CN1836654A - Pharmaceutical composition for stabilizing ambroxol hydrochloride granula - Google Patents
Pharmaceutical composition for stabilizing ambroxol hydrochloride granula Download PDFInfo
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- CN1836654A CN1836654A CN 200510013242 CN200510013242A CN1836654A CN 1836654 A CN1836654 A CN 1836654A CN 200510013242 CN200510013242 CN 200510013242 CN 200510013242 A CN200510013242 A CN 200510013242A CN 1836654 A CN1836654 A CN 1836654A
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- pharmaceutical composition
- ambroxol hydrochloride
- stabilizing agent
- ambroxol
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Abstract
The stabilized medicine composition of ambroxol hydrochloride granule consists of ambroxol hydrochloride as effective component, stabilizer and pharmaceutically acceptable soluble supplementary material in proportion of 1 to 0.01-1 to 15-50, preferably 1 to 0.05-0.2 to 15-30. The medicine composition of the present invention has no chemical pick-up forming unstable brown agglomeration during the combination of ambroxol hydrochloride with monosaccharide or polysaccharide, especially lactose, has simple operation and low cost, and is suitable for industrial production.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, in particular, is the granule of the sticking expectorant expectorant-ambroxol hydrochloride of a kind of desaturation.
Background technology
The ambroxol hydrochloride chemistry is by name: methyl-amino trans 4-[(2-amino-3,5 two bromo-phenyl)] the Hexalin hydrochlorate.Its preparation method is referring to GB1991, and 2239242.Have following structure:
Ambroxol hydrochloride is the respiratory mucus regulator of a new generation, has the superior usefulness of eliminating the phlegm, and the synthetic and secretion of alveolar surfactant is had significant facilitation.Ambroxol hydrochloride can stimulate the bronchorrhea glandular secretion to be easier to mobile mucus to make sputum dilution, and toughness reduces, and can increase the generation and the secretion of pulmonary surfactant, thereby reduction airway resistance, reduce mucous adhesive force, activate mucociliary blanket function, promote the mucociliary transhipment.Compare with the first generation and second filial generation expelling phlegm drugs, ambroxol hydrochloride is except that having powerful mucolysis effect, and its maximum characteristics are that it can stimulate alveolar type II cells, promotes the synthetic and secretion of alveolar surfactant, thereby effectively strengthen mucus transport, promote expectoration.
Ambroxol hydrochloride is to act on one of the strongest expectorant at present clinically, be applicable to that acute/chronic bronchitis, asthmatic bronchitis, bronchial asthma and chronic pneumonia thick sputum are difficult for the patient of expectoration or dry cough without phlegm, also can be used for congenital alveolar dysplasia, clinical efficacy is very sure, and ambroxol hydrochloride is safe in utilization, better tolerance is reused no drug accumulation.
What gone on the market at present, has ambroxol hydrochloride tablet, capsule, syrup, injection, slow releasing capsule or the like.
Owing in the ambroxol hydrochloride molecule, there is uncle's ammonia, so when particularly lactose mixed with a large amount of monosaccharide or disaccharide, the generation chemistry was picked up and should be formed brown caking.Well-known lactose all is the chemical compound of using always of making filler in tablet, capsule, the granule for example at many pharmaceutical dosage forms, has good flowability and compressibility.So,, can bring inconvenience to large-scale industrial production, and influence the quality of medicine if in the pharmaceutical composition prescription, do not use especially lactose of monosaccharide and disaccharide.
Summary of the invention
The objective of the invention is to, the shortcoming that overcomes prior art provides a kind of stable Pharmaceutical composition of ambroxol hydrochloride granula that makes with deficiency.Make it when particularly lactose mixes with monosaccharide or disaccharide, also good stability can be arranged.
A kind of stable Pharmaceutical composition of ambroxol hydrochloride granula that makes of the present invention is made up of active ingredient hydrochloric acid ambroxol, stabilizing agent and medicinal acceptable solubility adjuvant.Active ingredient hydrochloric acid ambroxol wherein: stabilizing agent: the weight ratio of other adjuvants is 1: 0.01-1: 15-50.Best weight ratio is 1: 0.05-0.2: 15-30.Stabilizing agent is one or more a compositions of sodium sulfite, potassium sulfite, sodium pyrosulfite, sodium sulfite, Potassium acid sulfite, thiourea, cysteine.Optimum stabilizing agent is one or more a compositions of sodium pyrosulfite, thiourea, cysteine.Medicinally one or more the compositions that acceptable solubility adjuvant is lactose, mannitol, glucose, sucrose, aspartame, stevioside, essence.This compositions can be made granule
With the ambroxol hydrochloride granula Pharmaceutical composition of the inventive method preparation, 1 be example to write out a prescription, with the Pharmaceutical composition related substance of the ambroxol hydrochloride granula that does not add stabilizing agent relatively.
Chromatographic condition:
0.01mol/L diammonium phosphate (regulating PH=7.0): acetonitrile=40: 60
ODS C
18Chromatographic column
Flow velocity 1min/L
30 ℃ of column temperatures
Measurement result is as follows:
| Accelerated test | |||||
| 0 month | 1 month | 2 months | 3 months | ||
| Add stabilizing agent | Related substance | 0.235％ | 0.245％ | 0.239％ | 0.241％ |
| Outward appearance | White particle | No significant change | No significant change | No significant change | |
| Do not add stabilizing agent | Related substance | 0.246％ | 1.152％ | 1.889％ | 2.546％ |
| Outward appearance | White particle | The light brown granule | The light brown granule | Brown particle | |
Result of the test shows that the stability of ambroxol hydrochloride granula obviously is better than not adding the pharmaceutical composition of stabilizing agent in the compositions of adding stabilizing agent.
The dosage form that compositions of the present invention is made is compared with prior dosage form and is had the following advantages:
(1) solved simply and effectively ambroxol hydrochloride and monosaccharide or polysaccharide especially lactose mix and chemistry takes place pick up and should form the wild effect of brown caking.Make the outward appearance and the period of storage of sample obtain tangible improvement.
(2) adopt the present invention easy and simple to handle, saved cost, be fit to large-scale industrial production more.
The specific embodiment
The present invention is described further below in conjunction with embodiment, and embodiment only means never that for indicative it limits the scope of the invention by any way.
Instantiation is as follows:
Example 1
Ambroxol hydrochloride 0.3g
Glucose 3.5g
Mannitol 5.5g
Aspartame 0.2g
Sodium pyrosulfite 0.005g
Essence 0.05g
Example 2:
Ambroxol hydrochloride 0.3g
Lactose 4.5g
Sucrose 5.0g
Aspartame 0.1g
Thiourea 0.01g
Essence 0.1g
Example 3:
Ambroxol hydrochloride 0.3g
Glucose 1.7g
Mannitol 4.6g
Aspartame 0.1g
Sodium sulfite (potassium) 0.03g
Essence 0.05g
Example 4:
Ambroxol hydrochloride 0.3g
Lactose 2.7g
Mannitol 1.6g
Stevioside 0.1g
Aminothiopropionic acid 0.01g
Essence 0.05g
Example 5:
Ambroxol hydrochloride 0.3g
Glucose 9.0g
Stevioside 0.2g
Sodium sulfite (potassium) 0.05g
Sodium pyrosulfite 0.05g
Essence 0.1g
Example 6:
Ambroxol hydrochloride 0.3g
Mannitol 9.4g
The sweet 0.2g of A Siba
Sodium pyrosulfite 0.003g
Essence 0.1g
The preparation technology of 1-6 embodiment:
Principal agent and adjuvant are crossed 100 mesh sieves respectively.Earlier adjuvant is fully mixed, take by weighing the recipe quantity adjuvant then and fully mix with principal agent.Add binding agent system soft material again, 20 mesh sieves are granulated, 55 ℃ of dryings, and 20 mesh sieve granulate sift out fine powder, packing.
Although the present invention has done detailed description in conjunction with its special embodiment, clearly concerning the skilled people in present technique field, still can make various changes and improvements, can not depart from spirit of the present invention and protection domain.
Claims (7)
1, a kind of stable Pharmaceutical composition of ambroxol hydrochloride granula that makes is characterized in that being made up of active ingredient hydrochloric acid ambroxol, stabilizing agent and medicinal acceptable solubility adjuvant.
2, Pharmaceutical composition according to claim 1 is characterized in that the active ingredient hydrochloric acid ambroxol: stabilizing agent: the weight ratio of other adjuvants is 1: 0.01-1: 15-50.
3, Pharmaceutical composition according to claim 2 is characterized in that the active ingredient hydrochloric acid ambroxol: stabilizing agent: the weight ratio of other adjuvants is 1: 0.05-0.2: 15-30.
4,, it is characterized in that described stabilizing agent is one or more a compositions of sodium sulfite, potassium sulfite, sodium pyrosulfite, sodium sulfite, Potassium acid sulfite, thiourea, cysteine according to the described Pharmaceutical composition of claim 1-3.
5, Pharmaceutical composition according to claim 4 is characterized in that described stabilizing agent is one or more a compositions of sodium pyrosulfite, thiourea, cysteine.
6, Pharmaceutical composition according to claim 1 is characterized in that medicinal one or more the compositions that acceptable solubility adjuvant is lactose, mannitol, glucose, sucrose, aspartame, stevioside, essence that.
7, Pharmaceutical composition according to claim 1 is characterized in that and this compositions can be made granule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100132425A CN100421655C (en) | 2005-03-25 | 2005-03-25 | Pharmaceutical composition for stabilizing ambroxol hydrochloride granula |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100132425A CN100421655C (en) | 2005-03-25 | 2005-03-25 | Pharmaceutical composition for stabilizing ambroxol hydrochloride granula |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1836654A true CN1836654A (en) | 2006-09-27 |
| CN100421655C CN100421655C (en) | 2008-10-01 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005100132425A Active CN100421655C (en) | 2005-03-25 | 2005-03-25 | Pharmaceutical composition for stabilizing ambroxol hydrochloride granula |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104027326A (en) * | 2013-03-04 | 2014-09-10 | 天津康鸿医药科技发展有限公司 | Ambroxol hydrochloride atomization inhalant, and preparation method and application thereof |
| CN107519129A (en) * | 2017-09-19 | 2017-12-29 | 哈药集团三精制药有限公司 | A kind of ambroxol hydrochloride oral solution and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1415287A (en) * | 2002-11-28 | 2003-05-07 | 沈阳药科大学 | Hydrochloric ambroxol osmotic pump type controlled release formulation and its preparation method |
-
2005
- 2005-03-25 CN CNB2005100132425A patent/CN100421655C/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104027326A (en) * | 2013-03-04 | 2014-09-10 | 天津康鸿医药科技发展有限公司 | Ambroxol hydrochloride atomization inhalant, and preparation method and application thereof |
| CN104027326B (en) * | 2013-03-04 | 2017-09-01 | 天津康鸿医药科技发展有限公司 | Ambroxol hydrochloride atomized inhalation and its preparation method and application |
| CN107519129A (en) * | 2017-09-19 | 2017-12-29 | 哈药集团三精制药有限公司 | A kind of ambroxol hydrochloride oral solution and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100421655C (en) | 2008-10-01 |
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| C10 | Entry into substantive examination | ||
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Assignee: Kanghong Medicine Tech Development Co., Ltd., Tianjin Assignor: Tianjin Institute of Pharmaceutical Research Contract record no.: 2011120000202 Denomination of invention: Pharmaceutical composition for stabilizing ambroxol hydrochloride granula Granted publication date: 20081001 License type: Exclusive License Open date: 20060927 Record date: 20111019 |