CN108567761A - A kind of Levofloxacin Hydrochloride Capsules and preparation method thereof - Google Patents
A kind of Levofloxacin Hydrochloride Capsules and preparation method thereof Download PDFInfo
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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- 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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
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- A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
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Abstract
The present invention relates to field of medicine preparing technology, more particularly to a kind of Levofloxacin Hydrochloride Capsules and preparation method thereof, the Levofloxacin Hydrochloride Capsules, including capsule and the lavo-ofloxacin hydrochloride particle being filled in capsule, the lavo-ofloxacin hydrochloride particle is made of the substance of following parts by weight：1 ~ 30 parts by weight of lavo-ofloxacin hydrochloride, 3 ~ 12 parts by weight of monohydric alcohol, 0.5 ~ 5 parts by weight of fatty acid alkali metal salt, 50 ~ 100 parts by weight of auxiliary material；The auxiliary material is camphor or the extract of peppermint.The Levofloxacin Hydrochloride Capsules of the present invention can quickly solution be collapsed by the interaction between auxiliary material, be made drug Fast Stripping, and then drug is made to play a role, improve drug effect；And drug local irritation is small, and drug local concentration can be avoided excessive, reduces the irritation of drug, also has the characteristics that manufacture craft is simple, saves cost, is suitble to large-scale industrial production.
Description
Technical field
The present invention relates to field of medicine preparing technology more particularly to a kind of Levofloxacin Hydrochloride Capsules and its preparation sides
Method.
Background technology
Lavo-ofloxacin hydrochloride is the levo form of Ofloxacin, and chemistry is entitled：(S)-(-) the fluoro- 2,3- dihydros -3- first of -9-
Base -10- (4- methyl-1s-piperazine) -7- oxygen -7H- pyridines parallel [1,2,3-de]-be [1,4] benzoxazine -6- carboxylic acid hydrochlorides
Hydrate.Its antibacterial activity is about twice of Ofloxacin, its main mechanism is to inhibit DNA of bacteria gyrase（Bacterium
Type Ⅱ topoisomerase）Activity, hinder bacterium DNA replication.It has the characteristics that strong with has a broad antifungal spectrum, antibacterial action.To most
Number enterobacteriaceae lactobacteriaceaes, as escherichia coli, Klebsiella, Serratia, Proteus, Shigella, Salmonella,
The gram-negative bacterias such as citrobacter, acinetobacter and pseudomonas aeruginosa, haemophilus influenzae, gonococcus have relatively strong
Antibacterial activity.To part methicillin-sensitivity staphylococcus, streptococcus pneumonia, micrococcus scarlatinae, hemolytic streptococcus etc.
Gram positive bacteria and Legionella, mycoplasma, Chlamydia also have good antibacterial action.Lavo-ofloxacin hydrochloride is suitable for sensitive bacteria
It is caused：1. urogenital infections, including pure, complexity urinary tract infections, bacterial prostatitis, NEISSERIA GONORRHOEAE
Urethritis or cervicitis (including person caused by producing enzyme strain).2. bronchus caused by respiratory tract infection, including sensitive gram negative bacilli
Infect acute attack and pulmonary infection.3. alimentary infection, by Shigella, Salmonella, enterotoxigenic escherichia coli, hydrophilic
Caused by Aeromonas, vibrio parahaemolytious etc..4. typhoid fever.5. bone and the infection of joint.6. skin soft-tissue infection.7. septicemia etc. is complete
Body infects.Lavo-ofloxacin hydrochloride
Lavo-ofloxacin hydrochloride have many uses it is general, Principle of Pain unbearably in the case of, it is better that drug effect plays a role sooner, this is just
Need the substance in Levofloxacin Hydrochloride Capsules that can quickly dissolve out, and then drug made to play a role, but at present because
The selection of disintegrant and lubricant is improper, keeps the dissolution rate of drug less desirable.
Invention content
In view of the deficiencies of the prior art, the present invention provides a kind of Levofloxacin Hydrochloride Capsules, can quickly make drug molten
Go out, manufacture craft is simple, saves cost, is suitble to large-scale industrial production.
The present invention provides a kind of Levofloxacin Hydrochloride Capsules, including capsule and the left oxygen fluorine of hydrochloric acid that is filled in capsule
Husky star particle, the lavo-ofloxacin hydrochloride particle are made of the substance of following parts by weight：1 ~ 30 weight of lavo-ofloxacin hydrochloride
Part, 3 ~ 12 parts by weight of monohydric alcohol, 0.5 ~ 5 parts by weight of fatty acid alkali metal salt, 50 ~ 100 parts by weight of auxiliary material；The auxiliary material is camphor
Or the extract of peppermint.
Preferably, the lavo-ofloxacin hydrochloride particle is made of the substance of following parts by weight：Lavo-ofloxacin hydrochloride 5 ~
15 parts by weight, 5 ~ 10 parts by weight of monohydric alcohol, 1 ~ 3 parts by weight of fatty acid alkali metal salt, 80 ~ 100 parts by weight of auxiliary material, auxiliary material 25 ~ 30
Parts by weight.
Preferably, the fatty acid alkali metal salt is capric acid, palmitic acid, stearic acid, oleic acid, undecenoic acid, sub- oil
At least one of the alkali metal salt of acid, leukotrienes etc..
Preferably, the monohydric alcohol is at least one of 6 or 6 monohydric alcohols below of carbon atom quantity.
Preferably, the auxiliary material collapses in agent, emulsifier, preservative, lubricant and thickener at least selected from filler, solution
It is a kind of.
It is further preferred that the filler is selected from starch, lactose, mannitol, dextrin, microcrystalline cellulose, carboxymethyl fibre
At least one of the plain sodium of dimension, low-substituted hydroxypropyl cellulose.
The disintegrant is at least one in crospovidone, sodium carboxymethyl starch and croscarmellose sodium
Kind；The lubricant is at least one of magnesium stearate, sodium stearyl fumarate and talcum powder.
The emulsifier is selected from odium stearate, stearic acid, enuatrol, lauryl sodium sulfate, sodium hexadecyl sulfate, sulphur
It is acidified at least one of castor oil, single stearic acid glycerine lipoprotein and Tween-80.The preservative is benzoic acid and salt, mountain
Potassium sorbate, propylparaben, calcium propionate, sodium Diacetate, sodium lactate, streptococcus lactis, receives that he is mould at dehydroactic acid sodium
At least one of element, hydrogen peroxide, sulfur dioxide, sulphite and nitrite etc..The thickener be selected from lanolin,
At least one of beeswax, atoleine, albolene and octadecyl alcolol.
Preferably, the capsule is made of the substance of following parts by weight：30 ~ 50 parts by weight of acrylic resin, atoleine
20 ~ 30 parts by weight, 1 ~ 3 parts by weight of 3 ~ 12 parts by weight of chitosan, 1,3 butanediol, 3 ~ 5 parts by weight and pH adjusting agent.
A kind of preparation method of the Levofloxacin Hydrochloride Capsules, includes the following steps：
（1）By acrylic resin, chitosan and 1,3 butanediols are uniformly mixed in water, then it is stirred to react 1 at 60 ~ 90 DEG C ~
5h, obtains acrylic resin modified, is uniformly mixed acrylic resin modified with atoleine and pH adjusting agent, obtains capsule breast
Liquid；
（2）Lavo-ofloxacin hydrochloride, fatty acid alkali metal salt are dissolved in monohydric alcohol, 0.2 ~ 0.3 μm of membrane filtration is used in combination to remove
Bacterium obtains mixed system 1；Then auxiliary material is uniformly mixed with mixed system 1, and the sterilizing 30 ~ 40 under the conditions of 121 ~ 125 DEG C
Min, then under normal temperature condition, with 8 ~ 10min of rotating speed cutting of 1000 ~ 1750r/min, then with 2000 ~ 2800r/min's
4 ~ 5min of rotating speed cutting obtains lavo-ofloxacin hydrochloride particle；
（3）Capsule lotion and lavo-ofloxacin hydrochloride particle are mixed, it is 0.5% ~ 5% sorbester p17 to add volume, after mixing
High-shear emulsifying disperses, while it is 5.8 ~ 6.3 to acidity that pH adjusting agent regulation system pH, which is slowly added dropwise, and capsule wall material is made to be precipitated
And it is coated on the surface of lavo-ofloxacin hydrochloride particle；Then it filters, it is dry, a small amount of aluminum magnesium silicate absorption residual liquid is added
Paraffin is to get Levofloxacin Hydrochloride Capsules.
Preferably, compressed value is being 300 ~ 4000 gf/cm2, fusing point is 30 ~ 80 DEG C.
Preferably, compressed value is being 500 ~ 3000 gf/cm2, fusing point is 45 ~ 75 DEG C.
Compared with prior art, the present invention has the following technical effects：The Levofloxacin Hydrochloride Capsules of the present invention pass through
Interaction between auxiliary material can quickly solution collapse, make drug Fast Stripping, and then drug is made to play a role, improve drug effect；And medicine
Object local irritation is small, and drug local concentration can be avoided excessive, reduces the irritation of drug, also has manufacture craft simple
The characteristics of, cost is saved, large-scale industrial production is suitble to.
Specific implementation mode
In order to make the purpose , technical scheme and advantage of the present invention be clearer, with reference to embodiments, to the present invention
It is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, it is not used to
Limit the present invention.
Embodiment 1
A kind of Levofloxacin Hydrochloride Capsules, including capsule and the lavo-ofloxacin hydrochloride particle being filled in capsule, the salt
Sour lavo-ofloxacin particle is made of the substance of following parts by weight：15 parts by weight of lavo-ofloxacin hydrochloride, 8 parts by weight of ethyl alcohol, palm fibre
2 parts by weight of palmitic acid acid sodium, 30 parts by weight of starch, 20 parts by weight of microcrystalline cellulose, 30 parts by weight of croscarmellose sodium, 12
2 parts by weight of sodium alkyl sulfate, 3 parts by weight of propylparaben, 5 parts by weight of beeswax；
The capsule is made of the substance of following parts by weight：35 parts by weight of acrylic resin, 30 parts by weight of atoleine, chitosan
1.2 parts by weight of 5 parts by weight, 1,3 butanediol, 3.8 parts by weight and citric acid.
The preparation method of the Levofloxacin Hydrochloride Capsules, steps are as follows：
（1）By acrylic resin, chitosan and 1,3 butanediols are uniformly mixed in water, are then stirred to react 3h at 75 DEG C, are obtained
To acrylic resin modified, it is uniformly mixed acrylic resin modified with atoleine and citric acid, obtains capsule lotion；
（2）Lavo-ofloxacin hydrochloride and sodium palmitate are dissolved in ethyl alcohol, 0.2 ~ 0.3 μm of membrane filtration degerming is used in combination, obtains
Mixed system 1；Then auxiliary material, mixed system 1 are uniformly mixed, and 40 min that sterilize under the conditions of 125 DEG C, then in room temperature item
Under part, with the rotating speed cutting 10min of 1500r/min, then with the rotating speed cutting 4min of 2500r/min, the left oxygen fluorine of hydrochloric acid is obtained
Husky star particle；
（3）Capsule lotion and lavo-ofloxacin hydrochloride particle are mixed, it is 5% sorbester p17, after mixing high shear to add volume
Emulsion dispersion, while atoleine regulation system pH is slowly added dropwise as 6.3 to acidity, so that capsule wall material is precipitated and is coated on salt
The surface of sour lavo-ofloxacin particle；Then filter, it is dry, be added a small amount of aluminum magnesium silicate absorption residual liquid paraffin to get
Levofloxacin Hydrochloride Capsules.
The compressed value of the Levofloxacin Hydrochloride Capsules paste is being 3500gf/cm2, and fusing point is 60 DEG C.
Embodiment 2
A kind of Levofloxacin Hydrochloride Capsules, including capsule and the lavo-ofloxacin hydrochloride particle that is filled in capsule, the salt
Sour lavo-ofloxacin particle is made of the substance of following parts by weight：10 parts by weight of lavo-ofloxacin hydrochloride, 5 parts by weight of ethyl alcohol, Asia
3 parts by weight of numb acid sodium, 20 parts by weight of starch, 15 parts by weight of low-substituted hydroxypropyl cellulose, 15 parts by weight of crospovidone, stearic acid
2 parts by weight of sodium, 3 parts by weight of sodium lactate, 5 parts by weight of lanolin；
The capsule is made of the substance of following parts by weight：45 parts by weight of acrylic resin, 25 parts by weight of atoleine, chitosan
2 parts by weight of 8 parts by weight, 1,3 butanediol, 5 parts by weight and acetic acid.
The preparation method of the Levofloxacin Hydrochloride Capsules, steps are as follows：
（1）By acrylic resin, chitosan and 1,3 butanediols are uniformly mixed in water, are then stirred to react 1h at 90 DEG C, are obtained
To acrylic resin modified, it is uniformly mixed acrylic resin modified with atoleine and acetic acid, obtains capsule lotion；
（2）Lavo-ofloxacin hydrochloride, leukotrienes sodium are dissolved in ethyl alcohol, 0.2 ~ 0.3 μm of membrane filtration degerming is used in combination, is mixed
Zoarium system 1；Then auxiliary material, mixed system 1 are uniformly mixed, and 30 min that sterilize under the conditions of 125 DEG C, then in normal temperature condition
Under, with the rotating speed cutting 10min of 1000r/min, then with the rotating speed cutting 4min of 2000r/min, obtain hydrochloric acid levofloxacin
Star particle；
（3）Capsule lotion and lavo-ofloxacin hydrochloride particle are mixed, it is 5% sorbester p17, after mixing high shear to add volume
Emulsion dispersion, while acetic acid regulation system pH is slowly added dropwise as 5.8 to acidity, capsule wall material is made to be precipitated and is coated on a hydrochloric acid left side
The surface of Ofloxacin particle；Then it filters, it is dry, a small amount of aluminum magnesium silicate is added and adsorbs residual liquid paraffin to get hydrochloric acid
Levofloxacin capsule.
The compressed value of the Levofloxacin Hydrochloride Capsules paste is being 3000gf/cm2, and fusing point is 55 DEG C.
Embodiment 3
A kind of Levofloxacin Hydrochloride Capsules, including capsule and the lavo-ofloxacin hydrochloride particle that is filled in capsule, the salt
Sour lavo-ofloxacin particle is made of the substance of following parts by weight：15 parts by weight of lavo-ofloxacin hydrochloride, 10 parts by weight of isopropanol,
1 parts by weight of leukotrienes sodium, 20 parts by weight of starch, 10 parts by weight of lactose, 10 parts by weight of dextrin, 15 weight of low-substituted hydroxypropyl cellulose
Part, 15 parts by weight of crospovidone, 2 parts by weight of odium stearate, 3 parts by weight of sodium lactate, 5 parts by weight of lanolin；
The capsule is made of the substance of following parts by weight：40 parts by weight of acrylic resin, 25 parts by weight of atoleine, chitosan
2 parts by weight of 8 parts by weight, 1,3 butanediol, 4 parts by weight and tartaric acid.
The preparation method of the Levofloxacin Hydrochloride Capsules, steps are as follows：
（1）By acrylic resin, chitosan and 1,3 butanediols are uniformly mixed in water, are then stirred to react 5h at 60 DEG C, are obtained
To acrylic resin modified, it is uniformly mixed acrylic resin modified with atoleine and tartaric acid, obtains capsule lotion；
（2）Lavo-ofloxacin hydrochloride, leukotrienes sodium are dissolved in isopropanol, 0.2 ~ 0.3 μm of membrane filtration degerming is used in combination, obtains
Mixed system 1；Then auxiliary material, mixed system 1 are uniformly mixed, and 40 min that sterilize under the conditions of 121 DEG C, then in room temperature item
Under part, the rotating speed cutting 8min of 1750r/min obtains lavo-ofloxacin hydrochloride then with the rotating speed cutting 5min of 2800r/min
Particle；
（3）Capsule lotion and lavo-ofloxacin hydrochloride particle are mixed, it is 0.5% sorbester p17 to add volume, high after mixing to cut
Emulsion dispersion is cut, while tartaric acid regulation system pH is slowly added dropwise as 6.3 to acidity, so that capsule wall material is precipitated and is coated on salt
The surface of sour lavo-ofloxacin particle；Then filter, it is dry, be added a small amount of aluminum magnesium silicate absorption residual liquid paraffin to get
Levofloxacin Hydrochloride Capsules.
The compressed value of the Levofloxacin Hydrochloride Capsules paste is being 2000 gf/cm2, and fusing point is 30 DEG C；
Embodiment 4
A kind of Levofloxacin Hydrochloride Capsules, including capsule and the lavo-ofloxacin hydrochloride particle that is filled in capsule, the salt
Sour lavo-ofloxacin particle is made of the substance of following parts by weight：30 parts by weight of lavo-ofloxacin hydrochloride, 3 parts by weight of isopropanol,
5 parts by weight of capric acid sodium, 20 parts by weight of starch, 10 parts by weight of lactose, 10 parts by weight of dextrin, 15 weight of low-substituted hydroxypropyl cellulose
Part, 15 parts by weight of crospovidone, 3 parts by weight of Tween-80,2 parts by weight of dehydroactic acid sodium, 5 parts by weight of lanolin；
The capsule is made of the substance of following parts by weight：50 parts by weight of acrylic resin, 20 parts by weight of atoleine, chitosan
3 parts by weight of 12 parts by weight, 1,3 butanediol, 3 parts by weight and tartaric acid.
The preparation method of the Levofloxacin Hydrochloride Capsules, steps are as follows：
（1）By acrylic resin, chitosan and 1,3 butanediols are uniformly mixed in water, are then stirred to react 2.5h at 75 DEG C,
It obtains acrylic resin modified, is uniformly mixed acrylic resin modified with atoleine and tartaric acid, obtains capsule lotion；
（2）Lavo-ofloxacin hydrochloride, capric acid sodium are dissolved in isopropanol, 0.2 ~ 0.3 μm of membrane filtration degerming is used in combination, obtains
Mixed system 1；Then auxiliary material, mixed system 1 are uniformly mixed, and 30 ~ 40 min that sterilize under the conditions of 125 DEG C, then normal
Under the conditions of temperature, with the rotating speed cutting 10min of 1500r/min, then with the rotating speed cutting 5min of 2200r/min, a hydrochloric acid left side is obtained
Ofloxacin particle；
（3）Capsule lotion and lavo-ofloxacin hydrochloride particle are mixed, it is 2.5% sorbester p17 to add volume, high after mixing to cut
Emulsion dispersion is cut, while tartaric acid regulation system pH is slowly added dropwise as 6.0 to acidity, so that capsule wall material is precipitated and is coated on salt
The surface of sour lavo-ofloxacin particle；Then filter, it is dry, be added a small amount of aluminum magnesium silicate absorption residual liquid paraffin to get
Levofloxacin Hydrochloride Capsules.
The compressed value of the Levofloxacin Hydrochloride Capsules paste is being 500gf/cm2, and fusing point is 60 DEG C.
Embodiment 5
A kind of Levofloxacin Hydrochloride Capsules, including capsule and the lavo-ofloxacin hydrochloride particle that is filled in capsule, the salt
Sour lavo-ofloxacin particle is made of the substance of following parts by weight：1 parts by weight of lavo-ofloxacin hydrochloride, 12 parts by weight of isopropanol,
0.5 parts by weight of capric acid sodium, 10 parts by weight of lactose, 10 parts by weight of dextrin, 15 parts by weight of low-substituted hydroxypropyl cellulose, the poly- dimension of crosslinking
15 parts by weight of ketone；
The capsule is made of the substance of following parts by weight：30 parts by weight of acrylic resin, 30 parts by weight of atoleine, chitosan
1 parts by weight of 3 parts by weight, 1,3 butanediol, 5 parts by weight and tartaric acid.
The preparation method of the Levofloxacin Hydrochloride Capsules, steps are as follows：
（1）By acrylic resin, chitosan and 1,3 butanediols are uniformly mixed in water, are then stirred to react 1 ~ 5h at 75 DEG C,
It obtains acrylic resin modified, is uniformly mixed acrylic resin modified with atoleine and tartaric acid, obtains capsule lotion；
（2）Lavo-ofloxacin hydrochloride, capric acid sodium are dissolved in isopropanol, 0.3 μm of membrane filtration degerming is used in combination, is mixed
System 1；Then auxiliary material, mixed system 1 are uniformly mixed, and the 30min that sterilizes under the conditions of 121 DEG C, then under normal temperature condition,
With the rotating speed cutting 10min of 1000r/min, then with the rotating speed cutting 4min of 2800r/min, lavo-ofloxacin hydrochloride is obtained
Grain；
（3）Capsule lotion and lavo-ofloxacin hydrochloride particle are mixed, it is 3.2% sorbester p17 to add volume, high after mixing to cut
Emulsion dispersion is cut, while tartaric acid regulation system pH is slowly added dropwise as 6.3 to acidity, so that capsule wall material is precipitated and is coated on salt
The surface of sour lavo-ofloxacin particle；Then filter, it is dry, be added a small amount of aluminum magnesium silicate absorption residual liquid paraffin to get
Levofloxacin Hydrochloride Capsules.
The compressed value of the Levofloxacin Hydrochloride Capsules paste is being 385gf/cm2, and fusing point is 68 DEG C；
Foregoing description is only the description to section Example of the present invention, not to any restriction of the scope of the invention, the industry
Those of ordinary skill can make above-described embodiment according to the present invention and improve or modify, but belong to the scope of the present invention.
Claims (9)
1. a kind of Levofloxacin Hydrochloride Capsules, including capsule and the lavo-ofloxacin hydrochloride particle being filled in capsule, spy
Sign is that the lavo-ofloxacin hydrochloride particle is made of the substance of following parts by weight：1 ~ 30 parts by weight of lavo-ofloxacin hydrochloride,
3 ~ 12 parts by weight of monohydric alcohol, 0.5 ~ 5 parts by weight of fatty acid alkali metal salt, 50 ~ 100 parts by weight of auxiliary material.
2. Levofloxacin Hydrochloride Capsules according to claim 1, which is characterized in that the lavo-ofloxacin hydrochloride particle
It is made of the substance of following parts by weight：5 ~ 15 parts by weight of lavo-ofloxacin hydrochloride, 5 ~ 10 parts by weight of monohydric alcohol, fatty acid alkali metal
1 ~ 3 parts by weight of salt, 80 ~ 100 parts by weight of auxiliary material.
3. Levofloxacin Hydrochloride Capsules according to claim 2, which is characterized in that the fatty acid alkali metal salt is sheep
At least one of the alkali metal salt of cerinic acid, palmitic acid, stearic acid, oleic acid, undecenoic acid, linoleic acid, leukotrienes etc..
4. Levofloxacin Hydrochloride Capsules according to claim 2, which is characterized in that the monohydric alcohol is carbon atom quantity
At least one of 6 or 6 monohydric alcohols below.
5. Levofloxacin Hydrochloride Capsules according to claim 2, which is characterized in that the auxiliary material is selected from filler, solution
Collapse at least one of agent, emulsifier, preservative, lubricant and thickener.
6. Levofloxacin Hydrochloride Capsules according to claim 1, which is characterized in that the capsule is by following parts by weight
Substance is made：30 ~ 50 parts by weight of acrylic resin, 20 ~ 30 parts by weight of atoleine, 3 ~ 12 parts by weight of chitosan, 1,3 butanediols
1 ~ 3 parts by weight of 3 ~ 5 parts by weight and pH adjusting agent.
7. the preparation method of the Levofloxacin Hydrochloride Capsules according to any one of claim 1 ~ 6, which is characterized in that
Include the following steps：
（1）By acrylic resin, chitosan and 1,3 butanediols are uniformly mixed in water, then it is stirred to react 1 at 60 ~ 90 DEG C ~
5h, obtains acrylic resin modified, is uniformly mixed acrylic resin modified with atoleine and pH adjusting agent, obtains capsule breast
Liquid；
（2）Lavo-ofloxacin hydrochloride, fatty acid alkali metal salt are dissolved in monohydric alcohol, 0.2 ~ 0.3 μm of membrane filtration is used in combination to remove
Bacterium obtains mixed system 1；Then auxiliary material, mixed system 1 are uniformly mixed, and the sterilizing 30 ~ 40 under the conditions of 121 ~ 125 DEG C
Min, then under normal temperature condition, with 8 ~ 10min of rotating speed cutting of 1000 ~ 1750r/min, then with 2000 ~ 2800r/min's
4 ~ 5min of rotating speed cutting obtains lavo-ofloxacin hydrochloride particle；
（3）Capsule lotion and lavo-ofloxacin hydrochloride particle are mixed, it is 0.5% ~ 5% sorbester p17 to add volume, after mixing
High-shear emulsifying disperses, while it is 5.8 ~ 6.3 to acidity that pH adjusting agent regulation system pH, which is slowly added dropwise, and capsule wall material is made to be precipitated
And it is coated on the surface of lavo-ofloxacin hydrochloride particle；Then it filters, it is dry, a small amount of aluminum magnesium silicate absorption residual liquid is added
Paraffin is to get Levofloxacin Hydrochloride Capsules.
8. the preparation method of Levofloxacin Hydrochloride Capsules according to claim 7, which is characterized in that the left oxygen of hydrochloric acid
The compressed value of Flucloxacillin capsule is being 300 ~ 4000 gf/cm2, fusing point is 30 ~ 80 DEG C.
9. the preparation method of Levofloxacin Hydrochloride Capsules according to claim 8, which is characterized in that the left oxygen of hydrochloric acid
The compressed value of Flucloxacillin capsule is being 500 ~ 3000 gf/cm2, fusing point is 45-75 DEG C.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108969502A (en) * | 2018-10-11 | 2018-12-11 | 田国荣 | A kind of atenolol sustained-release piece and preparation method thereof |
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| CN108969502A (en) * | 2018-10-11 | 2018-12-11 | 田国荣 | A kind of atenolol sustained-release piece and preparation method thereof |
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