CN1316967C - Diclofenac diethylamine gel agent - Google Patents
Diclofenac diethylamine gel agent Download PDFInfo
- Publication number
- CN1316967C CN1316967C CNB2004100607985A CN200410060798A CN1316967C CN 1316967 C CN1316967 C CN 1316967C CN B2004100607985 A CNB2004100607985 A CN B2004100607985A CN 200410060798 A CN200410060798 A CN 200410060798A CN 1316967 C CN1316967 C CN 1316967C
- Authority
- CN
- China
- Prior art keywords
- liquid
- present
- weight portion
- diclofenac diethylammonium
- gel
- 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 - Lifetime
Links
- 229960001259 diclofenac Drugs 0.000 title abstract 3
- VTRAEEWXHOVJFV-UHFFFAOYSA-N olmesartan Chemical compound CCCC1=NC(C(C)(C)O)=C(C(O)=O)N1CC1=CC=C(C=2C(=CC=CC=2)C=2NN=NN=2)C=C1 VTRAEEWXHOVJFV-UHFFFAOYSA-N 0.000 title abstract 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 25
- 229960005466 diclofenac diethylammonium Drugs 0.000 claims description 24
- KPHWPUGNDIVLNH-UHFFFAOYSA-M diclofenac sodium Chemical compound [Na+].[O-]C(=O)CC1=CC=CC=C1NC1=C(Cl)C=CC=C1Cl KPHWPUGNDIVLNH-UHFFFAOYSA-M 0.000 claims description 24
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 22
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 17
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims description 5
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 claims description 5
- GYCKQBWUSACYIF-UHFFFAOYSA-N o-hydroxybenzoic acid ethyl ester Natural products CCOC(=O)C1=CC=CC=C1O GYCKQBWUSACYIF-UHFFFAOYSA-N 0.000 claims description 5
- 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 claims description 4
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 4
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 4
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 abstract description 8
- 239000000758 substrate Substances 0.000 abstract description 5
- 238000000034 method Methods 0.000 abstract description 3
- 238000012797 qualification Methods 0.000 abstract description 3
- 239000000084 colloidal system Substances 0.000 abstract description 2
- 239000003349 gelling agent Substances 0.000 abstract 2
- 230000000202 analgesic effect Effects 0.000 abstract 1
- 230000000694 effects Effects 0.000 abstract 1
- 239000007788 liquid Substances 0.000 description 28
- 238000003756 stirring Methods 0.000 description 17
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 15
- 235000019441 ethanol Nutrition 0.000 description 11
- 239000012153 distilled water Substances 0.000 description 9
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 description 8
- 229920002125 Sokalan® Polymers 0.000 description 8
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 7
- 229960001631 carbomer Drugs 0.000 description 7
- 239000003795 chemical substances by application Substances 0.000 description 6
- 239000003814 drug Substances 0.000 description 5
- 235000011187 glycerol Nutrition 0.000 description 5
- 206010061218 Inflammation Diseases 0.000 description 4
- 229910021529 ammonia Inorganic materials 0.000 description 4
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 description 3
- 230000002421 anti-septic effect Effects 0.000 description 3
- 239000000839 emulsion Substances 0.000 description 3
- 239000002904 solvent Substances 0.000 description 3
- 230000008961 swelling Effects 0.000 description 3
- AXTGDCSMTYGJND-UHFFFAOYSA-N 1-dodecylazepan-2-one Chemical compound CCCCCCCCCCCCN1CCCCCC1=O AXTGDCSMTYGJND-UHFFFAOYSA-N 0.000 description 2
- 208000034656 Contusions Diseases 0.000 description 2
- 239000001913 cellulose Substances 0.000 description 2
- 229920002678 cellulose Polymers 0.000 description 2
- 235000010980 cellulose Nutrition 0.000 description 2
- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 description 2
- 230000009519 contusion Effects 0.000 description 2
- 239000006185 dispersion Substances 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 238000005457 optimization Methods 0.000 description 2
- 230000000149 penetrating effect Effects 0.000 description 2
- 229920000136 polysorbate Polymers 0.000 description 2
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 description 1
- JVTIXNMXDLQEJE-UHFFFAOYSA-N 2-decanoyloxypropyl decanoate 2-octanoyloxypropyl octanoate Chemical compound C(CCCCCCC)(=O)OCC(C)OC(CCCCCCC)=O.C(=O)(CCCCCCCCC)OCC(C)OC(=O)CCCCCCCCC JVTIXNMXDLQEJE-UHFFFAOYSA-N 0.000 description 1
- RFVNOJDQRGSOEL-UHFFFAOYSA-N 2-hydroxyethyl octadecanoate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCCO RFVNOJDQRGSOEL-UHFFFAOYSA-N 0.000 description 1
- WLAMNBDJUVNPJU-UHFFFAOYSA-N 2-methylbutyric acid Chemical compound CCC(C)C(O)=O WLAMNBDJUVNPJU-UHFFFAOYSA-N 0.000 description 1
- 239000001828 Gelatine Substances 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 229920001219 Polysorbate 40 Polymers 0.000 description 1
- 229920001214 Polysorbate 60 Polymers 0.000 description 1
- 229920002642 Polysorbate 65 Polymers 0.000 description 1
- 208000026137 Soft tissue injury Diseases 0.000 description 1
- 235000010489 acacia gum Nutrition 0.000 description 1
- 239000001785 acacia senegal l. willd gum Substances 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 235000001014 amino acid Nutrition 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 230000036592 analgesia Effects 0.000 description 1
- 230000001760 anti-analgesic effect Effects 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 229910021538 borax Inorganic materials 0.000 description 1
- 229940082484 carbomer-934 Drugs 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 229960004926 chlorobutanol Drugs 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000003205 fragrance Substances 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 229920005615 natural polymer Polymers 0.000 description 1
- NOOLISFMXDJSKH-UHFFFAOYSA-N p-menthan-3-ol Chemical compound CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 230000036407 pain Effects 0.000 description 1
- 206010033675 panniculitis Diseases 0.000 description 1
- 239000001814 pectin Substances 0.000 description 1
- 235000010987 pectin Nutrition 0.000 description 1
- 229920001277 pectin Polymers 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical compound O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 description 1
- 229920000191 poly(N-vinyl pyrrolidone) Polymers 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 235000010483 polyoxyethylene sorbitan monopalmitate Nutrition 0.000 description 1
- 239000000249 polyoxyethylene sorbitan monopalmitate Substances 0.000 description 1
- 239000001816 polyoxyethylene sorbitan tristearate Substances 0.000 description 1
- 235000010988 polyoxyethylene sorbitan tristearate Nutrition 0.000 description 1
- 229950008882 polysorbate Drugs 0.000 description 1
- 229940101027 polysorbate 40 Drugs 0.000 description 1
- 229940099511 polysorbate 65 Drugs 0.000 description 1
- 239000011736 potassium bicarbonate Substances 0.000 description 1
- 229910000028 potassium bicarbonate Inorganic materials 0.000 description 1
- 235000015497 potassium bicarbonate Nutrition 0.000 description 1
- TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 description 1
- 235000011118 potassium hydroxide Nutrition 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000004886 process control Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 235000010413 sodium alginate Nutrition 0.000 description 1
- 239000000661 sodium alginate Substances 0.000 description 1
- 229940005550 sodium alginate Drugs 0.000 description 1
- 235000011121 sodium hydroxide Nutrition 0.000 description 1
- 239000004328 sodium tetraborate Substances 0.000 description 1
- 235000010339 sodium tetraborate Nutrition 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 230000003637 steroidlike Effects 0.000 description 1
- 210000004304 subcutaneous tissue Anatomy 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 229920001059 synthetic polymer Polymers 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- GYICYQJEVCIYJY-UHFFFAOYSA-N thiophen-1-ylidenemethanone Chemical compound O=C=S1C=CC=C1 GYICYQJEVCIYJY-UHFFFAOYSA-N 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The present invention discloses a diclofenac diethylamine gelling agent. The gelling agent mainly comprises diclofenac diethylamine and aquosity gelling substrate; through the indication of clinical curative effect observation, the present invention has stronger antipyrotic and analgesic effect; simultaneously, the present invention has the advantages of simple process, easy operation and control, low production cost, high qualification rate and high stability; because the product is colorless and transparent colloid, clothes can not be polluted, and the present invention is easy to accept by patients.
Description
(1) technical field: the invention belongs to medicine, be specifically related to a kind of anti-inflammation analgesis medicament diclofenac diethylammonium gel.
(2) background technology: diclofenac diethylammonium is the potent anti-inflammation analgesia medicine of a kind of non-steroidal of external, is mainly used in closure contusion and spraining property soft tissue injury, limitation rheumatism; After being prepared into corresponding external preparation and rubbing wiping, can make its active component transdermal, be gathered in subcutaneous tissue, resist chronic inflammatory reaction, inflammatory swelling is significantly alleviated.At present, domestic existing diclofenac diethylammonium emulsion agent listing, but for general pharmacy corporation, the difficult control of emulsion agent manufacturing process easily causes quality problems such as product stability is poor, breakdown of emulsion, layering, and the manufacturing equipment costliness, the production cost height.
(3) summary of the invention: purpose of the present invention is improved the diclofenac diethylammonium exterior-applied formulation exactly, and it is simple to propose a kind of production technology, and process control parameter is few, and cost is low, constant product quality, the diclofenac diethylammonium gel that qualification rate is high.
The diclofenac diethylammonium and the aqueous gel substrate that contain the 8-15 weight portion in the every 1000g gel of diclofenac diethylammonium gel of the present invention.
Can also contain in penetrating agent, solubilizing agent, PH regulator, antiseptic or the wetting agent one or more in the above-mentioned diclofenac diethylammonium gel.
One of optimization formula of the present invention is diclofenac diethylammonium, 5-20 weight portion carbomer and PH regulator and the water that every 1000g gel contains the 10-13 weight portion.
Two of optimization formula of the present invention is diclofenac diethylammonium, 200-300 parts by weight of ethanol, 20-60 weight portion cellulose derivative and antiseptic and the water that every 1000g gel contains the 10-13 weight portion.
Most preferably one of prescription of the present invention is diclofenac diethylammonium, 10-16 weight portion carbomer, 200-300 parts by weight of ethanol, 50-100 weight portion propylene glycol, 5-20 weight portion Polysorbate and proper ammonia and the distilled water that every 1000g gel contains the 10.5-12.7 weight portion.
Two of most preferably prescription of the present invention is that every 1000g gel contains 10-13 weight portion diclofenac diethylammonium, 20-50 weight portion sodium carboxymethyl cellulose, 15-80 weight portion glycerol, 200-300 parts by weight of ethanol, 1-2 weight portion ethyl hydroxybenzoate and suitable quantity of water.
Described aqueous gel substrate also can be selected any in other natural or synthetic multiple polymers such as glycerin gelatine, pectin, arabic gum, sodium alginate, cellulose derivative, kollidon, Polyethylene Glycol or carbomer (Carbopol) series for use, penetrating agent can be selected one or more in propylene glycol, azone, Mentholum or the thiophene ketone for use, solubilizing agent can be selected tween series or Myrij class for use, and antiseptic can be selected any or combination in ethanol, glycerol, benzyl alcohol, ethyl hydroxybenzoate, the chlorobutanol for use; The PH regulator can use in ammonia, sodium hydroxide, potassium hydroxide, potassium bicarbonate, Borax, amino acids or the triethanolamine any.
The present invention can be made by following method: 1. with natural or synthetic polymer water swelling, in case of necessity, can add other adjuvants, be stirred well to fully and disperse, make A liquid; 2. the principal agent diclofenac diethylammonium is dissolved in a certain amount of ethanol, can add solubilizing agent in case of necessity, make B liquid; 3. A liquid is added to mix homogeneously in the B liquid, adds water to full dose, stir evenly, promptly.
Gel among the present invention, the selection of its aqueous gel substrate and other components is the physicochemical properties according to the principal agent diclofenac diethylammonium, it is all multifactor to take all factors into consideration stability after dispersibility, the permeability in skin, zest and the gel-type vehicle and the medicament mixed of medicine in substrate, production cost etc., preferably comes out by optimal seeking method at last; The product made sealing shading packing back also keeps sample through accelerated test three months and room temperature and to investigate 36 months, and its character, content and related substance have no significant change, steady quality.And manufacturing process is simple, easy operating control, and technological parameter is few, and scope is big, and production cost is low, the qualification rate height.Owing to be the water white transparency colloid, pollution clothes not during use has simple and elegant fragrance, is easy to accept into the patient.
Simultaneously, diclofenac diethylammonium gel of the present invention divides into groups through adopting randomized to 80 routine closure soft tissue contusions and limitation rheumatism (each 40 example) through Wuhan Union Hospital, carrying out the dosage and the course of treatment clinical observation on the therapeutic effect in accordance with regulations shows, symptom and signs such as observed case pain (VRS), local tenderness, lump, function damage limitation of movement have significant change (P＜0.05-0.01) before and after the treatment; Show that this product has stronger anti-inflammatory and analgesic effect; And untoward reaction is few.
(4) specific embodiment:
Embodiment 1:
1. the 5g Acritamer 940 is dissolved in the 200ml distilled water, makes carbomer solution, add the 50g propylene glycol, fully stir, the reuse weak ammonia transfers to about PH7.0, makes A liquid;
2. diclofenac diethylammonium 8g is dissolved in the mixed liquor of 200ml ethanol and 5g polysorbate 65, fully stirs, B liquid is made in dissolving;
3. A liquid is added in the B liquid, adding distil water fully stirs, promptly to full dose.
Embodiment 2:
1. the 20g Carbopol 941 is dissolved in and makes carbomer solution in the 600ml distilled water, add the 10g azone, fully stir, the reuse triethanolamine is transferred about PH6.0, makes A liquid;
2. diclofenac diethylammonium 15g is dissolved in the mixed liquor of 200ml ethanol and 5g Myrj 52, fully stirs, B liquid is made in dissolving.
3. A liquid is added in the B liquid, adding distil water fully stirs, promptly to full dose.
Embodiment 3:
1. the 10g carbomer 934 is dissolved in and makes carbomer solution in the 300ml distilled water, add the 100g propylene glycol, fully stir, reuse ammonia is transferred about PH7.0, makes A liquid;
2. diclofenac diethylammonium 10.5g is dissolved in the polysorbate 40 of 300ml ethanol and 20g, fully stirs, B liquid is made in dissolving.
3. A liquid is added in the B liquid, adding distil water fully stirs, promptly to full dose.
Embodiment 4:
1. the 16g Acritamer 940 is dissolved in and makes carbomer solution in the 700ml distilled water, add the 50g propylene glycol, fully stir, the reuse triethanolamine is transferred about PH8.0, makes A liquid;
2. diclofenac diethylammonium 12.7g is dissolved in the 200ml ethanol and the 15g polyoxyethylene sorbitan monoleate in, fully stir, B liquid is made in dissolving.
3. A liquid is added in the B liquid, adding distil water fully stirs, promptly to full dose.
Embodiment 5:
1. get 20g sodium carboxymethyl cellulose swelling in the 200ml distilled water, add 80g glycerol again, the 2g ethyl hydroxybenzoate is stirred well to dissolving dispersion fully, makes A liquid;
2. the 10g diclofenac diethylammonium is dissolved in the 200ml ethanol, fully stirs, B liquid is made in dissolving.
3. A liquid is added to mix homogeneously in the B liquid, adds distilled water, fully stir, add water to full dose again, promptly to full dose.
Embodiment 6:
1. get 50g sodium carboxymethyl cellulose swelling in the 400ml distilled water, add 15g glycerol again, the 1g ethyl hydroxybenzoate is stirred well to dissolving dispersion fully, makes A liquid;
2. the 13g diclofenac diethylammonium is dissolved in the 300ml ethanol, fully stirs, B liquid is made in dissolving.
3. A liquid is added to mix homogeneously in the B liquid, adds distilled water, fully stir, add water to full dose again, promptly to full dose.
Claims (1)
1. diclofenac diethylammonium gel, it is characterized in that: every 1000g gel contains 10-13 weight portion diclofenac diethylammonium, 20-50 weight portion sodium carboxymethyl cellulose, 15-80 weight portion glycerol, 200-300 parts by weight of ethanol, 1-2 weight portion ethyl hydroxybenzoate and suitable quantity of water.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100607985A CN1316967C (en) | 2004-09-04 | 2004-09-04 | Diclofenac diethylamine gel agent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100607985A CN1316967C (en) | 2004-09-04 | 2004-09-04 | Diclofenac diethylamine gel agent |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1742715A CN1742715A (en) | 2006-03-08 |
| CN1316967C true CN1316967C (en) | 2007-05-23 |
Family
ID=36138343
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2004100607985A Expired - Lifetime CN1316967C (en) | 2004-09-04 | 2004-09-04 | Diclofenac diethylamine gel agent |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1316967C (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101138544B (en) * | 2006-09-06 | 2010-09-29 | 上海医药工业研究院 | Diclofenac or its salt topical film-forming gel composition and application thereof |
| CN102525886B (en) * | 2012-01-13 | 2013-03-13 | 湖北科益药业股份有限公司 | Diclofenac diethylamine emulgel and preparation method thereof |
-
2004
- 2004-09-04 CN CNB2004100607985A patent/CN1316967C/en not_active Expired - Lifetime
Non-Patent Citations (3)
| Title |
|---|
| 新辅料卡波姆在凝胶制剂中的应用实例 夏泉，中国药师，第2卷第3期 1999 * |
| 生物黏附凝胶剂的研究与开发 卢文荟，药学进展，第27卷第2期 2003 * |
| 生物黏附凝胶剂的研究与开发 卢文荟，药学进展，第27卷第2期 2003;新辅料卡波姆在凝胶制剂中的应用实例 夏泉，中国药师，第2卷第3期 1999 * |
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| Publication number | Publication date |
|---|---|
| CN1742715A (en) | 2006-03-08 |
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Owner name: YELLOWSTONE HEALTH MATERIALS MEDICINE INDUSTRY CO. Free format text: FORMER OWNER: LIN YE Effective date: 20090731 |
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| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20090731 Address after: No. 386, Shen Lu, Huangshi, Hubei Patentee after: Huangshi Hygienic Material Pharmacy Co.,Ltd. Address before: No. 1275, Huangshi Avenue, Huangshi, Hubei Patentee before: Lin Ye |
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Granted publication date: 20070523 |
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