CN1429558A - Mannosan peptide injection and its preparation and use method - Google Patents
Mannosan peptide injection and its preparation and use method Download PDFInfo
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- CN1429558A CN1429558A CN 03100883 CN03100883A CN1429558A CN 1429558 A CN1429558 A CN 1429558A CN 03100883 CN03100883 CN 03100883 CN 03100883 A CN03100883 A CN 03100883A CN 1429558 A CN1429558 A CN 1429558A
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Abstract
A manna peptide injection for intravenous drip is prepared from manna peptide, isotonic substance and water through preparing an aqueous solution of manna peptide, mixing it with an aqueous solution of isotonic substance, loading in bottle, sealing and sterilizing. The application method of this injection is also disclosed.
Description
Technical field
The present invention relates to drug world, particularly a kind of mannan peptide injection.This mannan peptide injection can directly apply to intravenous drip.The present invention also relates to mannatide injection preparation and using method.
Background technology
Mannatide is a kind of polysaccharose substance that extracts from alpha-Hemolytic streptococcus, and its chemical constitution is α-mannatide, and English name is mannatide, is also referred to as mannan or polyactin (Polyactin A).It generally is to utilize from the isolating alpha-Hemolytic streptococcus of healthy human mouth bottleneck throat (α-hemolytic streptococci) 33
#Bacterial strain gets through ethanol extraction from culture fluid through submerged fermentation.Mannatide is the amorphous powder of white or yellowish odorless, tasteless, mean molecule quantity is 71700, mainly contain polysaccharide (about 85～90%), wherein the ratio of mannose and a small amount of glucose is about 16: 1, and contain protein about 4.5～6.2%, and this mannatide has 15 seed amino acids approximately after hydrolysis, referring to national drug standards WS
1-(X-099)-and 2000Z and Hu Qile etc., Chinese antibiotic magazine, 1991 (2) 151～156.
Now work out mannatide and had following pharmacological action:
1. the effect of body reticuloendothelial system
Reticuloendothelial system (RES) phagocytic function plays an important role in organism immune response, has become one of dominant mechanism of immunization therapy so improve the RES phagocytic function.For example, referring to Hu Qile etc., Chinese antibiotic magazine, 1991 (2) 151-156; Yan Jialin etc., Chinese antibiotic magazine, 1988 (5) 361-364; Zhuan Zhenhua etc., antibiotic, 1982 (2) 80-82.Mannatide can activate body RES phagocytic function, and its effect strengthens along with the increase of dosage and number of times.At the tumor growth animated period, body RES phagocytic function generally descends, and uses after the mannatide, and body RES phagocytic function improves more than 150% immediately, demonstrates tangible tumour immunity effect.
2. to the effect of physical stress function
Stress the causing immunosuppressant of physical property and promote tumor growth.Tumor itself also stress equally have immunosuppressive action with other.But the time-to-live of mannatide significant prolongation animal under high temperature (75 ℃), improve the animal heat-resisting ability; Can significantly increase high temperature and cold (5 ℃) stimulates the content of Vitc in the following animal adrenal gland; Can increase the tumor animal spleen weight.The effect of improvement and enhancing body emergency function is arranged.Referring to, Hu Qile etc., Chinese antibiotic magazine, 1991 (2) 151～156; Zhuan Zhenhua etc., antibiotic, 1982 (4) 249～254.The above-mentioned mannatide that studies show that is used for the treatment of tumour patient, can resist or immunosuppressive action that tumor remission growth itself is produced, recovers the immunocompetence of body, thereby tumor growth is slowed down or stops.
3. to the effect of blood system
Leukocyte has defence and protective effect preferably to body; but present most antitumor drug can not only the direct killing cancerous cell; can also injure organism normal cell simultaneously; particularly particularly outstanding to the influence of bone marrow stem cell; thereby the body leucocyte level is descended, even destroy normal hematopoietic function, weaken the defence capability of body; patient is interrupted, and sb.'s illness took a turn for the worse.The mannan Toplink stimulates and recovers the hemopoietic function of marrow hemopoietic stem cells, keep the body leucocyte level and recover aplastic anemia patient's hemopoietic function, for the treatment tumour patient carry out smoothly and treat aplastic anemia certain guarantee and foundation are provided.Reference, Zhuan Zhenhua etc., antibiotic, 1982 (4) 249～254.
4. to the influence of immunocyte
Macrophage is a kind of important cells in the immunocyte, and it can participate in nonspecific immunity, especially cellular immunization; Play an important role to handling antigen, complement activation etc. simultaneously.The mannan Toplink increases the formation of antigen binding cell, promotes the phagocytosis of macrophage, improves the external lymphocytic conversion ratio of inducing, the human body immunity improving function.Reference, Ceng Xiangyuan etc., Chinese Journal of Hematology, 1987 (9) 531～532; Strong Wenan etc., Chinese antibiotic magazine, 1994 (4) 313～317.Experiment showed, that it can also resist immunosuppressant as caused by chemotherapeutic medicines such as cyclophosphamide, reach the purpose of the immunologic hypofunction of correcting pathogenic or chemotherapy.
Toxicological effect for mannan alcohol studies show that its toxicological effect is very little:
Mouse mainline mannan alcohol, LD
50Be 545mg/kg, lumbar injection LD
50Be 1500mg/kg, every 10 minutes intravenous injection 5mg, 8mg/kg, it was breathed and blood pressure there is no ANOMALOUS VARIATIONS to cat and Canis familiaris L..Rats by intraperitoneal injection 4mg/kg was not seen their feeds, movable unusual, to internal organs pathologic findings such as its heart, liver, spleen, lung, kidney yet no abnormality seen in continuous two months.Mice before the copulation was injected mannan alcohol 7 days continuously, and post-coitum is observed the embryo, does not see that lethal mutation takes place; To pregnant mouse intravenous injection mannan alcohol, do not see teratogenecity.
The clinical practice of mannan alcohol:
1. prevent and the treatment infantile respiratory tract infection repeatedly
Immunologic inadequacy is the common cause that recurrent respiratory tract infection takes place the child.But congenital T, B cell function defective only are minority, clinically be more common in antibacterial, virus or protozoan infection, the application of antibiotic, adrenocortical hormone, and malnutrition etc. causes the secondary immune deficiency state, thus increased the sickness rate of infantile respiratory tract infection repeatedly.Therefore, improve nutriture, promoting body's immunity is the important means of control recurrent respiratory tract infection.Mannatide is that a kind of to have certain active stimulation former, can change the immune state of body.Use mannatide treatment recurrent respiratory tract infection child, clinical total effective rate reaches 95.6%.Serum IgM, IgA level increase after taking medicine, and be very fast with IgM level rising time of occurrence especially, demonstrates curative effect preferably.And in the observation period, do not see toxicity.Referring to, Luo Chunhua etc., West China medical science, 1991 (6) 293.
2. be used for the treatment of leukopenia
Leukocyte is the important composition composition of nonspecific immunity system, in infection, play a part very outstanding, but because the pollution of environment, the use of a large amount of chemical substances, make people's leukocyte that general downward trend be arranged, particularly accept the tumour patient of chemicotherapy, for a long time the person that contacts the radioactive substance leukopenia more so.Mannan alcohol also can make the leukocyte in the reservoir discharge in blood, so can treat leukopenia because leukocytic generation is increased.Have report to treat leukopenia 110 examples with mannan alcohol, total effective rate reaches 88.2%, and drug withdrawal was followed up a case by regular visits to after 6 months, and most of leukocyte are still normal, also have the hemoglobin of increasing and platelet simultaneously, thus the effect of raise immunity.Referring to, Zheng Huajin etc., practical internal medicine magazine, 1991 (2) 80～81.
3. treatment aplastic anemia
Aplastic anemia is marrow hematopoiesis function failure, is reduced to main performance with the whole blood small cell.Its pathogeny is because the minimizing or the abnormal quality of marrow hemopoietic stem cells quantity.Mannatide has protection to hematopoietic stem cell and promotes the function of its growth promoter, and the regeneration that can stimulate hemocytoblast recovers its hemopoietic function, reaches the purpose of treatment aplastic anemia.The clinical practice proof is single treats aplastic anemia with mannatide, total effective rate 77.8%.Short term effect is remarkable, is a kind of safer, convenient, effective aplastic anemia medicine.Referring to, Zheng Huajin etc., Chinese Journal of Hematology, 1991 (5) 256.
4. adjuvant therapy of malignant tumor
Adopt the randomized, double-blind method that 60 routine cancer patients are divided into two groups through No.3 Hospital of Baiqiuen Medical Univ., every group 30 example, carry out thinking that the chemotherapy patients is had the health invigorating effect after the clinical experiment, and can improve cancer patient PS index, total effective rate 76.7%, can prevent to accept chemotherapy cancer patient leukopenia, obviously improve the cancer patient immunity function, change and strengthen ratio as PPD, PHA sun and increase; Improve CP
3, CD
3, the NK cell quantity; And can improve lymhocyte transformation rate, SIL-2R obviously descends.Referring to, Ceng Xiangyuan etc., antibiotic, 1985,10,43～46.
Because the above-mentioned effect of mannatide has been carried out extensive studies to it at home and abroad.The domestic product that is developed to the liquid drugs injection injection from the eighties, list marketing already, and be clinical selected widely, 2000 the end of the year National Drug Administration mannatide tablet, oral liquid, the injection of former local standard are risen to national standard, the standard No. of mannatide is WS
1-XG-053-2000, the standard No. of mannatide sodium chloride injection is WS
1-XG-056-2000.
The research of relevant oral liquid is more, and the patent documentation that should be mentioned in that has: CN93107863.6 is to file an application on June 29th, 1993, and December in 1999 bulletin on the 8th is authorized; CN98124870.5 is to file an application on November 27th, 1998, and on August 21st, 2002, bulletin was authorized; CN98121898.9 is that December in 1998 was filed an application on the 9th, and November 28 calendar year 2001, bulletin was authorized.They are introduced among the application as a reference.
Mannatide is as immunostimulant, because its can enhancing body's immunological function, the phagocytic activity of activating macrophage, rising periphery white blood cell count, improve the stress ability of bone marrow hematogenesis function and body, so be widely used in the auxiliary treatment etc. of immunologic hypofunction, recurrent respiratory tract infection, leukopenia, aplastic anemia and tumor.Its main preparation has oral liquid, tablet, small-volume injection.Yet because drug content is less in the existing dosage form of mannatide, and existing injection mannatide (when referring to use in the adding transfusion) when clinical use causes secondary pollution easily, infusion reaction easily takes place, sometimes also can mistake take place and produce malpractice, so exist heavy dose of and can avoid the needs of the mannatide novel form of secondary pollution.The present invention is devoted to provide a kind of like this mannatide intravenous fluid exactly, and the present invention also provides the method and the using method thereof of a kind of like this mannatide of preparation.
Summary of the invention
One aspect of the present invention has provided a kind of novel mannan peptide injection, and the amount of it is characterized in that is big, and volume is between 50～1000ml, and containing principal agent α-mannatide is 1mg～100mg, can be directly used in the patients clinical transfusion.If the concentration with α-mannatide represents, the concentration of this injection at 1mg/L between the 2000mg/L.According to the specification difference, can also further supply with a plurality of patients and use.
When preparation mannan alcohol injection of the present invention, except principal agent composition α-mannatide, can contain compositions such as sodium chloride, glucose, make it become isosmotic solution so that human body uses.
Second aspect of the present invention provided the new method on a kind of preparation, and this method comprises the ingredient of effective dose and compositions such as glucose or sodium chloride are dissolved in the water, the injection solution that preparation is heavy dose of.Mannan peptide injection with the method for the invention preparation provides novel form clinically.
The method of the invention can be applied in other medicine.If it is less that a kind of medicine belongs to toxic and side effects, can be heavy dose of be applied to patient; Perhaps a kind of medicine has and strengthens patient's immunity or similar effect, can be applied to a plurality of patients, just in hospital or the medicine that has a large amount of consumption characteristics in other medical institutions all can use the method for the invention.Therefore, the scope of application of the method for the invention is not restricted to prepare mannan peptide injection of the present invention, and it can be applied in the preparation of other medicine.
The 3rd aspect of the present invention provided a kind of using method of novelty.For mannan peptide injection recited above, because be the isosmotic solution of high capacity supply, so can needn't dilute preparation directly as transfusion usefulness.The injection of this heavy dose can allow patient use in medical institutions such as hospital, also can allow patient use at home.Make things convenient for patient and medical worker, and removed pollution and the mistake in the dilution from.Owing to be preparation in a large number in factory, it is highly consistent that its concentration can keep, and can control dosage preferably in addition.
Description of drawings
Fig. 1 is preparation technology's flow process of mannan alcohol of the present invention.It also is an embodiment of the method for the invention.
Detailed Description Of The Invention
Term " mannatide ", " mannosan ", " polyactin " and " α-mannosan Peptide ", " mannatide " and english term " α-Polyresistin ", " Polyactin A ", " Streptococel ", " Alphahemolytic " etc. can Alternates, They all refer to mannatide of the present invention. This material is to be used for facing by China at first In the bed, reduce the side effect in the treatment of cancer. Still widely do not know in the Western countries. The strongest medicament for immunity enhancement is thought by China. This is a kind of from first from first type hemolytic A kind of polysaccharose substance that the streptococcus fermentation forms, its polysaccharide part contains take mannose as main A small amount of glucose and other monose contain peptide chain structure in addition. According to coming of mannatide The source difference, the content of mannose wherein and the content of other glycan molecule and arrangement and peptide wherein The The Nomenclature Composition and Structure of Complexes of chain also is difference to some extent. For example, mushroom bacterium mannatide, its polysaccharide Part contains a small amount of glucose take mannose as main, the fucose, galactolipin, wood sugar of trace, Arabinose, and peptide chain is by asparatate, histidine, serine, lysine, paddy ammonia 18 seed amino acids such as acid form. Mannatide of the present invention can be from multiple biology, such as The konjacmannan peptide, yeast mannatide, mushroom bacterium mannatide etc. In calendar year 2001 In the Chinese patent 98121898.9 of November 28 bulletin, the basidiomycete polysaccharide of description, every Basidiomycete polysaccharide, pore fungus polysaccharide, agaric fungi polysaccharide also are to be used for the present invention. Certain mannatide of the present invention also can be composite injection, wherein can comprise several The mannatide of separate sources in order to produce in vivo cooperative effect, produces better effect.
Pharmacological evaluation proves that mannosan alcohol can suppress S-180 sarcoma, Emhorn outside animal body The DNA of the cell lines such as ascites carcinoma and squamous cell carcinoma Tca8113 and RNA synthetic and Glucose metabolism; Can suppress in animal body EC and S-180 sarcoma, HePA liver cancer The growth of ascites tumor (tumour inhibiting rate 63%) can promote peripheral leukocytes, strengthen reticuloendothelial system Phagocytic function, activated macrophage and lymphocyte induce thymic lymphocytes to produce active matter Matter is improved and enhanced machine body immunity function and stress ability. After this product is injected human body, have sharp Swallow sth. raw and whole phagocyte, NK cell, the effect of TB cell subsets; Inducement interferon and interleukin etc. are arranged Effect. Can make the chromosome breakages such as tumour cell, virus, make it apoptosis, can induce multiple effect Answer cell and cell factor to produce " Cocktail of cytokines " effect, the wide spectrum kill virus, cause Germ and wide spectrum are induced apoptosis of tumor. Non-clinical toxicological study shows does not have carcinogenicity, life Grow toxicity, genetoxic and long term toxicity.
Adopt the intravenous injection of Bliss method in Kunming kind small white mouse, single administration, dosage are 675.3～4018.0mg/kg, observe seven days, record LD50Be 1707.0mg/kg; Lumbar injection is in Kunming Kind is little of mouse, and single administration, dosage are 6097.5～11687.5mg/kg, observe seven days, record LD50Be 8041.2mg/kg.
So mannatide is used for the treatment of as immunopotentiator that immunity function lowly causes Various diseases; Can be used for treating various viruses, pathogenic infection; Can treat Recurrent respiratory tract infection, Chronic bronchitis; Can be used for treating alpastic anemia, have increase leucocyte and blood little The effect of plate. Can be used for treating various tumours, with chemotherapy, chemotherapy combined radiotherapy treatment lung cancer, liver cancer, The various tumours such as cancer of the stomach, intestinal cancer, cancer of the esophagus, nasopharyngeal carcinoma, breast cancer, leukaemia have attenuation Synergistic effect in art, the postoperative medication, can reduce recurrence rate, the rate of transform, also is used for the treatment of Thoracic cavity, seroperitoneum and improvement are appeased life in patients and are prolonged life span.
And, complete because mannosan alcohol absorbs soon, can be by body utilization, ginseng after the absorption Metabolic activity with body.
The inventor thinks that mannan alcohol owing to action range, can use, and be applicable to multiple patient, so large usage quantity in multiple disease.Therefore can be prepared into jumbo injection uses for single patient or a group patient.The active drug content of existing injectable powder, tablet, oral liquid, injection is less, and specification is less, and is cumbersome during use.And when using injectable powder in hospital or medical institutions, need preparations such as sodium salt, this can cause secondary pollution, and can be because carelessness causes malpractice.The invention provides a kind of jumbo mannan alcohol injection, can be used for quiet of single patient, perhaps also can once be used for a plurality of patients, this has brought convenience for patient and medical worker.
The inventor directly with jumbo bottle-packaging solution supply, has satisfied patient and medical worker's needs by mannan alcohol is mixed with solution.
Technical process with reference to the accompanying drawings illustrates this method.
In accompanying drawing 1, describe the preparation process of mannatide sodium chloride injection of the present invention in detail.But core of the present invention is to provide a kind of jumbo mannan peptide injection.So the present invention is not limited by the details in the accompanying drawing 1, purpose of the present invention and spirit provide a kind of jumbo mannatide injection, more specifically are a kind of isoosmotic mannatide injection.Exactly mannatide is dissolved in the water, regulates its osmotic pressure, be prepared into heavy dose of solution that can directly use with sodium chloride, glucose etc.So the process shown in the accompanying drawing 1 can have various variations, can omit or increase other step, do not deviate from spirit of the present invention.
This mannan peptide injection contains mannatide and a kind of etc. oozes material, and all the other are water.The grade of adding in the injection of the present invention is oozed one or several the mixture that material can be selected from glucose, sodium chloride, dextran, sorbitol, mannitol.For example, a kind of mannatide and glucose of consisting of of mannan peptide injection of the present invention, all the other are water.Another of mannan peptide injection of the present invention consists of mannatide and glucose, and all the other are water.Certainly under the situation of the effective dose that guarantees mannatide, can use other composition to be mixed with solution with it, also can add the other medicines composition, play synergy.
Its concrete technical process comprises: the sodium chloride of getting injection is formulated as the sodium chloride concentrated solution, the sodium chloride solution such as 20% in right amount with the water of injection.Can certainly further comprise and use an amount of activated carbon adsorption to remove thermal source, this will depend on the situation of above-mentioned each composition and decide.Be heated to then and boil about 15 minutes, filter filtrate for later use.This processing procedure can be carried out with reference to relevant open source literature, and various changes can be made for its details, as long as preparation is fit to the concentrated sodium chloride of injection.
Mannatide is dissolved in water, also is prepared into solution.If solid insoluble is wherein arranged, can filter, keep standby.
The solution that above-mentioned two processes are obtained mixes, and adds the injection water again, is mixed with full dose.Notice that the order of above-mentioned two processes needs not to be certain, sequencing can change, and also can carry out simultaneously.
The solution of above-mentioned gained is filtered, in the infusion bottle of packing into, adopt pressure sterilizing.In one embodiment of the invention, the filtering with microporous membrane that uses 0.22um is to clear and bright, and embedding is rolled lid in the 100ml infusion bottle, 115 ℃ of following 30 minutes pressure sterilizings, wherein heating power value F
o〉=8.
Be lamp inspection and packing then, this is the general step in the pharmacy, is not summary of the invention of the present invention.
For the dissolubility of principal agent mannatide, at national drug standards WS
1Among-the XG-053-2000, its shape description is " this product is easily molten in water ... "; According to the description of two note on the use dissolubility of Chinese Pharmacopoeia version in 2000, its concentration is 1mg/L～2000mg/L.Preferred concentration is 10mg/L～1000mg/L, 100mg/L～500mg/L more preferably, and more preferably concentration is 100mg/L～300mg/L, most preferable concentrations is 100mg/L.
If concentration is 100mg/L, according to national drug standards WS1-(X-099)-2000Z, the ampoule of the mannatide of injection is 5～10mg, and 1～2 time on the one, the specification of mannan peptide injection is 100ml, wherein contains the 10mg mannatide.
In one embodiment of the invention, prepared the water injection that contains that contains mannatide and glucose.Be mannatide injection water wiring solution-forming, and glucose is made into suitable concentrated solution, then above-mentioned two kinds of solution are mixed, add the injection water to requirement with the treatment effective dose.Be filtered to transparently then, embedding is rolled lid in infusion bottle, pressure sterilizing.The condition of pressure sterilizing is 115 ℃ of temperature, and pressure is 1.5kg/cm
2, 30 minutes time.Various variations for this process also are included within the scope of the present invention as previously mentioned.
The content of the mannatide in every or the every bottle of injection is 1mg～1000mg.Its specification is every or every bottled mannan peptide injection of the present invention that 30ml～100ml is arranged.
Mannan peptide injection of the present invention is applicable to multiple disease of treatment or sufferer, especially is suitable for the treatment of immunodeficiency illness, all kinds of intractable virus infection, gynecological diseases.
The high capacity mannan peptide injection stable in properties for preparing does not above contain hazardous substance, and clarity is good.In use, do not need to use diluent or lytic agent.The patient can be in and directly use.In addition, because be the medicine that one kind of multiple diseases can be used, so can use one bottle of injection to a plurality of patients in hospital or other medical institutions, these usings method are that those skilled in the art are known.
Be the present invention to be described in more detail below with embodiment.Data described in the embodiment and condition only are case histories of the invention process, can various variations be arranged to it, and this does not deviate from the spirit and scope of the present invention yet.As, what those skilled in the art understood is such, and the present invention only is subjected to the restriction of claims.
Embodiment
Embodiment 1
The preparation specification is the mannan peptide injection of 100ml, wherein contains mannatide 10mg, sodium chloride 0.9g.
Prescription or prescription are:
Mannatide (by dry product) 0.1g
Sodium chloride 9.0g
Water for injection adds to 1000ml
Wherein mannatide is the principal agent of this product, and sodium chloride is isoosmotic adjusting agent.
Process:
Get the recipe quantity sodium chloride for injection and add the injection water and be made into about 20% sodium chloride concentrated solution in right amount, add proper amount of active carbon and stir, be heated to about 15mm that boils, filtration, filtrate for later use.
Get the recipe quantity mannatide and add the injection water and make dissolving in right amount, filter, filtrate.
Above-mentioned two solution merging is added the injection water to recipe quantity, and extremely clear and bright with the filtering with microporous membrane of 0.22um, embedding is rolled lid in the 100ml infusion bottle, 115 ℃ of 30min pressure sterilizing (heating power value F
o〉=8).
Lamp inspection is packed then.
Preparation technology's flow chart is referring to accompanying drawing 1.
The principal element of influence prescription comprise principal agent dissolubility, character, clarity, insoluble granule.Principal agent mannan alcohol is soluble in water, in every 100ml water, can dissolve the mannan up to 100mg.
This product principal agent is white or little yellow amorphous powder, and odorless is tasteless, soluble in water, and three batches of the mannatide sodium chloride injections that above-mentioned technical process is mixed with are used 010210-21 respectively, and 010210-22 and 010210-23 represent.The color and luster and the character that detect its heat run front and back change.Heat run adopts sterilising conditions, and promptly temperature is 115 ℃, and the time is 30 minutes.The result sees following table:
Mannatide sodium chloride injection character experimental result
Lot number 010210-21 010210-22 010210-23
Achromatism and clarity achromatism and clarity achromatism and clarity before the heating
Heating back achromatism and clarity achromatism and clarity achromatism and clarity
This product is through heating (temperature is 115 ℃, and the time is 30 minutes) as can be known from the above table, and the color and luster before and after the test does not change.This illustrates that the prepared mannatide sodium chloride injection character of this technology is stable.
Embodiment 2
The preparation specification is the mannan peptide injection of 100ml, wherein contains mannatide 10mg, glucose 5g.
Prescription or prescription are:
Mannatide (by dry product) 0.1g
Glucose 50g
Water for injection adds to 1000ml
Wherein mannatide is the principal agent of this product, and glucose is an isoosmotic adjusting agent.
Process:
Get the recipe quantity glucose and add the injection water and be made into about 20% glucose concentrated solution in right amount, add proper amount of active carbon and stir, be heated to about 15mm that boils, filtration, filtrate for later use.
Get the recipe quantity mannatide and add the injection water, filter, get filtrate to recipe quantity.
Above-mentioned two solution merging is added the injection water to recipe quantity, and extremely clear and bright with the filtering with microporous membrane of 0.22um, embedding is rolled lid in the 100ml infusion bottle, 115 ℃ of 30min pressure sterilizing (heating power value F
o〉=8).
Lamp inspection is packed then.
Preparation technology's flow chart is referring to accompanying drawing 1.
The principal element of influence prescription comprise principal agent dissolubility, character, clarity, insoluble granule.Principal agent mannan alcohol is soluble in water, in every 100ml water, can dissolve the mannan up to 100mg.
This product principal agent is white or little yellow amorphous powder, and odorless is tasteless, soluble in water, three batches of the mannatide glucose injections that above-mentioned technical process is mixed with, and the color and luster and the character that detect before and after its heat run change, and method is referring to embodiment 1.The result shows that the color and luster before and after the test does not change.This illustrates that the prepared mannatide glucose injection character of this technology is stable.
Claims (17)
1. mannan peptide injection, wherein contain mannatide, wait and ooze material, all the other are water, it is characterized in that: wherein the concentration of contained mannatide is 1mg/L～2000mg/L in injection, and the volume of the described injection of adorning is 50～1000ml in every or every bottle.
2. mannan peptide injection as claimed in claim 1, wherein said grade ooze one or several the mixture that material is selected from glucose, sodium chloride, dextran, sorbitol, mannitol.
3. mannan peptide injection as claimed in claim 1 or 2, wherein said mannatide can be selected from one or several in alpha streptococcus mannatide, konjacmannan peptide, yeast mannatide and the Lentinus Edodes mannatide.
4. mannan peptide injection as claimed in claim 1 or 2 has the purposes of the intravenous drip medicine that is used for human body.
5. mannan peptide injection as claimed in claim 3 has the purposes of the intravenous drip medicine that is used for human body.
6. method of producing mannan peptide injection as claimed in claim 1, comprising mannatide is made into aqueous solution, ooze the material aqueous solution with grade, be distributed into every or every bottle specification that contains the described mixture of 50～1000ml, roll lid, pressure sterilizing.
7. method as claimed in claim 6 when wherein said mannatide is made into aqueous solution, is to add water for injection to recipe quantity in the mannatide of recipe quantity.
8. when method as claimed in claim 6, wherein said grade are oozed material and be made into aqueous solution, be to add water for injection in the material to recipe quantity waiting to ooze.
9. method as claimed in claim 7 wherein is made into mannatide after the aqueous solution, may further include: stir the adding active carbon, and the described solution of heated and boiled, and the process filtration obtains filtrate.
10. when method as claimed in claim 8, wherein said grade are oozed material and be made into aqueous solution, may further include filtration.
11. method as claimed in claim 6, the condition of wherein said pressure sterilizing is: 115 ℃ of temperature, pressure are 1.5kg/cm
2, 30 minutes time.
12. the mannan peptide injection with the method for claim 1 preparation is characterized in that, wherein contains mannatide, waits and oozes material, all the other are water.
13. mannan peptide injection as claimed in claim 12, its concentration is 1mg/L～2000mg/L, and the volume of the described injection of adorning is 50～1000ml in every or every bottle.
14. mannan peptide injection as claimed in claim 13, its concentration is 10mg/L～1000mg/L, and the volume of the described injection of adorning is 50～1000ml in every or every bottle.
15. mannan peptide injection as claimed in claim 14, its concentration is 100mg/L～500mg/L, and the volume of the described injection of adorning is 50～1000ml in every or every bottle.
16. mannan peptide injection as claimed in claim 15, its concentration is 100mg/L～300mg/L, and the volume of the described injection of adorning is 50～1000ml in every or every bottle.
17. the using method of mannan peptide injection as claimed in claim 12 is characterized in that: needn't dilute with other solution and water during use.
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| CN100360179C (en) * | 2003-12-31 | 2008-01-09 | 赵恒� | Medicine for treating infantile anorexia |
| CN100408087C (en) * | 2003-12-31 | 2008-08-06 | 西安亨通光华制药有限公司 | Medicine for treating bronchial asthma |
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| CN100413510C (en) * | 2005-01-05 | 2008-08-27 | 成都利尔药业有限公司 | Mannosan peptide injection and preparation method thereof |
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