CN100409835C - Composition and great volume injection containing bromhexine salt and the injection preparing process - Google Patents
Composition and great volume injection containing bromhexine salt and the injection preparing process Download PDFInfo
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- CN100409835C CN100409835C CNB2007100903588A CN200710090358A CN100409835C CN 100409835 C CN100409835 C CN 100409835C CN B2007100903588 A CNB2007100903588 A CN B2007100903588A CN 200710090358 A CN200710090358 A CN 200710090358A CN 100409835 C CN100409835 C CN 100409835C
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Abstract
The present invention discloses one kind of composition containing bromhexine salt, great volume injection and the injection preparing process. The composite includes bromhexine salt as the active component in 0.03-0.8 wt%, ethanol as co-solvent in 1.5-36 wt%, and stabilizer in 1.0-40 wt%, and has pH 3.0-7.0. The stabilizer is poloxamer, hydroxypropyl cellulose, hydroxypropyl methyl cellulose and/or hydroxyethyl cellulose. The composition of the present invention has high stability, and may be preserved for long period without bromhexine salt crystal separated out.
Description
Technical field
The present invention relates to a kind of compositions and bulk capacity injection and injection preparation method that contains bromhexine salt.
Background technology
Bromhexine is the synthetic analog that duck chews colored alkali, has the sticking expectorant effect of stronger dissolving, can make apoplexy due to phlegm acid mucopolysaccharide fiber decompose fracture, and suppress the synthetic of acidoglycoprotein in mucous gland and the goblet cell, making one of acid mucopolysaccharide composition in the sputum---sialic acid content reduces, and reduces sputum viscosity.In addition, bromhexine can also stimulate gastric mucosa reflexive ground to cause that the respiratory tract glandular secretion increases, and makes the sputum dilution, more than acts on the cough that all helps expectorant and goes out.Be first-selected expectorant commonly used both at home and abroad.
Experiment shows: bromhexine can improve the living element of antibiotics such as tetracycline, erythromycin, amoxicillin and cefalexin and penetrate bronchial ability, usually be used for the treatment of respiratory tract infectious disease as adjuvant with antimicrobial drug, comparative study shows that share bromhexine can obtain better effect.
This product still has nauseating property phlegm-dispelling functions.Be mainly used in chronic bronchitis, asthma, bronchiectasis, the sticking expectorant of adularescents such as pneumosilicosis is difficult for the patient of expectoration again; Also can give birth to element and share the treatment respiratory tract infectious disease with antibiotics; Be particularly useful for surgical operation and critical patient.
Bromhexine commonly used at present is a Bisolvon, owing to Bisolvon, lactic acid bromhexine, acetic acid bromhexine, Aspartic Acid bromhexine, citric acid bromhexine etc. are water insoluble, influenced by pH value, cosolvent and compound method etc., and above-mentioned bromhexine salt is easily separated out.According to present technical merit, in order to obtain stable bromhexine salt preparation, usually it is formulated as little pin or powder pin, need during use intravenous drip is carried out in its dilution or dissolving then; The bulk capacity injection of bromhexine has been prepared by some producer, but poor stability is easily separated out crystallization, and content descends, and should not apply on a large scale.The inventor applies for the preceding disclosing among the CN1411806 and uses ethanol as cosolvent, prepares stable Bisolvon glucose injection.In after this several years, the inventor increases the specific stabilizing agent of other again and can prepare the compositions that contains bromhexine salt that stability is better, zest is littler through deep discovering.
Summary of the invention
The objective of the invention is to overcome above-mentioned defective, promptly overcome the pollution and inconvenience of using powder pin, little pin to be brought, a kind of stable composition that contains bromhexine salt is provided; A further object of the present invention just provides the littler bulk capacity injection that contains the bromhexine salt composite of stimulation and the preparation method of the stable bulk capacity injection that contains the bromhexine salt compositions of preparation is provided.
For achieving the above object, the present invention adopts following technical scheme:
A kind of compositions that contains bromhexine salt of the present invention, described compositions comprises the active component bromhexine salt and as the ethanol and the stabilizing agent of cosolvent, and comprise glucose or sodium chloride, wherein: bromhexine salt be in Bisolvon, lactic acid bromhexine, acetic acid bromhexine, Aspartic Acid bromhexine or the citric acid bromhexine one or more; Stabilizing agent is poloxamer and/or hydroxypropyl cellulose, and the weight ratio of bromhexine salt and ethanol and stabilizing agent is 1: 30: 40 ~ 1: 60: 100.
Preferably, the weight ratio of described bromhexine salt and ethanol and stabilizing agent is 1: 20: 25 ~ 1: 50: 60.
The present invention discloses a kind of injection of making by the described compositions that contains bromhexine salt, in the described injection, the weight content of bromhexine salt is 0.03% ~ 0.8%, alcoholic acid weight content is 1.5% ~ 36%, the weight content of stabilizing agent is 1.0% ~ 40%, and the pH value of injection is 3.0 ~ 7.0.
Preferably, in the described injection, the weight content of bromhexine salt is 0.06% ~ 0.4%; Alcoholic acid weight content is 3.0% ~ 20%; The weight content 4.0% ~ 20% of stabilizing agent; The pH value of injection is 3.0 ~ 5.0.
The invention also discloses a kind of method for preparing described injection, described method comprises the following steps:
Take by weighing stabilizing agent and be dissolved in the water for injection, fully swelling; Measure ethanol, add the injection water, heating adds bromhexine salt, stirring and dissolving; Stir and slowly add the bromhexine salt alcoholic solution in the stabiliser solution down, add glucose or sodium chloride again, fully stirring and dissolving adds water to full dose, stirs, the weight content of bromhexine salt is 0.03% ~ 0.8%, alcoholic acid weight content is 1.5% ~ 36%, and the weight content of stabilizing agent is 1.0% ~ 40%, and the injection pH value is 3.0 ~ 7.0, through the following aperture of 0.45 μ m filtering with microporous membrane, fill is in infusion bottle or transfusion bag.
The present composition as active component, adds suitable stabilizing agent with bromhexine salt, is formulated in the certain pH value scope preparation of can long preservation and can not cause the bromhexine salt crystallization to be separated out.
The present invention has enriched prior art, and multiple character, the diverse stabilizing agent of structure are provided, to prepare better bromhexine salt compositions of stability.
Ethanol in the present composition is cosolvent.
According to those skilled in the art's general general knowledge, in compositions of the present invention, also can add pH buffer agent, antibacterial and active carbon etc., its addition is the usual amounts of corresponding dosage form.
Compositions of the present invention can be mixed with bulk capacity injection, injectable powder or small-volume injection, especially is mixed with bulk capacity injection.Its stability of bulk capacity injection according to compositions preparation of the present invention obviously improves, and zest significantly reduces.When the various dosage form of preparation, bromhexine salt example hydrochloric acid bromhexine, lactic acid bromhexine, acetic acid bromhexine, Aspartic Acid bromhexine, citric acid bromhexine etc. can be united glucose preparation or the sodium chloride preparation that forms bromhexine with glucose or sodium chloride, wherein preference Bisolvon glucose preparation.
The specific embodiment
Embodiment 1
Component content (weight %)
Bisolvon 0.075%
Ethanol 3.25%
Poloxamer 1.86%
Hydroxypropyl cellulose 1.86%
Glucose 92.955%
Embodiment 2
Component content (weight %)
Bisolvon 0.32%
Ethanol 13.68%
Poloxamer 7.82%
Hydroxypropyl cellulose 7.82%
Sodium chloride 70.36%
Embodiment 3
Hydroxypropyl cellulose among the embodiment 1 is replaced with hydroxypropyl emthylcellulose.
Embodiment 4
Hydroxypropyl cellulose among the embodiment 2 is replaced with hydroxyethylmethyl-cellulose.
Embodiment 5
Poloxamer among the embodiment 1 is replaced with hydroxypropyl emthylcellulose.
Embodiment 6
Poloxamer among the embodiment 2 is replaced with hydroxyethylmethyl-cellulose.
Embodiment 7 preparations contain the bulk capacity injection of Bisolvon glucose
Bisolvon 0.04g
Ethanol 1.75g
Poloxamer 1.0g
Hydroxypropyl cellulose 1.0g
Glucose 50g
Water for injection adds to 1000ml
Compound method
Take by weighing poloxamer 1.0g, hydroxypropyl cellulose 1.0g and be dissolved in an amount of water for injection, fully swelling; Measure the ethanol of 1.75g, add an amount of water for injection, be heated to proper temperature, add the bromhexine salt of 0.04g, stirring and dissolving; Stirring down slowly adds the bromhexine salt alcoholic solution in the aforementioned swollen stabiliser solution, reenter glucose 50g, abundant stirring and dissolving, add water to full dose, after stirring, through the following aperture of 0.45 μ m filtering with microporous membrane, fill is in infusion bottle or transfusion bag, through the routine sterilization, lamp inspection makes salt bromhexine salt bulk capacity injection after the quality inspection.Embodiment 8 preparations contain the bulk capacity injection of Bisolvon glucose
Bisolvon 0.08g
Ethanol 7.5g
Poloxamer 4.0g
Hydroxypropyl cellulose 4.0g
Glucose 50g
Water for injection adds to 1000ml
Compound method
Take by weighing poloxamer 4.0g, hydroxypropyl cellulose 4.0g and be dissolved in an amount of water for injection, fully swelling; Measure the ethanol of 7.5g, add an amount of water for injection, be heated to proper temperature, add the bromhexine salt of 0.08g, stirring and dissolving; Stirring down slowly adds the bromhexine salt alcoholic solution in the aforementioned swollen stabiliser solution, reenter glucose 50g, abundant stirring and dissolving, add water to full dose, after stirring, through the following aperture of 0.45 μ m filtering with microporous membrane, fill is in infusion bottle or transfusion bag, through the routine sterilization, lamp inspection makes salt bromhexine salt bulk capacity injection after the quality inspection.Embodiment 9 preparations contain the bulk capacity injection of Bisolvon glucose
Bisolvon 0.06g
Ethanol 3.5g
Poloxamer 2.0g
Hydroxypropyl cellulose 2.0g
Glucose 50g
Water for injection adds to 1000ml
Compound method
Take by weighing poloxamer 2.0g, hydroxypropyl cellulose 2.0g and be dissolved in an amount of water for injection, fully swelling; Measure the ethanol of 3.5g, add an amount of water for injection, be heated to proper temperature, add the bromhexine salt of 0.06g, stirring and dissolving; Stirring down slowly adds the bromhexine salt alcoholic solution in the aforementioned swollen stabiliser solution, reenter glucose 50g, abundant stirring and dissolving, add water to full dose, after stirring, through the following aperture of 0.45 μ m filtering with microporous membrane, fill is in infusion bottle or transfusion bag, through the routine sterilization, lamp inspection makes salt bromhexine salt bulk capacity injection after the quality inspection.
Embodiment 10
Bisolvon 0.04g
Ethanol 1.75g
Poloxamer 1.0g
Hydroxypropyl cellulose 1.0g
Sodium chloride 9.0g
Water for injection adds to 1000ml
Compound method
Take by weighing poloxamer 1.0g, hydroxypropyl cellulose 1.0g and be dissolved in an amount of water for injection, fully swelling; Measure the ethanol of 1.75g, add an amount of water for injection, be heated to proper temperature, add the bromhexine salt of 0.04g, stirring and dissolving; Stirring down slowly adds the bromhexine salt alcoholic solution in the aforementioned swollen stabiliser solution, reenter sodium chloride 9g, abundant stirring and dissolving, add water to full dose, after stirring, through the following aperture of 0.45 μ m filtering with microporous membrane, fill is in infusion bottle or transfusion bag, through the routine sterilization, lamp inspection makes salt bromhexine salt bulk capacity injection after the quality inspection.
Embodiment 11
Bisolvon 0.06g
Ethanol 3.5g
Poloxamer 2.0g
Hydroxypropyl cellulose 2.0g
Sodium chloride 9.0g
Water for injection adds to 1000ml
Compound method
Take by weighing poloxamer 2.0g, hydroxypropyl cellulose 2.0g and be dissolved in an amount of water for injection, fully swelling; Measure the ethanol of 3.5g, add an amount of water for injection, be heated to proper temperature, add the bromhexine salt of 0.06g, stirring and dissolving; Stirring down slowly adds the bromhexine salt alcoholic solution in the aforementioned swollen stabiliser solution, reenter sodium chloride 9g, abundant stirring and dissolving, add water to full dose, after stirring, through the following aperture of 0.45 μ m filtering with microporous membrane, fill is in infusion bottle or transfusion bag, through the routine sterilization, lamp inspection makes salt bromhexine salt bulk capacity injection after the quality inspection.
Embodiment 12
Bisolvon 0.08g
Ethanol 7.5g
Poloxamer 4.0g
Hydroxypropyl cellulose 4.0g
Sodium chloride 9.0g
Water for injection adds to 1000ml
Compound method
Take by weighing poloxamer 4.0g, hydroxypropyl cellulose 4.0g and be dissolved in an amount of water for injection, fully swelling; Measure the ethanol of 7.5g, add an amount of water for injection, be heated to proper temperature, add the bromhexine salt of 0.08g, stirring and dissolving; Stirring down slowly adds the bromhexine salt alcoholic solution in the aforementioned swollen stabiliser solution, reenter sodium chloride 9g, abundant stirring and dissolving, add water to full dose, after stirring, through the following aperture of 0.45 μ m filtering with microporous membrane, fill is in infusion bottle or transfusion bag, through the routine sterilization, lamp inspection makes salt bromhexine salt bulk capacity injection after the quality inspection.
Embodiment 13
Hydroxypropyl cellulose among the embodiment 2 is replaced with hydroxypropyl emthylcellulose.
Embodiment 14
Hydroxypropyl cellulose among the embodiment 1 is replaced with hydroxyethylmethyl-cellulose.
Embodiment 15
Poloxamer among the embodiment 2 is replaced with hydroxypropyl emthylcellulose.
Embodiment 16
Poloxamer among the embodiment 1 is replaced with hydroxyethylmethyl-cellulose.
Bisolvon compositions local irritation test report of the present invention is as follows:
Sample source: embodiment 7-12 sample
Control sample: the little pin of Bisolvon
One, test objective:
When investigating the intravenous drip of Bisolvon composition injection, whether can cause blood vessel irritation.
Two, animal:
Experimental rabbit, male and female half and half, body weight 2.0-2.5k g,
Three, test method
Get 42 of healthy experimental rabbits, fix 1 hour after, at its left auricular vein with a certain amount of test sample of 4# scalp acupuncture intravenous drip (by the conversion of clinical application amount, 1ml/ branch), for three days on end, every day 1 time; Auris dextra gives equivalent 5% glucose injection or sodium chloride injection with same procedure.The close observation vein has or not expansion, spasm and part to have or not phenomenons such as hyperemia, edema.Observing venous simultaneously, hard of hearing corresponding site does not have or insufficiency of blood pipe place difference subcutaneous injection test sample and normal saline solution in the left and right sides, and diameter about 0.5cm in skin mound observes the skin mound and has or not hyperemia, edema and extinction time.After last administration finishes, cut one section away from the about 2cm in needle point the place ahead place blood vessel rapidly, fix with 10% formalin be, conventional embedding, stained, microscopically is observed and is had or not pathological change.
Four, result
| The sample title | The result |
| Embodiment 7 samples | Do not have obviously hyperemia, edema, spasm, do not have expansion and erythrocyte and spill |
| Embodiment 8 samples | Do not have obviously hyperemia, edema, spasm, do not have expansion and erythrocyte and spill |
| Embodiment 9 samples | Do not have obviously hyperemia, edema, spasm, do not have expansion and erythrocyte and spill |
| Embodiment 10 samples | Do not have obviously hyperemia, edema, spasm, do not have expansion and erythrocyte and spill |
| Embodiment 11 samples | Do not have obviously hyperemia, edema, spasm, do not have expansion and erythrocyte and spill |
| Embodiment 12 samples | Do not have obviously hyperemia, edema, spasm, do not have expansion and erythrocyte and spill |
| Small-volume injection | Slight hyperemia, edema, spasm do not have expansion and erythrocyte and spill |
Five, conclusion
Above results suggest, embodiment 7-12 sample does not have obvious irritation to rabbit ear edge vein blood vessel and rabbit ear subcutaneous tissue, the slight hyperemia of small-volume injection, edema, spasm.So can think that the local excitation of Bisolvon compositions is less than non-compositions.The investigation of Bisolvon composition stable
According to the requirement of two appendix XIXC of Chinese Pharmacopoeia version in 2005 medicine stability test guideline, study on the stability is through 40 ℃ of six months (being equivalent to room temperature 2 years) of acceleration and 12 months study on the stability of long-term stable experiment, and the result is as follows:
40 ℃ are quickened six months results:
Accelerated test result show the Bisolvon composition sample through six months changes of contents of 40 ℃ of high temperature within 0.3%, but not six months changes of contents of 40 ℃ of high temperature of composition sample reach 1.4%, pH value also rises 0.4, and visible Bisolvon compositions high-temperature stability is better than non-compositions.
12 months results of long term test:
Long-term test results shows that the Bisolvon composition sample places 12 months changes of contents within 0.2% through 25 ℃, but not 12 months changes of contents of 25 ℃ of placements of composition sample reach 1.0%, pH value also rises 0.3, illustrates that Bisolvon compositions long-time stability are better than non-compositions.
Conclusion: the long-term stable experiment explanation bromhexine composition stable of six months by a definite date accelerated test and 12 months is better than non-compositions.
The present invention is not limited to above-mentioned preferred forms, and other any identical with the present invention or akin products that anyone draws under enlightenment of the present invention all drop within protection scope of the present invention.
Claims (5)
1. compositions that contains bromhexine salt is characterized in that: described compositions comprises the active component bromhexine salt and as the ethanol and the stabilizing agent of cosolvent, and comprises glucose or sodium chloride; Wherein: bromhexine salt be in Bisolvon, lactic acid bromhexine, acetic acid bromhexine, Aspartic Acid bromhexine or the citric acid bromhexine one or more; Stabilizing agent is poloxamer and hydroxypropyl cellulose; The weight ratio of bromhexine salt and ethanol and stabilizing agent is 1: 30: 40 ~ 1: 60: 100.
2. the compositions that contains bromhexine salt as claimed in claim 1 is characterized in that: the weight ratio of described bromhexine salt and ethanol and stabilizing agent is 1: 20: 25 ~ 1: 50: 60.
3. injection of making by claim 1 or the 2 described compositionss that contain bromhexine salt, it is characterized in that: in the described injection, the weight content of bromhexine salt is 0.03% ~ 0.8%, alcoholic acid weight content is 1.5% ~ 36%, the weight content of stabilizing agent is 1.0% ~ 40%, and the pH value of injection is 3.0 ~ 7.0.
4. injection as claimed in claim 3 is characterized in that: in the described injection, the weight content of bromhexine salt is 0.06% ~ 0.4%; Alcoholic acid weight content is 3.0% ~ 20%; The weight content 4.0% ~ 20% of stabilizing agent; The pH value of injection is 3.0 ~ 5.0.
5. method for preparing injection as claimed in claim 3, it is characterized in that: described method comprises the following steps:
Take by weighing stabilizing agent and be dissolved in the water for injection, fully swelling; Measure ethanol, add the injection water, heating adds bromhexine salt, stirring and dissolving; Stir and slowly add the bromhexine salt alcoholic solution in the stabiliser solution down, add glucose or sodium chloride again, fully stirring and dissolving adds water to full dose, stirs, the weight content of bromhexine salt is 0.03% ~ 0.8%, alcoholic acid weight content is 1.5% ~ 36%, and the weight content of stabilizing agent is 1.0% ~ 40%, and the injection pH value is 3.0 ~ 7.0, through the following aperture of 0.45 μ m filtering with microporous membrane, fill is in infusion bottle or transfusion bag.
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| CNB2007100903588A CN100409835C (en) | 2007-04-06 | 2007-04-06 | Composition and great volume injection containing bromhexine salt and the injection preparing process |
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| CNB2007100903588A CN100409835C (en) | 2007-04-06 | 2007-04-06 | Composition and great volume injection containing bromhexine salt and the injection preparing process |
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| CN100409835C true CN100409835C (en) | 2008-08-13 |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101502494B (en) * | 2009-04-01 | 2012-10-17 | 王保明 | A kind of bromhexine hydrochloride freeze-dried powder injection and preparation method thereof |
| JP5979763B2 (en) * | 2010-07-12 | 2016-08-31 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | Aqueous composition comprising bromhexine |
| CN102293741B (en) * | 2011-08-24 | 2013-02-20 | 石家庄东方药业有限公司 | Bromhexine hydrochlorie injection, its preparation method and application |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1396834A (en) * | 2000-01-31 | 2003-02-12 | 新药物研究瑞典股份公司 | Stabilised pharmaceutical compositions and process for their preparation comprising antibiobic and expectorant |
| CN1411806A (en) * | 2002-09-10 | 2003-04-23 | 南昌亿博医药科技有限公司 | Bromhexine hydrochloride injection and its preparation method |
| CN1557285A (en) * | 2004-02-05 | 2004-12-29 | 马小歧 | Bromhexine Hydrochloride aseptic freeze-drying formulation for injection and its preparation method |
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2007
- 2007-04-06 CN CNB2007100903588A patent/CN100409835C/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1396834A (en) * | 2000-01-31 | 2003-02-12 | 新药物研究瑞典股份公司 | Stabilised pharmaceutical compositions and process for their preparation comprising antibiobic and expectorant |
| CN1411806A (en) * | 2002-09-10 | 2003-04-23 | 南昌亿博医药科技有限公司 | Bromhexine hydrochloride injection and its preparation method |
| CN1557285A (en) * | 2004-02-05 | 2004-12-29 | 马小歧 | Bromhexine Hydrochloride aseptic freeze-drying formulation for injection and its preparation method |
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Assignee: Jiangxi Kelun Pharmaceutical Co., Ltd. Assignor: Zhang Song Contract fulfillment period: 2009.6.9 to 2027.4.6 Contract record no.: 2009360000036 Denomination of invention: Composition and great volume injection containing bromhexine salt and the injection preparing process Granted publication date: 20080813 License type: Exclusive license Record date: 20090713 |
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Free format text: EXCLUSIVE LICENSE; TIME LIMIT OF IMPLEMENTING CONTACT: 2009.6.9 TO 2027.4.6; CHANGE OF CONTRACT Name of requester: JIANGXI COLOGNE MEDICINE CO., LTD. Effective date: 20090713 |
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Effective date of registration: 20220211 Address after: No.2 Wenzhou Road, Dongsheng Industrial Park, Dongxiang County, Fuzhou City, Jiangxi Province Patentee after: JIANGXI YIYOU PHARMACEUTICAL Co.,Ltd. Address before: Jiangxi province Dongxiang County 331800 benevolent Street No. 129 Jiangxi Yibo Medical Technology Development Co Ltd Patentee before: Zhang Song |