CN106176708A - A kind of tetracaine hydrochloride pharmaceutical composition and preparation method thereof - Google Patents
A kind of tetracaine hydrochloride pharmaceutical composition and preparation method thereof Download PDFInfo
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- CN106176708A CN106176708A CN201610752315.0A CN201610752315A CN106176708A CN 106176708 A CN106176708 A CN 106176708A CN 201610752315 A CN201610752315 A CN 201610752315A CN 106176708 A CN106176708 A CN 106176708A
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- Prior art keywords
- pharmaceutical composition
- tetracaine hydrochloride
- dimethylamino
- benzoic acid
- amino
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Classifications
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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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/235—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
- A61K31/24—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
- A61K31/245—Amino benzoic acid types, e.g. procaine, novocaine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/534—Mentha (mint)
-
- 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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
Abstract
The invention discloses a kind of tetracaine hydrochloride pharmaceutical composition, this tetracaine hydrochloride pharmaceutical composition is by purifying 4 (fourth amino) benzoic acid 2 (dimethylamino) carbethoxy hydrochloride crude product, and 4 (fourth amino) benzoic acid 2 (dimethylamino) carbethoxy hydrochloride after purifying is obtained by mixing with Polyethylene Glycol, Oleum menthae and Oleum Vitis viniferae successively.The invention also discloses the preparation method of a kind of tetracaine hydrochloride pharmaceutical composition, including: 4 (fourth amino) benzoic acid 2 (dimethylamino) carbethoxy hydrochloride crude product is purified, obtains purifying afterproduct；Polyethylene Glycol and purification afterproduct mixing are stirred, are subsequently adding Oleum menthae and Oleum Vitis viniferae, are stirred and are concentrated in vacuo cooling and obtain tetracaine hydrochloride pharmaceutical composition.Tetracaine hydrochloride pharmaceutical composition prepared by the present invention has the advantage that purity is high, lubricity is good, pharmaceutical quantities is little, anaesthetic effect is good.
Description
Technical field
The present invention relates to technical field of pharmaceuticals, it is more particularly related to a kind of purity is high, lubricity is good, to body
Body nonirritant and tetracaine hydrochloride pharmaceutical composition in good taste and preparation method thereof.
Background technology
Along with raising and the change of dietary structure of people's living standard, increasing people is by the stomach such as gastritis, colitis
Intestinal diseases is perplexed.Gastroscopy technology has become current diagnosis digestive tract disease method the most frequently used, most reliable, and it can be to trouble
The gastric situation of person is directly observed, and other any inspection method, including upper digestive tract barium meal, clectrogastrogram and gastrointestinal tract
B ultrasonic etc. all can not substitute it.
Tetracaine hydrochloride is a kind of local anaesthetics, has pain relieving, the advantage that anaesthetic effect is definite, is widely used in microscopy neck
Territory.But the lubricant in existing tetracaine hydrochloride is fat-soluble lubricant, and the mouthfeel of fat-soluble lubricant is the best, and also deposits
In the shortcoming that purity is the highest.
Summary of the invention
It is an object of the invention to solve at least the above, and the advantage that at least will be described later is provided.
It is a still further object of the present invention to provide a kind of tetracaine hydrochloride pharmaceutical composition, this tetracaine hydrochloride medicine group
Compound has the advantage that purity is high and lubricity is good.
It is a still further object of the present invention to provide the preparation method of a kind of tetracaine hydrochloride pharmaceutical composition, the method with
4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product, Polyethylene Glycol, Oleum menthae and Oleum Vitis viniferae are raw material,
By the mixed liquor after 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product being processed and processing
Mix with Polyethylene Glycol, Oleum menthae and Oleum Vitis viniferae, obtained the tetracaine hydrochloride medicine that purity is high and lubricity is good
Compositions.
To achieve these goals, the invention provides a kind of tetracaine hydrochloride pharmaceutical composition, this tetracaine hydrochloride medicine
Compositions is by purifying 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product, after purifying
4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride mix with Polyethylene Glycol, Oleum menthae and Oleum Vitis viniferae successively and
Obtain.
4-(fourth amino) benzoic acid-2-preferably, in described tetracaine hydrochloride pharmaceutical composition, after described purification
(dimethylamino) carbethoxy hydrochloride, described Polyethylene Glycol, described Oleum menthae, the weight ratio of described Oleum Vitis viniferae be 10～50: 1～
2: 0.5～0.8: 0.2～0.5.
Present invention also offers the preparation method of a kind of tetracaine hydrochloride pharmaceutical composition, comprise the following steps:
Step one, in retort, add a certain amount of distilled water, and be heated to 40～50 DEG C, by 4-(fourth amino) benzene first
Acid-2-(dimethylamino) carbethoxy hydrochloride crude product joins in described retort, performs stirring operation, and dripping with 50g/min
Acceleration drips sodium carbonate liquor in described retort, and the pH value to described reaction pot liquid is 7～9, obtains the first mixing
Liquid；
Step 2, in bleacher, add a certain amount of distilled water, and be heated to 80～90 DEG C, by described first mixed liquor
Join in described bleacher, and with sodium carbonate liquor regulation pH value to 9～10, in described bleacher, add activated carbon carry out
Insulation desolventing technology, performs filter operation and filtrate is warming up to 80～85 DEG C, adds hydrochloric acid and carry out in described filtrate
Being acidified to pH value is 3.0～3.5, uses 0.22 μm microporous filter membrane to filter, the filtrate after acidifying to be filtrated to get
Filter cake is dried and weighs, 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride after being purified；
Step 3,4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride after described purification is joined temperature
Degree is in the distilled water of 80～85 DEG C, is subsequently adding Polyethylene Glycol, uses cutter once to stir it, obtains second and mixes
Close liquid, wherein, the rotating speed of described cutter is 1800～2000r/min, and rotor aperture is 2～3mm, mixing time be 15～
30min；Then the temperature of the second mixed liquor is down to 50～60 DEG C, in described second mixed liquor, adds Oleum menthae and Semen Vitis viniferae
Oil also carries out secondary stirring, and the rotating speed of cutter described in described secondary stirring is 2000～2500r/min, and rotor aperture is 1
～2mm, mixing time is 5～10min；Finally the second mixed liquor after secondary stirring is concentrated in vacuo cooling, controls fall
Temperature cooldown rate is 7～12 DEG C/h, obtains tetracaine hydrochloride pharmaceutical composition when temperature is down to 4～8 DEG C；And at 4～8 DEG C
At a temperature of described tetracaine hydrochloride pharmaceutical composition is carried out preservation.
4-(fourth ammonia preferably, in the preparation method of described tetracaine hydrochloride pharmaceutical composition, after described purification
Base) weight ratio of benzoic acid-2-(dimethylamino) carbethoxy hydrochloride and described Polyethylene Glycol is 15～20: 1.
Preferably, in the preparation method of described tetracaine hydrochloride pharmaceutical composition, in described step 2, described hydrochloric acid
Rate of addition be 10～20mL/min.
Preferably, in the preparation method of described tetracaine hydrochloride pharmaceutical composition, described Polyethylene Glycol is poly-second two
Alcohol 400.
Preferably, in the preparation method of described tetracaine hydrochloride pharmaceutical composition, in described step one, described 4-
(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product is 1: 8～10 with the weight ratio of described distilled water.
Preferably, in the preparation method of described tetracaine hydrochloride pharmaceutical composition, in described step 2, described first
Mixed liquor is 1: 5 with the weight ratio of described distilled water.
Preferably, in the preparation method of described tetracaine hydrochloride pharmaceutical composition, in described step one, described stirring
The mixing speed of operation is 100～500r/min.
Preferably, in the preparation method of described tetracaine hydrochloride pharmaceutical composition, described step one and described step
In two, the concentration of described sodium carbonate liquor is 0.1～3.0mol/L.
The present invention at least includes following beneficial effect:
1, tetracaine hydrochloride pharmaceutical composition of the present invention includes water miscible lubricant, adds people and swallows
Time mouthfeel, and coordinate Oleum menthae and Oleum Vitis viniferae, further increase the effect of lubrication, and a kind of refrigerant mouth
Sense, meanwhile, Oleum menthae can be as the anesthetis in tetracaine hydrochloride pharmaceutical composition, and Oleum Vitis viniferae can be as tetracaine hydrochloride medicine
Antioxidant in compositions, thus improve the performance of tetracaine hydrochloride pharmaceutical composition.
2, by using cheap 4-(fourth ammonia in the preparation method of tetracaine hydrochloride pharmaceutical composition of the present invention
Base) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product it is purified, and purification purity may be up to 99～100%,
By 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride after purification successively with lubricant, anesthetis and antioxygen
The mixing of agent, has obtained that purity is high, lubricity is good, oxidation resistance is good and anaesthetizes the tetracaine hydrochloride medicine group of excellent performance
Compound.
Part is embodied by the further advantage of the present invention, target and feature by description below, and part also will be by this
Invention research and practice and be understood by the person skilled in the art.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in further detail, to make those skilled in the art with reference to description
Word can be implemented according to this.
Should be appreciated that used herein such as " have ", " comprising " and " including " term are not precluded from one or many
Other element individual or the existence of a combination thereof or interpolation.
<embodiment one>
The invention provides a kind of tetracaine hydrochloride pharmaceutical composition, this tetracaine hydrochloride pharmaceutical composition is by following raw material
Composition:
4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product (this crude product is carried out purification processes), poly-
Ethylene glycol, Oleum menthae and Oleum Vitis viniferae.
Wherein, 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product, Polyethylene Glycol, Herba Menthae after purification
Oil, the weight ratio of Oleum Vitis viniferae are 10: 1: 0.5: 0.2.
<embodiment two>
The invention provides a kind of tetracaine hydrochloride pharmaceutical composition, this tetracaine hydrochloride pharmaceutical composition is by following raw material
Composition:
4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product (this crude product is carried out purification processes), poly-
Ethylene glycol, Oleum menthae and Oleum Vitis viniferae.
Wherein, 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product, Polyethylene Glycol, Herba Menthae after purification
Oil, the weight ratio of Oleum Vitis viniferae are 50: 2: 0.8: 0.5.
<embodiment three>
The invention provides a kind of tetracaine hydrochloride pharmaceutical composition, this tetracaine hydrochloride pharmaceutical composition is by following raw material
Composition:
4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product (this crude product is carried out purification processes), poly-
Ethylene glycol, Oleum menthae and Oleum Vitis viniferae.
Wherein, 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product, Polyethylene Glycol, Herba Menthae after purification
Oil, the weight ratio of Oleum Vitis viniferae are 15: 1: 0.7: 0.3.
<embodiment four>
Present invention also offers the preparation method of a kind of tetracaine hydrochloride pharmaceutical composition, comprise the following steps:
Step one, in retort, add a certain amount of distilled water, and be heated to 40～50 DEG C, by 4-(fourth amino) benzene first
Acid-2-(dimethylamino) carbethoxy hydrochloride crude product joins in described retort, performs stirring operation, and mixing speed is 500r/
Min, and the weight ratio of 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product and distilled water is 1: 8, and with
The rate of addition of 50g/min drips the sodium carbonate liquor of 1.0mol/L in described retort, to described reaction pot liquid
PH value is 7, obtains the first mixed liquor；
Step 2, in bleacher, add a certain amount of distilled water, and be heated to 80～90 DEG C, by described first mixed liquor
Joining in described bleacher, the weight ratio of the first mixed liquor and distilled water is 1: 5, uses the sodium carbonate liquor of 0.5mol/L to adjust
Joint pH value, to 9, adds activated carbon in described bleacher and carries out being incubated desolventing technology, performs filter operation and is heated up by filtrate
To 85 DEG C, adding hydrochloric acid and carry out being acidified to pH value being 3.5 in described filtrate, the rate of addition of hydrochloric acid is 10～20mL/
Min, uses 0.22 μm microporous filter membrane to filter the filtrate after acidifying, dries the filter cake being filtrated to get and claim
Weight, 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride after being purified；
Step 3,4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride after described purification is joined temperature
Degree is in the distilled water of 80～85 DEG C, is subsequently adding Polyethylene Glycol, uses cutter once to stir it, obtains second and mixes
Closing liquid, wherein, the rotating speed of described cutter is 1800r/min, and rotor aperture is 3mm, and mixing time is 30min；Then by
The temperature of two mixed liquors is down to 60 DEG C, adds Oleum menthae and Oleum Vitis viniferae and carry out secondary stirring in described second mixed liquor,
The rotating speed of cutter described in described secondary stirring is 2000r/min, and rotor aperture is 1mm, and mixing time is 10min；Finally
The second mixed liquor after secondary stirring is concentrated in vacuo cooling, and controlling cooling down speed is 7 DEG C/h, when temperature is down to 4
DEG C time obtain tetracaine hydrochloride pharmaceutical composition；And at a temperature of 4～8 DEG C, described tetracaine hydrochloride pharmaceutical composition is entered
Row preservation；
Wherein, 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride, Polyethylene Glycol, Oleum menthae, Portugal after purification
The weight ratio of grape seed oil is 10: 1: 0.5: 0.2.
<embodiment five>
Step one, in retort, add a certain amount of distilled water, and be heated to 40～50 DEG C, by 4-(fourth amino) benzene first
Acid-2-(dimethylamino) carbethoxy hydrochloride crude product joins in described retort, performs stirring operation, and 4-(fourth amino) benzene first
The weight ratio of acid-2-(dimethylamino) carbethoxy hydrochloride crude product and distilled water is 1: 10, and with the rate of addition of 50g/min to institute
Dripping the sodium carbonate liquor of 1.5mol/L in stating retort, the pH value to described reaction pot liquid is 9, obtains the first mixed liquor；
Step 2, in bleacher, add a certain amount of distilled water, and be heated to 80～90 DEG C, by described first mixed liquor
Joining in described bleacher, the weight ratio of the first mixed liquor and distilled water is 1: 5, and adjusts with the sodium carbonate liquor of 3.0mol/L
Joint pH value, to 10, adds activated carbon in described bleacher and carries out being incubated desolventing technology, perform filter operation and by filtrate liter
Temperature, to 80 DEG C, adds hydrochloric acid in described filtrate and carries out being acidified to pH value being 3.0, and the rate of addition of hydrochloric acid is 10～20mL/
Min, uses 0.22 μm microporous filter membrane to filter the filtrate after acidifying, dries the filter cake being filtrated to get and claim
Weight, 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride after being purified；
Step 3,4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride after described purification is joined temperature
Degree is in the distilled water of 80～85 DEG C, is subsequently adding Polyethylene Glycol, uses cutter once to stir it, obtains second and mixes
Closing liquid, wherein, the rotating speed of described cutter is 2000r/min, and rotor aperture is 2mm, and mixing time is 15min；Then by
The temperature of two mixed liquors is down to 50 DEG C, adds Oleum menthae and Oleum Vitis viniferae and carry out secondary stirring in described second mixed liquor,
The rotating speed of cutter described in described secondary stirring is 2500r/min, and rotor aperture is 2mm, and mixing time is 5min；The most right
The second mixed liquor after secondary stirring carries out being concentrated in vacuo cooling, and controlling cooling down speed is 12 DEG C/h, when temperature is down to 8 DEG C
Time obtain tetracaine hydrochloride pharmaceutical composition；And at a temperature of 4～8 DEG C, described tetracaine hydrochloride pharmaceutical composition is carried out
Preservation.
Wherein, 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product, Polyethylene Glycol, Herba Menthae after purification
Oil, the weight ratio of Oleum Vitis viniferae are 50: 2: 0.8: 0.5.
Or 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product, Polyethylene Glycol, Herba Menthae after Ti Chuning
Oil, the weight ratio of Oleum Vitis viniferae are 15: 1: 0.7: 0.3.
As a example by 1000 patients, the tetracaine hydrochloride pharmaceutical composition described in 1～1.5g various embodiments of the present invention is dripped
In the Sublingual of 1000 patients, make patient do swallowing act, play anesthetic action at once, knowable to taking result, 1000 patients
All do not occur due to taste or the reason of mouthfeel and dysphagia or the situation having other abnormal response, and pharmaceutical quantities
Little, lubricity is good simultaneously, can farthest reduce the misery of patient.
Although embodiment of the present invention are disclosed as above, but it is not restricted in description and embodiment listed
Using, it can be applied to various applicable the field of the invention completely, for those skilled in the art, and can be easily
Realizing other amendment, therefore under the general concept limited without departing substantially from claim and equivalency range, the present invention does not limit
In specific details.
Claims (10)
1. a tetracaine hydrochloride pharmaceutical composition, it is characterised in that this tetracaine hydrochloride pharmaceutical composition is by 4-(fourth ammonia
Base) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product purifies, 4-(fourth amino) benzoic acid-2-(two after purifying
Methylamino) carbethoxy hydrochloride is obtained by mixing with Polyethylene Glycol, Oleum menthae and Oleum Vitis viniferae successively.
2. tetracaine hydrochloride pharmaceutical composition as claimed in claim 1, it is characterised in that the 4-(fourth amino) after described purification
Benzoic acid-2-(dimethylamino) carbethoxy hydrochloride, described Polyethylene Glycol, described Oleum menthae, the weight ratio of described Oleum Vitis viniferae are
10～50: 1～2: 0.5～0.8: 0.2～0.5.
3. a preparation method for the tetracaine hydrochloride pharmaceutical composition as described in any one of claim 1～2, its feature exists
In, comprise the following steps:
Step one, in retort, add a certain amount of distilled water, and be heated to 40～50 DEG C, by 4-(fourth amino) benzoic acid-
2-(dimethylamino) carbethoxy hydrochloride crude product joins in described retort, performs stirring operation, and with the dropping speed of 50g/min
Degree drips sodium carbonate liquor in described retort, and the pH value to described reaction pot liquid is 7～9, obtains the first mixed liquor；
Step 2, in bleacher, add a certain amount of distilled water, and be heated to 80～90 DEG C, described first mixed liquor is added
In described bleacher, and with sodium carbonate liquor regulation pH value to 9～10, in described bleacher, add activated carbon be incubated
Desolventing technology, performs filter operation and filtrate is warming up to 80～85 DEG C, adds hydrochloric acid and be acidified in described filtrate
It is 3.0～3.5 to pH value, uses 0.22 μm microporous filter membrane to filter, the filtrate after acidifying to the filter cake being filtrated to get
Dry and weigh, 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride after being purified；
Step 3,4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride after described purification is joined temperature it is
In the distilled water of 80～85 DEG C, it is subsequently adding Polyethylene Glycol, uses cutter that it is once stirred, obtain the second mixing
Liquid, wherein, the rotating speed of described cutter is 1800～2000r/min, and rotor aperture is 2～3mm, mixing time be 15～
30min；Then the temperature of the second mixed liquor is down to 50～60 DEG C, in described second mixed liquor, adds Oleum menthae and Semen Vitis viniferae
Oil also carries out secondary stirring, and the rotating speed of cutter described in described secondary stirring is 2000～2500r/min, and rotor aperture is 1
～2mm, mixing time is 5～10min；Finally the second mixed liquor after secondary stirring is concentrated in vacuo cooling, controls fall
Temperature cooldown rate is 7～12 DEG C/h, obtains tetracaine hydrochloride pharmaceutical composition when temperature is down to 4～8 DEG C；And at 4～8 DEG C
At a temperature of described tetracaine hydrochloride pharmaceutical composition is carried out preservation.
4. the preparation method of tetracaine hydrochloride pharmaceutical composition as claimed in claim 3, it is characterised in that after described purification
4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride is 15～20: 1 with the weight ratio of described Polyethylene Glycol.
5. the preparation method of tetracaine hydrochloride pharmaceutical composition as claimed in claim 3, it is characterised in that described step 2
In, the rate of addition of described hydrochloric acid is 10～20mL/min.
6. the preparation method of tetracaine hydrochloride pharmaceutical composition as claimed in claim 3, it is characterised in that described Polyethylene Glycol
For PEG400.
7. the preparation method of tetracaine hydrochloride pharmaceutical composition as claimed in claim 3, it is characterised in that described step one
In, the weight ratio of described 4-(fourth amino) benzoic acid-2-(dimethylamino) carbethoxy hydrochloride crude product and described distilled water be 1: 8～
10。
8. the preparation method of tetracaine hydrochloride pharmaceutical composition as claimed in claim 3, it is characterised in that described step 2
In, described first mixed liquor is 1: 5 with the weight ratio of described distilled water.
9. the preparation method of tetracaine hydrochloride pharmaceutical composition as claimed in claim 3, it is characterised in that described step one
In, the mixing speed of described stirring operation is 100～500r/min.
10. the preparation method of tetracaine hydrochloride pharmaceutical composition as claimed in claim 3, it is characterised in that described step one
With in described step 2, the concentration of described sodium carbonate liquor is 0.1～3.0mol/L.
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1103288A (en) * | 1993-12-02 | 1995-06-07 | 张洁 | Local anaesthetic and its preparing method |
| WO2011153334A2 (en) * | 2010-06-04 | 2011-12-08 | Trilogic Pharma Llc | Bioadhesive compositions for epithelial drug delivery |
| CN105188670A (en) * | 2013-03-15 | 2015-12-23 | 微分药物发展联合有限公司 | Emulsion formulations |
| CN105646259A (en) * | 2014-11-18 | 2016-06-08 | 上海朝晖药业有限公司 | A preparing method of high-purity 2-(dimethylamino)ethyl 4-(butylamino)benzoate hydrochloride |
| CN105769839A (en) * | 2016-05-17 | 2016-07-20 | 山西远扬医药科技有限公司 | Compound lidocaine medicine composition and preparation method thereof |
-
2016
- 2016-08-30 CN CN201610752315.0A patent/CN106176708A/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1103288A (en) * | 1993-12-02 | 1995-06-07 | 张洁 | Local anaesthetic and its preparing method |
| WO2011153334A2 (en) * | 2010-06-04 | 2011-12-08 | Trilogic Pharma Llc | Bioadhesive compositions for epithelial drug delivery |
| CN105188670A (en) * | 2013-03-15 | 2015-12-23 | 微分药物发展联合有限公司 | Emulsion formulations |
| CN105646259A (en) * | 2014-11-18 | 2016-06-08 | 上海朝晖药业有限公司 | A preparing method of high-purity 2-(dimethylamino)ethyl 4-(butylamino)benzoate hydrochloride |
| CN105769839A (en) * | 2016-05-17 | 2016-07-20 | 山西远扬医药科技有限公司 | Compound lidocaine medicine composition and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 乐逢庆等: "以丁卡因代替可卡因配制五官科麻醉剂", 《中国医院药学杂志》 * |
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Application publication date: 20161207 |