CN101919865A - Capsule type budesonide dry powder inhalation and preparation process thereof - Google Patents
Capsule type budesonide dry powder inhalation and preparation process thereof Download PDFInfo
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- CN101919865A CN101919865A CN2009100527305A CN200910052730A CN101919865A CN 101919865 A CN101919865 A CN 101919865A CN 2009100527305 A CN2009100527305 A CN 2009100527305A CN 200910052730 A CN200910052730 A CN 200910052730A CN 101919865 A CN101919865 A CN 101919865A
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Abstract
The invention provides a capsule type budesonide dry powder inhalation and a preparation process thereof. The budesonide dry powder inhalation comprises the following components by weight: 0.16 g-0.24 g of budesonide and 20 g-30 g of lactose. As blank lactose granules are prepared, the invention can control the loading quantity easily during split charging and improve the product yield and is beneficial for industrial production. When being used, the invention reduces the content of auxiliaries entering the lung when a patient takes medicine to ease the lunge burden of the patient, reduces the side effect during the medication and has relatively large application value.
Description
Technical field:
The present invention relates to pharmaceutical preparation, be specifically related to a kind of capsule type budesonide dry dust cloud inhalant and preparation technology thereof.
Background technology:
Pathogenesis of asthma mechanism mainly is chronic nonspecific inflammation.At present, anti-inflammatory treatment is still the main therapeutic scheme of bronchial asthma, and this just makes the corticosteroids medicine become the choice drug of the various asthma of treatment.Budesonide is a kind of glucocorticoid, developed by AstraZeneca drugmaker the nineties in 20th century, it can strengthen the stability of endotheliocyte, smooth muscle cell and lysosome membrane, suppress immunoreation and reduce antibody synthetic, thereby reduce release and its active reduction of irritated active mediums such as histamine, and can alleviate antigen-antibody in conjunction with the time enzymatic processes that excites, thus, suppress the synthetic and release of bronchoconstriction material, alleviate the contractile response of smooth muscle.Be mainly used in the treatment of breathing and chronic obstructive disease of lung.At present in all asthma medications, the consumption maximum of budesonide.
Now the budesonide aerosol of Shi Yonging can stimulate bronchial mucosa and damage the ozone layer because of containing the freon propellant, on the other hand, because autonomous air-breathing and pressing when using, easily produce dyssynergia, along with China adds " Montreal Convention ", this series products will face delisting.
Current, that alternative in the world freon is used for the medicinal aerosol preparation is hydrofluoroalkane (HFA).Anapnotherapy is the prefered method of internationally recognized treating asthma, and the suction powder spray of exploitation treating asthma will be the needs of clinical treatment medication, make things convenient for patient's medication.
The patent disclosure of application number CN200810181032.0 budesonide R capsule type inhalation dust cloud agent and preparation method thereof.This method is mixed together the grinding back reuse equivalent method of progressively increasing with principal agent and a small amount of excipient and adds adjuvant, and still, it also not exclusively is applicable to suitability for industrialized production, and, in this method, the dust cloud of excipient after grinding, easily enter pulmonary when the patient uses, strengthened the burden of pulmonary.
Summary of the invention:
Technical problem to be solved by this invention is to overcome above-mentioned weak point, and research design capsule type budesonide dry powder spray and preparation technology thereof make this technology more be applicable to suitability for industrialized production, and reduces the pulmonary's burden after the patient sucks medicine.
The invention provides a kind of capsule type budesonide dry powder spray.It is made up of following components by weight ratio:
Budesonide 0.16g-0.24g
Lactose 20g-30g
Another purpose of the present invention provides a kind of preparation technology of capsule type budesonide dry powder spray, and this technology comprises the following steps:
(1) micronization of budesonide: get the budesonide raw material,, put and be as cold as room temperature in 55 ℃ of-65 ℃ of dryings 2 hours; Raw material is put fluid energy mill and is carried out micronization processes; Principal agent after the micronization processes is put microscopically and is observed, and the micronization budesonide ratio of particle diameter 1 μ m-5 μ m should reach 50%-70%.
(2) preparation of blank lactose granule: get lactose, pulverize, cross 100 mesh sieves; Play the lactose behind the powder, granulate, cross 20 mesh sieves, put 55 ℃ of-65 ℃ of baking oven 24-32min, cross 40 mesh sieve granulate, put 55 ℃ of-65 ℃ of oven dry, cross 80 mesh sieves with the ethanol liquid of 40%-60% (W/W), standby.
(3) get micronized budesonide and lactose granule, adopt the equivalent multiplication method of progressively increasing to mix.
(4) behind the mix homogeneously, it is 0.5%-0.8% that budesonide content is surveyed in sampling, qualified after, be packed in No. 3 capsules, make every capsule that contains budesonide 0.2mg, add capsule cap cap seal mouth, promptly get the capsule type budesonide dry powder spray.
Advantage of the present invention is:
(1) by the blank lactose granule of preparation, loading amount more easy to control in minute process of assembling improves the finished product yield, more helps commercial production.
Enter the content of the adjuvant of pulmonary when (2) helping reducing patient's medication, thereby alleviate pulmonary's burden of patient, reduce the side effect in the medication process.
The adjuvant that the present invention adopts does not all have influence to content, effective fraction medicine amount and the stability of this product, and the every index of capsule type budesonide dry powder spray of preparation all meets the requirements.The inventive method simply is suitable for suitability for industrialized production, and bigger using value is arranged.
The specific embodiment:
Embodiment 1
Prescription: budesonide 0.16g, lactose 20g.
Get the budesonide raw material,, put and be as cold as room temperature in 60 ℃ of dryings 2 hours; Raw material is put fluid energy mill and is carried out micronization processes; Principal agent after the micronization processes is put microscopically and is observed, and the micronization budesonide ratio of particle diameter 1 μ m-5 μ m should reach 50%.Get lactose, pulverize, cross 100 mesh sieves; Play lactose behind the powder, granulate, cross 20 mesh sieves, put 60 ℃ of about 30min of baking oven, cross 40 mesh sieve granulate, dry with the ethanol liquid of 50% (W/W), 80 mesh sieves, standby.Get micronization principal agent and blank lactose granule ratio, adopt the equivalent multiplication method of progressively increasing to mix with recipe quantity.Behind the mix homogeneously, it is 0.5%-0.8% that budesonide content is surveyed in powder body different parts sampling, qualified after, be packed in No. 3 capsules, make every capsule that contains budesonide 0.2mg, add cap and seal promptly.Extract to fill the back sample, examine (uniformity of dosage units for ± 20%, Emptying Rate is not less than 90.0%, the effective fraction medicine amount is greater than 10%), qualified back packing entirely.
Embodiment 2
Prescription: budesonide 0.2g, lactose 25g.
Get the budesonide raw material,, put and be as cold as room temperature in 60 ℃ of dryings 2 hours; Raw material is put fluid energy mill and is carried out micronization processes; Principal agent after the micronization processes is put microscopically and is observed, and the micronization budesonide ratio of particle diameter 1 μ m-5 μ m should reach 70%.Get lactose, pulverize, cross 100 mesh sieves; Play lactose behind the powder, granulate, cross 20 mesh sieves, put 60 ℃ of about 30min of baking oven, cross 40 mesh sieve granulate, dry with the ethanol liquid of 50% (W/W), 80 mesh sieves, standby.Get micronization principal agent and blank lactose granule ratio, adopt the equivalent multiplication method of progressively increasing to mix with recipe quantity.Behind the mix homogeneously, it is 0.5%-0.8% that budesonide content is surveyed in powder body different parts sampling, qualified after, be packed in No. 3 capsules, make every capsule that contains budesonide 0.2mg, add cap and seal promptly.Extract to fill the back sample, examine (uniformity of dosage units for ± 20%, Emptying Rate is not less than 90.0%, the effective fraction medicine amount is greater than 10%), qualified back packing entirely.
Embodiment 3
Prescription: budesonide 0.24g, lactose 30g.
Get the budesonide raw material,, put and be as cold as room temperature in 60 ℃ of dryings 2 hours; Raw material is put fluid energy mill and is carried out micronization processes; Principal agent after the micronization processes is put microscopically and is observed, and the micronization budesonide ratio of particle diameter 1 μ m-5 μ m should reach 60%.Get lactose, pulverize, cross 100 mesh sieves; Play lactose behind the powder, granulate, cross 20 mesh sieves, put 60 ℃ of about 30min of baking oven, cross 40 mesh sieve granulate, dry with the ethanol liquid of 50% (W/W), 80 mesh sieves, standby.Get micronization principal agent and blank lactose granule ratio, adopt the equivalent multiplication method of progressively increasing to mix with recipe quantity.Behind the mix homogeneously, it is 0.5%-0.8% that budesonide content is surveyed in powder body different parts sampling, qualified after, be packed in No. 3 capsules, make every capsule that contains budesonide 0.2mg, add cap and seal promptly.Extract to fill the back sample, examine (uniformity of dosage units for ± 20%, Emptying Rate is not less than 90.0%, the effective fraction medicine amount is greater than 10%), qualified back packing entirely.
Claims (2)
1. capsule type budesonide dry powder spray is characterized in that described budesonide powder spray is made up of following components by weight ratio: budesonide 0.16g-0.24g and lactose 20g-30g.
2. a preparation technology who is used for the described production capsule type budesonide dry of claim 1 powder spray is characterized in that this method comprises the following steps:
(1) micronization of budesonide: get the budesonide raw material,, put and be as cold as room temperature in 55 ℃ of-65 ℃ of dryings 2 hours; Raw material is put fluid energy mill and is carried out micronization processes; Principal agent after the micronization processes is put microscopically and is observed, and the micronization principal agent ratio of particle diameter 1 μ m-5 μ m should reach 50%-70%;
(2) preparation of blank lactose granule: get lactose, pulverize, cross 100 mesh sieves; Play the lactose behind the powder, granulate, cross 20 mesh sieves, put 55 ℃ of-65 ℃ of baking oven 24-32min, cross 40 mesh sieve granulate, put 55 ℃ of-65 ℃ of oven dry, cross 80 mesh sieves with the ethanol liquid of 40%-60%W/W, standby;
(3) get micronized budesonide and lactose granule, adopt the equivalent multiplication method of progressively increasing to mix;
(4) behind the mix homogeneously, it is 0.5%-0.8% that budesonide content is surveyed in sampling, qualified after, be packed in No. 3 capsules, make every capsule that contains budesonide 0.2mg, add capsule cap cap seal mouth, promptly get the capsule type budesonide dry powder spray.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200910052730 CN101919865B (en) | 2009-06-09 | 2009-06-09 | Capsule type budesonide dry powder inhalation and preparation process thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200910052730 CN101919865B (en) | 2009-06-09 | 2009-06-09 | Capsule type budesonide dry powder inhalation and preparation process thereof |
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| CN101919865A true CN101919865A (en) | 2010-12-22 |
| CN101919865B CN101919865B (en) | 2013-04-03 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108553445A (en) * | 2018-06-12 | 2018-09-21 | 安徽医科大学 | A kind of preparation method of taxol powder spray |
| CN110251492A (en) * | 2019-07-04 | 2019-09-20 | 珠海瑞思普利生物制药有限公司 | A kind of SB 209509 inhalation powder spray and its preparation method and application |
| CN110585176A (en) * | 2019-07-04 | 2019-12-20 | 珠海瑞思普利生物制药有限公司 | Capsule-type eletriptan nasal inhalation powder aerosol and preparation method and application thereof |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100428938C (en) * | 2005-09-28 | 2008-10-29 | 天津药业研究院有限公司 | Glucocorticoid capsule type inhaling atomized powder and preparation method |
| CN101401811A (en) * | 2008-11-21 | 2009-04-08 | 首都医科大学 | Budesonide R capsule type inhalation dust cloud agent and preparation method thereof |
-
2009
- 2009-06-09 CN CN 200910052730 patent/CN101919865B/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108553445A (en) * | 2018-06-12 | 2018-09-21 | 安徽医科大学 | A kind of preparation method of taxol powder spray |
| CN110251492A (en) * | 2019-07-04 | 2019-09-20 | 珠海瑞思普利生物制药有限公司 | A kind of SB 209509 inhalation powder spray and its preparation method and application |
| CN110585176A (en) * | 2019-07-04 | 2019-12-20 | 珠海瑞思普利生物制药有限公司 | Capsule-type eletriptan nasal inhalation powder aerosol and preparation method and application thereof |
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| CN101919865B (en) | 2013-04-03 |
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