Compound dry powder inhalant and application thereof

A dry powder inhaler and compound technology, applied in anti-inflammatory agents, anti-toxic agents, pharmaceutical formulations, etc., can solve the problems of low blood concentration of drugs, poor patient compliance, low drug targeting, etc., to reduce pulmonary fibrosis, Reduces inflammation and oxidative damage and prolongs the effect of residence time

Active Publication Date: 2021-11-19
TIANJIN UNIV OF TRADITIONAL CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] In addition, the current clinical prevention and treatment of IPF is mainly based on oral administration and intravenous injection. Oral administration has gastrointestinal irritation and liver first-pass effect, and the drug concentration in the blood is low, resulting in low bioavailability and ineffective curative effect. However, the selection of injections has disadvantages such as poor patient compliance, low drug targeting, and high systemic toxicity.

Method used

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  • Compound dry powder inhalant and application thereof
  • Compound dry powder inhalant and application thereof
  • Compound dry powder inhalant and application thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0053] The preparation embodiment of compound dry powder inhalation

[0054] B-90 nanometer spray dryer is used to produce compound dry powder inhaler. Configure the PBS solutions of baicalin, ambroxol hydrochloride and L-leucine with different mass contents respectively as the feed solution, wherein, in each embodiment, the composition ratio of the feed solution is as shown in the following table 1, each feed The solution is spray-dried under the same parameters: inlet temperature 80°C, air flow 100L min -1 , pump speed 23%, spray rate 60%, internal pressure 34Mbar. After spray drying, the DPI dry powder was collected in a normal temperature drying environment, weighed and sealed, and stored in a normal temperature desiccator.

[0055] Table 1

[0056]

[0057] Quality evaluation of compound dry powder inhaler

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Abstract

The invention provides a compound dry powder inhalant which comprises baicalin, ambroxol hydrochloride, L-leucine and phosphate, the mass of the compound dry powder inhalant is as follows: the L-leucine accounts for 0-50%, the mass of the phosphate accounts for 15-35%, the total mass of the baicalin and the ambroxol hydrochloride accounts for 15-85%, and the mass ratio of the baicalin to the ambroxol hydrochloride is 1:(0.2-2); and the Dv90 of the compound dry powder inhaler is less than or equal to 5 microns. The combination of baicalin and ambroxol hydrochloride can effectively reduce inflammation and oxidative damage of lung tissues, relieve pulmonary edema and histopathologic change, and relieve pulmonary dysfunction and fibrosis. The compound dry powder inhalant is administrated through the lung, so that the half-life period and the in-vivo residence time of the medicine in plasma are obviously prolonged, the bioavailability of the medicine in lung tissue is improved, the clearance rate of the medicine in the lung tissue is reduced, the residence time of the medicine in the lung is prolonged, and the medicine can fully play a role in the lung tissue.

Description

technical field [0001] The present application relates to the field of pharmaceutical technology, in particular to a compound dry powder inhaler and its application. Background technique [0002] Idiopathic pulmonary fibrosis (IPF, idiopathic pulmonary fibrosis) is a kind of chronic and irreversible diffuse alveolitis and alveolar structural disorder with unknown etiology and easy to occur in middle-aged and elderly people. Deposition causes extensive lung remodeling, which eventually leads to lung disease called pulmonary interstitial fibrosis (PF, pulmonary fibrosis). While most pulmonary fibrosis is of unknown etiology, idiopathic pulmonary fibrosis is characterized by diffuse alveolitis and deranged alveolar architecture, eventually leading to pulmonary interstitial fibrosis. The development of IPF involves lung injury, inflammation, myofibroblast formation, and accumulation of extracellular matrix, which ultimately leads to structural dysfunction of the lung. Its path...

Claims

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Application Information

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IPC IPC(8): A61K31/7048A61K9/72A61K47/02A61K47/18A61P7/10A61P11/00A61P29/00A61P39/06A61K31/137
CPCA61K31/7048A61K31/137A61K9/0075A61K47/183A61K47/02A61P11/00A61P29/00A61P39/06A61P7/10A61K2300/00A61K31/198
Inventor 刘志东祁东利彭辉皮佳鑫郭盼邓秀平李佳玮
Owner TIANJIN UNIV OF TRADITIONAL CHINESE MEDICINE
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