CN115364043A - Clindamycin hydrochloride gel and preparation method thereof - Google Patents
Clindamycin hydrochloride gel and preparation method thereof Download PDFInfo
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- CN115364043A CN115364043A CN202110545025.XA CN202110545025A CN115364043A CN 115364043 A CN115364043 A CN 115364043A CN 202110545025 A CN202110545025 A CN 202110545025A CN 115364043 A CN115364043 A CN 115364043A
- Authority
- CN
- China
- Prior art keywords
- gel
- clindamycin hydrochloride
- clindamycin
- propylene glycol
- dodecyl sulfate
- 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.)
- Pending
Links
- KDLRVYVGXIQJDK-AWPVFWJPSA-N clindamycin Chemical compound CN1C[C@H](CCC)C[C@H]1C(=O)N[C@H]([C@H](C)Cl)[C@@H]1[C@H](O)[C@H](O)[C@@H](O)[C@@H](SC)O1 KDLRVYVGXIQJDK-AWPVFWJPSA-N 0.000 title claims abstract description 57
- 229960001200 clindamycin hydrochloride Drugs 0.000 title claims abstract description 51
- 238000002360 preparation method Methods 0.000 title abstract description 15
- 238000001879 gelation Methods 0.000 title description 2
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical group CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 45
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 27
- 238000003756 stirring Methods 0.000 claims description 19
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical group [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 14
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 10
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 10
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 10
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical group OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 7
- 238000001816 cooling Methods 0.000 claims description 6
- 239000004480 active ingredient Substances 0.000 claims description 5
- 239000002250 absorbent Substances 0.000 claims description 4
- 230000002745 absorbent Effects 0.000 claims description 4
- 238000000034 method Methods 0.000 claims description 4
- 239000004094 surface-active agent Substances 0.000 claims description 4
- 229960003943 hypromellose Drugs 0.000 claims description 3
- 208000015181 infectious disease Diseases 0.000 claims description 3
- 239000011159 matrix material Substances 0.000 claims description 3
- 239000003349 gelling agent Substances 0.000 claims description 2
- 239000008236 heating water Substances 0.000 claims description 2
- 230000007935 neutral effect Effects 0.000 claims description 2
- 206010061218 Inflammation Diseases 0.000 claims 1
- 230000004054 inflammatory process Effects 0.000 claims 1
- 239000003002 pH adjusting agent Substances 0.000 claims 1
- 239000000243 solution Substances 0.000 description 9
- 229960002227 clindamycin Drugs 0.000 description 6
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 5
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 5
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 5
- 229940071676 hydroxypropylcellulose Drugs 0.000 description 5
- 238000010438 heat treatment Methods 0.000 description 4
- 239000008213 purified water Substances 0.000 description 4
- UFUVLHLTWXBHGZ-MGZQPHGTSA-N [(2r,3r,4s,5r,6r)-6-[(1s,2s)-2-chloro-1-[[(2s,4r)-1-methyl-4-propylpyrrolidine-2-carbonyl]amino]propyl]-4,5-dihydroxy-2-methylsulfanyloxan-3-yl] dihydrogen phosphate Chemical compound CN1C[C@H](CCC)C[C@H]1C(=O)N[C@H]([C@H](C)Cl)[C@@H]1[C@H](O)[C@H](O)[C@@H](OP(O)(O)=O)[C@@H](SC)O1 UFUVLHLTWXBHGZ-MGZQPHGTSA-N 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 229960002291 clindamycin phosphate Drugs 0.000 description 3
- 238000004128 high performance liquid chromatography Methods 0.000 description 3
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- 239000006071 cream Substances 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 description 2
- 230000007062 hydrolysis Effects 0.000 description 2
- 238000006460 hydrolysis reaction Methods 0.000 description 2
- 239000000787 lecithin Substances 0.000 description 2
- 235000010445 lecithin Nutrition 0.000 description 2
- 229940067606 lecithin Drugs 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 206010040872 skin infection Diseases 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- CHHHXKFHOYLYRE-UHFFFAOYSA-M 2,4-Hexadienoic acid, potassium salt (1:1), (2E,4E)- Chemical compound [K+].CC=CC=CC([O-])=O CHHHXKFHOYLYRE-UHFFFAOYSA-M 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 206010048685 Oral infection Diseases 0.000 description 1
- HVUMOYIDDBPOLL-XWVZOOPGSA-N Sorbitan monostearate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O HVUMOYIDDBPOLL-XWVZOOPGSA-N 0.000 description 1
- 208000010641 Tooth disease Diseases 0.000 description 1
- 206010048762 Tooth infection Diseases 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 235000010354 butylated hydroxytoluene Nutrition 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 229960000541 cetyl alcohol Drugs 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 description 1
- 235000010228 ethyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000004403 ethyl p-hydroxybenzoate Substances 0.000 description 1
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 229940057995 liquid paraffin Drugs 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 235000010241 potassium sorbate Nutrition 0.000 description 1
- 239000004302 potassium sorbate Substances 0.000 description 1
- 229940069338 potassium sorbate Drugs 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000012088 reference solution Substances 0.000 description 1
- 208000017520 skin disease Diseases 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 239000012085 test solution Substances 0.000 description 1
- 239000003871 white petrolatum Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/7056—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing five-membered rings with nitrogen as a ring hetero atom
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oncology (AREA)
- Dermatology (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Communicable Diseases (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention provides clindamycin hydrochloride gel and a preparation method thereof. The clindamycin hydrochloride gel disclosed by the invention is simple in formula, simple in preparation process, easy to operate and stable in performance.
Description
Technical Field
The invention relates to clindamycin hydrochloride gel and a preparation method thereof.
Background
Clindamycin has a long history of being used for treating pets, is mainly used for treating gram-negative bacteria infection, such as oral infection and skin infection, and is commonly prepared into tablets, capsules and solutions. However, solutions and tablets have certain drawbacks in terms of administration, and therefore a new mode of administration, clindamycin gel, has been developed.
CN 103405383B discloses a clindamycin phosphate gel and a preparation method thereof, and the formula of the clindamycin phosphate gel comprises clindamycin phosphate, hydroxypropyl cellulose and lecithin. Lecithin serves to protect the clindamycin complex from hydrolysis of the active ingredient.
CN 105395473A discloses a clindamycin hydrochloride cream and its preparation method, wherein the preparation is prepared from clindamycin hydrochloride, cetyl alcohol, light liquid paraffin, white vaseline, propylene glycol, span 60, potassium sorbate, ethylparaben, 2, 6-di-tert-butyl-p-cresol, essence, and pH value is adjusted by phosphoric acid solution or citric acid aqueous solution. The oil phase matrix is adopted to carry out inclusion on the clindamycin hydrochloride serving as an active ingredient, and the hydrolysis of the raw materials is avoided by controlling the pH range of the finished cream product. The addition of essence can avoid unpleasant odor during application.
Clindamycin adds a number of additives during the preparation of the gel, resulting in a change in the long-term stability of clindamycin, but according to embodiments of the invention, the gel is stable over long-term experiments.
According to the embodiment of the invention, the gel can be directly applied to the affected part in the treatment of the tooth and skin diseases of pets, can be directly administrated in the case of tooth infection, and can protect the skin from external secondary damage in the case of skin infection. Meanwhile, the gel can be used as a new drug delivery pattern, and the gel is mixed in food or smeared on pet toys, so that the gel has a good effect on the whole body or part, especially on the treatment of dental infection.
In order to achieve this object, the selection of the viscosity of the gel has been studied and experiments have shown that the gel has a viscosity in the range of 5000 to 20000mPa · s and can be used for application to the teeth and skin of animals.
Disclosure of Invention
The invention provides clindamycin hydrochloride gel, wherein a formula comprises an active component, a surfactant, a gelling agent and a moisture absorbent.
In the gel, the active ingredient is clindamycin hydrochloride.
In the gel, the gel matrix is hydroxypropyl methylcellulose.
In the gel of the invention, the moisture absorbent is propylene glycol.
In the gel of the invention, the surfactant is sodium dodecyl sulfate.
In the gel of the invention, the pH regulator is sodium hydroxide solution.
In the gel, the gel contains 0.1-2.7% (w/w) clindamycin hydrochloride, 4-9% (w/w) hypromellose, 1-2.5% (w/w) sodium dodecyl sulfate, 5-50% (w/w) propylene glycol, and the balance of pH regulator and water.
The preparation method of the clindamycin hydrochloride gel comprises the following steps:
(1) Heating water to 80-90 deg.C, and adding hypromellose under slow stirring; slowly stirring and cooling to room temperature to form gel;
(2) Adding propylene glycol, sodium dodecyl sulfate and clindamycin hydrochloride into the gel, and uniformly stirring;
(3) And (4) adjusting the pH value to be neutral by taking a sodium hydroxide solution.
The invention has the advantages of simplifying the prescription and the preparation process of the clindamycin hydrochloride gel, researching the stability and stabilizing the quality.
Detailed Description
Example 1
The clindamycin hydrochloride gel provided by the invention contains 2.7% (w/w) of clindamycin hydrochloride, 9% (w/w) of hydroxypropyl methylcellulose, 1% (w/w) of sodium dodecyl sulfate, 30% (w/w) of propylene glycol, and the balance of pH regulator and water.
The preparation process of the clindamycin hydrochloride gel comprises the following steps:
(1) Stirring and dissolving sodium dodecyl sulfate and a proper amount of purified water, uniformly mixing, heating to 80-90 ℃, slowly adding hydroxypropyl cellulose, uniformly stirring, taking out, slowly stirring, and cooling to room temperature to form a gel system;
(2) Adding propylene glycol and clindamycin hydrochloride, and stirring for dissolving;
(3) The pH of the sodium hydroxide solution is adjusted to 6.0-6.5.
The viscosity of the clindamycin hydrochloride gel prepared by the step (2) is beyond the viscosity range of the device (the maximum is 100000 mPas), and the pH value of the gel is adjusted by the step (3) to reduce the viscosity to 26000 mPas.
The gel of the clindamycin hydrochloride prepared in the step (3) is colorless transparent gel, and after the clindamycin hydrochloride gel is sealed and placed for 24 hours, the gel of the clindamycin hydrochloride is light yellow transparent gel, and the viscosity of the gel is unchanged.
Example 2
The clindamycin hydrochloride gel provided by the invention contains 2.7% (w/w) of clindamycin hydrochloride, 8% (w/w) of hydroxypropyl methylcellulose, 1% (w/w) of sodium dodecyl sulfate, 30% (w/w) of propylene glycol, and the balance of pH regulator and water.
The preparation process of the clindamycin hydrochloride gel comprises the following steps:
(1) Heating a proper amount of purified water to 80-90 ℃, slowly adding hydroxypropyl cellulose, uniformly stirring, taking out, slowly stirring, and cooling to room temperature to form a gel system;
(2) Adding propylene glycol, sodium dodecyl sulfate and clindamycin hydrochloride, and stirring for dissolving;
(3) The pH of the sodium hydroxide solution is adjusted to 6.0-6.5.
And (4) adjusting the pH value of the gel according to the step (3) to reduce the viscosity to 70000 mPas.
The gel of the clindamycin hydrochloride prepared in the step (3) is colorless transparent gel, and the gel of the clindamycin hydrochloride is colorless transparent gel after being sealed and placed for 24 hours, so that the viscosity is unchanged.
Example 3
The clindamycin hydrochloride gel provided by the invention contains 2.7% (w/w) of clindamycin hydrochloride, 6% (w/w) of hydroxypropyl methylcellulose, 1% (w/w) of sodium dodecyl sulfate, 30% (w/w) of propylene glycol, and the balance of pH regulator and water.
The preparation process of the clindamycin hydrochloride gel comprises the following steps:
(1) Heating a proper amount of purified water to 80-90 ℃, slowly adding hydroxypropyl cellulose, uniformly stirring, taking out, slowly stirring, and cooling to room temperature to form a gel system;
(2) Adding propylene glycol, sodium dodecyl sulfate and clindamycin hydrochloride, and stirring for dissolving;
(3) The pH of the sodium hydroxide solution is adjusted to 6.0-6.5.
The viscosity of the clindamycin hydrochloride gel prepared according to the step (3) is 27000mPa & s.
Example 4
The clindamycin hydrochloride gel provided by the invention contains 2.7% (w/w) of clindamycin hydrochloride, 4% (w/w) of hydroxypropyl methylcellulose, 1% (w/w) of sodium dodecyl sulfate, 30% (w/w) of propylene glycol, and the balance of pH regulator and water.
The preparation process of the clindamycin hydrochloride gel comprises the following steps:
(1) Heating a proper amount of purified water to 80-90 ℃, slowly adding hydroxypropyl cellulose, uniformly stirring, taking out, slowly stirring, and cooling to room temperature to form a gel system;
(2) Adding propylene glycol, sodium dodecyl sulfate and clindamycin hydrochloride, and stirring for dissolving;
(3) The pH of the sodium hydroxide solution is adjusted to 6.0-6.5.
The clindamycin hydrochloride gel prepared according to the step (3) has the viscosity of 5000 mPas.
Test example 1
This test example 1 relates to a sample of clindamycin hydrochloride gel prepared according to example 2 of the present invention.
Inspection method
The characteristics are as follows: visually inspected, and should be a colorless transparent gel.
And (3) identification: the retention time of the main peak of the test solution is consistent with that of the main peak of the reference solution by HPLC detection.
The contents are as follows: and (3) detecting by using an HPLC method, wherein the clindamycin hydrochloride content is 90.0% -110.0% of the marked amount according to the calculation of clindamycin.
The content of related substances is as follows: the total amount of impurities is not more than 6.0% by HPLC.
Test results
A summary of the test results for the clindamycin hydrochloride gel prepared according to example 2 of the present invention is shown below:
the result shows that the prepared clindamycin hydrochloride gel has stable properties, content, related substances and viscosity after being placed.
Claims (7)
1. A clindamycin hydrochloride gel, wherein the prescription comprises active ingredients, a surfactant, a gelling agent and a moisture absorbent; the gel is characterized in that the active ingredient is clindamycin hydrochloride, the gel matrix is hydroxypropyl methylcellulose, the moisture absorbent is propylene glycol, and the surfactant is sodium dodecyl sulfate.
2. The clindamycin hydrochloride gel of claim 1, wherein the pH regulator is sodium hydroxide solution.
3. The clindamycin hydrochloride gel according to claims 1-2, which comprises 0.1-2.7% (w/w) of clindamycin hydrochloride, 4-9% (w/w) of hypromellose, 1-2.5% (w/w) of sodium dodecyl sulfate, 5-50% (w/w) of propylene glycol, and the balance of pH regulator and water, all by weight of the composition.
4. A method for preparing clindamycin hydrochloride gel according to claims 1-3, characterized by comprising the following steps:
(1) Heating water to 80-90 deg.C, adding hydroxypropyl methylcellulose under slow stirring; slowly stirring and cooling to room temperature to form gel;
(2) Adding propylene glycol, sodium dodecyl sulfate and clindamycin hydrochloride into the gel, and uniformly stirring;
(3) And (4) adjusting the pH value to be neutral by taking a sodium hydroxide solution.
5. The method of claim 4 wherein the addition of the pH adjusting agent sodium hydroxide solution changes the viscosity of the gel product.
6. The manufactured clindamycin hydrochloride gel according to the claim, which is used for treating pets.
7. The manufactured clindamycin hydrochloride gel according to the claim, which is used for treating inflammation and infection of skin and tooth parts of pets.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110545025.XA CN115364043A (en) | 2021-05-19 | 2021-05-19 | Clindamycin hydrochloride gel and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110545025.XA CN115364043A (en) | 2021-05-19 | 2021-05-19 | Clindamycin hydrochloride gel and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN115364043A true CN115364043A (en) | 2022-11-22 |
Family
ID=84059495
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110545025.XA Pending CN115364043A (en) | 2021-05-19 | 2021-05-19 | Clindamycin hydrochloride gel and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN115364043A (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6251619A (en) * | 1985-08-30 | 1987-03-06 | Wako Pure Chem Ind Ltd | Gel pharmaceutical for external use |
| US6117843A (en) * | 1992-02-18 | 2000-09-12 | Lloyd J. Baroody | Compositions for the treatment of acne containing clindamycin and benzoyl peroxide |
| CN109646392A (en) * | 2017-10-11 | 2019-04-19 | 多多药业有限公司 | A kind of gelling agent and its preparation process containing clindamycin phosphate |
-
2021
- 2021-05-19 CN CN202110545025.XA patent/CN115364043A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6251619A (en) * | 1985-08-30 | 1987-03-06 | Wako Pure Chem Ind Ltd | Gel pharmaceutical for external use |
| US6117843A (en) * | 1992-02-18 | 2000-09-12 | Lloyd J. Baroody | Compositions for the treatment of acne containing clindamycin and benzoyl peroxide |
| CN109646392A (en) * | 2017-10-11 | 2019-04-19 | 多多药业有限公司 | A kind of gelling agent and its preparation process containing clindamycin phosphate |
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Application publication date: 20221122 |