CN107961215A - A kind of levocetirizine injection - Google Patents
A kind of levocetirizine injection Download PDFInfo
- Publication number
- CN107961215A CN107961215A CN201610917733.0A CN201610917733A CN107961215A CN 107961215 A CN107961215 A CN 107961215A CN 201610917733 A CN201610917733 A CN 201610917733A CN 107961215 A CN107961215 A CN 107961215A
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- China
- Prior art keywords
- injection
- levocetirizine
- salt
- osmotic pressure
- pharmaceutically acceptable
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
Abstract
The invention discloses a kind of levocetirizine to inject novel form, a kind of and method for preparing levocetirizine injection, with raw materials such as levocetirizine, pH adjusting agent, osmotic pressure regulators, the Cetirizine Hydrochloride injection that a kind of content is stable, impurity content is low, the term of validity is grown has been prepared, the levocetirizine injection that the present invention is prepared is safely, effectively, it can effectively alleviate and eliminate allergic reaction, and without undesirable hemolytic reaction, fill up domestic and international such technological gap.
Description
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of levocetirizine injection.
Background technology
Anaphylactia is classified as 21 century by the World Health Organization needs one of the three big diseases of primary study and prevention.I
The anaphylactia incidence almost 40% of state, coastal cities incidence are higher than hinterland, and Heavy industrial city is higher than light industry
City.According to statistics, for China's antiallergic retail market capacity at 1,200,000,000 yuan or so, market potential is huge at present.Antihistamine drug
It is widely used kind in clinic, is mainly used for the desensitization treatment of human immune system's allergic disease, in nettle rash and mistake
Played an important role in the treatment of quick property dermatitis, allergic rhinitis and allergic asthma.
By exploitation for many years, the product structure of antihistamine drug is gradually perfect, with the update of product, from
A generation develops into third generation kind.Over the past two years, the representative kind chlorphenamine of first generation antihistamine drug, diphenhydramine and
Fenazil is influenced by stronger Central nervous depressant, its market share is reduced year by year, and especially folk prescription medication is calm
Slight second generation antihistamine drug is acted on to be substituted.At the same time, second generation antihistamine drug A Si meter azoles, RMI 9918 because
There is obvious cardiac toxic and exit clinic.At present, the govern-house-variety of in the market is with Loratadine, fexofenadine and miaow
Azoles sting is the second generation antihistamine drug of representative, and the third generation of desloratadine, LEVO CITRAZINE and setastine resists
Histamine medicine.
Levocetirizine is initially developed by Belgian UCB. S.A. (BE) Bruxelles Belgium, it is the levo form of cetirizine, thus pharmacological action with
Cetirizine is similar, and levocetirizine dosage is the half of cetirizine, but side effect is less, fast with oral absorption
The features such as fast, rapid-action, persistent, metabolic rate are low, adverse reaction rate is low.Cetirizine has slight central nervous system
System inhibitory action, research show that the central nervous system impression effect of cetirizine is mainly its d-isomer and intracerebral associated receptor
Have that certain affinity is related, so the single optical isomer of cetirizine --- LEVO CITRAZINE dexterously avoids west and replaces
The central nervous system side effect such as calm, drowsiness of sharp piperazine, but anti-histamine activity is still similar to cetirizine.
At present, levocetirizine has listed conventional tablet, dispersible tablet, capsule and oral administration solution both at home and abroad, there is no injection
Listing.Traditional view thinks that nonsedating antihistamine cannot be by traditional injection administration, but since its is insoluble
It is found that in the second generation and third generation antihistamine, only the compound based on cetirizine is readily soluble in water, i.e., only spreads out
It is water-soluble to be born from the compound of cetirizine or its isomers, can successful formulation into parental injection product, particularly west is replaced
Sharp piperazine and its isomers levocetirizine is used to be injected intravenously substantially without the haemocylolysis of its parent hydroxyzine.
However, current levocetirizine there are property it is unstable the shortcomings that, easily with formula other materials occur
Chemical reaction, so as to be had an impact to the quality of product, and then is possible to influence the security of product.In addition, levocetirizine
After being prepared as injection, content is unstable, and impurity content is high, and the term of validity is short, is unfavorable for the transport and storage of product, and exist
Potential safety issue.Therefore, develop safely and effectively, property is stable, permanently effective levocetirizine injection into
The prior art needs the problem solved.
The content of the invention
To overcome prior art defect, the present invention provides a kind of content is stable, impurity content is low, a left side for term of validity length
Cetirizine injection.
It is a further object to provide the preparation method of the injection of levocetirizine containing active ingredient.
It is also another object of the present invention to provide the medicine group of the stabilization of the administrated by injection of levocetirizine containing active ingredient
Compound, including active ingredient levocetirizine, its pharmaceutically acceptable salt or its polymorph are He Seepage presses conditioning agent, PH thoroughly
Conditioning agent, sterile water for injection.
Wherein every injection contains levocetirizine, its pharmaceutically acceptable salt, or its polymorph 1mg~
10mg, osmotic pressure regulator 3.5mg~16.5mg, pH adjusting agent adjust pH to 4.5~6.5
Agent activity component levocetirizine pharmaceutically acceptable salt of the present invention is to be adapted to medicinal any salt, example
Such as, there are the acid-addition salts of compound alkaline enough in invention, for example, the acid-addition salts obtained with inorganic acid or organic acid,
Such as hydrochloride, hydrobromate, nitrate, mesylate, sulfate, phosphate, trifluoroacetate, tosilate, 2-
Sym-toluenesulfonic acid salt, citrate, acetate, tartrate, fumarate, lactate, succinate, malate, third
Diacid salt, maleate, 1,2- ethane disulfonates, adipate, aspartate, benzene sulfonate, benzoate, ethane sulphur
Hydrochlorate or nicotinate.In addition, the suitable pharmacy available salt of invention compound, can have invention compound acid enough
Base addition salts, for example, metal salt, such as sodium salt, sylvite, calcium salt, magnesium salts, zinc salt or aluminium salt, the salt formed with organic base can
Physiologically acceptable cation is provided, these salt include, quaternary ammonium hydroxide, for example, methylamine, ethamine, diethylamine, trimethylamine,
Tert-butylamine, triethylamine, dibenzylamine, N, N- dibenzylethylamines, cyclohexylethylamine, three-(2- ethoxys) amine, ethoxy diethyl
Amine, (1R, 2S) -2- hydroxyl indenes -1- amine, morpholine, N- methyl piperidines, N-ethylpiperidine, piperazine, methyl piperazine, amantadine,
Choline hydroxide, t-butyl ammonium hydroxide, three-(methylol) methylamine hydroxide, L-arginine, N- methyl d-glucosamine,
Lysine or arginine.
As other drugs, levocetirizine or the big I of the dosage of its pharmaceutically acceptable salt or polymorph
Adjusted according to series of factors, these factors include but not limited to age, weight or coincident with severity degree of condition.Left west in the present invention
It is about 1mg-10mg daily for sharp piperazine or the effective dose of its pharmaceutically acceptable salt or polymorph, is preferably 2~8mg,
More preferably 3~6mg.Adult human dose daily about 5mg is considered as by the enough of intravenous route.According to volume size,
Levocetirizine, pharmaceutically acceptable salt or polymorph, its amount about 0.1% to about 2%w/v.In some embodiment party
In formula, levocetirizine or pharmaceutically acceptable salt, polymorph, its amount about 0.2% to about 1.5%w/v.At some
In embodiment, levocetirizine or pharmaceutically acceptable salt, polymorph, its amount about 0.25% to about 1%w/v.
In some embodiments, levocetirizine or pharmaceutically acceptable salt, polymorph, its amount about 0.5% is to about
0.8%w/v.In 1mL dosage, suitable dosage is about 0.5%w/v levocetirizines or pharmaceutically acceptable salt, polymorphic
Thing.
The osmotic pressure regulator used in injection of the present invention refers to one or more pharmaceutically acceptable auxiliary materials, the auxiliary material
Make solution and blood compatibility.Suitable osmotic pressure regulator include glycerine, lactose, mannitol, glucose, sodium chloride, sodium sulphate,
Sorbierite etc..Preferable osmotic pressure regulator includes mannitol, sorbierite, lactose and sodium chloride.Most preferably sodium chloride.Osmotic pressure
Conditioning agent is added to realize the injection of approximate physiological osmotic pressure molar density in injection, i.e., about 255mOsm/kg is to about
315mOsm/kg, the injection of osmotic pressure molar density within this range, it is considered to be isotonic.Inject hypertonic and hypotonic solution
Afterwards, complicated and undesirable effect can be produced.Injection described in the present invention is isotonic, to reduce or avoid this
Class acts on.Osmotic pressure regulator amount is added in the present invention and includes 3.5mg~16.5mg for every injection, preferably 7.5mg~
13.5mg, is most preferably 12.5mg.
Optional pH adjusting agent includes bronsted lowry acids and bases bronsted lowry, such as citric acid, hydrochloric acid, phosphoric acid, sodium hydroxide, phosphoric acid in the present invention
Disodium hydrogen, sodium dihydrogen phosphate, are not limited to hydrochloric acid and sodium hydroxide.Acid can be added to reduce pH value, add alkali rise pH value.One
In the case of a little, one kind can be used, or use bronsted lowry acids and bases bronsted lowry at the same time.In some embodiments, pH adjusting agent compensation infiltration is selected
Conditioning agent is pressed, similar ion is provided in the solution.For example, when using NaCl as osmotic pressure regulator, salt can be used
Acid and/or sodium hydroxide, as pH adjusting agent.Be preferably added in the present invention pH adjusting agent adjust injection pH value for 4.5~
6.5, more preferably under 4.8~5.3, such as certain situation, injection pH value of the present invention can be adjusted to 5.0, in the case of other
PH value can be adjusted to 5.1 or 5.2.
Using sterile water for injection, the volume of injection is increased to the level of needs.Other compositions, as active ingredient,
Auxiliary material, diluent, buffer, preservative etc., can use, to make injection holding etc. blend stabilization.The one of the present invention
Preservative is not contained in a little embodiments.In some embodiments, injection of the invention is substantially without any supplementary element.
Injection single dose of the present invention can be about 0.2mL to the total volume injecteds of about 10mL, and can be with
Take the form of low capacity parenterai administration (SVP) injection.In some embodiments, total volume injected about 0.5mL is extremely
About 5mL.In other embodiment, total volume injected is about 2mL.In other embodiment, total injection
Volume is about 1mL.
In certain embodiments, injection of the present invention contains the total volume injecteds of 1mL;About 5mg levocetirizines or its
Pharmaceutically acceptable salt (preferably levo-cetirizine hydrochloride), polymorph;About 12.5mg NaCl;Use HCl and/or NaOH
PH value is adjusted to 5.5+/- 1.0 (being preferably 4.8~5.3);And appropriate sterile water for injection.
The injection is suitable for intramuscular or intravenous injection.In certain embodiments, the injection especially suitable for
Intravenous injection.The injection can be by the form of unit dose, loaded on ampoule, small-volume injection (SVP) bottle, large capacity note
Penetrate in agent (LVP) bottle, prefilled syringe, low capacity infusion or multi-dose container and use.
Since allergic reaction (including systemic anaphylaxis) is rapid onset, usual patient does not have time enough arrival
Medical care institutions seek to treat.Under situation in view of concerning life living or death herein, patient oneself can carry out medicine immediately
Treatment is favourable.Therefore, it may be selected, using oneself operation and ready-to-use automatic injector product, either have pin still
Needleless, automatic injector are a kind of devices, it designs permissible user oneself, usually in case of emergency, by subcutaneous or
Intramuscular, give oneself one surveyed measured medicine composition dose, to provide the quick of non-sedative antihistamine ejection preparation
Administration, typical automatic injector such as type cartridge bottle syringe pen.In certain embodiments, there is provided a kind of automatic injector, it is permitted
The injectable nonsedating antihistamine thing of self-administering one pre-weighing dosage in family allowable, the syringe is using subcutaneously or intramuscularly
Injection, it includes shell, includes the cell for accommodating nonsedating antihistamine and the dispersed components thereof with cell intercommunication in shell, its
Middle nonsedating antihistamine thing includes levocetirizine or its pharmaceutically acceptable salt or polymorphous Injectable solution such as
Levocetirizine injection as described above of the invention.In other embodiments, injection of the invention is included in automatic injection
In device, and it is positioned in kit and uses.
Present invention also offers the preparation method of above-mentioned levocetirizine injection, comprise the following steps that:Claim by dosage
Levocetirizine, its pharmaceutically acceptable salt or its polymorph, and osmotic pressure regulator are taken, adds water for injection, fully
It is stirred to dissolve, then plus pH adjusting agent adjusts pH value, adds water for injection to complement to batch volumes, the process such as sterilized, filling
After be made.
Present inventor is studied by a large number of experiments and found:Levocetirizine property is unstable, after being prepared as injection,
The Testing index such as appearance, visible foreign matters, insoluble microparticle is not usually up to standard in long-term stable experiment.Present inventor attempts
Adjustment solution ph is improved, and finds solution ph adjustment in OK range, cetirizine appearance, visible foreign matters, insoluble
The indexs such as particulate can reach the standard of satisfaction.The levocetirizine injection that the present invention is prepared at the same time safely, effectively, can have
Effect is alleviated and eliminates allergic reaction, and without undesirable hemolytic reaction, has filled up domestic and international such technological gap.
Embodiment
Embodiment 1
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:5mg/ bottles, prescription is as follows:
Embodiment 2
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:5mg/ bottles, prescription is as follows:
Embodiment 3
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:5mg/ bottles, prescription is as follows:
Embodiment 4
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:5mg/ bottles, prescription is as follows:
Embodiment 5
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:5mg/ bottles, prescription is as follows:
Embodiment 6
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:5mg/ bottles, prescription is as follows:
Embodiment 7
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:5mg/ bottles, prescription is as follows:
Embodiment 8
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:5mg/ bottles, prescription is as follows:
Embodiment 9
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:5mg/ bottles, prescription is as follows:
Embodiment 10
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:5mg/ bottles, prescription is as follows:
Embodiment 11
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:5mg/ bottles, prescription is as follows:
Embodiment 12
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:3mg/ bottles, prescription is as follows:
Embodiment 13
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:3mg/ bottles, prescription is as follows:
Embodiment 14
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:3mg/ bottles, prescription is as follows:
Embodiment 15
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:6mg/ bottles, prescription is as follows:
Embodiment 16
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:6mg/ bottles, prescription is as follows:
Embodiment 17
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:6mg/ bottles, prescription is as follows:
Embodiment 18
Single bottle dosage:Cumulative volume:1ml/ bottles, levocetirizine amount:6mg/ bottles, prescription is as follows:
First, 1~18 levo-cetirizine hydrochloride injection stability test of the embodiment of the present invention
1~18 levo-cetirizine hydrochloride injection stability test testing index of embodiment is in the present invention:PH value, clarification
Degree, visible foreign matters, particulate matter 4, pH value use《Chinese Pharmacopoeia》(2015 editions), the pH determination methods of the record of general rule 0631,
Clarity uses《Chinese Pharmacopoeia》(2015 editions), the clarity inspection technique of the record of general rule 0902, visible foreign matters use《Middle traditional Chinese medicines
Allusion quotation》(2015 editions), the visible foreign matters inspection technique of the record of general rule 0904, particulate matter use《Chinese Pharmacopoeia》(2015 editions), lead to
The then 0903 particulate matter inspection technique recorded.Measurement result see the table below:
2nd, injection clinical trial results of the present invention
Experimental group and control group totally 8 people, are the adult allergic symptom patient (nettle rash or erythema) between 20~40 years old,
The 1ml injections prepared according to the formula of the embodiment of the present invention 1,12 and 17,6 people that intravenous injection administration is administered to experimental group are (real
Apply each 2 people in example 1,12 and 17), control group is the inactive liquid of equal volume, other 2 people is administered to, to investigate the present invention
The validity and security of levocetirizine injection, as a result compared with control group, using the experiment of levocetirizine injection
Allergic symptom mitigates or even disappears rapidly within half an hour after group 6 people injection, and 6 people react and reacted without calmness, whole people
Do not find haemocylolysis.
Claims (14)
- A kind of 1. levocetirizine injection, it is characterised in that including active ingredient levocetirizine, pharmaceutically acceptable salt, Or its polymorph, osmotic pressure regulator, pH adjusting agent, sterile water for injection.
- 2. injection as claimed in claim 1, wherein the osmotic pressure regulator is selected from:Sodium chloride, potassium chloride, sodium sulphate, One or more combinations in sorbierite, mannitol.
- 3. such as claim 1~2 any one of them injection, wherein the pH adjusting agent be selected from citric acid, hydrochloric acid, phosphoric acid, One or more in sodium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate.
- 4. such as claims 1 to 3 any one of them injection, wherein the pharmaceutically acceptable salt is to be adapted to medicinal appoint What salt, such as hydrochloride, hydrobromate, nitrate, mesylate, sulfate, phosphate, trifluoroacetate, p-methyl benzenesulfonic acid Salt, 2- sym-toluenesulfonic acids salt, citrate, acetate, tartrate, fumarate, lactate, succinate, malic acid Salt, malonate, maleate, 1,2- ethane disulfonates, adipate, aspartate, benzene sulfonate, benzoate, Ethane sulfonate or nicotinate.
- 5. such as Claims 1 to 4 any one of them injection, wherein the active ingredient be levo-cetirizine hydrochloride, it is described Osmotic pressure regulator is selected from sodium chloride, and the pH adjusting agent is selected from sodium hydroxide.
- 6. such as Claims 1 to 5 any one of them injection, wherein every injection contain levocetirizine, its pharmaceutically Acceptable salt, or its polymorph 1mg~10mg, osmotic pressure regulator 3.5mg~16.5mg, pH adjusting agent adjust pH to 4.5~6.5.
- 7. such as claim 1~6 any one of them injection, wherein every injection contain levocetirizine, its pharmaceutically Acceptable salt or its polymorph 3mg~6mg, sodium chloride 7.5mg~13.5mg, sodium hydroxide adjusting pH to 4.5~6.5.
- 8. claim 1~7 any one of them injection, wherein every injection contains levocetirizine, it pharmaceutically may be used The salt of receiving or its polymorph 5mg, sodium chloride 12.5mg, sodium hydroxide adjusting pH to 4.9~5.2.
- 9. claim 1~8 any one of them injection, wherein the single dosage of the injection for 0.2mL extremely The total volume injecteds of 10mL, are preferably the total volume injecteds of 1mL to 2mL.
- 10. such as claim 1~9 any one of them injection, wherein also containing diluent, buffer, preservative, cosolvent One or both of more than.
- 11. such as claim 1~10 any one of them injection, wherein the injection is free of preservative or buffer.
- 12. a kind of automatic injector, it is characterised in that it includes claim 1~11 any one of them injection.
- 13. a kind of kit, it is characterised in that include the injection described in claim 1~11.
- 14. the preparation method of any one of claim 1~11 injection, it is characterised in that first by osmotic pressure regulator and Levocetirizine is dissolved in water for injection, and then stirring adds pH adjusting agent and adjust pH to 4.5~6.5 to dissolving, sterile Filter, is filling, the sterilizing small-volume injection of 0.5ml to 20ml is made.
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Cited By (2)
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CN113876702A (en) * | 2021-11-04 | 2022-01-04 | 南京恒道医药科技有限公司 | Levocetirizine hydrochloride eye drops and preparation method thereof |
CN114306227A (en) * | 2022-01-20 | 2022-04-12 | 江苏艾立康医药科技有限公司 | Levocetirizine hydrochloride injection and preparation method thereof |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
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US9180090B2 (en) * | 2009-07-03 | 2015-11-10 | Jdp Therapeutics, Inc. | Non-sedating antihistamine injection formulations and methods of use thereof |
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Publication number | Priority date | Publication date | Assignee | Title |
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US9180090B2 (en) * | 2009-07-03 | 2015-11-10 | Jdp Therapeutics, Inc. | Non-sedating antihistamine injection formulations and methods of use thereof |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN113876702A (en) * | 2021-11-04 | 2022-01-04 | 南京恒道医药科技有限公司 | Levocetirizine hydrochloride eye drops and preparation method thereof |
CN114306227A (en) * | 2022-01-20 | 2022-04-12 | 江苏艾立康医药科技有限公司 | Levocetirizine hydrochloride injection and preparation method thereof |
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