CN1167412C - Transdermal physiotherapeutic medicine gel - Google Patents
Transdermal physiotherapeutic medicine gel Download PDFInfo
- Publication number
- CN1167412C CN1167412C CNB001221825A CN00122182A CN1167412C CN 1167412 C CN1167412 C CN 1167412C CN B001221825 A CNB001221825 A CN B001221825A CN 00122182 A CN00122182 A CN 00122182A CN 1167412 C CN1167412 C CN 1167412C
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- CN
- China
- Prior art keywords
- gel
- diclofenac sodium
- medicine
- physiotherapeutic
- transdermal
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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- 239000003814 drug Substances 0.000 title claims abstract description 25
- 229960001193 diclofenac sodium Drugs 0.000 claims abstract description 27
- JGMJQSFLQWGYMQ-UHFFFAOYSA-M sodium;2,6-dichloro-n-phenylaniline;acetate Chemical compound [Na+].CC([O-])=O.ClC1=CC=CC(Cl)=C1NC1=CC=CC=C1 JGMJQSFLQWGYMQ-UHFFFAOYSA-M 0.000 claims abstract description 27
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 11
- 239000000463 material Substances 0.000 claims abstract description 9
- 150000001875 compounds Chemical class 0.000 claims abstract description 8
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 10
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 9
- 230000000149 penetrating effect Effects 0.000 claims description 8
- NWUYHJFMYQTDRP-UHFFFAOYSA-N 1,2-bis(ethenyl)benzene;1-ethenyl-2-ethylbenzene;styrene Chemical compound C=CC1=CC=CC=C1.CCC1=CC=CC=C1C=C.C=CC1=CC=CC=C1C=C NWUYHJFMYQTDRP-UHFFFAOYSA-N 0.000 claims description 6
- 239000003456 ion exchange resin Substances 0.000 claims description 6
- 229920003303 ion-exchange polymer Polymers 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 6
- 239000002250 absorbent Substances 0.000 claims description 5
- 230000002745 absorbent Effects 0.000 claims description 5
- 238000001035 drying Methods 0.000 claims description 5
- AXTGDCSMTYGJND-UHFFFAOYSA-N 1-dodecylazepan-2-one Chemical compound CCCCCCCCCCCCN1CCCCCC1=O AXTGDCSMTYGJND-UHFFFAOYSA-N 0.000 claims description 4
- 239000012153 distilled water Substances 0.000 claims description 4
- 238000010438 heat treatment Methods 0.000 claims description 4
- 238000002360 preparation method Methods 0.000 claims description 4
- 230000008961 swelling Effects 0.000 claims description 3
- 239000011521 glass Substances 0.000 claims description 2
- 230000009471 action Effects 0.000 abstract description 3
- 230000008859 change Effects 0.000 abstract description 3
- 230000005684 electric field Effects 0.000 abstract description 3
- 239000006096 absorbing agent Substances 0.000 abstract 1
- 230000001737 promoting effect Effects 0.000 abstract 1
- 239000000499 gel Substances 0.000 description 31
- 238000000554 physical therapy Methods 0.000 description 9
- 241000283973 Oryctolagus cuniculus Species 0.000 description 8
- 229940079593 drug Drugs 0.000 description 8
- 238000009792 diffusion process Methods 0.000 description 6
- 230000008676 import Effects 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 238000012360 testing method Methods 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 3
- 239000002552 dosage form Substances 0.000 description 3
- 239000004372 Polyvinyl alcohol Substances 0.000 description 2
- 230000003187 abdominal effect Effects 0.000 description 2
- 230000000202 analgesic effect Effects 0.000 description 2
- 230000037396 body weight Effects 0.000 description 2
- 239000001768 carboxy methyl cellulose Substances 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- -1 hydroxypropyl Chemical group 0.000 description 2
- 238000001764 infiltration Methods 0.000 description 2
- 230000008595 infiltration Effects 0.000 description 2
- 150000002500 ions Chemical class 0.000 description 2
- 239000011505 plaster Substances 0.000 description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 239000011347 resin Substances 0.000 description 2
- 229920005989 resin Polymers 0.000 description 2
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 2
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- 206010006811 Bursitis Diseases 0.000 description 1
- 206010013935 Dysmenorrhoea Diseases 0.000 description 1
- 201000005569 Gout Diseases 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 229910021607 Silver chloride Inorganic materials 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 208000007271 Substance Withdrawal Syndrome Diseases 0.000 description 1
- 208000025865 Ulcer Diseases 0.000 description 1
- 210000001015 abdomen Anatomy 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 description 1
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 description 1
- 239000004745 nonwoven fabric Substances 0.000 description 1
- 239000002674 ointment Substances 0.000 description 1
- 201000008482 osteoarthritis Diseases 0.000 description 1
- 206010033675 panniculitis Diseases 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 230000000552 rheumatic effect Effects 0.000 description 1
- 201000003068 rheumatic fever Diseases 0.000 description 1
- 206010039073 rheumatoid arthritis Diseases 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- HKZLPVFGJNLROG-UHFFFAOYSA-M silver monochloride Chemical compound [Cl-].[Ag+] HKZLPVFGJNLROG-UHFFFAOYSA-M 0.000 description 1
- 210000004304 subcutaneous tissue Anatomy 0.000 description 1
- 239000000829 suppository Substances 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
- 235000021419 vinegar Nutrition 0.000 description 1
- 239000000052 vinegar Substances 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a medical gel for percutaneous physical treatment, which is composed of a diclofenac sodium medicine comprising an absorbing agent, a hydrophilicity high molecular material, a compound permeation promoting agent, etc. The gel can reduce the change of a pH value before and after the action of an electric field, a pad does not need to be added when the gel is used, and the operation of the medical gel for percutaneous physical treatment is simple and convenient. The medical gel for percutaneous physical treatment enhances the operability of medical personnel and strengthens the elasticity of patients.
Description
The present invention relates to the pharmaceutics field, mainly is a kind of physiotherapeutic medicine gel, is fit to clinical percutaneous physical therapy medication.
Current, in clinical department of physiotherapy treatment, usually adopt the method for iontophoresis, its purpose has double: one for utilizing the double treatment effect of electric current and medicine, thereby two for utilizing medicine ion that the percutaneous transhipment of promotion medicine takes place to move under the electric field force effect.For the diclofenac sodium that mainly produces therapeutical effect in the part, iontophoresis is effective means.Also have at present and adopt as vinegar iontophoresis bony spur etc., but it is convenient to lack in the physical therapy process, ideal dosage form, and often adopt gauze or sponge to adsorb drug solution, operation inconvenience, and for fear of the zest to skin that causes owing to the caused pH change of electrolysate, often tens layers gauze on the nearly skin side pad of stereotype, so patient's compliance is relatively poor, operation is also inconvenient.
Diclofenac sodium (Diclofenac Sodium, DS) be a kind of potent antiinflammatory, analgesic, analgesic, be mainly used in treatment rheumatic and rheumatoid arthritis clinically, for some diseases such as osteoarthritis, slightly to moderate pain, primary dysmenorrhea, heating, bursitis and acute gout etc. also have certain curative effect, be used widely in more than 120 country in the whole world at present, related dosage form comprises tablet, suppository, ointment etc., oral administration is the mode that the most extensively adopts clinically, but it is reported that the diclofenac sodium oral administration has 12% patient to produce gastrointestinal side effect approximately, when needs heavy dose and long term administration, may cause digestive tract hemorrhage, ulcer etc., therefore and drug withdrawal has limited its application clinically to a certain extent and have 1% patient.Xie Xianyun (patent publication No. CN1174031A) is principal agent with the diclofenac sodium, with the hydrophilic pressure sensitive gel matrix, be coated with on the base paper behind the mixings such as compound penetrating agent, reuse comprises that the material of mounting of PVC or non-woven fabrics makes diclofenac sodium skin-penetrating delayed plaster, this plaster is mainly used in and adheres on the skin carrying out passive diffusion, and is not used in clinical physical therapy.Adopt the method for percutaneous dosing, can eliminate it stimulates gastrointestinal, produces lasting effective function and interruption of the administration at any time.But percutaneous dosing often is subjected to the restriction of keratodermatitis barrier action, and the passive diffusion rate of medicine is less, is difficult to reach valid density, often needs to add penetrating agent or adopts the short infiltration method of physics to improve the transport through skin of medicine.Also there are some reports to adopt the diclofenac sodium percutaneous dosing both at home and abroad.
It is single to the objective of the invention is to overcome the physical therapy dosage form that above-mentioned prior art exists, use some shortcomings parts such as inconvenience, for clinical physical therapy provides a kind of transdermal physiotherapeutic medicine gel agent, this gel can reduce the change of the preceding pH value of electric field action, need not during use to add the cushions, easy and simple to handle, both improved medical worker's operability, strengthen compliance of patients again.
The present invention is achieved through the following technical solutions: this drug gel reaches glycerol and forms by containing diclofenac sodium medicine, hydrophilic macromolecular material, compound penetrating agent azone and the propylene glycol of ion exchange resin as absorbent.
Used absorbent is an ion exchange resin, and its consumption is 0.1～1.0g.
The preparation of drug gel of the present invention is to select for use two or more to be soaked in that certain hour makes it swelling in the distilled water hydrophilic macromolecular material, the heating in water bath dissolving, add compound penetrating agent and absorbent, stir, add diclofenac sodium at last, stir and the impouring culture dish in, drying.
The consumption of used medicine diclofenac sodium is 0.25～1.0g.The used polyvinyl alcohol that comprises, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, the hydrophilic macromolecular material of polyvinylpyrrolidone, adopt above-mentioned two or more, consumption is 0.2～8.0g.Compound penetrating agent comprises azone and propylene glycol, and its consumption is 0.5～15ml.
The present invention has following characteristics: (1) the present invention adopts macromolecular material to prepare diclofenac sodium percutaneous physical therapy gel, and appearance white is transparent, and moisture retention and intensity are all better.(2) use gel of the present invention, easy and simple to handle, have the operability and the patient compliance of clinical practice preferably.(3) gel of the present invention can increase the percutaneous rate of diclofenac sodium, and the pH value that makes diclofenac sodium import front and back changes not obvious, therefore can avoid the use of liner, strengthens the actual application value of clinical physical therapy.(4) percutaneous physical therapy of the present invention imports with the percutaneous of gel applicable to nonsteroidal antiinflammatory drug.
(the *: de-electrifying of recession in four hours) of curve chart when Fig. 1 is used as medicine for percutaneous ion guide in the diclofenac sodium gel rabbit body.
The present invention is further described in conjunction with the embodiments.
Embodiment 1: 6 gels prescription of the present invention:
Prescription numbers 123456
Form
Diclofenac sodium (g) 0.25 0.25 0.4 0.45 0.6 1.0
Polyvinyl alcohol (g) 5.0 5.0 3.0 8.0 3.0 8.0
Sodium carboxymethyl cellulose (g) 1.5 0 1.0 1.5 3.0 0
Hydroxypropyl emthylcellulose (g) 2.0 1.0 1.0 0 3.0 1.5
Polyvinylpyrrolidone (g) 1.0 1.5 2.0 0.5 1.5 0
Glycerol (ml) 2.0 0 2.5 3.0 5.0 2.0
Azone (ml) 0.5 1.0 2.0 1.0 3.0 1.0
Propylene glycol (ml) 10.0 10.0 5.0 10.0 5.0 15.0
Exchanger resin (g) 0.1 0.5 0.3 0.50 1.0 0
Distilled water (ml) 30.0 40.0 30.0 70.0 30.0 50.0
The preparation of drug gel of the present invention is to select for use two or more to be soaked in that certain hour makes it swelling in the distilled water hydrophilic macromolecular material, the heating in water bath dissolving, add compound penetrating agent and absorbent, stir, add diclofenac sodium at last, stir and the impouring glass drying oven in, drying.
Embodiment 2: the drug gel with embodiment 1 provides, carry out isolated test:
1. the preparation of isolated skin
Get the male SD rat of heavily about 200g, disconnected neck is put to death, and cuts off the skin of abdomen hair, and clip skin is peeled off subcutaneous tissue and embathe use after 30 minutes in normal saline.
2. experimental provision and method
(area is 4.5cm to adopt improvement Franz diffusion cell
2, volume is 14ml), the control bath temperature is 37 ± 0.5 ℃, makes rat skin corium towards receiving chamber.Horny layer sticks moistening drug gel, presses stereotype, connects the negative pole of regulated power supply, connects positive source with the Ag/AgCl electrode, inserts in the receiving chamber, and acceptable solution is the phosphate buffer of pH7.4, control current intensity 0.2mA/cm
2, sampling is at regular intervals pressed the double wave regular way and is surveyed trap at 276nm and 350nm place, and unit of account area accumulation infiltration capacity and percutaneous rate.
3. pH value compares before and after the external iontophoresis of diclofenac sodium gel
Get before a certain amount of importing respectively and the diclofenac sodium gel after importing, place small beaker, adding distil water 50ml makes dissolving, shakes up the back and survey pH value on the PHS-10B digital ph.
Isolated test the results are shown in Table 1, table 2, table 3
The passive diffusion experiment result of table 1 diclofenac sodium gel
| The prescription number | 1 | 2 | 3 | 4 | 5 | 6 |
| Percutaneous rate (μ g/h.cm 2) | 22.53± 2.36 | 28.68± 3.92 | 20.66± 2.19 | 17.43± 4.51 | 21.76± 3.77 | 30.12± 2.38 |
Table 2 diclofenac sodium gel percutaneous iontophoresis experimental result
| The prescription number | 1 | 2 | 3 | 4 | 5 | 6 |
| Percutaneous rate (μ g/h.cm 2) | 35.21± 2.98 | 61.40± 2.11 | 41.75± 7.63 | 25.66± 5.34 | 37.24± 3.16 | 48.95± 4.33 |
PH before and after the different prescription of the table 3 diclofenac sodium gel iontophoresis relatively
| Gel number | PH value before importing | Import the back pH value | ΔpH |
| 1 | 7.28±0.07 | 7.86±0.10 | 0.58±0.14 |
| 2 | 7.36±0.12 | 7.83±0.11 | 0.47±0.15 |
| 3 | 7.30±0.08 | 7.98±0.16 | 0.68±0.37 |
| 4 | 7.29±0.06 | 8.01±0.25 | 0.72±0.29 |
| 5 | 7.37±0.18 | 7.95±0.23 | 0.58±0.13 |
| 6 | 7.39±0.13 | 9.03±0.17 | 1.64±0.25 |
Embodiment 3: in the body test, select No. 2 prescriptions and prepare the same gel that does not contain exchanger resin simultaneously to carry out testing at body.
1. passive diffusion
Get healthy rabbits, about body weight 2.0 ± 0.5kg.Rabbit is fixed on the rabbit plate, removes a 50cm at the rabbit abdominal scissors
2About hair, stick gel cutting on the clean skin, get hematometry every half an hour at auricular vein.
2. get healthy rabbits, about body weight 2.0 ± 0.5kg.Rabbit is fixed on the rabbit plate, gets two 50cm at abdominal part
2About the position cropping, cut on the clean skin at one and to stick gel, add stereotype and fix that (the stereotype area is 54cm
2), connecing the regulated power supply negative pole, another piece skin applies the impregnated gauze of water, adds stereotype and fixes, and connects positive pole of stabilized voltage supply.And make between the two apart from being 2cm.Current intensity is controlled at 0.3mA/cm
2, get hematometry in auricular vein every half an hour.
3. get before a certain amount of importing respectively and the diclofenac sodium gel after importing, place small beaker, adding distil water 50ml makes dissolving, shakes up the back and survey pH value on the accurate pH meter of pHS-3C type.
Result in the body test is:
Very low in the passive diffusion of body because of vivo medicine concentration, can not measure.The blood drug level of diclofenac sodium is seen Fig. 1 behind the iontophoresis, and the pH variation sees Table 4.
The different prescription of table 4 diclofenac sodium gel pH value before and after body imports compares
| PH value before importing | Import the back pH value | ΔpH | t | P | |
| Gel 1 | 7.37±0.03 | 9.20±0.04 | 1.83±0.05 | 23.96 | P＜0.01 |
| Gel 2 | 7.36±0.12 | 7.71±0.12 | 0.33±0.14 |
Annotate: gel 1: do not add ion exchange resin gel 2: add ion exchange resin
Claims (2)
1. a transdermal physiotherapeutic medicine gel mainly is made up of diclofenac sodium medicine, hydrophilic macromolecular material, compound penetrating agent azone and propylene glycol and glycerol, it is characterized in that: also comprise the ion exchange resin as absorbent.
2. the preparation method of transdermal physiotherapeutic medicine gel as claimed in claim 1, it is characterized in that: be to select for use two or more to be soaked in that certain hour makes it swelling in the distilled water hydrophilic macromolecular material, the heating in water bath dissolving, add compound penetrating agent and ion exchange resin, stir, add diclofenac sodium at last, stir and the impouring glass drying oven in, drying.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB001221825A CN1167412C (en) | 2000-08-03 | 2000-08-03 | Transdermal physiotherapeutic medicine gel |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB001221825A CN1167412C (en) | 2000-08-03 | 2000-08-03 | Transdermal physiotherapeutic medicine gel |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1337225A CN1337225A (en) | 2002-02-27 |
| CN1167412C true CN1167412C (en) | 2004-09-22 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB001221825A Expired - Fee Related CN1167412C (en) | 2000-08-03 | 2000-08-03 | Transdermal physiotherapeutic medicine gel |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1167412C (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101756789B (en) * | 2009-05-22 | 2012-07-25 | 刘加升 | Preferential three-step method of production process for diclofenac sodium mucilage |
| KR20170117390A (en) * | 2014-12-23 | 2017-10-23 | 스티븐 호프만 | Transdermal formulations |
| CN105213463A (en) * | 2015-11-18 | 2016-01-06 | 重庆市中药研究院 | A kind of colguhoumia root external preparation for eczema, preparation method and application thereof |
-
2000
- 2000-08-03 CN CNB001221825A patent/CN1167412C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CN1337225A (en) | 2002-02-27 |
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