CN102085180B - Dobutamine hydrochloride injection and preparation method thereof - Google Patents
Dobutamine hydrochloride injection and preparation method thereof Download PDFInfo
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- CN102085180B CN102085180B CN201110028874A CN201110028874A CN102085180B CN 102085180 B CN102085180 B CN 102085180B CN 201110028874 A CN201110028874 A CN 201110028874A CN 201110028874 A CN201110028874 A CN 201110028874A CN 102085180 B CN102085180 B CN 102085180B
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Abstract
The invention relates to a dobutamine hydrochloride injection which contains the following constituents: 10.0-30.0g of dobutamine hydrochloride, 0.4-1.2mg of cysteine hydrochloride, 10.0-30.0g of mannitol and the balance of water for injection for supplementing to the total volume of 2000ml. The invention also relates to a preparation method of the dobutamine hydrochloride injection, which has the advantages of simple process, good quality stability of prepared products and high clinical safety.
Description
Technical field
The invention belongs to field of medicaments, particularly relate to a kind of dobutamine hydrochloride aqueous injection and preparation method thereof.
Background technology
1. general introduction
Dobutamine hydrochloride is a kind of shock vasoactive drug and improves heart and brain circulation medicine; The clinical heart failure that myocardial contraction descends and causes when being used for organic heart disease; LOS due to comprising after the cardiac operation under direct vision is as short-term Supporting Therapy.The preparation specification is: 2ml:20mg.
The molecular formula of dobutamine hydrochloride is C
18H
23NO
3HCl, molecular weight is 337.85, molecular structure is following:
2. the Technology present situation of dobutamine hydrochloride injection
English name: DOBUTAMINE HYDROCHLORIDE INJECTION.
Dobutamine hydrochloride in aqueous solution through 115 ℃, the general instability in 35min sterilization back.
2.1 the formulation and technology of dobutamine hydrochloride injection in the prior art
(1) prescription is formed: dobutamine hydrochloride; Glucose; Sodium sulfite; Water for injection.
(2) production technology: get glucose and be dissolved in the hot water for injection, transfer pH to 3.8～4.0, add the needle-use activated carbon about 0.1%, boil 15-20min with the 1.0mol/L hydrochloric acid solution; Take off charcoal while hot, add an amount of water for injection, add dobutamine hydrochloride, sodium sulfite again, dissolving; Regulate pH to 3.5～4.0 with 20% hydrochloric acid, add the injection water, add 0.01% needle-use activated carbon, stirred about 15 minutes to capacity; Left standstill 30 minutes, and used 0.45 μ m successively, 0.22 μ m filtering with microporous membrane, sampling and measuring pH value and content; After qualified, embedding, in 100 ℃, 30min sterilization, visible foreign matters is checked, packs, is promptly got after the assay was approved.
2.2 the problem that exists
(1) product that makes of above-mentioned formulation and technology; Found in the long-term study on the stability through 2 years at normal temperatures, separate out flaky crystal easily, dobutamine hydrochloride content reduces (decreasing by more than 10%); Exceed the scope of labelled amount 90.0%～110.0%, unstable product quality is described.
(2) the dobutamine hydrochloride injection in process of production, the pressure sterilizing method of employing is 100 ℃ of down sterilization 30min, fails to reach the aseptic assurance level (F of existing injection with small volume
0>=8).
Summary of the invention
1. the present invention's technical problem that will solve
Improve through prescription adjustment, production technology, make the dobutamine hydrochloride injection both can adopt F
0>=8 pressure sterilizing technologies satisfy aseptic assurance level, can guarantee the quality stability of dobutamine hydrochloride injection simultaneously again, thereby improve clinical application safety.
2. the technical scheme that the present invention adopted
Dobutamine hydrochloride aqueous injection of the present invention contains following component: dobutamine hydrochloride 10.0-30.0g; Cysteine hydrochloride 0.4-1.2mg; Mannitol 10.0-30.0g; Water for injection adds to 2000ml.
Preferably, described dobutamine hydrochloride aqueous injection contains following component: dobutamine hydrochloride 10.0-20.0g; Cysteine hydrochloride 0.4-0.8mg; Mannitol 10.0-20.0g; Water for injection adds to 2000ml.
More preferably, described dobutamine hydrochloride aqueous injection contains following component: dobutamine hydrochloride 20.0g; Cysteine hydrochloride 0.8mg; Mannitol 20.0g; Water for injection adds to 2000ml.
The present invention also provides the method for preparing of described dobutamine hydrochloride aqueous injection, and this method comprises the steps:
1) preparation: the cysteine hydrochloride that takes by weighing recipe quantity dissolves with 800-1000ml water for injection; The mannitol that adds recipe quantity; Be stirred to dissolving fully; Add the needle-use activated carbon of 0.15%-0.3% (is the percentage composition on basis with the solution weight) again, be heated to 70-75 ℃ and stir 15-30min, filtering decarbonization must be filtrated; Get the recipe quantity dobutamine hydrochloride, add the dissolving of 600-800ml water for injection, get solution; Merge gained filtrating and solution, add water for injection, transfer pH to 3.0～3.3, use 0.8 μ m, 0.22 μ m filtering with microporous membrane successively, get medicinal liquid with the hydrochloric acid solution of 0.1mol/L to 2000ml;
2) embedding: medicinal liquid is carried out the inflated with nitrogen embedding;
3) sterilization, leak detection: the product to after the embedding is sterilized, is hunted leak;
4) lamp inspection, packing: the visible foreign matters of inspection product under 1000lx-1500lx illumination, qualified back packing obtains finished product.
Preferably; Step 1) is: the cysteine hydrochloride that takes by weighing recipe quantity dissolves with 800-900ml water for injection; The mannitol that adds recipe quantity is stirred to dissolving fully, adds the needle-use activated carbon of 0.15%-0.2% (is the percentage composition on basis with the solution weight) again; Be heated to 72-74 ℃ and stir 15-20min, filtering decarbonization must be filtrated; Get the recipe quantity dobutamine hydrochloride, add the dissolving of 600-700ml water for injection, get solution; Merge gained filtrating and solution, add water for injection, transfer pH to 3.0～3.3, use 0.8 μ m, 0.22 μ m filtering with microporous membrane successively, get medicinal liquid with the hydrochloric acid solution of 0.1mol/L to 2000ml.
More preferably; Step 1) is: the cysteine hydrochloride that takes by weighing recipe quantity dissolves with 900ml water for injection; The mannitol that adds recipe quantity is stirred to dissolving fully, adds the needle-use activated carbon of 0.2% (is the percentage composition on basis with the solution weight) again; Be heated to 73 ℃ and stir 20min, filtering decarbonization must be filtrated; Get the recipe quantity dobutamine hydrochloride, add the dissolving of 700ml water for injection, get solution; Merge gained filtrating and solution, add water for injection, transfer pH to 3.0～3.3, use 0.8 μ m, 0.22 μ m filtering with microporous membrane successively, get medicinal liquid with the hydrochloric acid solution of 0.1mol/L to 2000ml.
Preferably, step 3) is at the 110-120 ℃ of 35-40min that sterilizes down, and sterilization pressure is 0.143-0.199MPa, adopts the leak detection of color water, rinses well.
More preferably, step 3) is at 115 ℃ of 35min that sterilize down, and sterilization pressure is 0.169MPa, adopts the leak detection of color water, rinses well.
The shelf-life of dobutamine hydrochloride aqueous injection of the present invention is 2 years.
In a preferred embodiment, through prescription and process modification, the dobutamine hydrochloride injection descends through content behind the pressure sterilizing and is no more than 2.0%, and pH value, visible foreign matters, related substance etc. all meet the national drug standards simultaneously.The result sees table 1.
Table 1 dobutamine hydrochloride injection is through the variation of content, pH value behind the pressure sterilizing
3. technique effect of the present invention
(1) prescription and preparing process improvement: the cysteine hydrochloride of selecting for use in the prescription is stabilizing agent, is antioxidant again, can improve the stability of dobutamine hydrochloride injection; Select mannitol and dobutamine hydrochloride hydrogen bond association in the prescription for use, help the stable of dobutamine hydrochloride solution; After adding needle-use activated carbon, needn't boil, only need be heated to 70-75 ℃ of stirring 15-30min and get final product, avoid temperature too high the effective ingredient structural damage; Medicinal liquid transfers pH can make dobutamine hydrochloride and cysteine hydrochloride more stable with the hydrochloric acid solution of 0.1mol/L, in the slant acidity environment of pH value 3.0～3.3, also helps stablizing of dobutamine hydrochloride molecular structure in addition.
(2) dosing technology improves: medicinal liquid embedding process adopts the inflated with nitrogen embedding, but deaeration is oxidized to avoid oxygen in the dobutamine hydrochloride ingress of air as far as possible.
(3) the present invention has overcome dobutamine hydrochloride injection in the prior art and can not adopt 115 ℃, the defective of 35min pressure sterilizing, has solved the problem of aseptic assurance level.Through prescription adjustment and process modification; Improved the heat stability of dobutamine hydrochloride, guaranteed that product still can be in steady statue through behind the pressure sterilizing, is improved the aseptic level that guarantees of product; Thereby reach the clinical safety that can improve product, can guarantee the purpose that it is stable again.
The specific embodiment
Following examples are used to explain the present invention, but are not used for limiting scope of the present invention.Under the situation that does not deviate from the present invention's spirit and essence, modification or replacement to the inventive method, step or condition are done all belong to scope of the present invention.
Embodiment 1
Lot number 090816; 1000 bottles of output
1. write out a prescription and method for preparing
1.1 prescription
Dobutamine hydrochloride 10.0g; Cysteine hydrochloride 0.4mg; Mannitol 10.0g; Water for injection adds to 2000ml.
1.2 method for preparing
(1) preparation: take by weighing the 0.4mg cysteine hydrochloride with the dissolving of 800ml water for injection, add 10.0g mannitol, be stirred to dissolving fully, add 0.15% needle-use activated carbon again, be heated to 72 ℃ and stir 15min, filtering decarbonization must be filtrated; Get the 10.0g dobutamine hydrochloride, add the dissolving of 600ml water for injection, get solution; Merge gained filtrating and solution, benefit adds to the full amount of water for injection, and transfers pH to 3.3 with the hydrochloric acid solution of 0.1mol/L, uses 0.8 μ m, 0.22 μ m filtering with microporous membrane successively, gets medicinal liquid.
(2) embedding: medicinal liquid is after the sampling detection is qualified, and defective products is chosen in the inflated with nitrogen embedding at any time in the embedding process, and the intermediate products after the embedding are sent in the sterilization leak detection cabinet.
(3) sterilization, leak detection: intermediate products adopt 120 ℃, 40min sterilization, and sterilization pressure is 0.143MPa, and the leak detection of color water after rinsing well, is delivered between turnover.
(4) lamp inspection, packing: intermediate products are checked a visible foreign matters by propping up under 1500lx illumination, qualified back lettering, packing.
Preparation specification: 2ml:10mg.
Packing specification: box/part in 10/capsule * 10 capsules/middle box * 10.
2. complete of product detects, and the result shows that product meets the national drug standards fully, sees table 2.
Table 2 lot number 090816 testing result
Embodiment 2
Lot number 090818; 1000 bottles of output
1. write out a prescription and method for preparing
1.1 prescription
Dobutamine hydrochloride 20.0g; Cysteine hydrochloride 0.8mg; Mannitol 20.0g; Water for injection adds to 2000ml.
1.2 method for preparing
(1) preparation: take by weighing the 0.8mg cysteine hydrochloride with the dissolving of 900ml water for injection, add 20.0g mannitol, be stirred to dissolving fully, add 0.2% needle-use activated carbon again, be heated to 73 ℃ and stir 20min, filtering decarbonization must be filtrated; Get the 20.0g dobutamine hydrochloride, add the dissolving of 700ml water for injection, get solution; Merge gained filtrating and solution, benefit adds to the full amount of water for injection, and transfers pH to 3.2 with the hydrochloric acid solution of 0.1mol/L, uses 0.8 μ m successively, and 0.22 μ m filtering with microporous membrane gets medicinal liquid.
(2) embedding: medicinal liquid is after the sampling detection is qualified, and defective products is chosen in the inflated with nitrogen embedding at any time in the embedding process, and the intermediate products after the embedding are sent in the sterilization leak detection cabinet.
(3) sterilization, leak detection: intermediate products adopt 115 ℃, 35min sterilization, and sterilization pressure is 0.169MPa, and the leak detection of color water after rinsing well, is delivered between turnover.
(4) lamp inspection, packing: intermediate products are checked a visible foreign matters by propping up under 1200lx illumination, qualified back lettering, packing.
Preparation specification: 2ml:20mg.
Packing specification: box/part in 10/capsule * 10 capsules/middle box * 10.
2. complete of product detects, and the result shows that product meets the national drug standards fully, sees table 3.
Table 3 lot number 090818 testing result
Embodiment 3
Lot number 090820; 1000 bottles of output
1. write out a prescription and method for preparing
1.1 prescription
Dobutamine hydrochloride 30.0g; Cysteine hydrochloride 1.2mg; Mannitol 30.0g; Water for injection adds to 2000ml.
1.2 method for preparing
(1) preparation: take by weighing the 1.2mg cysteine hydrochloride with the dissolving of 1000ml water for injection, add 30.0g mannitol, be stirred to dissolving fully, add 0.3% needle-use activated carbon again, be heated to 74 ℃ and stir 30min, filtering decarbonization must be filtrated; Get the 30.0g dobutamine hydrochloride, add the dissolving of 800ml water for injection, get solution; Merge gained filtrating and solution, benefit adds to the full amount of water for injection, and transfers pH to 3.3 with the hydrochloric acid solution of 0.1mol/L, uses 0.8 μ m successively, and 0.22 μ m filtering with microporous membrane gets medicinal liquid.
(2) embedding: medicinal liquid is after the sampling detection is qualified, and defective products is chosen in the inflated with nitrogen embedding at any time in the embedding process, and the intermediate products after the embedding are sent in the sterilization leak detection cabinet.
(3) sterilization, leak detection: intermediate products adopt 110 ℃, 35min sterilization, and sterilization pressure is 0.199MPa, and the leak detection of color water after rinsing well, is delivered between turnover.
(4) lamp inspection, packing: intermediate products are checked a visible foreign matters by propping up under 1000lx illumination, qualified back lettering, packing.
Preparation specification: 2ml:30mg.
Packing specification: box/part in 10/capsule * 10 capsules/middle box * 10.
2. complete of product detects, and the result shows that product meets the national drug standards fully, sees table 4.
Table 4 lot number 090820 testing result
Embodiment 4
Lot number 090416; 1000,000 bottles of output
1.1 prescription
Dobutamine hydrochloride 10.0kg; Cysteine hydrochloride 0.4g; Mannitol 10.0kg; Water for injection adds to 2000L.
1.2 method for preparing
With embodiment 1.
Embodiment 5
Lot number 090418; 1000,000 bottles of output
1.1 prescription
Dobutamine hydrochloride 20.0kg; Cysteine hydrochloride 0.8g; Mannitol 20.0kg; Water for injection adds to 2000L.
1.2 method for preparing
With embodiment 2.
Embodiment 6
Lot number 090420; 1000,000 bottles of output
1.1 prescription
Dobutamine hydrochloride 30.0kg; Cysteine hydrochloride 1.2g; Mannitol 30.0kg; Water for injection adds to 2000L.
1.2 method for preparing
With embodiment 3.
Experimental example 1 study on the stability
1 stable accelerated test
The three lot sample article (lot number 090416,090418,090420) of getting embodiment 4-6 preparation carry out stable accelerated test.
The method of stability accelerated test is: under the condition of temperature (40 ± 2) ℃, relative humidity (75 ± 5) %, sample placed carried out accelerated test in 6 months.Respectively in the quality index of 0,1,3,6 monthly test test sample article.
After 6 months accelerated tests, product character, pH value, related substance, visible foreign matters, five indexs of investigating project of content do not have significant change, all meet the standard code of relevant dobutamine hydrochloride injection in the Chinese Pharmacopoeia.The result sees table 5.
The stable accelerated test result of table 5
The result shows that the dobutamine hydrochloride injection stability that adopts new prescription and method for preparing to obtain is fine.
2 stable content property analyses
Detect the sample that keeps sample after 6 months stable accelerated tests of above-mentioned three lot sample article, each item index all meets the national drug standards, the 6th the end of month sample changes of contents be respectively 1.12%, 1.15%, 1.13%, average out to (1.13 ± 0.02) %, RSD=1.77.Further verified the reliability of new recipe of the present invention and method for preparing.
Accelerated test is in the time of 0 month, and three batches of full testing results of product are seen table 6, and the result shows that three batches of products all meet the national drug standards.
Table 6 testing result (0 month)
Detect the sample that keeps sample after 6 months stable accelerated tests, three batches of full testing results of product are seen table 7.
Table 7 testing result (June)
Can know that by above experimental result dobutamine hydrochloride aqueous injection of the present invention is under the specification of 10mg-30mg/2ml, and is all highly stable through quality after 6 months accelerated tests, and then guarantee the safety of product clinical practice.
Claims (8)
1. a dobutamine hydrochloride aqueous injection is characterized in that, contains following component: dobutamine hydrochloride 10.0-30.0g; Cysteine hydrochloride 0.4-1.2mg; Mannitol 10.0-30.0g; Water for injection adds to 2000ml.
2. dobutamine hydrochloride aqueous injection according to claim 1 is characterized in that, contains following component: dobutamine hydrochloride 10.0-20.0g; Cysteine hydrochloride 0.4-0.8mg; Mannitol 10.0-20.0g; Water for injection adds to 2000ml.
3. dobutamine hydrochloride aqueous injection according to claim 2 is characterized in that, contains following component: dobutamine hydrochloride 20.0g; Cysteine hydrochloride 0.8mg; Mannitol 20.0g; Water for injection adds to 2000ml.
4. the method for preparing of each described dobutamine hydrochloride aqueous injection of claim 1-3 is characterized in that, comprises the steps:
1) preparation: the cysteine hydrochloride that takes by weighing recipe quantity dissolves with 800-1000ml water for injection; The mannitol that adds recipe quantity; Be stirred to dissolving fully; Adding in the solution weight percentage composition is the needle-use activated carbon of 0.15%-0.3% again, is heated to 70-75 ℃ and stirs 15-30min, and filtering decarbonization must be filtrated; Get the recipe quantity dobutamine hydrochloride, add the dissolving of 600-800ml water for injection, get solution; Merge gained filtrating and solution, add water for injection, transfer pH to 3.0～3.3, use 0.8 μ m, 0.22 μ m filtering with microporous membrane successively, get medicinal liquid with the hydrochloric acid solution of 0.1mol/L to 2000ml;
2) embedding: medicinal liquid is carried out the inflated with nitrogen embedding;
3) sterilization, leak detection: the product to after the embedding is sterilized, is hunted leak;
4) lamp inspection, packing: the visible foreign matters of inspection product under 1000lx-1500lx illumination, qualified back packing obtains finished product.
5. method according to claim 4; It is characterized in that step 1) is: the cysteine hydrochloride that takes by weighing recipe quantity adds the mannitol of recipe quantity with the dissolving of 800-900ml water for injection; Be stirred to dissolving fully; Adding in the solution weight percentage composition is the needle-use activated carbon of 0.15%-0.2% again, is heated to 72-74 ℃ and stirs 15-20min, and filtering decarbonization must be filtrated; Get the recipe quantity dobutamine hydrochloride, add the dissolving of 600-700ml water for injection, get solution; Merge gained filtrating and solution, add water for injection, transfer pH to 3.0～3.3, use 0.8 μ m, 0.22 μ m filtering with microporous membrane successively, get medicinal liquid with the hydrochloric acid solution of 0.1mol/L to 2000ml.
6. method according to claim 5; It is characterized in that step 1) is: the cysteine hydrochloride that takes by weighing recipe quantity adds the mannitol of recipe quantity with the dissolving of 900ml water for injection; Be stirred to dissolving fully; Adding in the solution weight percentage composition is 0.2% needle-use activated carbon again, is heated to 73 ℃ and stirs 20min, and filtering decarbonization must be filtrated; Get the recipe quantity dobutamine hydrochloride, add the dissolving of 700ml water for injection, get solution; Merge gained filtrating and solution, add water for injection, transfer pH to 3.0～3.3, use 0.8 μ m, 0.22 μ m filtering with microporous membrane successively, get medicinal liquid with the hydrochloric acid solution of 0.1mol/L to 2000ml.
7. according to each described method of claim 4-6, it is characterized in that step 3) is at the 110-120 ℃ of 35-40min that sterilizes down, sterilization pressure is 0.143-0.199MPa, adopts the leak detection of color water, rinses well.
8. method according to claim 7 is characterized in that, step 3) is at 115 ℃ of 35min that sterilize down, and sterilization pressure is 0.169MPa, adopts the leak detection of color water, rinses well.
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| CN104706572A (en) * | 2013-12-14 | 2015-06-17 | 山东方明药业集团股份有限公司 | Preparation method of dobutamine hydrochloride injection |
| CN104490795B (en) * | 2014-12-15 | 2018-02-23 | 马鞍山丰原制药有限公司 | A kind of injection of the pharmaceutical composition containing oxytocin and preparation method thereof |
| CN114617844A (en) * | 2022-04-20 | 2022-06-14 | 江苏吴中医药集团有限公司 | Preparation method of dobutamine hydrochloride water injection |
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| 徐少民等.盐酸多巴酚丁胺注射液处方与制备工艺研究.《北方医学》.2010,第7卷(第5期),16-18. * |
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