6 results about "Bromhexine hydrochloride" patented technology

The application discloses a modified bromhexine hydrochloride inhalation solution with enhanced stability and a preparation method thereof, and belongs to the technical field of medical preparations. The inhalation solution is mainly prepared from a targeting impurity control modified bromhexine hydrochloride inclusion compound, a special composite buffer mother liquor for inhibiting impurity B, inhalation grade sodium chloride, pharmaceutical grade sodium hydroxide and water for injection, and the pH value of the finished product is 4.5-5.5. The application constructs a three-stage progressive modification system, covalently grafts a mercapto-activated L-cysteine derivative onto hydroxypropyl-gamma-cyclodextrin to prepare a functional carrier, and realizes molecular-level isolation of bromhexine hydrochloride through host-guest inclusion, thereby blocking the generation of impurity B of bromhexine hydrochloride from the whole path, and solving the core pain points of easy impurity exceeding, short effective period and airway irritation of the existing product. The application can realize long-acting stable storage for 36 months, is suitable for the existing industrial production line, and has high clinical application and industrialization values.

The invention belongs to the technical field of medicine quality detection, and particularly relates to a method for detecting bacterial endotoxin of a raw material medicine in bromhexine hydrochloride injection. According to the method, a mode of heating and dissolving the hydrochloric acid solution with the pH value of 4.0 is adopted, and the 001 * 7 type cation exchange resin microcolumn purification is combined, so that the inhibition effect of cation impurities in the raw material medicine on agglutination reaction of the tachypleus amebocyte lysate can be effectively eliminated, and a stable and uniform test solution is prepared. According to the process, the minimum non-interference dilution multiple is obviously reduced to 160 times, and the operation error and the detection sensitivity loss caused by high-multiple dilution are reduced. As the dilution ratio is greatly reduced, a tachypleus amebocyte lysate with the sensitivity of 0.25 EU.mL <-1 > can be selected in the method. Compared with a high-sensitivity reagent needed in the prior art, the reagent of the specification is easier to purchase and lower in cost, solves the problems that the high-sensitivity reagent is large in daily purchase difficulty and high in price, and is more suitable for conventional application in industrial quality control.

The present invention provides a solid composition comprising the following components: (a) bromhexine or a salt thereof; (b) a nonionic surfactant; and (c) a compound selected from the group consisting of vitamin antioxidants, phenolic antioxidants, meloxicam, and acetaminophen (wherein R1 represents a hydrogen atom or a hydrogen atom). The pharmaceutical composition does not contain ibuprofen, clemastine fumarate, dihydrocodeine phosphate, noscapine, racemic methyephedrine hydrochloride, anhydrous caffeine, bromhexine hydrochloride, tranexamic acid, riboflavin, benfotiamine, ascorbic acid, hesperidin, D-mannitol, low-substitution-degree hydroxy propyl cellulose, crystalline cellulose, hydroxy propyl cellulose and polyoxyethylene hydrogenated castor oil 60, and the pharmaceutical composition can be used for preparing the pharmaceutical composition. The invention relates to a solid composition of hydroxypropyl methylcellulose, talc, hydroxy propyl cellulose and light anhydrous silicic acid.

This invention relates to the field of pharmaceutical analysis technology, and provides a method for detecting N-methylcyclohexylamine hydrochloride in bromhexine hydrochloride. The method involves dissolving N-methylcyclohexylamine in an organic solvent as a reference solution, and dissolving bromhexine hydrochloride in an organic solvent containing an acid-binding agent as the test solvent, followed by headspace gas chromatography for detection. This method is simple, efficient, specific, sensitive, repeatable, and stable, and can be used for the quality control of bromhexine hydrochloride raw material, providing technical support for its production.

This invention discloses a method for synthesizing bromhexine hydrochloride, with the following specific steps: Step (1), using 2-amino-3,5-dibromobenzoic acid as a raw material, reacting it with trimethylacetyl chloride via an anhydride method under the action of an acid-binding agent to obtain compound 2-amino-3,5-dibromobenzoic acid anhydride; Step (2), the 2-amino-3,5-dibromobenzoic acid anhydride obtained in Step 1 undergoes nucleophilic addition with N-methylcyclohexylamine to obtain compound 5, bromhexine hydrochloride intermediate; Step (3), the above compound 5, bromhexine hydrochloride intermediate undergoes amide reduction and salt formation reaction to obtain bromhexine hydrochloride. This process provides a new route for preparing bromhexine hydrochloride, avoiding the heavily regulated chlorination process, reducing the release of toxic gases from strong halogen reagents such as thionyl chloride, significantly reducing safety risks and environmental protection investment, and the reaction itself is safe and fast, which is conducive to industrial production.

The invention discloses bromhexine hydrochloride sustained-release micro-tablets and a preparation process thereof. The bromhexine hydrochloride sustained-release micro-tablets are prepared from the following raw materials through direct powder compression: 5-20 parts of bromhexine hydrochloride, 15-35 parts of hydroxypropyl methylcellulose, 5-15 parts of carbomer, 5-15 parts of ethyl cellulose, 10-40 parts of microcrystalline cellulose, 2-8 parts of povidone and 0.5-5 parts of a lubricant. The preparation method comprises the following steps: sieving and mixing the raw materials except the lubricant for 20-40 minutes, adding the lubricant, continuously mixing for 3-8 minutes, and pressing into micro-tablets with the diameter of 2-4mm. Wherein the povidone is added in the form of dry powder, is used as a dry powder adhesive, and forms a composite sustained-release skeleton together with the hydroxypropyl methylcellulose, the carbomer and the ethyl cellulose to cooperatively control drug release. Through the synergistic effect of the ternary composite skeleton and the dry povidone powder, 24-hour stable release of bromhexine hydrochloride is realized, and the release behavior is not influenced by pH; the process avoids the influence of damp and hot factors on the drug stability; the dosage form of the micro-tablet obviously improves the medication compliance of children, old people and patients with dysphagia.