CN106491516A - A kind of temperature sensitive type Dyclonine Hydrochloride Gel and preparation method thereof - Google Patents
A kind of temperature sensitive type Dyclonine Hydrochloride Gel and preparation method thereof Download PDFInfo
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- CN106491516A CN106491516A CN201611002059.XA CN201611002059A CN106491516A CN 106491516 A CN106491516 A CN 106491516A CN 201611002059 A CN201611002059 A CN 201611002059A CN 106491516 A CN106491516 A CN 106491516A
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- dyclonine hydrochloride
- gel
- temperature sensitive
- sensitive type
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- 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
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4453—Non condensed piperidines, e.g. piperocaine only substituted in position 1, e.g. propipocaine, diperodon
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- 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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
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Abstract
The invention belongs to technical field of medicine, the invention discloses a kind of temperature sensitive type Dyclonine Hydrochloride Gel, by following weight percent into being grouped into：Thermo-sensitive gel matrix 1% ~ 10%, dyclonine hydrochloride 1% ~ 5%, viscosity modifier 0% ~ 5%, preservative 0.08% ~ 2%, flavouring 0.1% ~ 2%, defoamer 1% ~ 10%, balance of water.The present invention is a kind of local anesthetic, larynx anesthesia and lubrication when checking for endoscope for upper digestive tract, at room temperature, preparation is liquid condition, when temperature rises to body temperature, gel can be formed in cavity or affected part, under the conditions of equal administered volume, holdup time and area coverage ratio are significantly increased, and play fast, the features such as steeping good effect and suitable mouthfeel of dispelling with strong, drug effect is anaesthetized, improve the compliance of patient, clinic application and popularization.
Description
Technical field
The invention belongs to scope anesthetic gel preparation technique field, and in particular to a kind of temperature sensitive type Dyclonine Hydrochloride Gel
And preparation method thereof.
Background technology
Temperature sensitive hydrogel is a kind of novel form of Recent study, and at room temperature, preparation is liquid for good fluidity
State, when temperature rises to body temperature, adhesiveness increases, and can form gel in cavity or affected part, so as in equal administered volume bar
Under part, holdup time and area coverage ratio are significantly increased.Therefore, the consumption and drug concentration of preparation can be significantly reduced, both
Patient adaptability can be improved, preparation cost is reduced again.
Dyclonine hydrochloride is a kind of local anesthetic, has been reported display and can significantly reduce patient's endoscope for upper digestive tract
The sense of discomfort of inspection.Therefore, the existing rubber cement and solution with dyclonine hydrochloride as main ingredient in market.But, rubber cement and solution
Agent is due to due to its own physical property, shorter in the time of staying of oesophagus and enteron aisle after oral or bowel lavage, and mobility is too
High, it is difficult to cover whole cavity inner surface, cause anaesthetic effect to reduce, if otherwise change formulation and reach preferable effect, need
Dosage is improved, drug cost is increased, simultaneously because patient's clothes after there is dyclonine hydrochloride itself bitter taste, concentration to improve
Used time can still produce certain sense of discomfort.Therefore, the research and development of temperature sensitive type Dyclonine Hydrochloride Gel, before effectively can improving operation in patients
Preparation, not only can alleviate stimulation and sense of discomfort that clinical alimentary tract endoscope inspection is brought to patient, can also improve
The definition that sight glass is checked, and then make diagnostic result relatively reliable.According to relevant clinical report, Current Domestic annual in peep
The patient of spectroscopy will break through 20,000,000, and market potential is larger, have broad prospects.
Content of the invention
It is an object of the invention to provide a kind of stability for improving medicine, the medication compliance that increases, minimizing patient's stomach microscopy
Quick type Dyclonine Hydrochloride Gel for the pain that looks into and preparation method thereof.
For achieving the above object, the technical solution used in the present invention is, a kind of temperature sensitive type Dyclonine Hydrochloride Gel, by under
State weight percentage into being grouped into：Thermo-sensitive gel matrix 0.2% ~ 10%, dyclonine hydrochloride 1% ~ 5%, viscosity modifier
0% ~ 5%, preservative 0.05% ~ 2%, flavouring 0.1% ~ 2%, defoamer 1% ~ 10%, balance of water.
Preferably, the thermo-sensitive gel matrix is poloxamer, shitosan, Carbomer, sodium alginate or Sodium Hyaluronate
In any one or several.
Preferably, the poloxamer is any one or two kinds of in poloxamer188 and PLURONICS F87.
Preferably, the viscosity modifier is any one or two kinds of in methylcellulose and hydroxypropyl methyl cellulose.
Described preservative can be benzoic acid, sorbic acid, formic acid and propionic acid and its esters（Such as Sodium Benzoate, sorbic acid
Potassium etc.）, and parabens such as methyl p-hydroxybenzoate, ethyl-para-hydroxybenzoate, propylparaben and to hydroxyl
One or more mixture in yl benzoic acid butyl ester, preferably sorbic acid and ethylparaben.
Preferably, the benzoic acid, sorbic acid, formic acid, the salt of propionic acid are sodium salt or sylvite.
Described flavouring can be sucrose, lactose and other carbohydrates, and polyalcohol（Such as sorbierite, glycerine etc.）, Chinese holly
One or more mixture in rafter acid, saccharin sodium, aspartame, honey element and stevioside；Preferably Sucralose,
Menthol and sweet orange taste soluble perfume.
Preferably, the defoamer is polyoxyethylene polyoxypropylene pentaerythrite ether.
Preferably, comprise the following steps：
1., under the conditions of 2 ~ 4 DEG C, thermo-sensitive gel matrix is dissolved in suitable quantity of water, and stirring and dissolving, standby；
2. viscosity modifier is added appropriate hot water（70~80℃）Dissolving, addition step is 1. in the solution of gained；
3. dyclonine hydrochloride is added appropriate hot water（70~80℃）Dissolving, adds preservative and flavouring, after stirring and dissolving, plus
Enter step 2. in the solution of gained；
4. defoamer is added to step 3. in the solution of gained, adds remaining water, stir, filtered, filling, obtain final product.
The beneficial effect comprise that：Temperature sensitive type Dyclonine Hydrochloride Gel prepared by the present invention can be with liquid oral
Administration, becomes gel-like after entering in vivo；In terms of the selection of temperature sensitive type Dyclonine Hydrochloride Gel agent mixed-matrix, mucous membrane
Adhesiveness, temperature sensitivity and can to extend the holdup time be the major criterion for selecting material, and new designed by the present invention
The superiority that delivery system is had compared with conventional dosage forms.Because temperature sensitive hydrogel material molecule amount is larger, dissolved in water
Journey is slow, and extremely sensitive to temperature, and the heat produced in whipping process can also affect the property of gel, so with regard to gel
Preparation method is compared ordinary preparation and also has very big difference.The temperature sensitive type Dyclonine Hydrochloride Gel of the present invention is placed as in room temperature
The milky white liquid of good fluidity, is gel when 37 DEG C.
Specific embodiment
With reference to specific embodiment, the invention will be further described, but the protection domain not limited to this that invents.
Embodiment 1
A kind of temperature sensitive type Dyclonine Hydrochloride Gel, by following weight percent into being grouped into：1% dyclonine hydrochloride,
2.5% poloxamer188,0.5% PLURONICS F87,0.3% hydroxypropyl methyl cellulose, 0.05% sorbic acid,
0.03% ethylparaben, 0.025% Sucralose, 0.06% menthol, 0.5% sweet orange taste soluble perfume and 3% poly-
Oxygen ethene polyoxypropylene pentaerythrite ether, balance of water.
The preparation method of the temperature sensitive type Dyclonine Hydrochloride Gel is as follows：Under the conditions of 2 ~ 4 DEG C, by poloxamer188
It is dissolved in suitable quantity of water with PLURONICS F87, stirs, places standby in preparing tank；Again with appropriate hot water dissolving's hydroxypropyl first
After base cellulose, add in preparing tank, stirring and dissolving；Then dyclonine hydrochloride main ingredient is added appropriate hot water dissolving, and is added
Preservative（Sorbic acid, ethylparaben）And flavouring（Sucralose, menthol and sweet orange taste soluble perfume）, add and match somebody with somebody
In tank processed, stir；Polyoxyethylene polyoxypropylene pentaerythrite ether and remaining water is eventually adding, is stirred and is obtained final product.
Embodiment 2
A kind of temperature sensitive type Dyclonine Hydrochloride Gel, by following weight percent into being grouped into：2% dyclonine hydrochloride,
2% poloxamer188,0.3% PLURONICS F87,0.1% hydroxypropyl methyl cellulose, 0.05% ethylparaben,
0.08% stevioside, 0.05% citric acid, 0.3% sweet orange taste soluble perfume and 1.5% polyoxyethylene polyoxypropylene season penta
Four alcohol ethers, balance of water.
The preparation method of the present embodiment temperature sensitive type Dyclonine Hydrochloride Gel is identical with embodiment 1.
Embodiment 3
A kind of temperature sensitive type Dyclonine Hydrochloride Gel, by following weight percent into being grouped into：5% dyclonine hydrochloride,
0.18% poloxamer188,0.1% PLURONICS F87,0.2% hydroxypropyl methyl cellulose, 0.03% sorbic acid,
0.05% ethylparaben, 0.02% Sucralose, 0.06% citric acid, 0.5% sweet orange taste soluble perfume and 2% poly-
Oxygen ethene polyoxypropylene pentaerythrite ether, balance of water.
The preparation method of the present embodiment temperature sensitive type Dyclonine Hydrochloride Gel is identical with embodiment 1.
The weight composition of dyclonine hydrochloride of the present invention and its auxiliary material, it is therefore intended that illustrate that their ratio is closed
System, in actual use, as long as the ratio, i.e., within protection scope of the present invention, and should be not limited to specific weight.
In addition, the ratio of each component is nor absolute numerical value, it is allowed to there is up-down error in actual use, therefore all should be in the present invention
Protection domain within.
This invention is placed as the milky white liquid of good fluidity in room temperature, is gel when 37 DEG C.Research finds pH value
At 3.0 ~ 5.0, preferably, the pH value that 1 temperature sensitive type Dyclonine Hydrochloride Gel of embodiment is measured is the stability of thermo-sensitive gel
4.1.
Temperature sensitive type Dyclonine Hydrochloride Gel of the present invention, tests through pharmacy influence factor, and it is 40 DEG C wherein to investigate condition
± 2 DEG C, relative humidity 75% ± 5% investigates standard：Content is 0.09-0.11g/（Every 10ml）, pH value is 3.0 ~ 5.0, sticks
With reference to viscosimetry when degree is 30 DEG C with gelation temperature（Chinese Pharmacopoeia the 4th the 3rd method of general rule 0633 of version in 2015）Determine,
Its dynamic viscosity should be less than 0.03Pa S, and when 37 DEG C, dynamic viscosity should be not less than 0.10Pa S.
Investigate result as shown in the table.
1 embodiment of table, 1 temperature sensitive type Dyclonine Hydrochloride Gel stability accelerates to investigate result
.
As can be seen from the above table, the stability through 6 months accelerates to investigate test, outside temperature sensitive type Dyclonine Hydrochloride Gel
See proterties relatively stable, less, other indexs also all meet the requirements changes of contents, illustrate inventive gel be a kind of quality very
Stable formulation.
The present invention be a kind of larynx anesthesia when checking for endoscope for upper digestive tract and lubrication temperature sensitive type hydrochloric acid up to gram
Luo Ning gels, specification：0.1g:10ml, usage is：Used time shakes up, and 8～10ml of this product is contained in bottleneck throat before gastrocopy,
Then slowly swallow, gastrocopy after about 10～15 minutes, can be carried out.The present invention can become gel in body temperature, be covered in and disappear
Change road.
Clinical therapeutic efficacy：
Select voluntarily to receive endoscopic patient 200 altogether, wherein 100 are used for control drug（Reference examples）, existing city
General anesthetic gel class on sale, 100 with temperature sensitive type Dyclonine Hydrochloride Gel in embodiment 1, by following bases for estimation
The curative effect of the present invention is investigated.
Judge that Main Basiss are：
1. mirror and anaesthetic effect are inserted：
Excellent：Smoothly, the uncomfortable reaction such as patient's without pain, anaesthetic effect are good for slotting mirror；
Good：Smoothly, the slightly nauseous without pain of patient, anaesthetic effect are good for slotting mirror；
In：Patient's nausea slightly pain once in a while, has substantially no effect on inspection；
Difference：Patient has nausea and pain, affects to check.
2. dispel bubble effect：
Excellent：Stomach and duodenum non-foam, get a clear view；
Good：Stomach and 12 rectum slightly foam, do not affect the visual field；
In：Stomach and duodenum have more foam, but have substantially no effect on the visual field；
Difference：Stomach and duodenum foam are excessive, affect the visual field.
3. the mouthfeel compliance of patient：
Excellent：In good taste, easily swallow；
Good：Mouthfeel is it is also possible that be easy to swallow；
In：Mouthfeel is general, can swallow；
Difference：Mouthfeel is bad, it is impossible to swallow.
Table 2 inserts mirror and Anesthetic Effect
.
Table 3 is dispelled and steeps effects observation
.
4 mouthfeel compliance effects of table are observed
.
Can be seen that by table 1-4：Medicine of the present invention checks for patient, inserts mirror and anaesthetic effect, dispels and steep effect and mouthfeel
Compliance is significantly better than that control group, and contrasts like product, and postoperative pharyngalgia rate substantially reduces.
Claims (9)
1. a kind of temperature sensitive type Dyclonine Hydrochloride Gel, it is characterised in that by following weight percent into being grouped into：Temperature sensitive
Gel-type vehicle 0.2% ~ 10%, dyclonine hydrochloride 1% ~ 5%, viscosity modifier 0% ~ 5%, preservative 0.05% ~ 2%, flavouring
0.1% ~ 2%, defoamer 1% ~ 10%, balance of water.
2. temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 1, it is characterised in that the thermo-sensitive gel matrix is pool Lip river
Any one or several in Sha Mu, shitosan, Carbomer, sodium alginate or Sodium Hyaluronate.
3. temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 2, it is characterised in that the poloxamer is poloxamer
407th, any one or two kinds of in PLURONICS F87.
4. temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 1, it is characterised in that the viscosity modifier is that methyl is fine
Any one or two kinds of in dimension element and hydroxypropyl methyl cellulose.
5. temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 1, it is characterised in that described preservative be benzoic acid,
Sorbic acid, formic acid, propionic acid, methyl p-hydroxybenzoate, ethylparaben, ethyl-para-hydroxybenzoate, P-hydroxybenzoic acid third
Any one or several in ester or butyl p-hydroxybenzoate.
6. temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 1, it is characterised in that the preservative is benzoic acid, mountain
Pears acid, formic acid, the sodium salt of propionic acid or sylvite.
7. temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 1, it is characterised in that the flavouring be sucrose, lactose,
Sorbierite, glycerine, citric acid, saccharin sodium, aspartame, honey element, stevioside, Sucralose, menthol and sweet orange taste are water-soluble
Any one or several in property essence.
8. temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 1, it is characterised in that the defoamer is poly- for polyoxyethylene
Oxypropylene pentaerythrite ether.
9. the preparation method of temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 1, it is characterised in that including following step
Suddenly：
1., under the conditions of 2 ~ 4 DEG C, thermo-sensitive gel matrix is dissolved in suitable quantity of water, and stirring and dissolving, standby；
2. viscosity modifier is added appropriate water dissolves, addition step is 1. in the solution of gained；
3. dyclonine hydrochloride is added appropriate water dissolves, adds preservative and flavouring, after stirring and dissolving, add step 2. gained
Solution in；
4. defoamer is added to step 3. in the solution of gained, adds remaining water, stir, filtered, filling, obtain final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201611002059.XA CN106491516A (en) | 2016-11-15 | 2016-11-15 | A kind of temperature sensitive type Dyclonine Hydrochloride Gel and preparation method thereof |
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| CN201611002059.XA CN106491516A (en) | 2016-11-15 | 2016-11-15 | A kind of temperature sensitive type Dyclonine Hydrochloride Gel and preparation method thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106692036A (en) * | 2017-01-19 | 2017-05-24 | 遂成药业股份有限公司 | Preparation method of temperature-sensitive dyclonine hydrochloride gel |
| CN111077241A (en) * | 2019-12-04 | 2020-04-28 | 遂成药业股份有限公司 | Method for detecting content of dyclonine hydrochloride mucilage or related substances by high performance liquid chromatography |
| CN112138202A (en) * | 2019-06-10 | 2020-12-29 | 戴建英 | Temperature sensitive digestive tract mucosa protective adhesive |
| CN113616796A (en) * | 2021-07-15 | 2021-11-09 | 江苏康禾生物制药有限公司 | Pain-relieving and anti-inflammatory compound sustained-release preparation |
| CN114177348A (en) * | 2021-12-14 | 2022-03-15 | 华北理工大学 | Medical liquid dressing and preparation method and application thereof |
| CN115025125A (en) * | 2022-06-24 | 2022-09-09 | 四川大学 | A pharmaceutical composition for treating oral ulcer and preparation method thereof |
| CN116869927A (en) * | 2023-09-06 | 2023-10-13 | 中国医学科学院北京协和医院 | Esophageal thermosensitive gel for treating eosinophilic esophagitis |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101703463A (en) * | 2009-11-25 | 2010-05-12 | 中国人民武装警察部队医学院 | Paracetamol temperature sensitive gel and preparation method and application thereof |
| CN104382842A (en) * | 2014-10-28 | 2015-03-04 | 中国人民解放军第二军医大学 | Endoscopic anesthesia gel preparation and application thereof |
-
2016
- 2016-11-15 CN CN201611002059.XA patent/CN106491516A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101703463A (en) * | 2009-11-25 | 2010-05-12 | 中国人民武装警察部队医学院 | Paracetamol temperature sensitive gel and preparation method and application thereof |
| CN104382842A (en) * | 2014-10-28 | 2015-03-04 | 中国人民解放军第二军医大学 | Endoscopic anesthesia gel preparation and application thereof |
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106692036A (en) * | 2017-01-19 | 2017-05-24 | 遂成药业股份有限公司 | Preparation method of temperature-sensitive dyclonine hydrochloride gel |
| CN112138202A (en) * | 2019-06-10 | 2020-12-29 | 戴建英 | Temperature sensitive digestive tract mucosa protective adhesive |
| CN111077241A (en) * | 2019-12-04 | 2020-04-28 | 遂成药业股份有限公司 | Method for detecting content of dyclonine hydrochloride mucilage or related substances by high performance liquid chromatography |
| CN113616796A (en) * | 2021-07-15 | 2021-11-09 | 江苏康禾生物制药有限公司 | Pain-relieving and anti-inflammatory compound sustained-release preparation |
| CN114177348A (en) * | 2021-12-14 | 2022-03-15 | 华北理工大学 | Medical liquid dressing and preparation method and application thereof |
| CN115025125A (en) * | 2022-06-24 | 2022-09-09 | 四川大学 | A pharmaceutical composition for treating oral ulcer and preparation method thereof |
| CN115025125B (en) * | 2022-06-24 | 2023-09-29 | 四川大学 | Pharmaceutical composition for treating dental ulcer and preparation method thereof |
| CN116869927A (en) * | 2023-09-06 | 2023-10-13 | 中国医学科学院北京协和医院 | Esophageal thermosensitive gel for treating eosinophilic esophagitis |
| CN116869927B (en) * | 2023-09-06 | 2023-11-10 | 中国医学科学院北京协和医院 | Esophageal thermosensitive gel for treating eosinophilic esophagitis |
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