CN104887622A - Stable ambroxol hydrochloride huge capacity injection and preparation method thereof - Google Patents
Stable ambroxol hydrochloride huge capacity injection and preparation method thereof Download PDFInfo
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- CN104887622A CN104887622A CN201510313930.7A CN201510313930A CN104887622A CN 104887622 A CN104887622 A CN 104887622A CN 201510313930 A CN201510313930 A CN 201510313930A CN 104887622 A CN104887622 A CN 104887622A
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Abstract
The invention discloses a stable ambroxol hydrochloride huge capacity injection and a preparation method thereof. According to the preparation method, a buffer system is added to ensure that the pH value of an ambroxol hydrochloride solution is stable before and after sterilization, so that an obvious change of the pH value is avoided before and after sterilization, and impurities generated are reduced; a special stabilizer is adopted; the pH value range is selected to be 3.8-4.5. The key step of the preparation method lies in that: a special buffer salt system is adopted to ensure that the pH value of the solution is stable to reduce or avoid the impurity generation caused by ambroxol hydrochloride degradation, so that the medicine curative effect is facilitated, and the side effect caused by impurity generation is avoided.
Description
Technical field
The invention belongs to a kind of medical injection, be specifically related to a kind of stable ambroxol hydrochloride high-capacity injection and preparation method thereof.
Background technology
Ambroxol hydrochloride is respiratory mucus regulator of new generation, has the characteristic that mucus is got rid of facilitation and dissolved secretions, and it can promote the eliminating of the inner thick secretions of respiratory tract and reduce the delay of mucus, thus significantly promotes expectoration, improves breath state.Be applicable to abnormal with sputum secretion and expectoration dysfunction acute, chronic respiratory system diseases.For clinical practice one of expectorant widely, certainly, safety is good for curative effect.
The clinical common formulations of existing ambroxol hydrochloride comprises the injection type such as the peroral dosage forms such as tablet, capsule, granule, solution, syrup and injection with small volume, powder pin, high-capacity injection (with glucose or sodium chloride for isoosmotic adjusting agent).For the patient of oral inconvenience, or the patient that the state of an illness is more serious or acute, commonly use ambroxol hydrochloride injection.
But because ambroxol hydrochloride is unstable under oxidation or alkali condition, decomposite free ambroxol, in storage process, related substance increases, and affects quality and the safety of medicine, in the prior art, the PH of the solution of ambroxol hydrochloride is controlled, lower or add stabilizing agent, improve the stability of ambroxol hydrochloride injection, but in medication process, because low PH can bring discomfort to human body, or use stabilizing agent, adds production technology, too increases production cost simultaneously.
Number of patent application 200510118511.4, publication date on May 2nd, 2007, discloses a kind of not containing the ambroxol hydrochloride lyophilized formulations of glucose.But lyophilized formulations cost is high, not through terminal sterilization, sterility assurance level is low.
Number of patent application 200710059969.6, publication date on April 29th, 2009, disclose a kind of ambroxol hydrochloride injection with small volume (not containing glucose) patent, it adopts the method controlling solution ph and add stabilizing agent to solve the ambroxol hydrochloride problem that related substance increases under oxidation or alkali condition, but add the complexity of prescription, too increase unsafe factor adding of surfactant simultaneously.
Number of patent application 201010611335.9, publication date on July 11st, 2012, disclose a kind of Ambroxol Hydrochloride Glucose Injection and preparation method thereof, provide a kind of Ambroxol Hydrochloride Glucose Injection, but poor chemical stability, ambroxol hydrochloride contains a free amine group, Maillard reaction may be there is under the high temperature conditions in this amino and glucose, namely may there is condensation in the aldehyde radical of amino wherein and glucose, related substance is increased, this condensation substance may impel glucose to make 5 hydroxymethyl furfural content defective to 5 hydroxymethyl furfural conversion simultaneously, thus have influence on the safety of product.The situations such as particularly content decline, related substance increase, appear in high temperature sterilize, chance light and the easily degraded of placement for a long time, even unqualified, thus have influence on the safety of product.
Number of patent application 201310332618.3, publication date on July 11st, 2012, disclose a kind of pharmaceutical composition comprising ambroxol hydrochloride and fructose, the Combination application packing specification that this invention provides is ambroxol hydrochloride injection 2ml:15mg or 4ml:30mg or 15mg/ bottle or 30mg/ bottle, fructose injection 250-500ml.Clinical practice needs secondary to prepare to be increased opportunities for contamination and uses inconvenience, is generally the helpless selection when Unstable Sample does not have better solution.
Summary of the invention
For solving the problems of the technologies described above, the invention provides a kind of stable ambroxol hydrochloride high-capacity injection and preparation method thereof, this injection component is simple, under the condition being relatively applicable to human body pH, the stability of active component is high, ensure that the safety of medication, the method preparation condition is gentle, easily controls, and is applicable to industrialized great production.
A kind of stable ambroxol hydrochloride high-capacity injection provided by the invention, containing following material: the nanometer formulation of ambroxol hydrochloride or ambroxol hydrochloride, fructose and stabilizing agent.
Described stabilizing agent is in gallic acid, citrate-phosphate disodium hydrogen or gallic acid, Acetic acid-sodium acetate any one group.
Further, a kind of stable ambroxol hydrochloride high-capacity injection, every 500ml injection contains following material: ambroxol hydrochloride 0.15g, fructose 25g, gallic acid 1.8g, citric acid 6.5g, sodium hydrogen phosphate 13.8g.
Or a kind of stable ambroxol hydrochloride high-capacity injection, every 1000ml injection contains following material: ambroxol hydrochloride 0.30g, fructose 50g, gallic acid 3.6g, sodium acetate 18g, glacial acetic acid 9.8ml.
The preparation method of a kind of stable ambroxol hydrochloride high-capacity injection provided by the invention, comprises the following steps:
(1) in dense preparing tank, by the fructose of recipe quantity at the water for injection being dissolved in recipe quantity 30%, add moistening medicinal charcoal, stir, filtering decarbonization, filters into dilute preparing tank, rinses dense preparing tank 3-5 time, and filter into dilute preparing tank with water for injection;
(2) in dilute preparing tank, add the water for injection to recipe quantity 75-85%, be 3.8-4.5 by 0.1mol/L hydrochloric acid solution adjust ph, add the nanometer formulation of recipe quantity ambroxol hydrochloride or ambroxol hydrochloride, stabilizing agent, osmotic pressure regulator and injection active carbon (consumption 0.1% ~ 0.5% (g/ml)), stirring and adsorbing, filtering decarbonization, benefit adds to the full amount of water for injection;
(3) with the microporous filter membrane fine straining of 0.22 μm, fill, sealing;
(4), after sterilizing, quick spraying cooling, offers for sale, and naturally cools to room temperature.
Further, step (1) described by the fructose of recipe quantity at the water for injection being dissolved in recipe quantity 30%, be specially: the water for injection adding recipe quantity 30% in dense preparing tank, temperature control 50-60 DEG C; Add the fructose of recipe quantity, stir and make it to dissolve.
Further, the amount of step (1) medicinal charcoal is: every 100ml fructose dissolves gained solution, adds 0.1g medicinal charcoal.
Further, in step (2), the temperature conditions of stirring and adsorbing is 55-65 DEG C, and optimum is 60 DEG C.
Further, in step (2), the preparation method of the nanometer formulation of described ambroxol hydrochloride is:
A, being medicine with ambroxol hydrochloride, take polylactic acid as high polymer adjuvant, medicine and high polymer adjuvant is dissolved with water for injection respectively to become mass percent be that 0.03% drug solution and mass percent are for being 1% high polymer adjuvant solution; Both mixings are obtained mixed solution;
B, mixed solution carry out ultrasonic emulsification, time 5-60 minute, obtain emulsion;
C, emulsion stir 0.5-2 hour under the condition of 200-1000 rev/min, obtain coagulation liquid;
Add quality 1-5% glutaraldehyde in D, coagulation liquid and constantly stir, mixing speed is 400-800 rev/min, stirs 0.5-2 hour, obtains the liquid of the ambroxol hydrochloride nanoparticle containing solidification.
Further, the condition of sterilizing is in step (4): in 115 DEG C of sterilizings 30 minutes or 121 DEG C of sterilizings 15 minutes.
Further, prepared stable ambroxol hydrochloride high-capacity injection, every 1000ml injection contains crude drug ambroxol hydrochloride 0.3g fructose 50g; The osmotic pressure of injection is 269 ~ 333mOsmol/kg, and pH value is 3.8 ~ 4.5.
The present invention guarantees solution by interpolation buffer system, and rear pH value is stable before sterilization, avoid pH value generation significant change before and after sterilizing, reduce the generation of impurity, select stabilizing agent to be gallic acid, citrate-phosphate disodium hydrogen (or gallic acid, Acetic acid-sodium acetate).And select pH scope between 3.8 ~ 4.5.The committed step of preparation method of the present invention utilizes specific buffer salt system guarantee solution ph to stablize, and reduces or avoid ambroxol hydrochloride to degrade generating impurity, be conducive to medicine and play curative effect, and avoid because impurity has side effects.
Accompanying drawing explanation
Fig. 1 is the ambroxol hydrochloride nanoparticle grain size distribution of preparation.
Detailed description of the invention
Embodiment 1
A stable ambroxol hydrochloride high-capacity injection, comprises following material: ambroxol hydrochloride 0.15g, fructose 25g, gallic acid 1.8g, citric acid 6.5g, and sodium hydrogen phosphate 13.8g, injects water to 500ml.
A stable ambroxol hydrochloride high-capacity injection, comprises the following steps:
(1) densely to join: the water for injection adding recipe quantity 30% in dense preparing tank, temperature control 50-60 DEG C; Add the fructose of recipe quantity, stir and make it to dissolve, add the moistening medicinal charcoal of recipe quantity 0.1% (g/ml), stir 30 minutes, filtering decarbonization, filters into dilute preparing tank, repeatedly rinses dense preparing tank with water for injection, and filters into dilute preparing tank;
(2) rarely to join: in dilute preparing tank, add the water for injection to recipe quantity 80%, be 3.8-4.5 by 0.1mol/L hydrochloric acid solution adjust ph, add recipe quantity ambroxol hydrochloride, citric acid, sodium hydrogen phosphate and medicinal charcoal, stir 30 minutes, filtering decarbonization, benefit adds to the full amount of water for injection;
(3) with the microporous filter membrane fine straining of 0.22 μm, fill, sealing;
(4) sterilizing: 121 DEG C of pressure sterilizings 15 minutes, quick spraying cooling, offers for sale, and naturally cools to room temperature.
Embodiment 2
A stable ambroxol hydrochloride high-capacity injection, comprises following material: ambroxol hydrochloride 0.30g, fructose 50g, gallic acid 3.6g, sodium acetate 18g, glacial acetic acid 9.8ml.Water for injection 1000mL.
A stable ambroxol hydrochloride high-capacity injection, comprises the following steps:
(1) densely to join: the water for injection adding recipe quantity 50% in dense preparing tank, temperature control 70-80 DEG C; Add the fructose of recipe quantity, stir and make it to dissolve, add the moistening medicinal charcoal of recipe quantity 0.1% (g/ml), stir 30 minutes, filtering decarbonization, filters into dilute preparing tank, repeatedly rinses dense preparing tank with water for injection, and filters into dilute preparing tank;
(2) rarely to join: in dilute preparing tank, add the water for injection to recipe quantity 90%, be 3.8-4.5 by 0.1mol/L hydrochloric acid solution adjust ph, be filled with nitrogen 10-45 minute, add recipe quantity ambroxol hydrochloride, aspartic acid, sodium acetate, glacial acetic acid and medicinal charcoal, stir 30 minutes, filtering decarbonization, benefit adds to the full amount of water for injection; Open cycle cooling water temperature is to 40-50 DEG C;
(3) with the microporous filter membrane fine straining of 0.22 μm, fill, sealing;
(4) sterilizing: 115 DEG C of pressure sterilizings 30 minutes, quick spraying cooling, offers for sale, and naturally cools to room temperature.
Embodiment 3
A stable ambroxol hydrochloride high-capacity injection, comprises following material: ambroxol hydrochloride nanoparticle (ambroxol-hydrochloride-containing 150mg), fructose 25g, gallic acid 1.8g, citric acid 6.5, sodium hydrogen phosphate 13.8g, water for injection 500mL.
The preparation method of described ambroxol hydrochloride nanoparticle is:
A, medicine ambroxol hydrochloride 0.15g and high polymer adjuvant polylactic acid 1.0g dissolved respectively become drug solution and high polymer adjuvant solution;
B, by drug solution and high polymer adjuvant solution mixing; The weight ratio of medicine and high polymer adjuvant is 15-85: 100;
C, mixed solution carry out ultrasonic emulsification, within emulsification times 5-60 minute, obtain emulsion;
D, emulsion stir 0.5-2 hour under the condition of 200-1000 rev/min, obtain coagulation liquid;
Add glutaraldehyde in E, coagulation liquid and constantly stir, mixing speed is 400-800 rev/min, stirs 0.5-2 hour, obtains the liquid of the ambroxol hydrochloride nanoparticle containing solidification.
Get a certain amount of ambroxol hydrochloride nanoparticle, measure its particle diameter and particle size distribution with laser particle size analyzer, grain size distribution is shown in Fig. 1.
A preparation method for stable ambroxol hydrochloride high-capacity injection, comprises the following steps:
(1) densely to join: the water for injection adding recipe quantity 30% in dense preparing tank, add the fructose of recipe quantity, stirring makes it to dissolve, add the moistening medicinal charcoal of recipe quantity 0.1% (g/ml), stir 30 minutes, filtering decarbonization, filters into dilute preparing tank, repeatedly rinse dense preparing tank with water for injection, and filter into dilute preparing tank;
(2) rarely to join: in dilute preparing tank, add the water for injection to recipe quantity 90%, be 3.8-4.5 by 0.1mol/L hydrochloric acid solution adjust ph, add recipe quantity ambroxol hydrochloride nanoparticle and medicinal charcoal, stir 30 minutes, filtering decarbonization, benefit adds to the full amount of water for injection;
(3) with the microporous filter membrane fine straining of 0.22 μm, fill, sealing;
(4) sterilizing: 121 DEG C of pressure sterilizings 15 minutes, quick spraying cooling, offers for sale, and naturally cools to room temperature.
Embodiment 4
A stable ambroxol hydrochloride high-capacity injection, comprises following material:
Ambroxol hydrochloride nanoparticle (ambroxol-hydrochloride-containing 300mg), fructose 50g, gallic acid 3.6g, sodium acetate 18g, glacial acetic acid 9.8ml, water for injection 1000mL.
The preparation method of described ambroxol hydrochloride nanoparticle is:
A, medicine ambroxol hydrochloride 0.30g and high polymer adjuvant polylactic acid 2.0g dissolved respectively become drug solution and high polymer adjuvant solution;
B, by drug solution and high polymer adjuvant solution mixing; The weight ratio of medicine and high polymer adjuvant is 15-85: 100;
C, mixed solution carry out ultrasonic emulsification, within emulsification times 5-60 minute, obtain emulsion;
D, emulsion stir 0.5-2 hour under the condition of 200-1000 rev/min, obtain coagulation liquid;
Add glutaraldehyde in E, coagulation liquid and constantly stir, mixing speed is 400-800 rev/min, stirs 0.5-2 hour, obtains the liquid of the ambroxol hydrochloride nanoparticle containing solidification.
A preparation method for stable ambroxol hydrochloride high-capacity injection, comprises the following steps:
(1) densely to join: the water for injection adding recipe quantity 30% in dense preparing tank, add the fructose of recipe quantity, stirring makes it to dissolve, add the moistening medicinal charcoal of recipe quantity 0.1% (g/ml), stir 30 minutes, filtering decarbonization, filters into dilute preparing tank, repeatedly rinse dense preparing tank with water for injection, and filter into dilute preparing tank;
(2) rarely to join: in dilute preparing tank, add the water for injection to recipe quantity 90%, be 3.8-4.5 by 0.1mol/L hydrochloric acid solution adjust ph, add recipe quantity ambroxol hydrochloride nanoparticle, sodium acetate, glacial acetic acid and medicinal charcoal, stir 30 minutes, filtering decarbonization, benefit adds to the full amount of water for injection;
(3) with the microporous filter membrane fine straining of 0.22 μm, fill, sealing;
(4) sterilizing: 121 DEG C of pressure sterilizings 15 minutes, quick spraying cooling, offers for sale, and naturally cools to room temperature.
Claims (9)
1. a stable ambroxol hydrochloride high-capacity injection, is characterized in that, described stable ambroxol hydrochloride high-capacity injection contains following material: the nanometer formulation of ambroxol hydrochloride or ambroxol hydrochloride, fructose and stabilizing agent.
2. stable ambroxol hydrochloride high-capacity injection according to claim 1, is characterized in that, described stabilizing agent is in gallic acid, citrate-phosphate disodium hydrogen or gallic acid, Acetic acid-sodium acetate any one group.
3. stable ambroxol hydrochloride high-capacity injection according to claim 1 and 2, it is characterized in that, described stable ambroxol hydrochloride high-capacity injection, every 500ml injection contains following material: ambroxol hydrochloride 0.15g, fructose 25g, gallic acid 1.8g, citric acid 6.5g, sodium hydrogen phosphate 13.8g.
4. stable ambroxol hydrochloride high-capacity injection according to claim 1 and 2, it is characterized in that, described stable ambroxol hydrochloride high-capacity injection, every 1000ml injection contains following material: ambroxol hydrochloride 0.30g, fructose 50g, gallic acid 3.6g, sodium acetate 18g, glacial acetic acid 9.8ml.
5. a preparation method for the stable ambroxol hydrochloride high-capacity injection described in any one of claim 1-4, it is characterized in that, described preparation method comprises the following steps:
(1) in dense preparing tank, by the fructose of recipe quantity at the water for injection being dissolved in recipe quantity 30%, add moistening medicinal charcoal, stir, filtering decarbonization, filters into dilute preparing tank, rinses dense preparing tank 3-5 time, and filter into dilute preparing tank with water for injection;
(2) in dilute preparing tank, add the water for injection to recipe quantity 75-85%, be 3.8-4.5 by 0.1mol/L hydrochloric acid solution adjust ph, add the nanometer formulation of recipe quantity ambroxol hydrochloride or ambroxol hydrochloride, stabilizing agent, osmotic pressure regulator and injection active carbon, stirring and adsorbing, filtering decarbonization, benefit adds to the full amount of water for injection; Activated carbon dosage is 0.1% ~ 0.5%g/ml;
(3) with the microporous filter membrane fine straining of 0.22 μm, fill, sealing;
(4), after sterilizing, quick spraying cooling, offers for sale, and naturally cools to room temperature.
6. preparation method according to claim 5, is characterized in that, in step (2), the temperature conditions of stirring and adsorbing is 55-65 DEG C.
7. the preparation method according to claim 5 or 6, is characterized in that, described in step (2), the preparation method of the nanometer formulation of ambroxol hydrochloride is:
A, being medicine with ambroxol hydrochloride, take polylactic acid as high polymer adjuvant, medicine and high polymer adjuvant is dissolved with water for injection respectively to become mass percent be that 0.03% drug solution and mass percent are for being 1% high polymer adjuvant solution; Both mixings are obtained mixed solution;
B, mixed solution carry out ultrasonic emulsification, time 5-60 minute, obtain emulsion;
C, emulsion stir 0.5-2 hour under the condition of 200-1000 rev/min, obtain coagulation liquid;
Add quality 1-5% glutaraldehyde in D, coagulation liquid and constantly stir, mixing speed is 400-800 rev/min, stirs 0.5-2 hour, obtains the liquid of the ambroxol hydrochloride nanoparticle containing solidification.
8. preparation method according to claim 5, is characterized in that, the condition of sterilizing is in step (4): in 115 DEG C of sterilizings 30 minutes or 121 DEG C of sterilizings 15 minutes.
9. the preparation method according to any one of claim 4, is characterized in that, the osmotic pressure of prepared stable ambroxol hydrochloride high-capacity injection is 269 ~ 333mOsmol/kg, and pH value is 3.8 ~ 4.5.
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Cited By (2)
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| CN105596292A (en) * | 2016-02-03 | 2016-05-25 | 广东新峰药业股份有限公司 | Preparation method of rotundine sulfate injection |
| CN106631837A (en) * | 2016-12-22 | 2017-05-10 | 合肥久诺医药科技有限公司 | Method of refining ambroxol hydrochloride for injection |
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| CN103083230A (en) * | 2013-01-18 | 2013-05-08 | 蚌埠丰原涂山制药有限公司 | Fructose-containing injection and preparation method thereof |
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| CN102552119A (en) * | 2010-12-28 | 2012-07-11 | 四川科伦药物研究有限公司 | Ambroxol hydrochloride glucose injection and preparation method thereof |
| CN103083230A (en) * | 2013-01-18 | 2013-05-08 | 蚌埠丰原涂山制药有限公司 | Fructose-containing injection and preparation method thereof |
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| CN105596292A (en) * | 2016-02-03 | 2016-05-25 | 广东新峰药业股份有限公司 | Preparation method of rotundine sulfate injection |
| CN106631837A (en) * | 2016-12-22 | 2017-05-10 | 合肥久诺医药科技有限公司 | Method of refining ambroxol hydrochloride for injection |
| CN106631837B (en) * | 2016-12-22 | 2019-04-16 | 合肥久诺医药科技有限公司 | A kind of refining methd of Ambroxol Hydrochloride for Injection |
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Application publication date: 20150909 |