CN104666281A - Asarin aerosol inhalant and preparation method thereof - Google Patents
Asarin aerosol inhalant and preparation method thereof Download PDFInfo
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Abstract
The invention provides an asarin aerosol inhalant and a preparation method thereof. The asarin aerosol inhalant is prepared from the following components in each liter of water for injection: 0.5-6 g of asarin, 1-100 g of an organic solvent, 1-30 g of a solubilizer, 0.01-0.2 g of a metal ion complexing agent, and an appropriate amount of a pH conditioning agent. The preparation method of the asarin aerosol inhalant comprises the following steps: dissolving the metal ion complexing agent into an appropriate amount of water to obtain a solution a; using the solvent to dissolve asarin, and then adding the solubilizer to obtain a solution b; mixing the solution a with the solution b to obtain a solution c; using the pH conditioning agent to regulate the pH value of the solution c, and then adding the balance of water to obtain the asarin aerosol inhalant. The aerosol inhalant disclosed by the invention is low in medication dosage, quick in taking effect, low in side effect, convenient to use, and effective in treatment, avoids the liver first pass effect, eliminates the pain of a patient, caused by injection administration, and improves the compliance of the patient.
Description
Technical field
The present invention relates to the formulation art of asarone, in particular to the atomized inhalation and preparation method thereof of asarone.
Background technology
Asarone is one of principle active component of Chinese medicine Rhizoma Acori Graminei, and chemistry Alpha-Asaronum by name, molecular formula is C
12h
16o
3, molecular weight is 208.26.Asarone have relieving asthma, cough-relieving, spasmolytic, spasmolytic, the multiple pharmacological effect such as convulsion and blood fat reducing, be mainly used in the diseases such as respiratory tract infection, pneumonia, asthma and epilepsy grand mal clinically, there is good curative effect.Current asarone realizes chemosynthesis, and cost of drugs decreases, and applies more extensive.
The Aarin preparation of current commercial type has tablet, capsule-type and injection.Due to the poorly water-soluble of asarone, by force fat-soluble, after causing tablet and capsule oral administration to use, bioavailability is low, is generally only 2 ~ 5%, and therapeutic effect is undesirable.Asarone injection patient poor compliance, and complex process, even if also there is the shortcomings such as atomizing effect difference, curative effect be low by Neulized inhalation, and Asarone injection is classified as excessive risk kind by State Food and Drug Administration.
In view of this, special proposition the present invention.
Summary of the invention
The first object of the present invention is the atomized inhalation providing a kind of asarone, the atomized inhalation of described asarone is compared with other preparation of the prior art, not only curative effect and atomizing effect significantly improve, and solve existing preparation poor compliance, poorly soluble problem.
The second object of the present invention is the preparation method of the atomized inhalation providing a kind of described asarone, and the method technique is simple, device therefor simple, and production efficiency is high.
In order to realize above-mentioned purpose of the present invention, spy by the following technical solutions:
The atomized inhalation of asarone, in often liter of water for injection, main containing following composition:
Asarone 0.5-6g, organic solvent 1-100g, solubilizing agent 1-30g, complexing of metal ion agent 0.01-0.2g and appropriate pH adjusting agent.
The atomized inhalation of above-mentioned asarone is solution morphology, and it is made up of with the proportioning of science asarone and solvent, solubilizing agent and complexing of metal ion agent, and a kind of new form of administration has been started in the application for asarone.Wherein, adding of solubilizing agent is to ensure that asarone has enough dissolubility, to ensure that the Neulized inhalation amount of medicine can be effective to disease; Complexing of metal ion agent is the metal ion in order to eliminate in asarone, ensures the quality safety of medicine.In addition, in this medicament, further comprises pH adjusting agent, to ensure that the suitable human mouth of the pH value (being generally 6.0 ~ 7.5) of solution sucks, improve the stability of medicament, to ensure the stable content of asarone in medicament simultaneously.
The atomized inhalation of this asarone can deliver medicine to individuality with injecting type nebulizer, breath actuated nebulizer or soniclizer, is generally oral cavity and sucks, and do not need to carry out the processing procedures such as dosing again before atomization, namely takes and namely uses.
Find through spray test, the atomized inhalation of above-mentioned asarone can suck microgranule than up to 78%, and when being used for the treatment of pneumonia, total effective rate is 100%, and wherein obvious effective rate is 29%, and effective percentage is 14.7%, raising evident in efficacy compared with conventional dosage forms.
Further, described organic solvent is one or more in ethanol, propylene glycol, glycerol, PEG400; These organic solvents have higher dissolubility to asarone, wherein preferred alcohol, and compare other solvent, ethanol has the advantages such as cheap, nontoxic.
Further, described solubilizing agent is one or more in macrogol ester, polysorbate40, polysorbate60, Tween 80, PLURONICS F87; Add the dissolubility that solubilizing agent can improve asarone, ensure that the Neulized inhalation amount of medicine can be effective to disease.Wherein preferred macrogol ester, it is compared with Tween 80, and in the process of high temperature sterilize, the ability of solubilising can not weaken, and asarone can not be separated out, and Tween 80 also can cause the untoward reaction such as irritated and haemolysis.And macrogol ester preferably adopts HS15.
Further, described complexing of metal ion agent be edetate, sodium calcium edetate, to desferrioxamine etc. in one or more; This several chelating agent has stronger complexing power to metal ion, and the particle kind of complexation is numerous, wherein preferred edetate (such as calcium salt, sodium salt), especially preferably disodiumedetate (EDTA-2Na), because it can improve the sterilizing of asarone solution withstand high temperatures, the content of asarone is avoided to reduce.
Further, also comprise following in one or more: antioxidant (such as sodium sulfate, sodium sulfite, cysteine), osmotic pressure regulator (such as sodium chloride, calcium chloride, potassium chloride); Adding antioxidant can shelf-life of prolong drug, and due to asarone be alkalescence material, select the sodium sulfite of meta-alkalescence as antioxidant, be conducive to the stable of asarone.
Further, described pH adjusting agent is hydrochloric acid solution, and/or sodium hydroxide solution, and these two kinds of materials are comparatively common, and cheap.
Further, the pH value of the atomized inhalation of described asarone is 6.5-7.5.
Research shows, the stability of acid-base value on solution of solution has impact in various degree, and this directly will have influence on the content of principal agent.Find through test, when pH value is 6.5-7.5, the stability of the atomized inhalation of asarone is higher.
The preparation method of the atomized inhalation of asarone, comprises the following steps:
Steps A: complexing of metal ion agent be dissolved in appropriate water for injection, obtains solution a;
Step B: asarone is dissolved with organic solvent, then add solubilizing agent, obtain solution b;
Step C: described solution a and described solution b is mixed, obtains solution c;
Step D: the pH value regulating described solution c by pH adjusting agent, then add the water for injection of surplus, obtain the atomized inhalation of asarone.
The preparation method of the atomized inhalation of above-mentioned asarone only needs the mixing of a few step to complete preparation, eliminates the complex steps such as homogenizing in traditional preparation methods, spraying dry, pelletize, greatly simplify technique.In addition, because technique simplifies, method equipment used is also simplified, and cost decreases, and only needs simple mix and blend equipment, does not need the not only expensive floor spaces but also large equipment such as homogenizer, spray dryer, comminutor.
In addition, add again in asarone solution after first complexing of metal ion agent being dissolved, be conducive to the dissolving of asarone.
Further, in described step C, the pH value of described solution c is adjusted to 6.5-7.5, to improve the stability of preparation.
Further, after described step D, also comprise: filter, to remove foreign material, activated carbon adsorption foreign material can also be added before filtration.
Further, after described step D, also comprise: fill nitrogen fill.Filling nitrogen can prevent medicine oxidized.In addition, also conventional sterilant is wanted when packing.
Compared with prior art, beneficial effect of the present invention is:
(1) dosage little, instant effect, few side effects, easy to use, can directly act on the affected part of patient, evident in efficacy, is a kind of desirable dosage form.
(2) compared with tablet, avoid liver first-pass effect, bioavailability improves.
(3) compared with injection, eliminate the misery that drug administration by injection brings to patient, improve the compliance of patient.
(4) preparation technology is simple, and equipment cost is low.
Detailed description of the invention
Below in conjunction with embodiment, embodiment of the present invention are described in detail, but it will be understood to those of skill in the art that the following example only for illustration of the present invention, and should not be considered as limiting the scope of the invention.Unreceipted actual conditions person in embodiment, the condition of conveniently conditioned disjunction manufacturer suggestion is carried out.Agents useful for same or the unreceipted production firm person of instrument, be and can buy by commercially available the conventional products obtained.
Note: hereinafter the percentage composition of each composition refers to mass body volume concentrations, such as, asarone 0.05 ~ 0.6% refers in 100mL solution containing asarone 0.05 ~ 0.6g.Water used is the water for injection meeting medical regulation.
Embodiment 1
The atomized inhalation of asarone consists of the following composition:
Asarone 0.05%, ethanol 0.1%, HS15 0.1%, disodiumedetate 0.001%, pH are 6.0, water standardize solution.
Embodiment 2
The atomized inhalation of asarone consists of the following composition:
Asarone 0.1%, ethanol 1%, HS15 0.6%, disodiumedetate 0.01%, pH are 6.5, water standardize solution.
Embodiment 3
The atomized inhalation of asarone consists of the following composition:
Asarone 0.3%, ethanol 5%, HS15 1.5%, disodiumedetate 0.014%, pH are 6.5, water standardize solution.
Embodiment 4
The atomized inhalation of asarone consists of the following composition:
Asarone 0.5%, ethanol 8%, HS15 2%, disodiumedetate 0.018%, pH are 7, water standardize solution.
Embodiment 5
The atomized inhalation of asarone consists of the following composition:
Asarone 0.6%, ethanol 10%, HS15 3%, disodiumedetate 0.02%, pH are 7, water standardize solution.
Embodiment 6
The atomized inhalation of asarone consists of the following composition:
Asarone 0.6%, propylene glycol 10%, PLURONICS F87 3%, sodium calcium edetate 0.02%, pH are 7.5, water standardize solution.
Embodiment 7
The atomized inhalation of asarone consists of the following composition:
Asarone 0.6%, PEG400 10%, polysorbate40 3%, 0.02%, the pH that desferrioxamines are 7.5, water standardize solution.
Embodiment 8
The preparation of the atomized inhalation of asarone
1, complexing of metal ion agent is dissolved in suitable quantity of water, obtains solution a;
2, with solvent, asarone is dissolved, then add solubilizing agent, obtain solution b;
3, described solution a and described solution b is mixed, obtain solution c;
4, regulate the pH value to 6.0 of described solution c by pH adjusting agent, then add the water of surplus, obtain the atomized inhalation of asarone.
Embodiment 9
The preparation of the atomized inhalation of asarone
1, complexing of metal ion agent be dissolved in and fill in nitrogen deoxygenation water for injection, stirring and evenly mixing, obtains solution a, seals for subsequent use; With filling in nitrogen deoxygenation water for injection the hydrochloric acid and the sodium hydroxide solution that prepare 10% respectively, seal for subsequent use.
2, asarone is joined in solvent, stir and make it to dissolve, then add solubilizing agent, stir, obtain solution b, for subsequent use.
3, by solution a impouring solution b, high-speed stirred is even, and constantly surveys its pH value, is controlled to be 7.0 ± 0.5 by pH value with the hydrochloric acid in step 1 and sodium hydroxide solution.
4, add in step 3 and fill nitrogen deoxygenation water for injection, standardize solution.
5, suitable filtering with microporous membrane is adopted.
6, the inspection of semifinished product, calculate loading amount, whole process fills nitrogen fill;
7, sterilizing, subpackage.
Embodiment 1-7 can adopt the method for embodiment 8 or 9 to obtain.
Embodiment 10
The atomized inhalation of asarone:
1, complexing of metal ion agent 0.1g EDTA-2Na being dissolved in 40mL fills in nitrogen deoxygenation water for injection, and stirring and evenly mixing, obtains solution a, seals for subsequent use; With filling in nitrogen deoxygenation water for injection the hydrochloric acid and the sodium hydroxide solution that prepare 10% respectively, seal for subsequent use.
2,5g asarone is joined in the ethanol of 50mL, stir and make it to dissolve, then add 10g macrogol ester, stir, obtain solution b, for subsequent use.
3, by solution a impouring solution b, high-speed stirred is even, and constantly surveys its pH value, is controlled to be 7.0 ± 0.5 by pH value with the hydrochloric acid in step one and sodium hydroxide solution.
4, add in step 3 and fill nitrogen deoxygenation water for injection to 10000mL.
5, suitable filtering with microporous membrane is adopted.
6, the inspection of semifinished product, calculate loading amount, whole process fills nitrogen fill;
7, sterilizing, finished product every bottle subpackage 10mL and get final product.
Embodiment 11
The atomized inhalation of asarone
1, complexing of metal ion agent 2g EDTA-2Na being dissolved in 100mL fills in nitrogen deoxygenation water for injection, and stirring and evenly mixing, obtains solution a, seals for subsequent use; With filling in nitrogen deoxygenation water for injection the hydrochloric acid and the sodium hydroxide solution that prepare 10% respectively, seal for subsequent use.
2,30g asarone is joined in the ethanol of 300mL, stir and make it to dissolve, then add 300g macrogol ester, stir, obtain solution b, for subsequent use.
3, by solution a impouring solution b, high-speed stirred is even, and constantly surveys its pH value, is controlled to be 7.0 ± 0.5 by pH value with the hydrochloric acid in step one and sodium hydroxide solution.
4, add in step 3 and fill nitrogen deoxygenation water for injection to 10000mL.
5, suitable filtering with microporous membrane is adopted.
6, the inspection of semifinished product, calculate loading amount, whole process fills nitrogen fill;
7, sterilizing, finished product every bottle subpackage 10mL and get final product.
Embodiment 12
The atomized inhalation of asarone
1, complexing of metal ion agent 0.1g EDTA-2Na being dissolved in 40mL fills in nitrogen deoxygenation water for injection, and stirring and evenly mixing, obtains solution a, seals for subsequent use; With filling in nitrogen deoxygenation water for injection the hydrochloric acid and the sodium hydroxide solution that prepare 10% respectively, seal for subsequent use.
2,60g asarone is joined in the ethanol of 600mL, stir and make it to dissolve, then add 10g macrogol ester, stir, obtain solution b, for subsequent use.
3, by solution a impouring solution b, high-speed stirred is even, and constantly surveys its pH value, is controlled to be 7.0 ± 0.5 by pH value with the hydrochloric acid in step one and sodium hydroxide solution.
4, add in step 3 and fill nitrogen deoxygenation water for injection to 10000mL.
5, suitable filtering with microporous membrane is adopted.
6, the inspection of semifinished product, calculate loading amount, whole process fills nitrogen fill;
7, sterilizing, finished product every bottle subpackage 10mL and get final product.
In order to further illustrate technique effect of the present invention, the following provide specific experiment example.
Experimental example 1
Different solubilizing agent is on the content of suction with asarone solution and the impact of clarity
The suction asarone solution of Example 10 gained, embedding, gland, in 120 DEG C of pressure sterilizing 40min, investigates the changes of contents of suction asarone solution.
PVOH ester in embodiment 10 is made into the asarone solution needed for tween 80 preparation test, embedding, gland, in 120 DEG C of pressure sterilizing 40min, investigate the changes of contents of suction asarone solution.
PVOH ester in embodiment 10 is made into the asarone solution needed for PLURONICS F87 preparation test, embedding, gland, in 120 DEG C of pressure sterilizing 40min, investigate the changes of contents of suction asarone solution.
Investigation result is as shown in table 1.
The content of the different solubilizing agent of table 1 on suction asarone solution and the impact of clarity
Note: in above table, the percentage composition of asarone refers to " in obtained atomized inhalation the content measured by reality of asarone and the percentage ratio of sign content ".
The data of upper table show, when using tween 80 for solubilizing agent, after sterilizing, the content of asarone can obviously decline, and this may be in the process of sterilizing, and temperature reaches the point covered with clouds of tween 80, the dissolubility causing asarone sharply declines, and causes asarone to be separated out.Further confirmation selects macrogol ester as the superiority of solubilizing agent, also demonstrates the stability of this suction asarone solution.
Experimental example 2
The different amounts of disodiumedetate (EDTA-2Na) affects the content of suction with asarone solution
By the preparation method of embodiment 10, the EDTA-2Na adding different amounts has respectively prepared suction asarone solution, obtains EDTA-2Na content and is respectively each one bottle of 0.001,0.01 and 0.02 (W/V%) inhalation solution, in 120 DEG C of pressure sterilizing 40min.Investigate the changes of contents of suction asarone solution.Result is as table 2.
The different amounts of table 2 EDTA-2Na affects the content of suction with asarone solution
As can be seen from data above, adding the stability of a certain amount of EDTA-2Na to the asarone solution needing to carry out sterilizing can impact.When the amount of EDTA-2Na (0.001%) is little, sucks by the ion complexation ability in asarone solution, make the content of asarone have slight decline; After the amount increase of EDTA-2Na, suck the relatively more complete of the complexing of metal ion using asarone solution, obvious impact can not be produced on the content of suction asarone solution.Consider the factor such as cost and safety, preferable amount is 0.01% (W/V).
Experimental example 3
Neulized inhalation asarone solution compares with the atomizing effect of injection
The technology of the art and document are recorded: the sucked particle diameter (RD) of human body should be less than 5 μm, and diameter of particle (DD) size of entrance can have influence on curative effect after atomizer atomization, therefore, particle diameter is less than the microgranule of 5 μm to characterize external atomizing effect, i.e. RF=RD/DD*100%, RF value is larger, and curative effect may be better.
The instruments such as suction asarone solution single dose PARTJuniorBOYN Neulized inhalation machine described in the embodiment of the present invention 1 are adopted to test.
Asarone injection used in experimental example is obtained by the embodiment 1 of patent CN201310715382.
Atomized inhalation is the medicine that the embodiment of the present invention 10 obtains.
Atomizer is adopted to measure diameter of particle data as following table 3 by after above-mentioned test specimen atomization.
Table 3 Neulized inhalation asarone solution compares with the atomizing effect of injection
Data above in table illustrate, the effect of the suction asarone solution atomization of this technological invention is better than existing injection, can reach better curative effect.
Experimental example 4
The effectiveness study of different way of administration treatment adult pneumonia
Asarone injection used in experimental example is obtained by the embodiment 1 of patent CN201310715382.
Asarone oral tablet used in experimental example is obtained by the embodiment 1 of patent CN200510073296.
Suction asarone solution used in experimental example is that the embodiment of the present invention 10 obtains.
Investigation method: 100 routine adult pneumonias divide three groups at random, the basis of Comprehensive Treatment adds with different Aarin preparations, treats respectively.Each group of preparation consumption is as table 4.Efficacy result is as shown in table 5 below,
The consumption of the different preparation of table 4
The curative effect of table 5 different way of administration treatment adult pneumonia
As can be seen from Table 5, the obvious effective rate of solution group increases significantly than other two groups, and when observing the symptom of patient, more oral group of time and the injection group of the symptom improvements such as solution group patient cough, pulmonary rale are short.In addition, the effective and effect of injection group and oral group of no significant difference.
Although illustrate and describe the present invention with specific embodiment, however it will be appreciated that can to make when not deviating from the spirit and scope of the present invention many other change and amendment.Therefore, this means to comprise all such changes and modifications belonged in the scope of the invention in the following claims.
Claims (10)
1. the atomized inhalation of asarone, is characterized in that, in often liter of water for injection, main containing following composition:
Asarone 0.5-6g, organic solvent 1-100g, solubilizing agent 1-30g, complexing of metal ion agent 0.01-0.2g and appropriate pH adjusting agent.
2. the atomized inhalation of asarone according to claim 1, is characterized in that, described organic solvent is one or more in ethanol, propylene glycol, glycerol, PEG400; Preferably, described organic solvent is ethanol.
3. the atomized inhalation of asarone according to claim 1, is characterized in that, described solubilizing agent is one or more in macrogol ester, polysorbate40, polysorbate60, Tween 80, PLURONICS F87; Preferably, described solubilizing agent is macrogol ester.
4. the atomized inhalation of asarone according to claim 1, is characterized in that, described complexing of metal ion agent is edetate, sodium calcium edetate, to desferrioxamine etc. in one or more; Preferably, described complexing of metal ion agent is edetate.
5. the atomized inhalation of asarone according to claim 1, is characterized in that, also comprise following in one or more: antioxidant, osmotic pressure regulator; Preferably, described pH adjusting agent is hydrochloric acid solution, and/or sodium hydroxide solution.
6. the atomized inhalation of asarone according to claim 1, is characterized in that, the pH value of the atomized inhalation of described asarone is 6.5-7.5.
7. the preparation method of the atomized inhalation of asarone according to claim 1, is characterized in that, comprises the following steps:
Steps A: complexing of metal ion agent be dissolved in appropriate water for injection, obtains solution a;
Step B: asarone is dissolved with organic solvent, then add solubilizing agent, obtain solution b;
Step C: described solution a and described solution b is mixed, obtains solution c;
Step D: the pH value regulating described solution c by pH adjusting agent, then add the water for injection of surplus, obtain the atomized inhalation of asarone.
8. the preparation method of the atomized inhalation of asarone according to claim 7, is characterized in that, in described step C, the pH value of described solution c is adjusted to 6.5-7.5.
9. the preparation method of the atomized inhalation of asarone according to claim 7, is characterized in that, after described step D, also comprises: filter.
10. the preparation method of the atomized inhalation of asarone according to claim 7, is characterized in that, after described step D, also comprises: fill nitrogen fill.
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| CN103877013A (en) * | 2013-12-23 | 2014-06-25 | 广西南宁科冠医药科技开发有限公司 | Asarin injection and preparation method thereof |
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| CN1657071A (en) * | 2004-02-03 | 2005-08-24 | 深圳市康瑞医药有限公司 | Asarone injection and its preparation method |
| CN1720906A (en) * | 2005-06-13 | 2006-01-18 | 广州中医药大学第一附属医院 | Treatment asthma spray |
| CN101088499A (en) * | 2006-06-12 | 2007-12-19 | 陈云生 | Dry asarol emulsion and its prepn and application |
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