Inhaled Preparation Of Isoglycyrrhizic Acid Or Salt Thereof, And Use In Preparing Drugs For Treating Respiratory System Diseases

Abstract

The present invention belongs to the field of medicine, relates to an inhaled preparation of isoglycyrrhizic acid or a salt thereof, and in particular relates to an inhaled preparation of magnesium isoglycyrrhizinate and the use thereof in preparing drugs for treating respiratory system diseases.

1 . An inhaled preparation, characterized in that the active ingredient is isoglycyrrhizic acid or a salt thereof. 
     
     
         2 . The inhaled preparation according to  claim 1 , characterized in that the salt is magnesium salt, ammonium salt, potassium salt, sodium salt or salt of various amino acids, preferably magnesium salt. 
     
     
         3 . The inhaled preparation according to  claim 1 , characterized in that the inhaled preparation is selected from inhalation aerosol, powder for inhalation, liquid preparation for use in nebulizers or preparation which can be converted into vapor, preferably powder for inhalation or liquid preparation for use in nebulizers. 
     
     
         4 . The inhaled preparation according to  claim 1 , characterized in that the inhaled preparation is powder for inhalation comprising: micronized magnesium isoglycyrrhizinate and one or more pharmaceutically acceptable carriers, wherein the magnesium isoglycyrrhizinate has a particle size of 0.5-10 μm, preferably 0.5-5 μm. 
     
     
         5 . The inhaled preparation according to  claim 4 , characterized in that the pharmaceutically acceptable carrier is selected from lactose, mannitol, trehalose or glycine, preferably lactose. 
     
     
         6 . The inhaled preparation according to  claim 4 , characterized in that the pharmaceutically acceptable carrier is ground lactose, sieved lactose or a mixture of sieved lactose and fine lactose, wherein the particle size distribution of the ground lactose ranges from 1 to 350 μm, the particle size distribution of the sieved lactose ranges from 1 to 200 μm, and the particle size distribution of the fine lactose ranges from 1 to 60 μm; preferably, the ground lactose has a particle size distribution of X 50 <30-110 μm, the sieve lactose has a particle size distribution of X 50 <35-115 μm, and the fine lactose has a particle size distribution of X 90 <45 μm. 
     
     
         7 . The inhaled preparation according to  claim 4 , characterized in that the micronized magnesium isoglycyrrhizinate and the carrier are mixed and filled into a capsule or a bubble-cap. 
     
     
         8 . The inhaled preparation according to  claim 7 , characterized in that each capsule or bubble-cap comprises 1-50 mg of micronized magnesium isoglycyrrhizinate and 0-50 mg of lactose. 
     
     
         9 . The inhaled preparation according to  claim 7 , characterized in that each capsule or bubble-cap comprises 1-30 mg of micronized magnesium isoglycyrrhizinate and 1-40 mg of lactose. 
     
     
         10 . The inhaled preparation according to  claim 4 , characterized in that the powder for inhalation further comprises: one or more pharmaceutically acceptable additives; preferably the additional agent is one or more selected from the group consisting of surfactants, lubricants and flavoring agents. 
     
     
         11 . The inhaled preparation according to  claim 10 , characterized in that the pharmaceutically acceptable additive is a surfactant and/or a lubricant, preferably magnesium stearate and/or phospholipid. 
     
     
         12 . The inhaled preparation according to  claim 1 , characterized in that the inhaled preparation is a liquid preparation for use in nebulizers, comprising magnesium isoglycyrrhizinate, an isotonicity adjusting agent, a pH adjusting agent, and water for injection, with the pH of 6.0-8.0, wherein the nebulizer is a continuous nebulizer or a quantitative nebulizer. 
     
     
         13 . The inhaled preparation according to  claim 12 , characterized in that the amount of the magnesium isoglycyrrhizinate is from 0.1 mg/ml to 5 mg/ml, preferably from 0.1 mg/ml to 2.5 mg/ml. 
     
     
         14 . The inhaled preparation according to  claim 12 , characterized in that the isotonicity adjusting agent is one or more selected from the group consisting of glucose, sodium chloride, potassium chloride, and mannitol, preferably sodium chloride. 
     
     
         15 . The inhaled preparation according to  claim 12 , characterized in that the pH adjusting agent is one or more selected from the group consisting of sodium hydroxide, ammonium hydroxide, hydrochloric acid, sodium carbonate, sodium bicarbonate, dilute sulfuric acid, citric acid, sodium citrate, acetic acid, tartaric acid, sodium acetate or disodium hydrogen phosphate, preferably ammonium hydroxide or sodium hydroxide. 
     
     
         16 . The inhaled preparation according to  claim 12 , characterized in that the pH is 6.5-7.0. 
     
     
         17 . The inhaled preparation according to  claim 12 , characterized in that the inhaled preparation is packaged in a single dose in a package size of 1 ml, 2 ml or 5 ml, preferably 2 ml. 
     
     
         18 . The inhaled preparation of isoglycyrrhizic acid or a salt thereof according to  claim 1 , characterized in that the administration frequency of the inhaled preparation to a subject is selected from: up to three times a day, up to twice a day, up to once a day and up to once every other day, preferably up to twice a day. 
     
     
         19 . A method for treating chronic obstructive pulmonary disease, for alleviating phlegm, or for treating chronic viral hepatitis, by administrating the inhaled preparation of isoglycyrrhizic acid or a salt thereof according to  claim 1  to a subject in need thereof, wherein the isoglycyrrhizic acid or a salt thereof is preferably magnesium isoglycyrrhizinate, and wherein magnesium isoglycyrrhizinate injection is additionally used by sequential therapy in the method for treating chronic viral hepatitis. 
     
     
         20 . (canceled) 
     
     
         21 . (canceled) 
     
     
         22 . A combination comprising the inhaled preparation of isoglycyrrhetic acid or a salt thereof according to  claim 1  and a magnesium isoglycyrrhizinate injection, wherein the isoglycyrrhizic acid or a salt thereof is preferably magnesium isoglycyrrhizinate.