Dry powder inhalant matched with pollen-shaped saccharide carrier as well as preparation and application methods thereof

Abstract

The invention provides a dry powder inhalant matched with a pollen-shaped saccharide carrier as well as preparation and application methods thereof. The dry powder inhalant comprises a ternary mixed component and the ternary mixed component comprises the following components: 0.01 to 2 parts of an effective medical component (with a preferred aerodynamic median diameter of 0.5 to 5 microns), 0 to 20 parts of a saccharide rough powder carrier (with a preferred aerodynamic median diameter of 10 to 100 microns) and 0 to 20 parts of a saccharide fine powder carrier (with a preferred aerodynamic median diameter of 1 to 10 microns), wherein the saccharide rough powder carrier and / or the saccharide fine powder carrier adopts prepared pollen-shaped saccharide carrier grains (the grains have rough surfaces and more pores inside and have a BET pore surface area of 10m<2> / g to 60m<2> / g; the density of the saccharide rough powder carrier is preferably 1 to 3 times as much as that of the saccharide fine powder carrier; the grain diameter of the saccharide rough powder carrier is preferably 5 to 10 times as much as that of the saccharide fine powder carrier; the fine powder distribution ratio (FPF) of the dry powder inhalant is 10%-50%. By adopting the preparation and application methods provided by the invention, higher drug loading amount, respiratory tract transportation capability and stability of inhaled drugs are realized and the dry powder inhalant has a better inhaled drug curative effect.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a dry powder inhaler formulated with a pollen-shaped carbohydrate carrier and a preparation and use method thereof. Background technique [0002] In recent years, due to the influence of air pollution and smoking, more and more patients with chronic obstructive pulmonary disease (COPD), lung cancer and asthma, dry powder inhaler (DPI) is the best way to treat these diseases. However, due to the high technical threshold of dry powder inhalers and the difficulty of imitation, the domestic dry powder inhaler market is largely occupied by foreign brands, and further technical improvement and innovation are urgently needed in China. [0003] The dry powder inhaler, its preparation method and application are recorded in the prior art (application number CN200810151281.5), and the inhalable drug powder with low density is prepared by foaming technology, which improves the effi...

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Problems solved by technology

[0003] The dry powder inhaler, its preparation method and application are recorded in the prior art (application number CN200810151281.5), and the inhalable drug powder with low density is prepared by foaming technology, which improves the efficacy of anti-tumor drugs from the preparation of raw materials. Pulmonary transmission effect, but the most important technical parameters of dry powder inhalation also include the design and proportion of the carrier, this method is not practical enough

[0004] Scopolamine hydrobromide nasal dry powder inhalation and its preparation method are recorded in the prior art (application number CN200510033328.4). This method prepares an excipient carrier containing drug components through adsorption technology, which has high stability and practicability, but is limited by The limitations of the carrier technology, this method is only used for nasal mucosal administration and cannot be used for pulmonary administration (in the narrow sense of dry powder inhalation)

[0005] In order to effectively use the carrier to deliver the drug, the prior art records a dry powder inhaler pharmaceutical composition and its preparation method (application number CN201610147903.1). After the dry powder inhaler drug is prepared, the drug is mixed with a suitable size lactose monohydrate carrier Mixing, using lactose microparticles to carry dry powder inhalation drugs to improve the effective delivery rate of dry powder inhalers to the lungs, but due to the limited surface area of ​​lactose monohydrate particles, no matter how they are ground and granulated, there is a low drug delivery capacity

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