Capreomycin dry powder inhalant and preparation process thereof

A dry powder inhaler, capreomycin technology, applied in powder delivery, aerosol delivery, medical preparations with inactive ingredients, etc., can solve the problems of reducing the cure rate, renal function damage, electrolyte disturbance, etc. Toxicity, improving R&D level, preventing the effect of drug resistance

Pending Publication Date: 2021-08-06
石家庄亿高生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] In the existing standard treatment plan for drug-resistant tuberculosis, capreomycin is the core drug, which requires continuous intramuscular injection for 6 months, which not only brings pain and inconvenience to patients, but also causes renal function damage, hearing impairment, Electrolyte disturbance and other adverse reactions
At the same time, because most tuberculosis patients cannot adhere to complete the full course of treatment, the cure rate is further reduced
What is even more tragic is that currently capreomycin is only administered by injection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] A preparation process of capreomycin dry powder inhalation, comprising capreomycin sulfate powder, dry powder carrier and filled capsules; the dry powder carrier component is ML003 lactose; the filled capsules are 3# HPMC capsules, and the filled capsule specifications It is 12.5㎎ / grain; its preparation method specifically comprises the following steps:

[0031] Step 1, placing the capreomycin sulfate crude drug in the stainless steel cup of the gas pulverizer;

[0032] Step 2, setting the crushing conditions of the pulverizer as follows: the pressure of the Venturi tube is set to 13.0 bar, the pressure of the crushing chamber is set to 12.5 bar, and the pulverizer is used to pulverize the capreomycin sulfate raw material drug to obtain capreomycin sulfate powder , the prepared capreomycin sulfate powder has a particle size of 6.88-9.99 μm;

[0033] Step 3. Put the capreomycin sulfate powder with a particle size of 6.88-9.99 μm and the same mass of dry powder carrier o...

Embodiment 2

[0036] A preparation process of capreomycin dry powder inhalation, comprising capreomycin sulfate powder, dry powder carrier and filled capsules; the dry powder carrier component is ML003 lactose; the filled capsules are 3# HPMC capsules, and the filled capsule specifications It is 12.5㎎ / grain; its preparation method specifically comprises the following steps:

[0037] Step 1, placing the capreomycin sulfate crude drug in the stainless steel cup of the gas pulverizer;

[0038] Step 2, setting the crushing conditions of the pulverizer as follows: the pressure of the Venturi tube is set to 13.16 bar, the pressure of the crushing chamber is set to 12.58 bar, and the pulverizer is used to pulverize and process the capreomycin sulfate raw material drug to obtain capreomycin sulfate powder , the prepared capreomycin sulfate powder has a particle size of 5.27-6.88 μm;

[0039] Step 3. Put the capreomycin sulfate powder with a particle size of 5.27-6.88 μm and the same mass of dry po...

Embodiment 3

[0042] A preparation process of capreomycin dry powder inhalation, comprising capreomycin sulfate powder, dry powder carrier and filled capsules; the dry powder carrier component is ML003 lactose; the filled capsules are 3# HPMC capsules, and the filled capsule specifications It is 12.5㎎ / grain; its preparation method specifically comprises the following steps:

[0043] Step 1, placing the capreomycin sulfate crude drug in the stainless steel cup of the gas pulverizer;

[0044] Step 2, setting the crushing conditions of the pulverizer as follows: the pressure of the Venturi tube is set to 13.32 bar, the pressure of the crushing chamber is set to 12.66 bar, and the pulverizer is used to pulverize the capreomycin sulfate raw material drug to obtain capreomycin sulfate powder , the prepared capreomycin sulfate powder has a particle size of 3.65-5.27 μm;

[0045] Step 3. Put the capreomycin sulfate powder with a particle size of 3.65-5.27 μm and the same mass of dry powder carrier...

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PUM

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Abstract

The invention discloses a capreomycin dry powder inhalant and a preparation process thereof. The capreomycin dry powder inhalant comprises capreomycin sulfate powder, a dry powder carrier and filling capsules, wherein the component of the dry powder carrier is ML003 lactose; and the filling capsules are 3#HPMC capsules with the specification of 12.5 mg/capsule. The capreomycin dry powder inhalant can be used for effectively curing the tuberculosis or multidrug-resistant tuberculosis patients, enables drugs to directly act on sputum-derived bacteria due to inhalation administration, and is expected to quickly kill bacteria.

Description

technical field [0001] The invention relates to a preparation process of a capreomycin dry powder inhaler, in particular to a preparation process of a capreomycin dry powder inhaler. Background technique [0002] In the existing standard treatment plan for drug-resistant tuberculosis, capreomycin is the core drug, which requires continuous intramuscular injection for 6 months, which not only brings pain and inconvenience to patients, but also causes renal function damage, hearing impairment, Electrolyte disturbance and other adverse reactions. At the same time, because most tuberculosis patients cannot adhere to complete the full course of treatment, the cure rate is further reduced. What is even more tragic is that capreomycin is currently only administered by injection. [0003] Compared with injections, capreomycin oral dry powder inhalation (powder mist) provides a non-invasive drug delivery method, which can greatly exert the targeted and local therapeutic effect, not...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K38/12A61K47/26A61P31/06
CPCA61K9/0073A61K38/12A61K47/26A61P31/06
Inventor 池俊英梁世豪
Owner 石家庄亿高生物科技有限公司
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