CN1552443A

CN1552443A - Lysozyme injection preparation

Info

Publication number: CN1552443A
Application number: CNA031266541A
Authority: CN
Inventors: 孙明杰; 王霆
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-05-26
Filing date: 2003-05-26
Publication date: 2004-12-08

Abstract

A lysozyme injection in the form of powder of freeze dried powder is disclosed, which features broad spectrum, that is, it can be used for preventing and treating different diseases, such as chronic paranasosinusitis, otitis media, allergic rhinitis, decayed tooth, pharyngolaryngitis, periodontitis, chronic branchitis, zoster, hepatitis, influenza, cancer, etc.

Description

The lysozyme ejection preparation

Invention field

The present invention is the new ejection preparation mode of lysozyme.The suitable multiple mucosa illness of department of eye that is used for clinically of said preparation is as mucosal inflammations such as treatment chronic paranasal rhinitis, children's's nasal sinusitis, otitis media, allergic rhinitis and stomatitis; Be used for caries prevention, pharyngolaryngitis, lichen planus, secretory otitis media and periodontitis etc.; With the discharge that is used for sticking puss such as the eliminating the phlegm of chronic bronchitis, rhinorrhea and otorrhea and the treatment of ulcerative colitis.And be used for the treatment of viral illness such as herpes zoster, parotitis, chicken chickenpox, hepatitis, influenza, serious acute respiratory disease; With the reparation that is used to comprise the reaction of nonspecific defence infection immunity, hemagglutinative function, gap conjunctive tissue, the biosynthetic metabolism that participates in mucopolysaccharide and antibacterial action etc. be used for the pain relieving of cancer and prevent and treat the leukopenia that carninomatosis patient chemotherapy or radiotherapy etc. cause; Prevent capillary hemorrhage, strengthen blood vessel wall with being used to, be used for occasions such as epistaxis, bloody sputum, spitting of blood, hematuria and postoperative hemorrhage.And share the infection disease that is used for refractory that heightens the effect of a treatment with antibiotic.

Background technology

Lysozyme (Lysozyme, Mrcopeptide-N-acetylmuramoylhydrolase, Muramidase, Mucopeptide glycohydrolase, EC3.2.1.17) be human body endogenous organized enzyme, it is widely distributed in the multiple organ-tissues such as people body-centered, liver, spleen, lung, kidney.Wherein the highest with kidney and lung content, hemocyte such as mononuclear cell, macrophage also contain this enzyme, and blood and various secretions etc. are lysozyme all.Lysozyme continues synthetic and secretion by granulocyte and mononuclear cell, because it has stronger bactericidal action and viricidal activity to gram positive bacteria, is a kind of important humoral immunization factor in the human body nonspecific immunity therefore.

Lysozyme is a glycoside hydrolase, and its antibacterial action is by acting on β-1,4 key between N-acetylglucosamine and the-acetylmuramic acid, can making the mucopolysaccharide composition hydrolysis in some bacteria cell wall, thereby have the bacteriolyze ability.The lysozyme antibiotic effect is by β-1,4 glycosidic bond between the N-acetylglucosamine in the cell wall that destroys antibacterial, makes the insoluble mucopolysaccharide of cell wall resolve into the solubility glucosides, causes cell wall rupture, and cellular content is overflowed and made bacterolysis.Lysozyme can also combine with the various acidic materials that bring out inflammation, makes its inactivation.

The lysozyme antivirus action is by combining with electronegative virus protein, form double salt with RNA, DNA, apoprotein, making virally inactivated.The up-to-date result of study of delivering shows: lysozyme anti-HIV-1 type virus mechanism is the same with the RNA enzyme.

Lysozyme also is used to the pain relieving of cancer and prevents and treats the leukopenia that carninomatosis patient chemotherapy or radiotherapy etc. cause.It also has the anti-fibrinolitic effect, is used to prevent capillary hemorrhage, strengthens blood vessel wall, occasions such as epistaxis, bloody sputum, spitting of blood, hematuria and postoperative hemorrhage.

Lysozyme is an endogenous active substance, be one of the extraneous self-defense response mechanism of invading of human body self opposing, nonspecific immunity factor, its enhancing immunity effect is by strengthening macrophage and leukocytic phagocytic function, and improve the leukopenia that cytostatics causes, strengthen the immunity of cell.Lysozyme is a clinical use old medicine for many years, and is the OTC medicine, and the lysozyme raw material that uses clinically all is to extract from Ovum Gallus domesticus album at present, and its safety has obtained the proof of clinical use for many years.

Lysozyme adult maximal dose every day is no more than 4g.By recommended dose, lysozyme is a safety, the less antipyretic analgesic of side effect, anaphylaxiss such as accidental erythra, drug fever, slight bronchospasm.

Lysozyme only has enteric coatel tablets and two kinds of tablets of buccal tablet at present, because lysozyme is a protease, difficulty is absorbed, and onset is slow, and bioavailability is lower.For this reason, we have developed the lysozyme ejection preparation, comprise it being dosage forms such as injection, powder pin, freeze-dried powder, infusion solutions, have solved the existing problem of oral lysozyme.

Summary of the invention

The present invention relates to the new preparation way of lysozyme (acetaminophen).Said preparation is to contain injectable powder and the lyophilized injectable powder that lysozyme 100 μ g-100g/ prop up.Said preparation has solved oral lysozyme tablet, and difficulty is absorbed, and onset is slow, and the problem that bioavailability is lower is for clinical use provides new selection.

Embodiment

Example one: the lysozyme ejection preparation preparation of raw material

From the humanized lysozyme raw material that extracts in Ovum Gallus domesticus album, the Urina Hominis/tear or biological engineering is expressed, through refining purification, the source of reducing phlegm and internal heat, aseptic process through the animal experiment inspection, reaches injection product standard.

Example two: the preparation of lysozyme powder injection

Adopt the injection lysozyme raw material after making with extra care, press the operation of powder pin process, the preparation injectable powder.

Example three: the preparation of lysozyme lyophilized injectable powder

Adopt the injection lysozyme raw material after making with extra care, press the operation of freeze-dried powder process, the preparation lyophilized injectable powder.

Example four: the preparation of lysozyme injection

Adopt the injection lysozyme raw material after making with extra care, press the operation of injection process, the preparation injection.

Example five: the preparation of lysozyme infusion solutions

Adopt the injection lysozyme raw material after making with extra care, press the operation of infusion solutions process, the preparation infusion solutions.

Claims

1, lysozyme ejection preparation mode, the suitable multiple mucosa illness of department of eye that is used for clinically of said preparation is as mucosal inflammations such as treatment chronic paranasal rhinitis, children's's nasal sinusitis, otitis media, allergic rhinitis and stomatitis; Be used for caries prevention, pharyngolaryngitis, lichen planus, secretory otitis media and periodontitis etc.; With the discharge that is used for sticking puss such as the eliminating the phlegm of chronic bronchitis, rhinorrhea and otorrhea and the treatment of ulcerative colitis.And be used for the treatment of viral illness such as herpes zoster, parotitis, chicken chickenpox, hepatitis, influenza, serious acute respiratory disease; With the reparation that is used to comprise the reaction of nonspecific defence infection immunity, hemagglutinative function, gap conjunctive tissue, the biosynthetic metabolism that participates in mucopolysaccharide and antibacterial action etc. be used for the pain relieving of cancer and prevent and treat the leukopenia that carninomatosis patient chemotherapy or radiotherapy etc. cause; Prevent capillary hemorrhage, strengthen blood vessel wall with being used to, be used for occasions such as epistaxis, bloody sputum, spitting of blood, hematuria and postoperative hemorrhage.And share the infection disease that is used for refractory that heightens the effect of a treatment with antibiotic.

2,, it is characterized in that said preparation is to contain the ejection preparation that lysozyme 100 μ g-100g/ prop up according to the preparation of claim 1.

3,, it is characterized in that said preparation is injection, powder pin, freeze-dried powder, infusion solutions according to the preparation of claim 2.

4, according to the preparation of claim 2, it is characterized in that said preparation contain one or more adjuvant or and the drug regimen of excipient, wherein contain the ejection preparation that lysozyme 100 μ g-100g/ prop up.

5,, it is characterized in that said preparation is injection, powder pin, freeze-dried powder, infusion solutions according to the preparation of claim 4.