CN103340853B - Compound 18-amino acid injection containing little amount of antioxidant and preparation method thereof - Google Patents
Compound 18-amino acid injection containing little amount of antioxidant and preparation method thereof Download PDFInfo
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- CN103340853B CN103340853B CN201310250245.5A CN201310250245A CN103340853B CN 103340853 B CN103340853 B CN 103340853B CN 201310250245 A CN201310250245 A CN 201310250245A CN 103340853 B CN103340853 B CN 103340853B
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Abstract
The invention relates to a compound 18-amino acid injection containing a little amount of antioxidant and a preparation method thereof. The injection contains 0.0005w/v% to 0.005w/v% of sodium hydrogen sulfite or sodium metabisulfite or mixture which is compounded with 18 kinds of amino acids and water for injection, wherein the content of dissolved oxygen in the injection is not greater than 0.1ppm (parts per million). The preparation method comprises the following steps of: 1) preparing: putting 18 kinds of compound amino acids, the sodium hydrogen sulfite or the sodium metabisulfiteor or the mixture into a tank by filling nitrogen ceaselessly under the conditions that content of oxygen in the tank is lower than 0.1% and the content of the dissolved oxygen contained in the injection is not greater than 0.1ppm; 2) filling and sealing; and 3) sterilizing. By optimizing a production process, the oxygen content of a medicine liquid and the oxygen content of a headspace are reduced fundamentally, so that the content of the sodium bisulfite/the sodium metabisulfite which is added for ensuring that the medicine liquid is not oxidized is reduced. Thus, the compound amino acid injection which can be well tolerated by a patient is produced, namely, the safety of the injection is improved. Therefore, the phenomenon that a sufficient dose of the injection cannot be accepted by the patient because the patient is worry about toxic and side effects is avoided. As a result, the injection provided by the invention has the great significance for guaranteeing the living and the life quality of the patient.
Description
Technical field
The present invention relates to a kind of 18 compound amino acid injection, relate in particular to a kind of 18 compound amino acid injection containing a small amount of antioxidant.
Background technology
The elementary cell of protein structure is aminoacid.Human body need to be taken in a certain amount of protein to meet the needs of vital movement every day, in the time cannot taking in q.s from gastrointestinal tract because of certain reason, just must input Freamine Ⅲ by vein supplements, Amino Acid Compound Injection (18AA) is very important amino acid supplements and therapeutic agent, plays an important role clinically.
Aminoacid is very unstable in solution, very easily oxidized and produce the harmful material of series of complex.From 20 world's amino acids sixties put into production use, for ensureing the stability of product, must add the sulphite compounds with unique antioxidant properties, as sodium sulfite, sodium pyrosulfite etc.Due to people, also not understand at that time this type of material harmful, thereby manufacturing enterprise is in order to ensure the stability of product, and without stint adds in a large number conventionally.But from the eighties in 20th century, along with the development of clinical pharmacy, pharmacology and medical science, people start to recognize the side effect of sulfites material and aspect the safety of sulphite, have carried out comparatively deep research.Meanwhile, the pharmaceutical control and administration authorities of western developed country also step up to collect countercharging of relevant clinical adverse.Modal relevant side reaction is sulphite allergy clinically, and symptom is bronchospasm, stridulate, and dyspnea, pernicious, laryngeal edema, hypotension, shock, even dead.
To the mid-80, sulphite is familiar with fully to the toxic and side effects of human body.Countries in the world are limited its application in medicine and food one after another for this reason.As the permission daily intaking amount (ADI) of sulphite in foods is restricted to about 0.7mgSO in western countries
2/ kg body weight, the people who is equivalent to 70 kilogram weights takes in sodium sulfite/sodium pyrosulfite of 80mg.China contains 0.2g～1.0g to being defined as in 1000ml product of the sulphite content in Amino Acid Compound Injection, basic identical with international standard.
Per day for adults need to be inputted 500～1000ml amino acid injection can meet physiological need.Taking in Freamine Ⅲ containing sodium sulfite/sodium pyrosulfite of 500mg/L as example, be forced to accept the sulphite than many 6～7 times of oral permission intake input 1000ml is amino acid whose simultaneously.Therefore, patient and doctor, in the face of awkward selection, reduce the use amount of amino acid injection if reduce the generation of toxic and side effects, and can not reach should be effective in cure.
For now, the oxidation resistance of sulphite can not be substituted in Amino Acid Compound Injection (18AA); With regard to prior art condition, also cannot output not contain or contain the few Amino Acid Compound Injection (18AA) of sulphite.
Summary of the invention
For above deficiency, the invention provides a kind of containing the few 18 compound amino acid injection of antioxidant, thereby make in meeting human body requirements, the toxic and side effects of human body is dropped to bottom line.
The present invention achieves the above object by following scheme:
A kind of 18 compound amino acid injection containing a small amount of antioxidant, contain sodium sulfite or sodium pyrosulfite or its mixture that percent weight in volume is 0.0005-0.005%, compound recipe 18 seed amino acids, water for injection, in described injection, dissolved oxygen content is no more than 0.1ppm.
In a preferred embodiment, also comprise adjuvant containing the 18 compound amino acid injection of a small amount of antioxidant.
In another preferred embodiment, above-mentioned is sorbitol or xylitol or glucose or fructose or two or more mixture wherein containing the adjuvant comprising in the 18 compound amino acid injection of a small amount of antioxidant, and sodium hydroxide or potassium hydroxide or its mixture.
In a preferred embodiment, be 5% or 12% containing the percent weight in volume content of compound recipe 18 seed amino acids that comprise in the 18 compound amino acid injection of a small amount of antioxidant.
Prepare the method containing the 18 compound amino acid injection of a small amount of antioxidant, comprise the following steps:
1) preparation: add water for injection in material-compound tank, open vacuum, make vacuum in tank reach-0.085～0.09 MPa, be filled with the nitrogen of purity 99.99% to normal pressure, repeatable operation is to ensureing in tank that oxygen content is lower than 0.1%, in injection, be no more than 0.1ppm containing dissolved oxygen, in the situation that constantly filling nitrogen, water for injection is heated to 80～85 DEG C, drop into compound recipe 18 seed amino acids, percent weight in volume is 0.0005～0.005% sodium sulfite or sodium pyrosulfite or its mixture, be stirred to dissolve, benefit injects water to amount of preparation, add needle-use activated carbon, stir, be back to clear and bright through the de-charcoal of titanium rod filter,
2) embedding: injection is filtered rear fill is sealed after evacuation-fill nitrogen;
3) sterilizing.
In a preferred embodiment, preparation is filled into the method containing the 18 compound amino acid injection of a small amount of antioxidant in non-PVC-soft-bag, still adopts above-mentioned step 1), above-mentioned step 2) and step 3) be respectively:
2) embedding: injection is filled in non-PVC-soft-bag after 0.22 micron filter filters is sealed after evacuation-fill nitrogen;
3) sterilizing: adopt with evacuation-the fill sterilizing cabinet sterilizing of nitrogen, sterilising temp is 115 DEG C～125 DEG C, sterilization time 8～40 minutes, open vacuum, make vacuum in cabinet reach-0.085～0.09 MPa, be filled with the nitrogen of purity 99.99% to normal pressure, repeatable operation three times, ensures in tank that oxygen content is lower than 0.1%;
Also comprise step 4), for:
4) cover outer bag: by the good product of sterilizing, pack in barrier bag, put into oxygen absorbent simultaneously, seal after evacuation-inflated with nitrogen.
In another embodiment, be also that preparation is filled into the method that contains the 18 compound amino acid injection of a small amount of antioxidant in non-PVC-soft-bag, the method has added the step of a cover outer bag between embedding and sterilizing, is specially:
Step 1) preparation is identical with above-mentioned steps;
2) embedding: injection is filled in non-PVC-soft-bag after 0.22 micron filter filters is sealed after evacuation-fill nitrogen;
3) cover outer bag: by the non-PVC-soft-bag of the good injection of embedding, pack in barrier bag and put into oxygen absorbent, sealing after evacuation-inflated with nitrogen;
4) sterilizing: sterilising temp is 115 DEG C-125 DEG C, sterilization time 8-40 minute.
In another embodiment, preparation is filled into the method containing the 18 compound amino acid injection of a small amount of antioxidant of glass infusion bottle, and the method still adopts above-mentioned step 1), but step 2) embedding and step 3) sterilizing be respectively:
2) fill: injection pours in glass infusion bottle after 0.22 micron filter filter with evacuation-fill nitrogen mode to ensure to enter without air in liquid, is sealed in embedding after evacuation-fill nitrogen;
3) sterilizing: sterilising temp is 115 DEG C～125 DEG C, sterilization time 8～40 minutes.
Preferably, the step 1) of above-mentioned ownership Preparation Method is:
1) preparation: add water for injection in material-compound tank, open vacuum, make vacuum in tank reach-0.085～0.09 MPa, be filled with the nitrogen of purity 99.99% to normal pressure, repeatable operation three times, to oxygen content in tank lower than 0.1%, in solution, be no more than 0.1ppm containing dissolved oxygen, constantly filling in nitrogen situation, water for injection is heated to 80～85 DEG C, add compound recipe 18 seed amino acids, sorbitol or xylitol or glucose or fructose or wherein two or more mixture, percent weight in volume is sodium sulfite or sodium pyrosulfite or its mixture of 0.0005-0.005%, be stirred to dissolve, regulating pH value with sodium hydroxide or potassium hydroxide or its mixture is 5.0-7.0, benefit injects water to amount of preparation, add needle-use activated carbon, stir, be back to clear and bright through the de-charcoal of titanium rod filter, for ensure in tank oxygen content lower than 0.1% and solution in be no more than 0.1ppm containing dissolved oxygen, employing evacuation-fill nitrogen repeatable operation to complete.
Further preferred, above-mentioned steps 1) in the percent weight in volume content of compound recipe 18 seed amino acids that add be 5% or 12%.
Sorbitol, xylitol, glucose, fructose are as the energy substance of human body, can play the effect that maintains heat, after inputting with aminoacid simultaneously, can obviously improve amino acid whose metabolism, for the synthetic energy that provides of protein, suppress the different glycogenic waste of aminoacid, aminoacid can be utilized by body fully.Sodium hydroxide, sodium hydroxide, as pH adjusting agent, can be controlled in suitable scope (5.0～7.0) pH value of amino acid injection by compound recipe, ensure amino acid whose stable.Sodium pyrosulfite/sodium sulfite, as antioxidant, is to control oxygen content and the stable important leverage of guarantee aminoacid in medicinal liquid.
Amino Acid Compound Injection (18AA) proper mass standard is recorded in " ministry of Health of China drug standard " two six biochemical drug first fascicles and " the drug standard WS1-XG-002-2011 of State Food and Drug Administration ", its sodium sulfite/sodium pyrosulfite amount is 0.4～0.5g/L, and the sodium sulfite, the sodium pyrosulfite amount that in Amino Acid Compound Injection of the present invention (18AA), comprise are only 0.005-0.05g/L.Difference is just that the content of wherein contained sodium sulfite, sodium pyrosulfite antioxidant is only like product 1/100th to 1/10th, thereby has better safety, lower toxic and side effects.
Injection products of the present invention is not to replace sulphite with another kind of antioxidant simply, but fundamentally solved the crux factor-oxygen that affects Amino Acid Compound Injection (18AA) stability, thereby solve puzzlement Amino Acid Compound Injection (18AA) manufacturing industry difficult problem for many years.Inventor finds under study for action, if the aminoacid in solution state with the oxygen of denier once contact, just can inspire amino acid whose oxidative decomposition, after this this chemical reaction just can go on automatically, might not need the continuous participation of extraneous oxygen.Although therefore solution is sealed in infusion bottle, product can constantly decompose, and cannot use until rotten.
Meaning of the present invention is by optimizing production process, reduce medicinal liquid oxygen content and head space oxygen content from root, thereby be reduced to the sodium sulfite/pyrosulfurous acid sodium content that ensures that medicinal liquid is not oxidized and add, so in injection sodium sulfite/pyrosulfurous acid sodium content far away the end in national standard, and have enough safeties, producing can be the Amino Acid Compound Injection (18AA) of the fine tolerance of patient.In this product, the content of sodium sulfite/sodium pyrosulfite is 0.0005～0.005%, in 1000ml solution, contains 5-50mg, is equivalent to the 0.01-0.1 of national standard.In per day for adults input 1000ml this product, the intake of sulphite is only 5-50mg, far below the day of the 80mg of developed country allowing intake.Thereby improved widely the safety of product, patient needn't worry can not accept because there is toxic and side effects the treatment of sufficient dosage, and the life and the quality of life that ensure patient are had to great meaning.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is further described.
Embodiment 1:
Amino Acid Compound Injection (18AA)
Amino acid w/v: 5%
Table 1
The formula of embodiment 1: (containing in every 1000ml injection)
Preparation process:
1) preparation: add water for injection in material-compound tank, open vacuum, make vacuum in tank reach-0.085～0.09 MPa, be filled with the nitrogen of purity 99.999% to normal pressure, repeatable operation three times, ensure in tank that oxygen content is lower than 0.1%, in solution, must not exceed 0.1ppm containing dissolved oxygen, ensure constantly to fill in nitrogen situation, water for injection is heated to 80～85 DEG C, drop into compound recipe 18 seed amino acids in above-mentioned table 1, sorbitol, xylitol, sodium sulfite is stirred to dissolve, with sodium hydroxide, potassium hydroxide regulates pH value, benefit injects water to amount of preparation, add needle-use activated carbon, stir, be back to clear and bright through the de-charcoal of titanium rod filter.For ensure in tank oxygen content lower than 0.1% and solution in must not exceed 0.1ppm containing dissolved oxygen, can adopt evacuation-fill nitrogen repeatable operation to complete.
2) embedding: medicinal liquid pours in non-PVC-soft-bag after 0.22 micron filter filter is sealed after evacuation-fill nitrogen.
3) sterilizing: adopt with evacuation-fill the sterilizing cabinet sterilizing of nitrogen, sterilising temp is 115 DEG C～125 DEG C sterilization times 8～40 minutes.Open vacuum, make vacuum in cabinet reach-0.085～0.09 MPa, be filled with the nitrogen of purity 99.99% to normal pressure, repeatable operation three times, makes the interior oxygen content of tank lower than 0.1%.
4) cover outer bag: by the non-PVC-soft-bag of amino acid injection good sterilizing, pack in barrier bag and put into oxygen absorbent, sealing after evacuation-inflated with nitrogen.
Embodiment bis-
Amino Acid Compound Injection (18AA)
Amino acid w/v: 12%
Table 2
The formula of embodiment 2: (containing in every 1000ml injection)
Preparation process:
1) preparation: add water for injection in material-compound tank, open vacuum, make vacuum in tank reach-0.085～0.09 MPa, be filled with the nitrogen of purity 99.999% to normal pressure, repeatable operation three times, ensure in tank that oxygen content is lower than 0.1%, in solution, must not exceed 0.1ppm containing dissolved oxygen, ensure constantly to fill nitrogen, water for injection is heated to 80～85 DEG C, drop into compound recipe 18 seed amino acids in above-mentioned table 2, fructose, sodium pyrosulfite is stirred to dissolve, with sodium hydroxide, potassium hydroxide regulates pH value, benefit injects water to amount of preparation, add needle-use activated carbon, stir, be back to clear and bright through the de-charcoal of titanium rod filter.For ensure in tank oxygen content lower than 0.1% and solution in must not exceed 0.1ppm containing dissolved oxygen, can adopt evacuation-fill nitrogen repeatable operation to complete.
2) embedding: solution pours in non-PVC-soft-bag after 0.22 micron filter filter is sealed after evacuation-fill nitrogen.
3) cover outer bag: by the non-PVC-soft-bag of amino acid injection good sterilizing, pack in barrier bag and put into oxygen absorbent, sealing after evacuation-inflated with nitrogen.
4) sterilizing: sterilising temp is 115 DEG C～125 DEG C, sterilization time 8～40 minutes.
Embodiment tri-
Amino Acid Compound Injection (18AA) (glass infusion bottle)
Amino acid w/v: 12%
Table 3
The formula of embodiment 3: (containing in every 1000ml injection)
Preparation process:
1) preparation: add water for injection in material-compound tank, open vacuum, make vacuum in tank reach-0.085～0.09 MPa, be filled with the nitrogen of purity 99.999% to normal pressure, repeatable operation three times, ensure in tank that oxygen content is lower than 0.1%, in solution, must not exceed 0.1ppm containing dissolved oxygen, ensure constantly to fill nitrogen, water for injection is heated to 80～85 DEG C, drop into compound recipe 18 seed amino acids in above-mentioned table 3, sorbitol, xylitol, glucose, fructose, sodium sulfite, sodium pyrosulfite is stirred to dissolve, with sodium hydroxide, potassium hydroxide regulates pH value, benefit injects water to amount of preparation, add needle-use activated carbon, stir, be back to clear and bright through the de-charcoal of titanium rod filter.For ensure in tank oxygen content lower than 0.1% and solution in must not exceed 0.1ppm containing dissolved oxygen, can adopt evacuation-fill nitrogen repeatable operation to complete.
2) embedding: solution pours in glass infusion bottle after 0.22 micron filter filter is sealed after evacuation-fill nitrogen.
3) sterilizing: sterilising temp is 115 DEG C～125 DEG C, sterilization time 8～40 minutes.
Embodiment 4:
Effect test is measured
The low antioxidant Amino Acid Compound Injection (18AA) of preparing in embodiment 1-3 is measured after influence factor's test and investigation test steady in a long-term, and it the results are shown in following table:
Table 4: test determination result
The above; it is only preferably specific embodiment of the present invention; but protection scope of the present invention is not limited to this; any be familiar with those skilled in the art the present invention disclose technical scope in; be equal to replacement or changed according to technical scheme of the present invention and design thereof, all should be encompassed in protection scope of the present invention.
Claims (4)
1. prepare the method containing the 18 compound amino acid injection of a small amount of antioxidant, it is characterized in that, comprise the following steps:
1) preparation: add water for injection in material-compound tank, open vacuum, make vacuum in tank reach-0.085～0.09 MPa, be filled with the nitrogen of purity 99.99% to normal pressure, repeatable operation three times, to oxygen content in tank lower than 0.1%, in solution, be no more than 0.1ppm containing dissolved oxygen, constantly filling in nitrogen situation, water for injection is heated to 80～85 DEG C, add compound recipe 18 seed amino acids, sorbitol or xylitol or fructose or wherein two or more mixture, percent weight in volume is 0.0005% sodium sulfite, be stirred to dissolve, regulating pH value with sodium hydroxide or potassium hydroxide or its mixture is 5.0-7.0, benefit injects water to amount of preparation, add needle-use activated carbon, stir, be back to clear and bright through the de-charcoal of titanium rod filter, for ensure in tank oxygen content lower than 0.1% and solution in be no more than 0.1ppm containing dissolved oxygen, employing evacuation-fill nitrogen repeatable operation to complete,
2) embedding: injection is filtered rear fill is sealed after evacuation-fill nitrogen;
3) sterilizing;
Described prepare containing the 18 compound amino acid injection of a small amount of antioxidant, contain percent weight in volume and be 0.0005% sodium sulfite, compound recipe 18 seed amino acids, water for injection, in described injection, dissolved oxygen content is no more than 0.1ppm;
Described 18 compound amino acid injection is:
In every 1000ml injection, comprise:
2. a kind of method of preparing containing the 18 compound amino acid injection of a small amount of antioxidant as claimed in claim 1, is characterized in that described step 2) and step 3) be respectively:
2) embedding: injection is filled in non-PVC-soft-bag after 0.22 micron filter filters is sealed after evacuation-fill nitrogen;
3) sterilizing: adopt with evacuation-the fill sterilizing cabinet sterilizing of nitrogen, sterilising temp is 115 DEG C～125 DEG C, sterilization time 8～40 minutes, open vacuum, make vacuum in cabinet reach-0.085～0.09 MPa, be filled with the nitrogen of purity 99.99% to normal pressure, repeatable operation three times, ensures in tank that oxygen content is lower than 0.1%;
Also comprise step 4), for:
4) cover outer bag: by the good product of sterilizing, pack in barrier bag, put into oxygen absorbent simultaneously, seal after evacuation-inflated with nitrogen.
3. a kind of method of preparing containing the 18 compound amino acid injection of a small amount of antioxidant as claimed in claim 1, is characterized in that, also comprises and be specially the step of overlapping outer bag between described embedding and sterilizing:
2) embedding: injection is filled in non-PVC-soft-bag after 0.22 micron filter filters is sealed after evacuation-fill nitrogen;
3) cover outer bag: by the non-PVC-soft-bag of the good injection of embedding, pack in barrier bag and put into oxygen absorbent, sealing after evacuation-inflated with nitrogen;
4) sterilizing: sterilising temp is 115 DEG C-125 DEG C, sterilization time 8-40 minute.
4. a kind of method of preparing containing the 18 compound amino acid injection of a small amount of antioxidant as claimed in claim 1, is characterized in that described step 2) embedding and step 3) sterilizing is respectively:
2) fill: injection pours in glass infusion bottle after 0.22 micron filter filter with evacuation-fill nitrogen mode to ensure to enter without air in liquid, is sealed in embedding after evacuation-fill nitrogen;
3) sterilizing: sterilising temp is 115 DEG C～125 DEG C, sterilization time 8～40 minutes.
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| CN106083220A (en) * | 2016-06-13 | 2016-11-09 | 湖北航天杜勒制药有限公司 | A kind of big tree nutritional solution compositing acid solution and processing technology thereof |
| CN107693805A (en) * | 2017-08-31 | 2018-02-16 | 芜湖杨燕制药有限公司 | A kind of sterilization process of insect-expelling saligna injection liquid |
| CN113332239B (en) * | 2021-07-07 | 2022-10-18 | 上海葆隆生物科技有限公司 | Adrenaline hydrochloride injection and preparation method thereof |
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| CN1370524A (en) * | 2002-03-06 | 2002-09-25 | 华瑞制药有限公司 | Lovamin and its prepn process |
| CN102145009A (en) * | 2010-12-29 | 2011-08-10 | 山东鲁抗辰欣药业有限公司 | Octadeca compound amino acid injection and preparation method thereof |
| CN102302489A (en) * | 2011-07-14 | 2012-01-04 | 青岛华仁药业股份有限公司 | Preparation method of compound amino acid injection |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1370524A (en) * | 2002-03-06 | 2002-09-25 | 华瑞制药有限公司 | Lovamin and its prepn process |
| CN102145009A (en) * | 2010-12-29 | 2011-08-10 | 山东鲁抗辰欣药业有限公司 | Octadeca compound amino acid injection and preparation method thereof |
| CN102302489A (en) * | 2011-07-14 | 2012-01-04 | 青岛华仁药业股份有限公司 | Preparation method of compound amino acid injection |
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