CN104352450A - Ethylenediamine diaceturate freeze-dried powder for injection and preparation method thereof - Google Patents
Ethylenediamine diaceturate freeze-dried powder for injection and preparation method thereof Download PDFInfo
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- CN104352450A CN104352450A CN201410531446.7A CN201410531446A CN104352450A CN 104352450 A CN104352450 A CN 104352450A CN 201410531446 A CN201410531446 A CN 201410531446A CN 104352450 A CN104352450 A CN 104352450A
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- diaceturate
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Abstract
The invention provides ethylenediamine diaceturate freeze-dried powder for injection. The ethylenediamine diaceturate freeze-dried powder comprises ethylenediamine diaceturate and lactose in the weight ratio of (16-27):3. According to the ethylenediamine diaceturate freeze-dried powder, the formula is simple, the kind of the auxiliary materials is fewer, the freeze-dried powder is applicable to popularization, side effects caused by excessive addition of auxiliary materials are avoided, and the safety of clinical use is improved. The invention further provides a preparation method of the ethylenediamine diaceturate freeze-dried powder for injection. Through accurate control on parameters, such as the heating speed, the holding temperature, the holding time, the pressure and the like, of freeze-drying process steps, the obtained ethylenediamine diaceturate freeze-dried powder for injection is more normative in preparation course, good in product quality and high in stability.
Description
Technical field
The present invention relates to pharmaceutical field, refer to a kind of ethylenediamine diaceturate for injection lyophilized powder and preparation method thereof especially.
Background technology
Ethyl Enediamine Diaceturate, main feature to impel Fibrinogen to become fibrin, accelerate blood coagulation and impel intra platelet free calcium blood coagulation activity material, strengthen hematoblastic aggregation and adhesiveness, shorten clotting time, produce anastalsis can intravenous drip, inject or intramuscular injection, digestive tract hemorrhage, eye epistaxis, gynecological bleeding, bleeding hemorrhoids, the surgery of being widely used in easy to use is hemorrhage etc., is applicable to each section office's feature of hospital: hemostasis rapidly, persistent.Pharmacology toxicity: (1) suppresses activator of plasminogen, plasminogen can not be activated as fibrinolysin, thus suppress fibrinous dissolving, produces anastalsis; (2) promote intra platelet free calcium active substance, strengthen hematoblastic aggregation and adhesiveness, shorten clotting time, produce anastalsis; (3) strengthen capillary resistance, reduce the permeability of blood capillary, thus reduce hemorrhage.Adapt to symptom: hemorrhage; Hemorrhage for prevention and therapy a variety of causes; Be applicable to surgical operation oozing of blood, respiratory tract hemorrhage, face be hemorrhage, gynecological bleeding, bleeding hemorrhoids, urinary tract are hemorrhage, cancer is hemorrhage, digestive tract hemorrhage, cranium cerebral hemorrhage etc.
At present, ethylenediamine diaceturate for injection mainly adopts the form of lyophilized powder to preserve, but because ethylenediamine diaceturate for injection lyophilized powder is in preparation process, step control procedure is not very specification, and the problem such as state modulator is accurate not, cause the quality of the ethylenediamine diaceturate for injection lyophilized powder obtained unstable, therefore pot-life has larger fluctuation scope, Clinical practice risk is larger, in addition, in order to improve the stability of pharmaceutical properties, add the risk that multiple auxiliary materials and the side effect that causes also increase Clinical practice.
Summary of the invention
Given this, the invention provides a kind of ethylenediamine diaceturate for injection lyophilized powder and preparation method thereof, formula is simple, preparation process process reasonable standard more, be suitable for promoting, the ethylenediamine diaceturate for injection lyophilized powder quality high stability obtained is good, and Clinical practice safety is high.
For solving the problems of the technologies described above, technical scheme of the present invention is:
A kind of ethylenediamine diaceturate for injection lyophilized powder, comprise Ethyl Enediamine Diaceturate and lactose, Ethyl Enediamine Diaceturate: the weight proportion of lactose is (16 ~ 27): 3, is prepared from according to following step: the preparation of S1 formula, S2 drug solution preparing, S3 fill and S4 lyophilization.
Further, Ethyl Enediamine Diaceturate: the weight proportion of lactose is 20:3.
Further, described step S2 drug solution preparing comprises:
S2-1: by Ethyl Enediamine Diaceturate and lactose dispersion in water for injection, is stirred to dissolve completely and obtains clear liquor;
S2-2: add medicinal carbon, stirs, and crosses and filters medicinal carbon;
S2-3: again obtain medicinal liquid through filtering with microporous membrane.
Further, described step S4 lyophilization comprises:
S4-1: medicinal liquid is lowered the temperature, cooling rate is 0.1 ~ 2 DEG C/min, makes medicinal liquid be down to-30 ~-40 DEG C from room temperature, and is incubated 2 ~ 6 hours, obtain semi-finished product;
S4-2: open vacuum pump evacuation, vacuum is 10 ~ 20 handkerchiefs;
S4-3: carry out first time intensification, programming rate is 0.1 ~ 1 DEG C/min for the first time, makes semi-finished product be warming up to-10 ~ 0 DEG C gradually, and disappear latter 5 ~ 25 hours at-10 ~ 0 DEG C of insulation to ice crystal;
S4-4: carry out second time and heat up, second time programming rate is 0.1 ~ 1 DEG C/min, makes semi-finished product be warming up to 20 ~ 40 DEG C gradually, and is incubated 2 ~ 6 hours.
A kind of preparation method of ethylenediamine diaceturate for injection lyophilized powder, comprise step: the preparation of S1 formula, S2 drug solution preparing, S3 fill and S4 lyophilization, wherein, formula composition comprises Ethyl Enediamine Diaceturate and lactose, Ethyl Enediamine Diaceturate: the weight proportion of lactose is (16 ~ 27): 3.
Further, described step S2 drug solution preparing comprises:
S2-1: by Ethyl Enediamine Diaceturate and lactose dispersion in water for injection, is stirred to dissolve completely and obtains clear liquor;
S2-2: add medicinal carbon, stirs, and crosses and filters medicinal carbon;
S2-3: again obtain medicinal liquid through filtering with microporous membrane.
Further, in described step S2-2, successively carry out filtering decarbonization through 0.45 μm of microporous filter membrane successively, and carry out fine straining through 0.22 μm of microporous filter membrane and take off charcoal.
Further, in described step S2-3, carry out fine straining through 0.22 μm of microporous filter membrane, obtain medicinal liquid.
Further, described step S4 lyophilization comprises:
S4-1: medicinal liquid is lowered the temperature, cooling rate is 0.1 ~ 2 DEG C/min, makes medicinal liquid be down to-30 ~-40 DEG C from room temperature, and is incubated 2 ~ 6 hours, obtain semi-finished product;
S4-2: open vacuum pump evacuation, vacuum is 10 ~ 20 handkerchiefs;
S4-3: carry out first time intensification, programming rate is 0.1 ~ 1 DEG C/min for the first time, makes semi-finished product be warming up to-10 ~ 0 DEG C gradually, and disappear latter 5 ~ 25 hours at-10 ~ 0 DEG C of insulation to ice crystal;
S4-4: carry out second time and heat up, second time programming rate is 0.1 ~ 1 DEG C/min, makes semi-finished product be warming up to 20 ~ 40 DEG C gradually, and is incubated 2 ~ 6 hours.
Further, described step S4 lyophilization comprises:
S4-1: medicinal liquid is lowered the temperature, cooling rate is 0.1 ~ 1 DEG C/min, makes medicinal liquid be down to-35 ~-38 DEG C from room temperature, and is incubated 3 ~ 4 hours, obtain semi-finished product;
S4-2: open vacuum pump evacuation, vacuum is 10 ~ 15 handkerchiefs;
S4-3: carry out first time intensification, programming rate is 0.1 ~ 0.5 DEG C/min for the first time, makes semi-finished product be warming up to-5 ~ 0 DEG C gradually, and disappear latter 12 ~ 18 hours at-5 ~ 0 DEG C of insulation to ice crystal;
S4-4: carry out second time and heat up, second time programming rate is 0.1 ~ 0.5 DEG C/min, makes semi-finished product be warming up to 25 ~ 30 DEG C gradually, and is incubated 2 ~ 3 hours.
Compared with prior art, the invention has the beneficial effects as follows:
The invention provides a kind of ethylenediamine diaceturate for injection lyophilized powder and preparation method thereof, by the adjustment to processing step, as the accurate control of programming rate, holding temperature, temperature retention time and pressure and other parameters, and the control etc. of multiple filtration, make the ethylenediamine diaceturate for injection lyophilized powder quality high stability that obtains good, Clinical practice safety is high, and preparation process is specification more, is suitable for promoting.In addition, formula of the present invention is simple, and adjuvant is less, avoids because adjuvant adds the too much side effect caused, improves Clinical practice safety.
Detailed description of the invention
For understanding the present invention better; below by following examples, elaboration concrete is further done to the present invention; but unintelligible is limitation of the invention; for some nonessential improvement and adjustment that those skilled in the art does according to foregoing invention content, be also considered as dropping in protection scope of the present invention.
Embodiment one
The invention provides a kind of ethylenediamine diaceturate for injection lyophilized powder, comprise Ethyl Enediamine Diaceturate 400g and lactose 60g, Ethyl Enediamine Diaceturate: the weight proportion of lactose is 20:3.
The preparation method of ethylenediamine diaceturate for injection lyophilized powder, comprises the following steps:
S1 formula prepares;
S2 drug solution preparing:
S2-1: by Ethyl Enediamine Diaceturate and lactose dispersion in water for injection, is stirred to dissolve completely and obtains clear liquor;
S2-2: add medicinal carbon, stirring makes it dispersed in 30 minutes, successively carry out filtering decarbonization through 0.45 μm of microporous filter membrane successively, with carry out fine straining through 0.22 μm of microporous filter membrane and take off charcoal, by the multi-level filter method of coarse filtration and fine straining to improve the quality of goods, medicinal carbon is used for the impurity in adsorbent solution, and does not affect other constituent concentration and the property of medicine of medicinal liquid;
S2-3: medicinal liquid after the assay was approved carries out fine straining through 0.22 μm of microporous filter membrane again, obtains qualified medicinal liquid.
Step S2 drug solution preparing process of the present invention can improve Ethyl Enediamine Diaceturate, the dispersibility of lactose and dissolubility, and then improves the quality stability of medicinal liquid.
S3 fill:
Adjustment racking machine, to specifying scale, by liquid medicine filling in vial, presses half plug.
S4 lyophilization:
S4-1: the vial that qualified medicinal liquid is housed is placed on the laminate of lyophilization mechanical goods room, open drying baker refrigeration machine, medicinal liquid is lowered the temperature, cooling rate is 0.5 DEG C/min, makes medicinal liquid be down to-35 DEG C from room temperature, and is incubated 4 hours, treat that medicinal liquid fully charge is real, pre-freeze-drying process terminates, and obtains semi-finished product, improves the content of medicine and the stability of each component materials;
S4-2: open vacuum pump evacuation, carry out further lyophilization to semi-finished product, vacuum is 10 handkerchiefs;
S4-3: carry out first time intensification, programming rate is 0.2 DEG C/min for the first time, semi-finished product are made to be warming up to 0 DEG C gradually, and disappear latter 12 hours to ice crystal 0 DEG C of insulation, make the complete lyophilizing of the moisture in semi-finished product, the vial swelling fracture that the insulation transition stage of 0 DEG C causes because of temperature shock when not only avoid direct outlet and product destroy, and further improve the content of medicine and the stability of each component materials;
S4-4: carry out second time and heat up, second time programming rate is 0.1 DEG C/min, makes semi-finished product be warming up to 30 DEG C gradually, and is incubated 3 hours, be incubated under being warming up to ambient temperature environment before outlet, ensures the stability before medicine outlet and the adaptability after outlet;
S4-5: carry out pressure test qualified after, press full plug, outlet, lyophilizing terminates, and obtains finished product.
The present invention, in step S4 freezing dry process, to the accurate control of each temperature, and is incubated the control of duration, ensure that the stability of medicine, improve the quality of finished product.
S5 packs:
Put in storage after pricking aluminium lid, lamp inspection, packaging.
Embodiment two to embodiment five
In embodiment one to embodiment five, the compositing formula of ethylenediamine diaceturate for injection lyophilized powder is as shown in table 1, its preparation method is all identical with embodiment one, finished product obtained for embodiment one to embodiment five is proceeded stability study at ambient temperature, can find out from table 1 data, the ethylenediamine diaceturate for injection lyophilized powder quality obtained is high, good stability, finished product water content is low, and the pot-life reaches more than 28 months.Particularly embodiment one, when Ethyl Enediamine Diaceturate: when the weight proportion of lactose is 20:3, the stability of gained ethylenediamine diaceturate for injection lyophilized powder is best, and the pot-life can reach 36 months.
The ethylenediamine diaceturate for injection lyophilized powder of the different compositing formula of table 1
Embodiment six to eight
In embodiment six to embodiment eight, the compositing formula of ethylenediamine diaceturate for injection lyophilized powder is all identical with embodiment one, preparation method is by the cooling in step S4-1 to S4-4 step, first time heats up, the programming rate that second time heats up, holding temperature, temperature retention time and vacuum replace with as shown in table 2 in numerical value, at ambient temperature stability study is proceeded to gained finished product, result is as shown in table 2, compared with prior art, the inventive method adopts vacuum freeze-drying at lower temperature technology, medicine is produced at hermetic container, ensure medicine not easily oxidation deterioration, overcome Yin Gaowen in production process and cause the problem of medicament decomposes, the ethylenediamine diaceturate for injection lyophilized powder quality obtained is high, good stability, finished product water content is low, pot-life reaches more than 28 months.Under the preparation process condition of particularly embodiment one, the stability of gained ethylenediamine diaceturate for injection lyophilized powder is best, and the pot-life can reach 36 months.
Table 2 different condition obtains the pot-life of ethylenediamine diaceturate for injection lyophilized powder
In addition, the interior packaging material used in the preparation process of ethylenediamine diaceturate for injection lyophilized powder of the present invention adopts following technological parameter sterilizing:
Plug: in 121 DEG C of moist heat sterilizations 40 minutes; Vial: be no less than 6 minutes in 350 DEG C of insulations; Aluminium lid: in 110 DEG C of insulations 120 minutes.
The inventive method adopts vacuum freeze-drying at lower temperature technology, medicine is produced at hermetic container, ensure medicine not easily oxidation deterioration, overcome Yin Gaowen in production process and cause the problem of medicament decomposes, formula of the present invention is simple, adjuvant is less, avoids because adjuvant adds the too much side effect caused, improves Clinical practice safety.The finished product that the inventive method is obtained proceeds stability study at ambient temperature, and gained ethylenediamine diaceturate for injection lyophilized powder quality is high, good stability, and finished product water content is low, extends the pot-life, and the pot-life can reach 36 months.
Should be appreciated that and above describe for the present invention to be as set forth in the claims only example and illustrative, not to be limited it.Content of the present invention disclosed by this paper, other embodiment of the present invention is apparent for a person skilled in the art.It should be noted that the present invention and embodiment only should be seen as example; those skilled in the art can make various change, amendment and/or modification to the present invention, and these all equivalent form of values fall within the protection domain that the application's appended claims limits equally.
Claims (10)
1. an ethylenediamine diaceturate for injection lyophilized powder, it is characterized in that, comprise Ethyl Enediamine Diaceturate and lactose, Ethyl Enediamine Diaceturate: the weight proportion of lactose is (16 ~ 27): 3, is prepared from according to following step: the preparation of S1 formula, S2 drug solution preparing, S3 fill and S4 lyophilization.
2. ethylenediamine diaceturate for injection lyophilized powder as claimed in claim 1, is characterized in that, Ethyl Enediamine Diaceturate: the weight proportion of lactose is 20:3.
3. ethylenediamine diaceturate for injection lyophilized powder according to claim 1, is characterized in that, described step S2 drug solution preparing comprises:
S2-1: by Ethyl Enediamine Diaceturate and lactose dispersion in water for injection, is stirred to dissolve completely and obtains clear liquor;
S2-2: add medicinal carbon, stirs, and crosses and filters medicinal carbon;
S2-3: again obtain medicinal liquid through filtering with microporous membrane.
4. ethylenediamine diaceturate for injection lyophilized powder according to claim 1, is characterized in that, described step S4 lyophilization comprises:
S4-1: medicinal liquid is lowered the temperature, cooling rate is 0.1 ~ 2 DEG C/min, makes medicinal liquid be down to-30 ~-40 DEG C from room temperature, and is incubated 2 ~ 6 hours, obtain semi-finished product;
S4-2: open vacuum pump evacuation, vacuum is 10 ~ 20 handkerchiefs;
S4-3: carry out first time intensification, programming rate is 0.1 ~ 1 DEG C/min for the first time, makes semi-finished product be warming up to-10 ~ 0 DEG C gradually, and disappear latter 5 ~ 25 hours at-10 ~ 0 DEG C of insulation to ice crystal;
S4-4: carry out second time and heat up, second time programming rate is 0.1 ~ 1 DEG C/min, makes semi-finished product be warming up to 20 ~ 40 DEG C gradually, and is incubated 2 ~ 6 hours.
5. the preparation method of an ethylenediamine diaceturate for injection lyophilized powder, it is characterized in that, comprise step: the preparation of S1 formula, S2 drug solution preparing, S3 fill and S4 lyophilization, wherein, formula composition comprises Ethyl Enediamine Diaceturate and lactose, Ethyl Enediamine Diaceturate: the weight proportion of lactose is (16 ~ 27): 3.
6. the preparation method of ethylenediamine diaceturate for injection lyophilized powder as claimed in claim 5, it is characterized in that, described step S2 drug solution preparing comprises:
S2-1: by Ethyl Enediamine Diaceturate and lactose dispersion in water for injection, is stirred to dissolve completely and obtains clear liquor;
S2-2: add medicinal carbon, stirs, and crosses and filters medicinal carbon;
S2-3: again obtain medicinal liquid through filtering with microporous membrane.
7. the preparation method of ethylenediamine diaceturate for injection lyophilized powder as claimed in claim 6, it is characterized in that, in described step S2-2, successively carry out filtering decarbonization through 0.45 μm of microporous filter membrane successively, and carry out fine straining through 0.22 μm of microporous filter membrane and take off charcoal.
8. the preparation method of ethylenediamine diaceturate for injection lyophilized powder as claimed in claim 6, is characterized in that, in described step S2-3, carry out fine straining, obtain medicinal liquid through 0.22 μm of microporous filter membrane.
9. the preparation method of ethylenediamine diaceturate for injection lyophilized powder as claimed in claim 5, it is characterized in that, described step S4 lyophilization comprises:
S4-1: medicinal liquid is lowered the temperature, cooling rate is 0.1 ~ 2 DEG C/min, makes medicinal liquid be down to-30 ~-40 DEG C from room temperature, and is incubated 2 ~ 6 hours, obtain semi-finished product;
S4-2: open vacuum pump evacuation, vacuum is 10 ~ 20 handkerchiefs;
S4-3: carry out first time intensification, programming rate is 0.1 ~ 1 DEG C/min for the first time, makes semi-finished product be warming up to-10 ~ 0 DEG C gradually, and disappear latter 5 ~ 25 hours at-10 ~ 0 DEG C of insulation to ice crystal;
S4-4: carry out second time and heat up, second time programming rate is 0.1 ~ 1 DEG C/min, makes semi-finished product be warming up to 20 ~ 40 DEG C gradually, and is incubated 2 ~ 6 hours.
10. the preparation method of ethylenediamine diaceturate for injection lyophilized powder as claimed in claim 9, it is characterized in that, described step S4 lyophilization comprises:
S4-1: medicinal liquid is lowered the temperature, cooling rate is 0.1 ~ 1 DEG C/min, makes medicinal liquid be down to-35 ~-38 DEG C from room temperature, and is incubated 3 ~ 4 hours, obtain semi-finished product;
S4-2: open vacuum pump evacuation, vacuum is 10 ~ 15 handkerchiefs;
S4-3: carry out first time intensification, programming rate is 0.1 ~ 0.5 DEG C/min for the first time, makes semi-finished product be warming up to-5 ~ 0 DEG C gradually, and disappear latter 12 ~ 18 hours at-5 ~ 0 DEG C of insulation to ice crystal;
S4-4: carry out second time and heat up, second time programming rate is 0.1 ~ 0.5 DEG C/min, makes semi-finished product be warming up to 25 ~ 30 DEG C gradually, and is incubated 2 ~ 3 hours.
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