CN106692036A - Preparation method of temperature-sensitive dyclonine hydrochloride gel - Google Patents
Preparation method of temperature-sensitive dyclonine hydrochloride gel Download PDFInfo
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- CN106692036A CN106692036A CN201710038992.0A CN201710038992A CN106692036A CN 106692036 A CN106692036 A CN 106692036A CN 201710038992 A CN201710038992 A CN 201710038992A CN 106692036 A CN106692036 A CN 106692036A
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- dyclonine hydrochloride
- gel
- preparation
- 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
-
- 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
-
- 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
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
Abstract
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a preparation method of a temperature-sensitive dyclonine hydrochloride gel. The method comprises the following steps: 1) under the condition of 2-6 DEG C, dissolving a temperature-sensitive gel substrate in a right amount of purified water, and stirring uniformly for later use; 2) dissolving a viscosity modifier in a right amount of purified water, and adding into the solution obtained in the step 1); 3) dissolving dyclonine hydrochloride in a right amount of purified water, simultaneously adding the dyclonine hydrochloride solution and a pH regulator into the solution obtained in the step 2), and dissolving by stirring; and 4) adding a preservative, a flavoring agent, a medical defoaming agent and the balance of purified water into the solution obtained in the step 3), and uniformly mixing. The gel prepared by the method is used for larynx anesthetization and lubrication during digestive tract endoscopy, greatly increases the retention time and coverage area under the condition of the same administration volume, has the characteristics of strong anesthetization, quick drug effect taking, favorable defoaming effect, proper mouthfeel and the like, enhances the compliance of the patient, and is worthy of clinical application and popularization.
Description
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of Dyclonine Hydrochloride Gel preparation of temperature sensitive type and
Its preparation method.
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, mobility and adhesiveness increase, and gel can be formed in cavity or affected part, so as to give on an equal basis
Under the conditions of medicine body product, holdup time and area coverage ratio are significantly increased.Therefore, the consumption and drug concentration of preparation can be notable
Reduce, the adaptability of patient can be improved, preparation cost is reduced again.
Dyclonine hydrochloride is a kind of local anesthetic, and it can significantly reduce and is peeped in patient's UGI to have been reported display
The sense of discomfort of spectroscopy.Therefore, the existing rubber cement and solution with dyclonine hydrochloride as main ingredient of in the market(Such as,
CN200510040093.1 discloses a kind of oral preparation comprising dyclonine hydrochloride), solution is mainly external application.Rubber cement due to its from
It is the reason for body physical property, shorter in the residence time of oesophagus and enteron aisle after oral or bowel lavage, and mobility is too high, it is difficult to cover
Whole cavity inner surface, causes anaesthetic effect to reduce.If otherwise change formulation and reach preferable effect, need to improve to medicament
Amount, increased drug cost, simultaneously because can still be produced when patient takes after there is dyclonine hydrochloride bitter taste, concentration to improve in itself
The certain sense of discomfort of life.Research and development accordingly, with respect to temperature sensitive type Dyclonine Hydrochloride Gel are extremely urgent.
The content of the invention
Present invention aim to overcome that prior art defect, there is provided a kind of Dyclonine Hydrochloride Gel preparation of temperature sensitive type
Preparation method, the gel preparation prepared using the method can not only alleviate what clinical alimentary tract endoscope inspection brought to patient
Stimulate and sense of discomfort, the definition of sight glass inspection can also be improved, so that diagnostic result is relatively reliable.
To achieve the above object, the present invention is adopted the following technical scheme that:
A kind of temperature sensitive type Dyclonine Hydrochloride Gel, it is by following percentage by weight into being grouped into:Dyclonine hydrochloride 1% ~
5%th, thermo-sensitive gel matrix 1% ~ 10%, viscosity modifier 5% ~ 10%, pH adjusting agent 0.1% ~ 1%, preservative 0.01% ~ 0.1%,
Flavouring 0.1% ~ 5%, medical defoamer 2% ~ 8%, balance of purified water.
The preparation method of above-mentioned temperature sensitive type Dyclonine Hydrochloride Gel, specifically includes following steps:
1)Under the conditions of 2-6 DEG C, thermo-sensitive gel matrix is dissolved in appropriate purified water, stirred, be put into standby in preparing tank;
2)After viscosity modifier is dissolved with appropriate purified water, step 1 is added)In resulting solution;
3)Main ingredient dyclonine hydrochloride is purified into water dissolves with appropriate, and step 2 is added simultaneously with pH adjusting agent)Resulting solution
In, stirring and dissolving;
4)To step 3)The purified water of preservative, flavouring, medical defoamer and surplus is added in resulting solution, mixing is equal
It is even, obtain final product.
Specifically, described thermo-sensitive gel matrix can be one or more in Families of poloxamers and shitosan
Mixture.Wherein, preferably poloxamer188 and PLURONICS F87.Poloxamer has good tolerance, and its is water-soluble
Liquid has the property of reverse gelling of being heated, and the wherein gelation temperature of poloxamer188 is all lower than the poloxamer of other models,
So it is combined with PLURONICS F87, its gelation temperature can be improved.
Specifically, described viscosity modifier can be Carbomer, methylcellulose, hydroxypropyl methyl cellulose, poly- second
One or more mixture in enol, sodium alginate and Sodium Hyaluronate etc..Wherein, preferably polyvinyl alcohol.
Specifically, described pH adjusting agent is preferably citric acid and sodium citrate.
Specifically, described preservative can be benzoic acid, sorbic acid, formic acid, propionic acid or its esters(As Sodium Benzoate,
Potassium sorbate etc.).Described preservative can also be parabens, such as:Methyl p-hydroxybenzoate, P-hydroxybenzoic acid second
One or more mixture in ester, propylparaben, butyl p-hydroxybenzoate and ethyl hydroxy benzoate.Its
In, preferably ethyl hydroxy benzoate.
Specifically, described flavouring can be other carbohydrates, the polyalcohols such as sucrose, lactose(Such as sorbierite, glycerine)、
One or more mixture in essence, saccharin sodium, aspartame and Steviosin.Wherein, preferably Steviosin, it is sweet
Oil, menthol and sweet orange taste soluble perfume.
Specifically, described medical defoamer is a kind of nonionic surface active agent, preferably polyoxyethylene polyoxy third
Alkene pentaerythrite ether, consumption is few and defoaming effect is good;Its hydrophily is strong, it is easy to be dispersed in and bubble is eliminated on upper gastrointestinal mucosa
Foam, makes the scope visual field apparent.
The effect of temperature sensitive type Dyclonine Hydrochloride Gel of the present invention can be liquid oral administration, into vivo after i.e. change
Gel.In terms of the selection of temperature sensitive type Dyclonine Hydrochloride Gel agent mixed-matrix, mucoadhesive, temperature sensitivity and
It is the major criterion for selecting material that the indexs such as holdup time can be extended, and is also novel Drug Delivery Systems and tradition designed by the present invention
Place of the formulation compared to had superiority.Because temperature sensitive hydrogel material molecule amount is larger, course of dissolution is slow in water, and
Extremely sensitive to temperature, the heat produced in whipping process can also influence the property of gel, so the preparation method on gel
Can also be made a big difference compared to ordinary preparation.
Temperature sensitive type Dyclonine Hydrochloride Gel of the present invention is a kind of local anesthetic, when being checked for endoscope for upper digestive tract
Larynx anesthesia and lubricate, at room temperature, preparation is liquid condition, when temperature rises to body temperature, can be formed in cavity or affected part
Gel, under the conditions of equal administered volume, holdup time and area coverage ratio are significantly increased, and are played with strong, drug effect is anaesthetized
Hurry up, effect is good and the features such as suitable mouthfeel, improves the compliance of patient, clinic promotion and application for bubble of dispelling.
Temperature sensitive type Dyclonine Hydrochloride Gel of the present invention can effectively improve the work of patient's Preoperative Method, can not only alleviate
Stimulation and sense of discomfort that clinical alimentary tract endoscope inspection brings to patient, can also improve the definition of sight glass inspection, so that
Make diagnostic result relatively reliable.Reported according to relevant clinical, the annual endoscopic patient of Current Domestic breaks through 20,000,000
Example, market potential is larger, has broad prospects.The present invention is ensuring the effectiveness and reliability basis close with like product
On, further improve the stability of medicine, increase medication compliance, reduce the pain of patient's gastrocopy.Through domestic many families
The report of emphasis hospital clinical is confirmed:It is in terms of slotting mirror and anaesthetic effect, dispel bubble effect, efficacy determination and mouthfeel, hence it is evident that be better than
Similar rubber cement dosage form product, is increasingly being applied in superior gastrointestinal endoscopy.
Specific embodiment
Technical scheme is further discussed in detail with reference to embodiments, but protection scope of the present invention
It is not limited thereto.
Embodiment 1
A kind of temperature sensitive type Dyclonine Hydrochloride Gel, it is by following percentage by weight into being grouped into:Dyclonine hydrochloride 1%, pool
Luo Shamu 407 2.5%, PLURONICS F87 0.5%, polyvinyl alcohol 5%, citric acid 0.3%, sodium citrate 0.1%, ethyl hydroxy benzoate
0.03%, glycerine 2.5%, Steviosin 0.08%, menthol 0.05%, sweet orange taste soluble perfume 0.5%, polyoxyethylene polyoxypropylene
Pentaerythrite ether 3%, balance of purified water.
The preparation method of above-mentioned temperature sensitive type Dyclonine Hydrochloride Gel, specifically includes following steps:
1)Under the conditions of 4 DEG C, the thermo-sensitive gel matrix that will be weighed up(Poloxamer188 and PLURONICS F87)It is dissolved in appropriate purifying
In water, stir, be put into standby in preparing tank;
2)With appropriate heat(40-60℃)Purified water is by viscosity modifier(Polyvinyl alcohol)After dissolving, in addition preparing tank;
3)By main ingredient dyclonine hydrochloride appropriate purifying water dissolves, and and pH adjusting agent(Citric acid and sodium citrate)Add simultaneously
In entering preparing tank, stirring and dissolving;
4)To adding preservative in preparing tank(Ethyl hydroxy benzoate), flavouring(Glycerine, Steviosin, menthol and sweet orange taste are water-soluble
Essence), medical defoamer(Polyoxyethylene polyoxypropylene pentaerythrite ether)And the purified water of surplus, stir, filter, fill
Dress, obtains final product.
Embodiment 2
A kind of temperature sensitive type Dyclonine Hydrochloride Gel, it is by following percentage by weight into being grouped into:Dyclonine hydrochloride 1%, pool
Luo Shamu 407 2%, PLURONICS F87 0.3%, polyvinyl alcohol 6%, citric acid 0.2%, sodium citrate 0.2%, ethylparaben
0.05%, Steviosin 0.05%, glycerine 2%, sweet orange taste soluble perfume 0.3%, polyoxyethylene polyoxypropylene pentaerythrite ether 5% is remaining
It is purified water to measure.
The preparation method of above-mentioned temperature sensitive type Dyclonine Hydrochloride Gel is with reference to embodiment 1.
Embodiment 3
A kind of temperature sensitive type Dyclonine Hydrochloride Gel, it is by following percentage by weight into being grouped into:Dyclonine hydrochloride 1%, pool
Luo Shamu 407 1.8%, PLURONICS F87 0.1%, polyvinyl alcohol 5%, citric acid 0.3%, sodium citrate 0.2%, ethyl hydroxy benzoate
0.01%, glycerine 2%, Sucralose 0.05%, menthol 0.05%, sweet orange taste soluble perfume 0.5%, polyoxyethylene polyoxypropylene
Pentaerythrite ether 4%, balance of purified water.
The preparation method of above-mentioned temperature sensitive type Dyclonine Hydrochloride Gel is with reference to embodiment 1.
Embodiment 4
A kind of temperature sensitive type Dyclonine Hydrochloride Gel, it is by following percentage by weight into being grouped into:Dyclonine hydrochloride 2%, shell
Glycan 3%, sodium alginate 3%, methylcellulose 2%, citric acid 0.1%, sodium citrate 0.1%, Sodium Benzoate 0.05%, glycerine 1%,
Steviosin 0.05%, menthol 1%, polyoxyethylene polyoxypropylene pentaerythrite ether 5%, balance of purified water.
The preparation method of above-mentioned temperature sensitive type Dyclonine Hydrochloride Gel is with reference to embodiment 1.
Embodiment 5
A kind of temperature sensitive type Dyclonine Hydrochloride Gel, it is by following percentage by weight into being grouped into:Dyclonine hydrochloride 2%, shell
Glycan 4%, Carbomer 0.4%, hydroxypropyl methyl cellulose 4%, citric acid 0.4%, sodium citrate 0.3%, ethyl-para-hydroxybenzoate
0.08%, glycerine 3%, menthol 1%, sweet orange taste soluble perfume 0.5%, polyoxyethylene polyoxypropylene pentaerythrite ether 6%, surplus
It is purified water.
The preparation method of above-mentioned temperature sensitive type Dyclonine Hydrochloride Gel is with reference to embodiment 1.
Embodiment 6
A kind of temperature sensitive type Dyclonine Hydrochloride Gel, it is by following percentage by weight into being grouped into:Dyclonine hydrochloride 2%, shell
Glycan 4%, polyvinyl alcohol 8%, citric acid 0.6%, sodium citrate 0.4%, potassium sorbate 0.03%, glycerine 1%, saccharin sodium 0.5% gathers
Oxygen ethene polyoxypropylene pentaerythrite ether 3%, balance of purified water.
The preparation method of above-mentioned temperature sensitive type Dyclonine Hydrochloride Gel is with reference to embodiment 1.
The weight composition of main ingredient dyclonine hydrochloride and its auxiliary material in gel of the present invention, it is therefore intended that illustrate them
Proportionate relationship, in actual use, as long as the ratio, i.e., should within protection scope of the present invention, and be not limited to tool
The weight of body.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 within protection scope of the present invention.
Temperature sensitive type Dyclonine Hydrochloride Gel of the present invention is placed as the milky white liquid of good fluidity in room temperature, at 37 DEG C
It is gel.Research finds pH value at 3.0 ~ 5.0, and preferably, the pH value that this product is measured is 4.1 to the stability of thermo-sensitive gel.
Temperature sensitive type Dyclonine Hydrochloride Gel of the present invention, tests by pharmacy influence factor, wherein the condition of investigation is 40 ± 2
DEG C, relative humidity 75 ± 5%;Investigation standard:Content is 0.09-0.11g/ branch(Every 10ml), pH value be 3.0 ~ 5.0, viscosity with
With reference to viscosimetry when gelation temperature is 30 DEG C(Chinese Pharmacopoeia the 4th method of general rule 0633 the 3rd of version in 2015)It is measured,
Its dynamic viscosity should be no more than 0.03PaS, and dynamic viscosity should be not less than 0.10PaS at 37 DEG C.
Investigate result as shown in the table.
The stability of the temperature sensitive type Dyclonine Hydrochloride Gel of table 1 accelerates to investigate result
As can be seen from the above table, accelerate to investigate experiment, the outward appearance of temperature sensitive type Dyclonine Hydrochloride Gel by the stability of 6 months
Proterties is relatively stable, and less, other indexs also all meet the requirements changes of contents, illustrate that inventive gel is that a kind of quality is very steady
Fixed formulation.
The present invention be a kind of larynx anesthesia when being checked 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 is shaken up, and 8~10ml of this product is contained in into bottleneck throat before gastrocopy,
Then slowly swallow, gastrocopy can be carried out after about 10~15 minutes.The present invention can become gel in body temperature, be covered in and disappear
Change road.
Clinical therapeutic efficacy:
Selection voluntarily receives endoscopic patient and amounts to 200, wherein 100 are used for control drug(It is existing commercially available
Dyclonine Hydrochloride Mucilage-revived up to oneself), 100 use temperature sensitive type Dyclonine Hydrochloride Gel of the present invention(The product of embodiment 1 to 5
Each 20), curative effect is investigated by following bases for estimation.The results are shown in Table 2 to 4.
The main judgment basis of curative effect are as follows.
1)Insert mirror and anaesthetic effect:
It is excellent:Insert mirror smoothly, the uncomfortable reaction such as patient's without pain, anaesthetic effect is good;
It is good:Insert mirror smoothly, the slightly nauseous without pain of patient, anaesthetic effect is good;
In:Patient's nausea slightly pain once in a while, has substantially no effect on inspection;
Difference:Patient has nausea and pain, and influence is checked.
2)Dispel bubble effect:
It is excellent:Stomach and duodenum non-foam, get a clear view;
It is good:Stomach and 12 rectum slightly foam, do not influence 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, influence the visual field.
3)The mouthfeel compliance of patient:
It is excellent:It is in good taste, easily swallow;
It is good:Mouthfeel is also possible that and is 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 bubble effect observation
The mouthfeel compliance effect observation of table 4
The investigation result of table 2 to 4 shows:Temperature sensitive type Dyclonine Hydrochloride Gel of the present invention inserts mirror and anesthesia for patient's inspection
Effect, bubble effect of dispelling and mouthfeel compliance are significantly better than that control group, and contrast like product, and postoperative pharyngalgia rate is substantially reduced.
Claims (8)
1. a kind of preparation method of temperature sensitive type Dyclonine Hydrochloride Gel, it is characterised in that the temperature sensitive type dyclonine hydrochloride
Gel is by following percentage by weight into being grouped into:Dyclonine hydrochloride 1% ~ 5%, thermo-sensitive gel matrix 1% ~ 10%, viscosity are adjusted
Section agent 5% ~ 10%, pH adjusting agent 0.1% ~ 1%, preservative 0.01% ~ 0.1%, flavouring 0.1% ~ 5%, medical defoamer 2% ~
8%, balance of purified water;Preparation method specifically includes following steps:
1)Under the conditions of 2-6 DEG C, thermo-sensitive gel matrix is dissolved in appropriate purified water, stirred, it is standby;
2)After viscosity modifier is dissolved with appropriate purified water, step 1 is added)In resulting solution;
3)Dyclonine hydrochloride is purified into water dissolves with appropriate, and step 2 is added simultaneously with pH adjusting agent)In resulting solution, stir
Mix dissolving;
4)To step 3)The purified water of preservative, flavouring, medical defoamer and surplus is added in resulting solution, mixing is equal
It is even, obtain final product.
2. the preparation method of temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 1, it is characterised in that described is temperature sensitive
Gel-type vehicle is one or more the mixture in poloxamer and shitosan.
3. the preparation method of temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 1, it is characterised in that described viscosity
Conditioning agent is in Carbomer, methylcellulose, hydroxypropyl methyl cellulose, polyvinyl alcohol, sodium alginate and Sodium Hyaluronate
One or more mixture.
4. the preparation method of temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 1, it is characterised in that described pH is adjusted
Section agent is citric acid and sodium citrate.
5. the preparation method of temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 1, it is characterised in that described anti-corrosion
Agent is benzoic acid, sorbic acid, formic acid, propionic acid or its esters.
6. the preparation method of temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 1, it is characterised in that described anti-corrosion
Agent is methyl p-hydroxybenzoate, ethyl-para-hydroxybenzoate, propylparaben, butyl p-hydroxybenzoate and oxybenzene
One or more mixture in ethyl ester.
7. the preparation method of temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 1, it is characterised in that described flavoring
Agent is one or more the mixture in sucrose, lactose, polyalcohol, essence, saccharin sodium, aspartame and Steviosin.
8. the preparation method of temperature sensitive type Dyclonine Hydrochloride Gel as claimed in claim 1, it is characterised in that described is medical
Defoamer is polyoxyethylene polyoxypropylene pentaerythrite ether.
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112138202A (en) * | 2019-06-10 | 2020-12-29 | 戴建英 | Temperature sensitive digestive tract mucosa protective adhesive |
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CN1729975A (en) * | 2005-05-16 | 2006-02-08 | 扬子江药业集团有限公司 | Orally administered formulation of dyclonine hydrochloride |
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CN112138202A (en) * | 2019-06-10 | 2020-12-29 | 戴建英 | Temperature sensitive digestive tract mucosa protective adhesive |
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Application publication date: 20170524 |