10 DEG C -20 DEG C of resolution temperature；(the magnificent XINGNAOJING ZHUSHEYEs Chinese medicine of money
Supercritical extraction process research [D] Southern Yangtze University master thesis, 2006.).
The borneol that the present invention is used need to meet States Pharmacopoeia specifications, and volatile oil should be 30 with borneol weight ratio:1,
The volatile oil consumption of the present invention is the 10%~20% of catablasm base material,.
Above-mentioned catablasm base material can be made up of the material of following weight proportion：
1. adhesive agent：Sodium alginate, starch, gelatin, Arabic gum, peach gum, methylcellulose, carboxymethyl cellulose and sodium
Salt, polyacrylic acid, ammonium polyacrylate, Sodium Polyacrylate, polyvinyl alcohol, polyvinylpyrrolidone, acrylate, polyethylene glycol,
Octadecyl alcolol etc..
2. filler：Kaolin, superfine silica gel powder, calcium carbonate, white bole, diatomite etc..
3. NMF：Glycerine, propane diols, sorbierite.
4. crosslinking agent：The metal oxides such as titanium dioxide, zinc oxide, alchlor, aluminum glycinate
5. transdermal enhancer：Azone, propane diols, oleic acid, surfactant etc.
6. PH conditioning agents：Citric acid, lactic acid, tartaric acid
Cataplasm agent prepares mainly point following steps in a kind of microneedle cutaneous system of compound Chinese medicinal preparation of the present invention：
1. take appropriate mixture of volatile oil, distilled water, with adhesive agent in container, heating water bath stirring and dissolving.
2. adding 1 after appropriate filler, NMF, crosslinking agent are mixed, mixed with magnetic stirring apparatus, make dissolving.
3. transdermal enhancer and borneol are mixed, 2 are added after being ground with homogenizer.
4. being eventually adding PH conditioning agents, stir and evenly mix, obtain lotion.
5. lotion is spread evenly across on non-woven fabrics, dries, cover polyethylene film, cut into suitable size, produce.
Microneedle patch prepared by the present invention, preferably metal micro-needle are pasted, and preparation method is as follows：With plating mode in polymer
Ti, Ni or Cu layers of spraying prepares metal micro-needle on upper or micro-silicon mould.It is adjacent with micropin top on hollow microneedles mould
Outer surface painting last layer shelters film and avoids plating.With Ni or NiFe electroplating baths, 10mAcm-26h is electroplated, is deposited certain thickness
Metal level to mould, which is filled up, can be made into different length solid microneedles, and the present invention uses micropin length for 200um.
To prove the superiority of the present invention, illustrate beneficial effects of the present invention below by way of contrast experiment：
The inventive method can treat angina pectoris, and the drug effect data that alcoholism, hyperpyretic convulsion disease are applied is as follows：
The present invention is through pharmacodynamic study, and its antipyretic reverse side is as follows：
Wister rats 40 are taken, male and female half and half, the continuous temperature measurement 3 times before testing, body temperature fluctuation is no more than 0.3 DEG C, with
Machine is divided into negative control, positive control, microneedle cutaneous preparation group, cataplasm group, and every group 10, stop eating 2hr during experiment, often
2 body temperature are measured every 30min, average temperature are taken, respectively injecting normal saline, tylenol (positive), microneedle cutaneous preparation,
Cataplasm group, each mouse injects heating agent immediately after administration, according to 0.5,1,2,4,6,8,10,12hr record body temperature, calculate body
Temperature approach, carries out antipyretic pharmacodynamic study.
Test result indicates that 4 hours temperature are gradually increasing after pyrogenicity, peak within 8 hours, positive control, micropin are saturating
Skin drug-delivery preparation group can substantially reduce heating temp, and microneedle cutaneous preparation cooling onset time is more early than positive controls,
The continued down time is more long, and the cooling of cataplasm group is not obvious.
The present invention is as follows to the pharmacodynamic study of alcoholism：
SD male rats 60 are taken, point three groups, every group 20, fasting 12h during experiment, respectively injecting normal saline pair
According to group, microneedle cutaneous preparation group, cataplasm group, it is administered 30 minutes, 50% alcohol gavage, rat alcohol is carried out according to body weight
Whether poisoning is disappeared for index with righting reflex, collection vein hematometry SOD and oxygen radical.
Test result indicates that microneedle cutaneous preparation group alcoholism symptom is lighter after rat alcoholism, alcohol tolerance
Time increases, and the drunk time shortens, while its oxidation index is significantly better than control group and cataplasm group.
The present invention is as follows to anginal pharmacodynamic study：
Wister rats 80 are taken, model group, control group (nitroglycerine patch), microneedle cutaneous preparation is randomly divided into
Group, cataplasm group, every group 20, daily 1 patch, one time a day, maintains 24 hours every time, the course for the treatment of 7 days, the 5th day to the 7th day, to right
According to group, microneedle cutaneous preparation group, cataplasm group injects isoprel respectively, and anesthesia checks the heart after being injected at the 7th day
Electrograph, blood sampling is checked and myocardium markers inspection.
Mitigate test result indicates that microneedle cutaneous preparation group and Deponit TTS have due to coronary disease and angina pectoris
The effect of the myocardial damage caused, wherein microneedle cutaneous preparation group and Deponit TTS group are lifted in cytology, ST sections
Absolute value and enzymes the aspect all no significant differences moved down, point out microneedle cutaneous preparation group and nitroglycerin patch
Agent mitigates basically identical in the degree of myocardial damage necrosis, but significantly better than cataplasm group.
The microneedle cutaneous system of the invention, application method is as follows：
1. peeling off micropin rubberized fabric, microneedle patch is positioned over dried flat skin surface, corresponding acupuncture point is noted, flicking 30s,
Throw off microneedle patch
2. cataplasm is affixed on microneedle patch position, flicking 30s, it is ensured that laminating, sustainable laminating 24 hours.
A kind of microneedle cutaneous system of compound Chinese medicinal preparation prepared by the present invention and other transdermal route phases
Comparing has following characteristics：Realize a variety of volatile oil components, solid drugs and be combined with micropin and be collectively forming efficient method of administration,
Medicated Permeation efficiency is improved, the availability of medicine in vivo is improved.
A kind of microneedle cutaneous system of compound Chinese medicinal preparation prepared by the present invention has important excellent in field of medicaments
Point and wide prospect, are mainly manifested in the following aspects：
1. Chinese medicine of the present invention uses modern extraction technique, faster, active constituents of medicine purity is higher for extraction efficiency, saves material
Expect cost.
2. the present invention uses micropin for physical enhancement technology, the transdermal penetration rates of medicine are improved, drug targeting can be released
To skin ad-hoc location, certain depth, and do not stimulate the nerve in relatively deep tissue, therefore without pain.
3. the present invention is the new formulation of this herbal mixture, accurate with medication, quickly, small volume is easy to carry, can be with
When stop or use drug therapy, and micropin using metal micro-needle it is with low cost, suitable for large-scale production.
4. the present invention is avoided that stomach absorbs, discharged by drug targeting, improve lesions position drug concentration, extension medicine
Effective acting time.
The present invention allows people it is unexpected that can treat angina pectoris, alcoholism, hyperpyretic convulsion disease by this method
Disease, and without using the inventive method, only use the medicine of the present invention of cataplasm, it is impossible to effectively treat angina pectoris, alcoholism, height
Febrile convulsion disease.
Brief description of the drawings
Fig. 1 accumulates for microneedle cutaneous drug transdermal
Embodiment
By following examples, the present invention is further illustrated, but without limitation.
Embodiment 1
Weigh：A variety of mixture of volatile oil 30g, borneol 1g, Sodium Polyacrylate 20g, gelatin 25g, kaolin 20g, glycerine
35g, zinc oxide 1g, Tween-80 5g, tartaric acid 1g.
Preparation method：By Sodium Polyacrylate 20g, gelatin 25g, water for injection 30g is put into container, is heated into after colloidal sol and is added
Enter a variety of volatile oil 30g, and be sufficiently mixed uniformly by magnetic stirring apparatus, then by kaolin 20g, glycerine 35g, zinc oxide 1g,
Water for injection 20g is added in container after being ground, and is stirred and evenly mixed；Borneol 1g, Tween 80 5g, tartaric acid 1g are passed through into homogenizer
Added after being ground in said vesse, stir 30min (rotating speed 800rpm), gained lotion is spread evenly across on non-woven fabrics,
Dry, cover polyethylene film, cut into suitable size, produce.
Metal micro-needle preparation method is as follows：Spray Ti, Ni or Cu on polymer or on micro-silicon mould with plating mode
Layer prepares metal micro-needle.On hollow microneedles mould, the outer surface painting last layer adjacent with micropin top shelters film and avoids plating.
With Ni or NiFe electroplating baths, 10mAcm-2 plating 6h, the certain thickness metal level of deposition is filled up to mould may be manufactured without same length
Solid microneedles are spent, the present invention uses micropin length for 200um.
Embodiment 2
Weigh：A variety of mixture of volatile oil 60g, borneol 2g, polyvinylpyrrolidone 20g, peach gum 50g, sodium alginate
20g, superfine silica gel powder 40g, sorbierite 70g, titanium dioxide 2g, Tween-80 10g, tartaric acid 1.5g.
Preparation method：By polyvinylpyrrolidone 20g, peach gum 50g, sodium alginate 20g, water for injection 60g is put into container
In, it is heated into after colloidal sol and adds a variety of volatile oil 60g, and is sufficiently mixed uniformly by magnetic stirring apparatus, then by superfine silica gel powder
40g, sorbierite 70g, titanium dioxide 2g, water for injection 40g are added in container after being ground, and are stirred and evenly mixed；By borneol 2g, tell
Warm 8010g, tartaric acid 2g are added in said vesse after being ground by homogenizer, 30min (rotating speed 800rpm) are stirred, by institute
Obtain lotion to be spread evenly across on non-woven fabrics, dry, cover polyethylene film, cut into suitable size, produce.
Metal micro-needle preparation method is with example 1
Embodiment 3
Prescription：A variety of mixture of volatile oil 30g, borneol 1g, Arabic gum 30g, polyacrylic acid 5g, polyethylene glycol 10g, silicon
Diatomaceous earth 20g, sorbierite 30g, alchlor 2g, azone 10g, lactic acid 1g
Preparation method：By Arabic gum 30g, polyacrylic acid 5g, polyethylene glycol 10g, water for injection 30g is put into container,
It is heated into after colloidal sol and adds a variety of volatile oil 30g, and is sufficiently mixed uniformly by magnetic stirring apparatus, then by polyethylene glycol 10g, silicon
Diatomaceous earth 20g, sorbierite 30g, alchlor 2g, water for injection 20g are added in container after being ground, and are stirred and evenly mixed；By borneol
1g, azone 10g, lactic acid 1g are added in said vesse after being ground by homogenizer, stir 30min (rotating speed 800rpm), will
Gained lotion is spread evenly across on non-woven fabrics, is dried, is covered polyethylene film, cuts into suitable size, produce.
Initial bonding strength is determined
Take cataplasm in example 1, reference《Chinese Pharmacopoeia》One relevant cataplasm adhesive force method for measuring, is tested with spin
Method is determined:Take 3 test products, test sample be placed in 300 hang plate center, and makes its cream upwardly, inclined-plane top 10cm and under
Mylar covering thick portion 15cm, centre reserves 5cm cream face, by the lower steel ball of each specification from 300 slope board oneself
By rolling down, the maximum number steel ball that observation cataplasm cream face can be clung, the size to its initial bonding strength is evaluated.Test sample 3 is
Steel ball can be sticked.
In-vitro percutaneous experiment
The rat skin handled well is positioned on the rubber slab of cleaning, paved；Respectively with 200um micropins in 5N active forces
Lower processing mouse skin 5min；Then rat skin is clipped in improved Franz diffusion cells mouthful, keratoderma outwardly, corium
Aspect is to receiving chamber.Cataplasm in example 1 is closely sticked on rat skin, receiving chamber fills it up with 20mL physiological saline, 37 DEG C of constant temperature
0.5 DEG C of scholar, diffusion cell is fixed on temperature adjustment perseverance control magnetic stirring apparatus.Magnetic stirrer is opened to stir with 100r/min speed,
In l5min, 30min, 1h, 2h, 4h, 6h, 8h takes liquid 1mL (to add equivalent constant temperature after per sub-sampling from acceptance pool respectively
Physiological saline).Totally 7 samples, are repeated 3 times, and the sample liquid are added into 1ml n-hexane extractions, separation n-hexane layer is in 2ml volumetric flasks
In, water layer adds 1ml n-hexanes fully to extract again, and separation n-hexane layer is imported in volumetric flask, is settled to scale, plus anhydrous sodium sulfate
0.5g, shakes up, and takes supernatant, filtering with microporous membrane, and precision measures 1ml sample hexane solutions, is mixed with 1ml inner mark solutions, makees
For need testing solution, sample introduction 1ul carries out GC measure by borneol chromatographic condition, its peak area is determined with GC methods, when calculating different
Between the transdermal amount of drug accumulation.
Claims (4)
1. the microneedle cutaneous system of a kind of compound Chinese medicinal preparation, it is characterised in that be with 1 by cataplasm and microneedle patch:1
Ratio is packaged together, wherein described cataplasm is the cataplasm prepared using traditional medicine volatile oil and borneol as medicine material,
Traditional medicine volatile oil is made up in terms of crude drug of following raw material：300 parts of cape jasmine, 300 parts of root tuber of aromatic turmeric, 75 parts of Moschus,
The part by weight of both traditional medicine volatile oil and borneol is 30：1.
2. microneedle cutaneous system according to claim 1, it is characterised in that the cataplasm by support layer, lotion,
Anti- mucous membrane composition, support layer is selected from：Cotton, non-woven fabrics, flannel, polyethylene film, glassine paper, lotion contain matrix and medicine
Thing, matrix is selected from：Adhesive agent, filler, NMF, crosslinking agent, transdermal enhancer, pH adjusting agent, anti-mucous membrane are selected from：It is anti-sticking
Paper, polyethylene film.
3. the preparation method of the microneedle cutaneous system described in claim 1, it is characterised in that wherein described cataplasm, system
Standby step is as follows：
1）Take mixture of volatile oil, distilled water, with adhesive agent in container, heating water bath stirring and dissolving；
2）Added after appropriate filler, NMF, crosslinking agent are mixed, mixed with magnetic stirring apparatus, make dissolving；
3）Transdermal enhancer and borneol are mixed, added after being ground with homogenizer；
4）PH adjusting agent is eventually adding, is stirred and evenly mixed, lotion is obtained；
5）Lotion is spread evenly across on non-woven fabrics, is dried, is covered polyethylene film, cuts into suitable size, produce；
Wherein described microneedle patch, preparation process is as follows：Micropin is sprayed on polymer film or on micro-silicon mould with plating mode, it is micro-
Pin is made of metal or alloy material.
4. microneedle cutaneous system described in claim 1 treats angina pectoris preparing, alcoholism, hyperpyretic convulsion disease
Application in medicine.
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Cited By (1)
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| WO2019200081A1 (en) * | 2018-04-13 | 2019-10-17 | North Carolina State University | Ros-responsive microneedle patch for acne vulgaris treatment |
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| CN105998184A (en) * | 2016-06-24 | 2016-10-12 | 赵晶晶 | Compound traditional Chinese medicine microneedle transdermal delivery patch capable of relaxing muscles and tendons and activating blood circulation and preparation method |
| CN106038957A (en) * | 2016-06-24 | 2016-10-26 | 安徽省小山卫生材料有限公司 | Compound traditional Chinese medicine microneedle transdermal delivery plaster for strain of lumbar muscles and preparation method thereof |
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| WO2019161272A1 (en) | 2018-02-15 | 2019-08-22 | North Carolina State University | Synthesis of micron and nanoscale carbon spheres and structures using hydrothemal carbonization |
| CN112957607B (en) * | 2021-01-30 | 2023-08-04 | 上海应用技术大学 | Microneedle transdermal patch and preparation method thereof |
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