A kind of isoniazid dry powder inhaler for treating pulmonary tuberculosis
A dry powder inhaler and isoniazid technology, which is applied in powder delivery, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of large amount of excipients, low drug loading, and reduced drug loading and other problems, to achieve the effects of simple preparation process, high drug delivery rate, and high formulation stability
Active Publication Date: 2022-03-11
SHENZHEN SCIENCARE MEDICAL INDUSTRIES CO. LTD.
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Problems solved by technology
The application uses a large amount of gelatin excipients in order to make the two drugs play a sustained release role. Gelatin is derived from animals and may have some immunogenicity when it enters the lungs, so the safety cannot be guaranteed. will reduce
[0006] It can be seen that the clinical demand for isoniazid inhalation dosage forms has not been met, and the currently known isoniazid inhalation dosage forms all suffer from low delivery efficiency, poor preparation stability, unguaranteed safety, and low drug loading, etc. question
Method used
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Effect test
Embodiment 1
[0032] Example 1: 10.0 g of isoniazid is passed through a fluidized bed supersonic jet pulverization method to make the particle size reach d 10 =0.5-2.0μm, d 50 =2.0-5.0μm, d 90 =5.0-9.5 μm, take the above-mentioned isoniazid micropowder, mix Inhalac 140 type lactose with isoniazid micropowder, the mixing weight ratio is 1:1; 5%.
Embodiment 2
[0033] Example 2: 10.0 g of isoniazid is passed through a fluidized bed supersonic jet pulverization method to make the particle size reach d 10 =0.5-2.0μm, d 50 =2.0-5.0μm, d 90 = 5.0-9.5 μm, take the above-mentioned isoniazid micropowder, mix Inhalac 230 type lactose with isoniazid micropowder, the mixing weight ratio is 1:1; 5%.
Embodiment 3
[0034]Example 3: 10.0 g of isoniazid is passed through a fluidized bed supersonic jet pulverization method to make the particle size reach d 10 =0.5-2.0μm, d 50 =2.0-5.0μm, d 90 = 5.0-9.5 μm, take the above-mentioned isoniazid micropowder, mix Inhalac 230 type lactose with isoniazid micropowder, the mixing weight ratio is 2:1; 5%.
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The invention relates to an isoniazid dry powder inhaler for treating pulmonary tuberculosis, which comprises isoniazid micropowder, and contains or does not contain carrier micropowder, and the isoniazid micropowder is made by a fluidized bed supersonic jet pulverization method or a spray drying method The particle size of the treatment is 0.1-10μm. Preferably, excipients leucine, mannitol or phospholipids are added to the dry powder inhaler to enhance the pelleting rate of the particles, and excipients magnesium stearate, mannitol, leucine and / or lactose are added to improve drug fluidity , to reduce particle agglomeration. The preparation process of the dry powder inhaler is simple, and the isoniazid dry powder inhaler with high stability can be prepared. The dry powder inhalation can effectively deliver medicine to the alveoli to effectively kill and inhibit Mycobacterium tuberculosis in the respiratory tract, and is especially suitable for treating pulmonary tuberculosis patients with impaired liver function.
Description
technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an isoniazid dry powder inhaler for treating pulmonary tuberculosis and a preparation method thereof, as well as its use in preparing medicines for treating various types of pulmonary tuberculosis. Background technique [0002] Tuberculosis is a highly contagious lung disease, which is very destructive to the lungs, and the treatment takes a long time, usually more than half a year. The current clinical treatment of pulmonary tuberculosis often adopts oral quadruple therapy of isoniazid, rifampicin, ethambutol and pyrazinamide. Among them, isoniazid has strong antibacterial activity against Mycobacterium tuberculosis, and is a very effective and rapid Mycobacterium tuberculosis fungicide. The effective concentration is 0.3-10 μg / mL, which can achieve very good antibacterial and bactericidal effects. However, conventional oral preparations have strong hepato...
Claims
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IPC IPC(8): A61K9/72A61K31/4409A61K47/26A61K47/12A61P31/06
CPCA61K9/145A61K9/0075A61K31/4409A61P31/06
Inventor 张桐桐王实强曲伟张涛张国立颜携国李勇梁民彩
Owner SHENZHEN SCIENCARE MEDICAL INDUSTRIES CO. LTD.