CN1981870A - Invert-sugar powdery injection and its production - Google Patents
Invert-sugar powdery injection and its production Download PDFInfo
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- CN1981870A CN1981870A CN 200510022298 CN200510022298A CN1981870A CN 1981870 A CN1981870 A CN 1981870A CN 200510022298 CN200510022298 CN 200510022298 CN 200510022298 A CN200510022298 A CN 200510022298A CN 1981870 A CN1981870 A CN 1981870A
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Abstract
An invertose powder injection is prepared from glucose and pectose through preparing aseptic pectose, preparing aseptic glucose, sterilizing tubular bottle, sterilizing butyl rubber plug, mixing aseptic pectose with aseptic glucose to become invertose, loading in aseptic tubular bottle, sealing, and packing.
Description
Technical field
The present invention relates to invert-sugar powdery injection and preparation method.
Background technology
In recent years, along with improving constantly of clinical treatment development of technology and living standards of the people, clinical demand to the saccharide transfusion increases rapidly.Yet for a long time, China's saccharide transfusion kind is single, and glucose infusion liquid is always in occupation of leading position.Though glucose infusion liquid has important effect clinically, it also has many shortcomings, and for example: big, the glucose of patient's blood glucose fluctuation runs off many, powerless etc. to patient that insulin resistant is arranged behind the infusion through urine.At present, developed a series of saccharide transfusions such as Nulomoline, xylitol abroad, wherein, the Nulomoline transfusion has been subjected to clinical high praise day by day with its obvious advantage that is shown in the saccharide transfusion.
The Nulomoline transfusion liquid that to be fructose form by 1 to 1 mixed with glucose.As parenteral alimentation agent and pharmaceutical diluents, Nulomoline is infused except common moisturizing, energy supply effect, reaches in anti-sealing, the electrolytical loss in safety to have remarkable advantages.
Summary of the invention
Invert srgar inj is the infusion solution that is mixed and made into by the glucose of equivalent and fructose, the mechanism of action of its mechanism of action and glucose and fructose is similar, can produce and single energy that equates with glucose, fructose wherein can make glucose be utilized by body quickly.All kinds of disease patients that surgical patient and other should not directly be taken food, coming makeup energy by the venoclysis nutritional solution is the clinical mode that must and often adopt.Glucose is clinical the most frequently used energy supplement agent, but the venoclysis glucose often causes fluctuating widely of blood sugar for human body level; And blood sugar content maintains certain level, and particularly the normal functional activity of cerebral tissue is very important to guaranteeing each histoorgan of human body.
Nulomoline transfusion metabolic advantage in vivo comprises fructose metabolism and glucose metabolism two parts.The mixture of glucose and fructose has following three big advantages in the intravital metabolism of people: 1, start metabolic pathway rapidly.Fructose starts the liver metabolism path rapidly after going into blood, in self metabolic while, has also accelerated glucose metabolism, and glucose then directly enters cell, and both additions are improved human body energy at short notice.2, walk around the insulin resistant link.Glucose in a large number, infusion in short-term, make that insulin sharply raises in the blood, and there is insulin resistant in some patient, makes effectively metabolism of glucose, causes the water of blood glucose big ups and downs and hypertonicity, electrolyte to lose on the contrary.The fructose metabolic pathway is not influenced by insulin, has walked around the insulin resistant link, thereby energy effectively is provided.3, form blood glucose slow release storehouse.Glucose in the Nulomoline can improve the blood glucose balance of body rapidly, and after fructose enters human body, except that energy is provided, can also be converted into glycogen to store, and becomes blood glucose slow release storehouse, and discharges to guarantee the stable of blood glucose with slow speed.
The advantage of Nulomoline transfusion clinical practice: provide energy rapid, blood glucose fluctuation is little, the energy supply longer duration.
Application in particular patients ': in some special disease patient, use the Nulomoline transfusion and have the incomparable advantage of glucose infusion liquid: 1. various wounds, the patient who burns and undergo surgery.Operation, burn wound and other stress due to lose blood, Hypovolemia and histanoxia, can cause that corresponding stress takes place neuroendocrine system, secretion such as body catecholamines neurotransmitter, glucocorticoid, glucagon increases, and insulin secretion then reduces
Also can produce insulin resistant in various degree simultaneously.In the input glucose process, must be noted that input speed, also want supplementation with insulin simultaneously, to improve the utilization of body, prevent hyperglycemia to glucose.By comparison, the transfusion of input Nulomoline can avoid occurring hyperglycemia or hypoglycemia problem, thereby safety and reliability.2. diabetics.Diabetics after gastrointestinal surgery, still needs makeup energy under some specific condition, in view of Nulomoline in the advantage of stablizing aspect blood glucose, the blood sugar control peak value, so the Nulomoline transfusion is the most desirable selection of diabetics.
Invert srgar inj (invert sugar injection) is mixed and made into by glucose and fructose equimolecular, has and glucose and similar metabolic characteristic and the effect of fructose, extensive use abroad at present, list marketing at home.
Injection Nulomoline (invert sugar for Injection) is the aseptic powder injection that glucose and the fructose by equivalent is mixed and made into, and these product belong to invert srgar inj and change agent and be chemistry registration classification five classes.Its stability and packed and transported all have clearly advantage than invert srgar inj, are the kinds that has future in the present supplementary that has gone on the market most.Abroad, secular checking has been passed through in the Nulomoline transfusion, its safety has gained public acceptance with the advantage that is had on anti-sealing, electrolyte loss, believes that China's saccharide transfusion level also will be improved along with the expansion of Nulomoline transfusion in China's clinical practice.
The pharmacokinetics characteristics of these product are: when 1, giving sheep infusion fructose or glucose separately, the half-life of glucose was respectively 16 minutes and 19 minutes, and fructose is 20 minutes; After the venoclysis Nulomoline transfusion, the half-life of Fructus Vitis viniferae is respectively 35 minutes and 25 minutes, fructose is 16 minutes.2, behind the Nulomoline solution that to give 6 Beagle Canis familiaris L. venoclysis concentration be 200g/L (1.0 or 0.5g/kg body weight), studied the half-life of glucose and fructose.The mean half-life of glucose is that 7.8 (changing between 6.0-13.5) are divided, and fructose is that 7.5 (changing between 4.5-11.0) are divided.After the transfusion of infusion Nulomoline, can cause lactic acid and the rising temporarily in the physiology limited field of acetone acid concentration in the blood, insulin concentration also one is crossed the property rising in the blood plasma, and free fatty acid levels reduces.3,42 masterhand's postoperative patients are 2610 caloric transfusions by 24 hours gross energy of parenteral approach acceptance, 10% Nulomoline by central vein line infusion 1500ml, except serum AST of short duration, a property crossed and AF rising, do not find important metabolism disorder.
Untoward reaction: it is reported that invert srgar inj may draw will and blush anaphylaxiss such as rubella, heating.Heavy dose of, fast infusion invert srgar inj may cause lactic acidosis and hyperuricemia.Long-term simple use can cause electrolyte disturbance.
Usage and dosage: intravenous drip, consumption needs to decide on the state of an illness.Adult's usual amounts is each 12.5g-50g.Drip velocity should be lower than 0.5g/kg/hr (in fructose).
The specification of invert srgar inj of having gone on the market at home is: 250ml: fructose 6.25g and glucose 6.25g.The specification of fructose for injection is 12.5g; 25g.We select specification is that every bottle of 12.5g injection Nulomoline is developed.
Eventually the above, invert srgar inj, it is rapid that the energy of providing is provided, blood glucose fluctuation is little, the clinical practice advantage of energy supply longer duration.The metabolic characteristic that it combines fructose and glucose has alleviated patient's metabolism burden, helps the recovery of disease.Its safety has been passed through secular checking with the advantage that is had on anti-sealing, electrolyte loss, obtained generally acknowledging.Chinese Journal of New Drugs and Clinical Remedies has reported that invert srgar inj has the safety suitable with glucose injection.
So these product have good clinical value to the medical industry of China.Quality standard is that the standard of formulating with reference to " invert srgar inj " and " injection Nulomoline " standard of declaring (draft) is carried out Quality Control.Through looking into no administrative protection of these product of new proof and Intellectual Property Rights Issues, declare production by medicine registration classification 5 classes.We have finished every research work by chemical drugs registration classification 5 classes and have declared at present.
Description of drawings
Fig. 1 moisture equilibrium at dry side curve chart
Preparation technology's flow chart of the aseptic fructose of Fig. 2
Preparation technology's flow chart of the aseptic glucose of Fig. 3
Aseptic fructose of Fig. 4 and the composite Nulomoline packing of aseptic glucose process chart
The specific embodiment
The inventor further describes the present invention in detail by embodiment.
Embodiment 1 injection Nulomoline prescription is determined
1, Nulomoline prescription
Prescription (specification: 12.5g)
1000 bottles
Fructose 6250g
Glucose 6250g
2, compound basis
1) selection of the definite and specification of dosage form
Injection Nulomoline (invert sugar for Injection) is the aseptic powder injection that glucose and the fructose by equivalent is mixed and made into, and these product belong to invert srgar inj and change agent and be chemistry registration classification five classes.
The specification of invert srgar inj of having gone on the market at home is: 250ml: fructose 6.25g and glucose 6.25g.The specification of fructose for injection is 12.5g; 25g.We select specification is that every bottle of 12.5g injection Nulomoline is developed.
2, prescription screening
According to the researching and analysing of domestic listing product invert srgar inj and the clinical operating position of fructose for injection, in addition should product specification big, determine these product not add any adjuvant in filling a prescription.This product is to get aseptic fructose and aseptic glucose feed through essence baking bag aseptic crystallization technology respectively with fructose and glucose feed, directly carries out aseptic subpackaged one-tenth injection Nulomoline again.Its quality of injection Nulomoline through the test of many times preparation meets " injection Nulomoline " quality standard draft.
Embodiment 2 injection Nulomoline Study on Preparation
Physicochemical property research
For for direct aseptic subpackaged raw material, requirement is the drug powder that is applicable to packing.At first should be appreciated that the physicochemical property of this medicine, to formulate rational production technology.
1, bulk density
To transform the glycogen powder and be filled in the graduated cylinder, and make vibration by certain mode, with the guarantee test term harmonization, favorable reproducibility, the micropowder volume of amount is tried to achieve bulk density by quality and volume.We measure its bulk density to injection Nulomoline (040901 batch).
Method: the consumption wound packages is gone into a certain amount of former medicated powder end, beats gently for several times, surveys its weight and volume.
Result: bulk density=0.72 (g/ml)
Result of the test: unit volume micropowder quality can satisfy the volumetrical requirement of packing of its specification fully.
2, the flowability of powder
The fineness of crude drug powder is related to medicine packing uniformity and weight differential, so the flowability of the crude drug powder of this product is investigated.Adopt the fixed funnel method to measure the drug powder mobility status, generally with representing angle of repose.We measure injection Nulomoline (040901 batch).
Method: get the former medicated powder of this product end in right amount, it is flowed down through funnel, funnel has certain distance with two dish, makes the turriform that is nature in the two again dish of its powder, measures the height of bullet.Calculate its angle (angle of repose).
Result: angle of repose=31.9 °
Result of the test: the good fluidity of this former powder meets the requirement of packing.Sample content uniformity through packing is up to specification.
3, moisture equilibrium at dry side test
It is an amount of that precision takes by weighing this product, places 8 uncovered flat bottles in 60 ℃ of drying under reduced pressure to constant weight respectively, spreads out＜thin layer of 5mm, and accurate the title decide weight, places the exsiccator of 8 different humidity more respectively, places after 10 days for 25 ℃, and moisture absorption is increased weight constant relatively.Accurate then title is fixed, is vertical coordinate with the moisture absorption weightening finish, is the abscissa mapping with the relative humidity.Obtaining critical relative humidity is more than 79.5%.Illustrate that this product has hygroscopicity, the production environment relative humidity should be controlled at below 75%.The results are shown in Table 1, Fig. 1.
Table 1 moisture equilibrium at dry side result of the test
| RH％ | 30 | 40 | 58 | 66 | 75 | 80 | 92.5 | 95 |
| Rate of body weight gain (%) | 1.13 | 0.024 | 0.88 | 2.77 | 6.35 | 12.40 | 24.56 | 32.67 |
The moisture equilibrium at dry side curve chart is seen Fig. 1
By the research to aseptic conversion glycogen powder physicochemical property, its result shows: aseptic conversion glycogen powder unit volume micropowder quality can satisfy the volumetrical requirement of packing of its specification fully; The fineness of its crude drug powder is moderate, and good fluidity can satisfy medicine packing uniformity fully.Three batches of injection Nulomoline sample content uniformity through packing meet the requirements, and the results are shown in Table 2.
Table 2 injection Nulomoline content uniformity result
Preparation technology
1, raw material is prepared
The preparation of aseptic fructose: injection fructose raw material is placed the interlayer retort, add 2% active carbon and stirred 15 minutes, remove by filter active carbon.Filtrate is after the 0.45um aseptic filtration, and the bucket formula filter through 0.22um filters once again, and the flat-panel filter with 0.22um filters at last.Filtrate concentrates with membrane evaporator, puts and continues to be concentrated into anhydrous steaming in the rotary evaporator, and the dense syrup of this fructose adds the ethanol of equivalent, the dissolving that refluxes of heating in water-bath.Under 8 ℃ ± 2 ℃ conditions behind the crystallisation by cooling, vacuum filtration.With behind the absolute ethanol washing the fructose crystallization, vacuum drying under 70 ℃ of conditions, aseptic fructose, pulverized 60 mesh sieves again, the former powder of aseptic fructose, packing after entirely examining.
The preparation of aseptic glucose: the injection glucose feed is placed the interlayer retort, add 2% active carbon and stirred 15 minutes, remove by filter active carbon.Filtrate is after the 0.45um aseptic filtration, and the bucket formula filter through 0.22um filters once again, and the flat-panel filter with 0.22um filters at last.Under 8 ℃ ± 2 ℃ conditions behind the crystallisation by cooling, vacuum filtration.With gained glucose crystallization behind the absolute ethanol washing, vacuum drying under 70 ℃ of conditions, get aseptic glucose, pulverized 60 mesh sieves again, get aseptic Fructus Vitis viniferae glycogen powder, packing after full inspection.
The injection container: the control injection bottle that the container of injection Nulomoline is made by the hard neutral density glass, cover and be butyl rubber plug.Its quality meets the quality standard of execution.
(1) aseptic process of control injection bottle
The washing of pressurized jet air water method is adopted in the steaming and decocting of pouring water earlier again.Open the tunnel sterilizing oven, 250～355 ℃ of sterilizing-dryings of temperature.
(2) butyl rubber plug aseptic process
Carry out sterilization treatment by disposable butyl rubber plug sterilizing methods, with 121 ℃ of moist heat sterilizations 1 hour.
(3) aluminium lid adopts ozone sterilization, 100 ℃ of sterilising temps, 1 hour.
2, packing
In the high cleaning sterilizing room, carry out packing according to the GMP aseptic manipulation.Divide and to install the back bottle and jump a queue immediately and seal with aluminium lid.(100 grades of fills, 10000 grades in other zone)
3, check
Every index is tested, and lamp inspection is adopted in inspection of foreign substance.
4, packing
Product through being up to the standards is signed at packing workshop inner poster, packing.
Technological process
Preparation technology's flow process of aseptic fructose is seen Fig. 2;
Preparation technology's flow process of aseptic glucose is seen Fig. 3;
Aseptic fructose and the composite Nulomoline packing of aseptic glucose process chart are seen Fig. 4;
Embodiment 3 injection Nulomoline influence factors test
This test is by " two appendix XI of Chinese pharmacopoeia version in 2000 XC medicine stability test guideline design; Test specimen meets the regulation of guideline.Because three lot numbers of this product, three specifications are all aseptic subpackaged and get by a collection of raw material respectively.Therefore, our a specification sample selecting a lot number for use is that influence factor's test is carried out in representative.
(1) sample: 031201 batch of (specification: 0.75g) experiment date: 2003.12.20～2004.1.5; The duration of test room temperature: 15 ℃～22 ℃, relative humidity: 55%～80%
(2) test item: the inspection of appearance luster, loss on drying, acid-base value, clarity of solution and color, pyridine and polymer, related substance, carbonate content, content and sign content.
(3) detection method: undertaken by declaration material 10 described every assay methods.
1, strong illumination test
The exposure experiments to light method of this product: get the sample of three specifications of this product, put into the flat weighing botle respectively, spread out＜thin layer of 5mm, place the light cupboard interior from the irradiation of daylight lamp 3cm place, illuminance 4200Lx.In sampling in 5,10 days, carry out the inspection of each gainer, the results are shown in table 3.Illumination 10 days, loss on drying slightly increases, and content and other every indexs have no significant change.
Table 3 injection Nulomoline light durability result of the test
| Time (my god) | Outward appearance | Solution colour | Clarity | Acid-base value | Loss on drying (%) | Pyridine (%) | Polymer (%) | Related substance (%) | Content (%) | Indicate content (%) |
| 0 | White powder | Up to specification | Clarification | 6.58 | 12.97 | 0.03 | Do not detect | 0.29 | 97.4 | 101.8 |
| 5 | White powder | Up to specification | Clarification | 7.59 | 13.36 | - | - | 0.48 | 97.2 | - |
| 10 | White | Meet | Clarification | 7.07 | 13.63 | 0.03 | Not inspection | 0.35 | 97.2 | - |
| Powder | Regulation | Go out |
2, hot test
It is an amount of to get this product, places flat weighing botle (not adding a cover), spreads out＜thin layer of 5mm, puts into 40 ℃, 60 ℃ calorstat respectively, detects every index in sampling in 5,10 days, the results are shown in Table 4, table 5.Data show, place 10 days down for 40 ℃, and content and other index have no significant change; Placed 10 days for 60 ℃, pyridine, polymer and related substance all have increase, and content also decreases.
40 ℃ of heat stabilization test results of table 4 injection Nulomoline
| Time (my god) | Outward appearance | Solution colour | Clarity | Acid-base value | Loss on drying (%) | Pyridine (%) | Polymer (%) | Related substance (%) | Content (%) | Indicate content (%) |
| 0 | White powder | Up to specification | Clarification | 6.58 | 12.97 | 0.03 | Do not detect | 0.29 | 97.4 | 101.8 |
| 5 | White powder | Up to specification | Clarification | 6.97 | 13.12 | - | - | 0.30 | 97.4 | - |
| 10 | White powder | Up to specification | Clarification | 6.97 | 13.14 | 0.03 | The end detects | 0.45 | 97.2 | - |
60 ℃ of heat stabilization test results of table 5 injection Nulomoline
| Time (my god) | Outward appearance | Solution colour | Clarity | Acid-base value | Loss on drying (%) | Pyridine (%) | Polymer (%) | Related substance (%) | Content (%) | Indicate content (%) |
| 0 | White powder | Up to specification | Clarification | 6.58 | 12.97 | 0.03 | Do not detect | 0.29 | 97.4 | 101.8 |
| 5 | White powder | Up to specification | Clarification | 7.15 | 12.54 | - | - | 0.92 | 96.3 | - |
| 10 | White powder | Up to specification | Clarification | 7.17 | 12.70 | 0.03 | Do not detect | 2.41 | 95.4 | - |
3, high wet test
It is an amount of to get this product, puts in the flat weighing botle and (does not add a cover), spreads out＜thin layer of 5mm, and accurate the title decided weight, places the close drying device of relative humidity 75% (containing saturated NaCl aqueous solution) and 92.5% (containing saturated KNO3 aqueous solution) respectively, 25 ℃ of constant temperature.Detect every index in sampling in 5,10 days, the results are shown in Table 6, table 7.Data show, place 10 days in above-mentioned two kinds of humidity environments, and this product increases weight 6.35% and 24.56% respectively, have draw more by force moist.Simultaneously, sample decomposes, and pyridine and polymer content all have increase, and related substance respectively increases by 5.72% and 20.45%, and content has reduced by 6.9% and 22.4%.
Table 6 injection Nulomoline relative humidity 75% result of the test
| Time (my god) | Outward appearance | Solution colour | Clarity | Acid-base value | Weightening finish (%) | Pyridine (%) | Polymer (%) | Related substance (%) | Content (%) | Indicate content (%) |
| 0 | White powder | Yellow No. 3 | Clarification | 6.58 | - | 0.03 | Do not detect | 0.29 | 97.4 | 101.8 |
| 5 | White powder | Yellow No. 2 | Clarification | 4.68 | 4.45 | - | - | 2.64 | 94.5 | - |
| 10 | White powder | Low yellow No. 3 | Clarification | 4.75 | 6.35 | 0.03 | Do not detect | 6.01 | 90.5 | - |
Table 7 injection Nulomoline relative humidity 92.5% result of the test
| Time (my god) | Outward appearance | Solution colour | Clarity | Acid-base value | Weightening finish (%) | Pyridine (%) | Polymer (%) | Related substance (%) | Content (%) | Indicate content (%) |
| 0 | White powder | Yellow No. 3 | Clarification | 6.58 | - | 0.03 | The end detects | 0.29 | 97.4 | 101.8 |
| 5 | White powder | Yellow No. 3 | Clarification | 4.75 | 17.19 | - | - | 5.89 | 92.2 | - |
| 10 | White powder | Low yellow No. 7 | Darker than No. 1 turbidity | 4.78 | 24.56 | 0.03 | Do not detect | 20.74 | 75.0 | - |
The study on the stability of embodiment 4 injection Nulomolines diluent compatibility commonly used
With this product 1.0～2.0g, after 10ml water for injection dissolving back reuse 100～200ml sodium chloride injection and the dilution of 5% glucose injection, measure solution purity behind placement 1h, 2h, the 4h, the results are shown in following table 8, table 9.
The study on the stability that table 8 sodium chloride injection diluent solution is placed
| Standing time (h) | Peak area | Purity (%) |
| 0 | 5147356 | 98.42 |
| 1 | 5199148 | 98.57 |
| 2 | 5154149 | 98.78 |
| 4 | 5202015 | 98.75 |
The study on the stability that table 9 5% glucose injection diluent solution is placed
| Standing time (h) | Peak area | Purity (%) |
| 0 | 5282302 | 98.72 |
| 1 | 5377548 | 98.56 |
| 2 | 5352112 | 98.96 |
| 4 | 5290147 | 97.93 |
The result shows: these two kinds of solution that diluent is made into, and complete stability in 4h, not having tangible impurity peaks increases.The usage (quiet time require to drip off in 30 minutes～60 minutes) of abideing by the kind of having gone on the market is perfectly safe.
Conclusion: in sum, ceftazidime for inj is stable to light; To heat (more than 40 ℃) instability; To wet extremely unstable (relative humidity 75% and 92.5%), have draw more by force moist.As long as temperature and humidity is controlled well, the prescription of ceftazidime for inj and technology are feasible.
With this prescription and prepared three batches of ceftazidime for inj, according to clinical application product quality draft standard check every index all meet the requirements (seeing Table 10) show that further this Recipe is feasible.
Table 10 injection Nulomoline three batch sample quality inspection results
| The sample lot number | Outward appearance | Solution colour | Clarity | Acid-base value | Loss on drying (%) | Pyridine (%) | Polymer (%) | Related substance (%) | Content (%) | Indicate content (%) |
| 040901 | White powder | Yellow No. 3 | Clarification | 6.58 | 12.97 | 0.03 | Do not detect | 0.29 | 97.5 | 101.8 |
| 040902 | White powder | Yellow No. 3 | Clarification | 6.56 | 13.12 | 0.03 | Do not detect | 0.28 | 97.4 | 101.3 |
| 040903 | White powder | Yellow No. 3 | Clarification | 6.61 | 13.06 | 0.03 | Do not detect | 0.29 | 97.5 | 101.7 |
Claims (2)
1, a kind of invert-sugar powdery injection, it consists of fructose 6.25g, glucose 6.25g.
2, a kind of preparation method of invert-sugar powdery injection, its processing step is as follows:
The preparation technology of A, the former powder of aseptic fructose:
I, the fructose raw material is placed the interlayer retort, add 2% active carbon and stirred 15 minutes, remove by filter active carbon.Filtrate is after the 0.45um aseptic filtration, and the bucket formula filter through 0.22um filters again, and the flat-panel filter with 0.22um filters at last.
II, filtrate concentrate with membrane evaporator, put and continue to be concentrated into anhydrous steaming in the rotary evaporator, get the dense syrup of fructose
III, the dense syrup of fructose add the ethanol of equivalent, the dissolving that refluxes of heating in water-bath.Under 8 ℃ ± 2 ℃ conditions behind the crystallisation by cooling, vacuum filtration.
IV, with behind the absolute ethanol washing the fructose crystallization, vacuum drying under 70 ℃ of conditions, aseptic fructose, pulverized 60 mesh sieves again, the former powder of aseptic fructose.
The preparation technology of B, aseptic Fructus Vitis viniferae glycogen powder:
I, glucose feed is placed the interlayer retort, add 2% active carbon and stirred 15 minutes, remove by filter active carbon.Filtrate is after the 0.45um aseptic filtration, and the bucket formula filter through 0.22um filters once again, and the flat-panel filter with 0.22um filters at last.
Under II, 8 ℃ ± 2 ℃ conditions behind the crystallisation by cooling, vacuum filtration.
III, with gained glucose crystallization behind the absolute ethanol washing, vacuum drying under 70 ℃ of conditions, aseptic glucose, pulverized 60 mesh sieves again, aseptic Fructus Vitis viniferae glycogen powder.
C, packing technology
The aseptic Fructus Vitis viniferae glycogen powder and the former powder equal proportion of aseptic fructose that make are mixed, pack into through the system injection bottle of aseptic process, with the butyl rubber plug and the aluminium lid sealing of aseptic process, check, packing at high cleaning sterilizing room branch.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101810585A (en) * | 2010-04-21 | 2010-08-25 | 陶灵刚 | Invertose (fructose/glucose) medicinal composition microsphere injection |
| CN101716181B (en) * | 2009-11-10 | 2011-09-14 | 陶灵刚 | Invert sugar medicament composition liposome injection and new application thereof |
| CN102379882A (en) * | 2011-03-10 | 2012-03-21 | 海南美好西林生物制药有限公司 | Invert sugar and injection medicinal preparation prepared from same |
| CN103520192A (en) * | 2013-10-25 | 2014-01-22 | 海南通用康力制药有限公司 | Invert sugar freeze-dried powder preparation for injection and preparation method thereof |
-
2005
- 2005-12-15 CN CN 200510022298 patent/CN1981870A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101716181B (en) * | 2009-11-10 | 2011-09-14 | 陶灵刚 | Invert sugar medicament composition liposome injection and new application thereof |
| CN101810585A (en) * | 2010-04-21 | 2010-08-25 | 陶灵刚 | Invertose (fructose/glucose) medicinal composition microsphere injection |
| CN101810585B (en) * | 2010-04-21 | 2012-02-15 | 陶灵刚 | Invertose (fructose/glucose) medicinal composition microsphere injection |
| CN102379882A (en) * | 2011-03-10 | 2012-03-21 | 海南美好西林生物制药有限公司 | Invert sugar and injection medicinal preparation prepared from same |
| CN103520192A (en) * | 2013-10-25 | 2014-01-22 | 海南通用康力制药有限公司 | Invert sugar freeze-dried powder preparation for injection and preparation method thereof |
| CN103520192B (en) * | 2013-10-25 | 2015-06-10 | 海南通用康力制药有限公司 | preparation method of invert sugar freeze-dried powder preparation for injection |
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