CN1555795A - Ondansijiong hydrochleride freeze dried powder ampoule for injection and its preparation method - Google Patents
Ondansijiong hydrochleride freeze dried powder ampoule for injection and its preparation method Download PDFInfo
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- CN1555795A CN1555795A CNA2004100138446A CN200410013844A CN1555795A CN 1555795 A CN1555795 A CN 1555795A CN A2004100138446 A CNA2004100138446 A CN A2004100138446A CN 200410013844 A CN200410013844 A CN 200410013844A CN 1555795 A CN1555795 A CN 1555795A
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- ondansetron
- hydrochloride
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Abstract
An ondansetron hydrochloride injection in the form of freeze dried powder for treating the nausea and emesis caused by chemicotherapy or radiotherapy is prepared from ondansetron hydrochloride, pharmacological acceptable excipient and water for injection through dissolving ondansetron hydrochloride in the water, adding excipient, stirring, regulating pH value, filtering, and freeze drying.
Description
Technical field
The invention belongs to Ondansetron Hydrochloride pharmaceutical preparation, specifically is a kind of hydrochloride for injection ondansetron lyophilized injectable powder and preparation method thereof.
Background technology
Ondansetron Hydrochloride is a kind of 5-hydroxy tryptamine 5HT of high selectivity
3Receptor antagonist is new potent Bendectin.Be applicable to the nausea and vomiting that processing is caused by cytotoxic chemotherapy and radiotherapy, also be applicable to prevention and treat postoperative nausea and vomiting.Ondansetron is mainly by antagonism periphery and axoneuron 5-hydroxy tryptamine 5HT
3Receptor, factors such as blocking-up chemotherapy or radiotherapy cause the 5HT that small intestinal discharges
3Play the emesis effect with receptors bind.This medicine clinical efficacy is good, and side effect is little, untoward reaction such as no extrapyramidal system reaction and excessive calmness.At present domestic have only its injection formulation using, because injection can make the effective ingredient instability when high temperature sterilize, curative effect is descended, and injection formulation also has inconvenience in transportation and in storing.
Summary of the invention
The objective of the invention is to provides a kind of nausea and vomiting that is caused by cytotoxic chemotherapy and radiotherapy that is used to handle at above-mentioned weak point, also is applicable to prevention and treats hydrochloride for injection ondansetron lyophilized injectable powder of postoperative nausea and vomiting and preparation method thereof.
Hydrochloride for injection ondansetron lyophilized injectable powder and preparation method are to take following scheme to realize:
Hydrochloride for injection ondansetron lyophilized injectable powder is formulated by active substance Ondansetron Hydrochloride, medically acceptable lyophilized injectable powder excipient, water for injection;
Medicinal raw material active substance Ondansetron Hydrochloride and medically acceptable lyophilized injectable powder excipient weight proportion are 2～10: 10～50, the water for injection surplus.
Described excipient is a kind of in mannitol, lactose, dextran, glucose, sorbitol, the sodium chloride etc.; Preferred mannitol is excipient.Its active ingredient hydrochloric acid ondansetron and medically acceptable lyophilized injectable powder excipient mannitol, its weight ratio is 2～10: 10～50.
A kind of preparation method of hydrochloride for injection ondansetron lyophilized injectable powder is characterized in that adopting following steps:
A. press preparation prescription, medicinal solid material Ondansetron Hydrochloride, excipient are dissolved in behind an amount of water for injection with hydrochloric acid solution regulator solution pH value 3.0～5.5, wherein the concentration of hydrochloric acid solution is 0.05～0.5mol/L, medicinal raw material active substance Ondansetron Hydrochloride and medically acceptable lyophilized injectable powder excipient weight proportion are 2～10: 10～50, the water for injection surplus.Described excipient is a kind of in mannitol, lactose, dextran, glucose, sorbitol, the sodium chloride etc.
B. with the solution of pH3.0～5.5 that prepare with 0.22 μ m filtering with microporous membrane degerming, be stored in the receiver, and measure intermediate content, add the injection water to recipe quantity.
C. medicinal liquid is sub-packed in the cillin bottle, the freeze dryer lyophilizing is used in half tamponade, tamponade, packing.
Lyophilization comprises pre-freeze and sublimation drying; Wherein the pre-freeze temperature of the preceding case of freeze dryer is-30 ℃～-40 ℃ in the pre-freeze process, insulation, and the temperature of the rear cabinet of freeze dryer is reduced to-40～-50 ℃ between soak; In the sublimation drying process, under the evacuation condition, with per hour 2～4 ℃ of distillations that heat up, until drying.
This hydrochloride for injection ondansetron freeze-dried powder reasonable recipe, preparation is loose porous and solubility is good, and moisture is low, and the purity height meets national standard.Its production overall process sterile working adopts the microporous filter degerming, cold drying, and product is not destroyed, and vacuum or noble gas are filled, and are difficult for oxidation takes place, and period of storage is long, good stability, effect duration is long, is convenient to transportation, stores.
The specific embodiment
Below in conjunction with example in detail.
Embodiment 1:4mg/ bottle specification, 1000 freeze-dried powder agent prescriptions:
Ondansetron Hydrochloride 5g
Mannitol 30g
Water for injection adds to 2000ml, makes 1000 altogether
Wherein, Ondansetron Hydrochloride is a principal agent, and specification is every bottle and contains ondansetron 4mg in the present embodiment, because of Ondansetron Hydrochloride contains 2 molecular crystalline water, convert according to molecular weight, Ondansetron Hydrochloride 5g is equivalent to ondansetron 4g, so should be Ondansetron Hydrochloride 5g when feeding intake.
Mannitol is excipient, as the skeleton support section of injection ondansetron injectable powder.According to bibliographical information and in conjunction with the production experience of my other lyophilized formulations of company.Test by simulating actual production, determine the ratio of principal agent and mannitol: 2～10: 10～50 ratio.Water for injection is as the solvent of dissolving raw material, and an amount of according to the loading amount adding of liquor strength and every medicine, the preparation technology of preparation is as follows:
A. press embodiment 1 preparation prescription batching, get Ondansetron Hydrochloride 5.0g, add the dissolving of 1800ml water for injection after, add 30g mannitol, stirring and dissolving is regulated pH to 3.0～5.5 with the 0.1mol/L hydrochloric acid solution.
B. with the solution of pH3.0～5.5 that prepare,, be stored in the receiver, measure intermediate content, add the injection water to recipe quantity with 0.22 μ m filtering with microporous membrane degerming.
C. medicinal liquid is sub-packed in the 10ml cillin bottle every bottled 2ml, half tamponade, sabot is sent in the freeze drying box, opens freeze dryer, utilize conduction oil that the product relaxing the bowels with purgatives of warm nature is fallen, when temperature is reduced to-35 ℃, kept this temperature 2 hours, trading halt is cold, and the open cold condenser is when condenser temperature is lower than-40 ℃, open vacuum system, open butterfly valve, begin the distillation that heats up, per hour be advisable for 2～4 ℃, when the final drying temperature is 35 ℃, be incubated 2 hours until drying.Close plug is put vacuum, outlet, and Zha Gai checks, packing.
Embodiment 2:8mg/ bottle specification, 1000 freeze-dried powder agent prescriptions:
Ondansetron Hydrochloride 10g
Mannitol 10g
Water for injection adds to 2000ml, makes 1000 altogether
Wherein, Ondansetron Hydrochloride is a principal agent, and specification is every bottle and contains ondansetron 8mg in the present embodiment, because of Ondansetron Hydrochloride contains 2 molecular crystalline water, convert according to molecular weight, Ondansetron Hydrochloride 10g is equivalent to ondansetron 8g, so should be Ondansetron Hydrochloride 10g when feeding intake.
Mannitol is excipient, as the skeleton support section of injection ondansetron injectable powder.Determine the ratio of principal agent Ondansetron Hydrochloride and mannitol: 10: 10 ratio.Water for injection is as the solvent of dissolving raw material, and an amount of according to the loading amount adding of liquor strength and every medicine, the preparation technology of preparation is as follows:
A. press embodiment 2 preparation prescriptions batchings, get Ondansetron Hydrochloride 10g, add the dissolving of 1800ml water for injection after, add 10g mannitol, stirring and dissolving is regulated pH to 3.0～5.5 with the 0.1mol/L hydrochloric acid solution.
B. with the solution of pH3.0～5.5 that prepare,, be stored in the receiver, measure intermediate content, add the injection water to recipe quantity with 0.22 μ m filtering with microporous membrane degerming.
C. medicinal liquid is sub-packed in the 10ml cillin bottle every bottled 2ml, half tamponade, sabot is sent in the freeze drying box, opens freeze dryer, utilize conduction oil that the product relaxing the bowels with purgatives of warm nature is fallen, when temperature is reduced to-35 ℃, kept this temperature 2 hours, trading halt is cold, and the open cold condenser is when condenser temperature is lower than-40 ℃, open vacuum system, open butterfly valve, begin the distillation that heats up, per hour be advisable for 2～4 ℃, when the final drying temperature is 35 ℃, be incubated 2 hours until drying.Close plug is put vacuum, outlet, and Zha Gai checks, packing.
Embodiment 3:1.6mg/ bottle specification, 1000 freeze-dried powder agent prescriptions:
Ondansetron Hydrochloride 2g
Mannitol 50g
Water for injection adds to 2000ml, makes 1000 altogether
Wherein, Ondansetron Hydrochloride is a principal agent, and specification is every bottle and contains ondansetron 1.6mg in the present embodiment, because of Ondansetron Hydrochloride contains 2 molecular crystalline water, convert according to molecular weight, Ondansetron Hydrochloride 2g is equivalent to ondansetron 1.6g, so should be Ondansetron Hydrochloride 2g when feeding intake.
Mannitol is excipient, as the skeleton support section of injection ondansetron injectable powder.Determine the ratio of principal agent Ondansetron Hydrochloride and mannitol: 2: 50 ratio.Water for injection is as the solvent of dissolving raw material, and an amount of according to the loading amount adding of liquor strength and every medicine, the preparation technology of preparation is as follows:
A. press embodiment 1 preparation prescription batching, get Ondansetron Hydrochloride 2g, add the dissolving of 1800ml water for injection after, add 50g mannitol, stirring and dissolving is regulated pH to 3.0～5.5 with the 0.1mol/L hydrochloric acid solution.
B. with the solution of pH3.0～5.5 that prepare,, be stored in the receiver, measure intermediate content, add the injection water to recipe quantity with 0.22 μ m filtering with microporous membrane degerming.
C. medicinal liquid is sub-packed in the 10ml cillin bottle every bottled 2ml, half tamponade, sabot is sent in the freeze drying box, opens freeze dryer, utilize conduction oil that the product relaxing the bowels with purgatives of warm nature is fallen, when temperature is reduced to-35 ℃, kept this temperature 2 hours, trading halt is cold, and the open cold condenser is when condenser temperature is lower than-40 ℃, open vacuum system, open butterfly valve, begin the distillation that heats up, per hour be advisable for 2～4 ℃, when the final drying temperature is 35 ℃, be incubated 2 hours until drying.Close plug is put vacuum, outlet, and Zha Gai checks, packing.
Embodiment 4:8mg/ bottle specification, 1000 freeze-dried powder agent prescriptions:
Ondansetron Hydrochloride 10.0g
Dextran 10 g
Water for injection adds to 2000ml, makes 1000 altogether
Its preparation process is as follows:
A. press embodiment 2 preparation prescriptions batchings, get Ondansetron Hydrochloride 10.0g, add the dissolving of 1800ml water for injection after, add the 10g dextran, stirring and dissolving is regulated pH to 3.0～5.5 with the 0.1mol/L hydrochloric acid solution.
B. with the solution of pH3.0～5.5 that prepare, to receiver, measure intermediate content, add the injection water to recipe quantity with 0.22 μ m filtering with microporous membrane degerming.
C. medicinal liquid is sub-packed in the 10ml cillin bottle every bottled 2.0ml, half tamponade, sabot is sent in the freeze drying box, opens freeze dryer, utilize conduction oil that the product relaxing the bowels with purgatives of warm nature is fallen, when temperature is reduced to-35 ℃, kept this temperature 2 hours, trading halt is cold, and the open cold condenser is when condenser temperature is lower than-40 ℃, open vacuum system, open butterfly valve, begin the distillation that heats up, per hour be advisable for 2～4 ℃, when the final drying temperature is 35 ℃, be incubated 2 hours until drying.Close plug is put vacuum, outlet, and Zha Gai checks, packing.
Embodiment 5:1.6mg/ bottle specification, 1000 freeze-dried powder agent prescriptions:
Ondansetron Hydrochloride 2g
Dextran 50g
Water for injection adds to 2000ml, makes 1000 altogether
Its preparation process is as follows:
A. press embodiment 2 preparation prescriptions batchings, get Ondansetron Hydrochloride 2g, add the dissolving of 1800ml water for injection after, add the 50g dextran, stirring and dissolving is regulated pH to 3.0～5.5 with the 0.1mol/L hydrochloric acid solution.
B. with the solution of pH3.0～5.5 that prepare, to receiver, measure intermediate content, add the injection water to recipe quantity with 0.22 μ m filtering with microporous membrane degerming.
C. medicinal liquid is sub-packed in the 10ml cillin bottle every bottled 2.0ml, half tamponade, sabot is sent in the freeze drying box, opens freeze dryer, utilize conduction oil that the product relaxing the bowels with purgatives of warm nature is fallen, when temperature is reduced to-35 ℃, kept this temperature 2 hours, trading halt is cold, and the open cold condenser is when condenser temperature is lower than-40 ℃, open vacuum system, open butterfly valve, begin the distillation that heats up, per hour be advisable for 2～4 ℃, when the final drying temperature is 35 ℃, be incubated 2 hours until drying.Close plug is put vacuum, outlet, and Zha Gai checks, packing.
Press WS-140 (X-120)-2002 standard test with the hydrochloride for injection ondansetron lyophilized injectable powder that above-mentioned preparation method is produced, the results are shown in Table 1.
Three batches of assays of table 1 hydrochloride for injection ondansetron lyophilized injectable powder
Content is equal
The aseptic clarity content of lot number character identification pH value related substance moisture (%) pyrogen (%)
Evenness
The white loose piece meets
1009 are positive reaction 5.1 2.1 102.4
Shape thing and powder regulation regulation regulation regulation regulation
The white loose piece meets
1021 are positive reaction 5.1 2.1 105.8
Shape thing and powder regulation regulation regulation regulation regulation
The white loose piece meets
1014 are positive reaction 5.0 2.4 105.3
Shape thing and powder regulation regulation regulation regulation regulation
The hydrochloride for injection ondansetron lyophilized injectable powder stability test that carries out with reference to the Ondansetron Hydrochloride quality standard of institute for drug control, Jiangsu Province check audit the results are shown in Table 2, table 3, table 4.
Table 2 hydrochloride for injection ondansetron influence factor tests stability (lot number: 20020503)
Standing time solution colour labelled amount related substance
Condition character clarity pH
(my god) and clarity (%) (%)
The white loose piece
0 clarification colourless up to specification 4.52 98.26 0.07
Shape thing and powder
The white loose piece
Illumination 5 clarifications colourless up to specification 4.56 98.27 0.06
Shape thing and powder
The white loose piece
10 clarifications colourless up to specification 4.55 99.04 0.07
Shape thing and powder
The white loose piece
5 clarifications colourless up to specification 4.50 96.88 0.07
Shape thing and powder
40℃
The white loose piece
10 clarifications colourless up to specification 4.53 96.9 0.07
Shape thing and powder
The white loose piece
5 clarifications colourless up to specification 4.55 98.12 0.06
Shape thing and powder
60℃
The white loose piece
10 clarifications colourless up to specification 4.51 97.93 0.07
Shape thing and powder
The accelerated test stability of table 3 hydrochloride for injection ondansetron (40 ℃, RH75%)
Time solution clarification labelled amount related substance
Lot number character clarity pH
(moon) degree and color (%) are (%)
The white loose piece
0 clarification colourless up to specification 4.52 98.26 0.07
Shape thing and powder
The white loose piece
1 clarification colourless up to specification 4.56 98.31 0.07
Shape thing and powder
The white loose piece
20,020,503 2 clarifications colourless up to specification 4.49 98.38 0.06
Shape thing and powder
The white loose piece
3 clarifications colourless up to specification 4.55 98.24 0.08
Shape thing and powder
The white loose piece
6 clarifications colourless up to specification 4.54 98.08 0.06
Shape thing and powder
The white loose piece
0 clarification colourless up to specification 4.37 96.98 0.08
Shape thing and powder
The white loose piece
1 clarification colourless up to specification 4.41 97.28 0.07
Shape thing and powder
The white loose piece
20,020,505 2 clarifications colourless up to specification 4.35 96.11 0.06
Shape thing and powder
The white loose piece
3 clarifications colourless up to specification 4.39 96.8 0.07
Shape thing and powder
The white loose piece
6 clarifications colourless up to specification 4.42 96.26 0.07
Shape thing and powder
The white loose piece
0 clarification colourless up to specification 4.46 98.07 0.07
Shape thing and powder
The white loose piece
1 clarification colourless up to specification 4.52 98.6 0.06
Shape thing and powder
The white loose piece
20,020,507 2 clarifications colourless up to specification 4.49 98.04 0.06
Shape thing and powder
The white loose piece
3 clarifications colourless up to specification 4.46 97.88 0.06
Shape thing and powder
The white loose piece
6 clarifications colourless up to specification 4.48 98.2 0.07
Shape thing and powder
The long term test stability of table 4 hydrochloride for injection ondansetron
Time solution clarification labelled amount related substance
Lot number character clarity pH
(moon) degree and color (%) are (%)
The white loose piece is up to specification
0 clarification colourless 4.52 98.26 0.07
Shape thing and powder
The white loose piece is up to specification
20,020,503 3 clarifications colourless 4.55 97.83 0.08
Shape thing and powder
The white loose piece is up to specification
6 clarifications colourless 4.43 99.23 0.08
Shape thing and powder
The white loose piece is up to specification
0 clarification colourless 4.37 96.98 0.08
Shape thing and powder
The white loose piece is up to specification
20,020,505 3 clarifications colourless 4.42 96.21 0.07
Shape thing and powder
The white loose piece is up to specification
6 clarifications colourless 4.39 96.74 0.07
Shape thing and powder
The white loose piece is up to specification
0 clarification colourless 4.46 98.07 0.07
Shape thing and powder
The white loose piece is up to specification
20,020,507 3 clarifications colourless 4.51 98.67 0.07
Shape thing and powder
The white loose piece is up to specification
6 clarifications colourless 4.43 98.28 0.07
Shape thing and powder
By aforementioned stable investigation and quality inspection, prove that hydrochloride for injection ondansetron quality is good, stable high.
The animal safety result of the test of this hydrochloride for injection ondansetron lyophilized injectable powder is as follows:
Test name: hydrochloride for injection ondansetron freeze-dried powder local toxicity and safety testing
Test unit: Nanjing Medical University's clinical pharmacology institute
Pilot project: local vascular irritation test, hemolytic test, sensitivity test
Test method:
A. local vascular irritation test: by perusal rabbit auricular vein infusion injection Ondansetron Hydrochloride medicinal liquid, its part has or not redness, hyperemia, blood vessel variable color, edema, scleroma and downright bad phenomenon and histopathologic examination to estimate this product local irritation.
B. hemolytic test: have or not haemolysis and agglutination to estimate to the rabbit erythrocyte that exsomatizes by observing medicine.
C. sensitivity test:, cause that the Cavia porcellus anaphylaxis estimates by observing guinea pig intraperitoneal injection hydrochloride for injection ondansetron medicinal liquid.
Result of the test shows that the hydrochloride for injection ondansetron is injected nonirritant to rabbit vein, and tame rabbit erythrocyte is not had haemolysis and agglutination, Cavia porcellus is injected this medicine do not have irritated reaction.
Claims (5)
1. hydrochloride for injection ondansetron lyophilized injectable powder is characterized in that by active substance Ondansetron Hydrochloride, medically acceptable lyophilized injectable powder excipient, water for injection formulated;
Medicinal raw material active substance Ondansetron Hydrochloride and medically acceptable lyophilized injectable powder excipient weight proportion are 2～10: 10～50, the water for injection surplus.
2. according to the described hydrochloride for injection ondansetron of claim 1 lyophilized injectable powder, it is characterized in that described excipient is a kind of in mannitol, lactose, dextran, glucose, sorbitol, the sodium chloride.
3. the preparation method of a hydrochloride for injection ondansetron lyophilized injectable powder is characterized in that adopting following steps:
A. press preparation prescription, medicinal solid material Ondansetron Hydrochloride, excipient are dissolved in behind an amount of water for injection with hydrochloric acid solution regulator solution pH value 3.0～5.5, wherein the concentration of hydrochloric acid solution is 0.05～0.5mol/L, medicinal raw material active substance Ondansetron Hydrochloride and medically acceptable lyophilized injectable powder excipient weight proportion are 2～10: 10～50, the water for injection surplus;
B. with the solution of pH3.0～5.5 that prepare with 0.22 μ m filtering with microporous membrane degerming, be stored in the receiver, and measure intermediate content, add the injection water to recipe quantity;
C. medicinal liquid is sub-packed in the cillin bottle, the freeze dryer lyophilizing is used in half tamponade, tamponade, packing.
4. according to the preparation method of the described hydrochloride for injection ondansetron of claim 4 lyophilized injectable powder, it is characterized in that described excipient is a kind of in mannitol, lactose, dextran, glucose, sorbitol, the sodium chloride.
5. according to the preparation method of the described hydrochloride for injection ondansetron of claim 3 lyophilized injectable powder, it is characterized in that lyophilization comprises pre-freeze and sublimation drying; Wherein the pre-freeze temperature of the preceding case of freeze dryer is-30 ℃～-40 ℃ in the pre-freeze process, insulation, and the temperature of the rear cabinet of freeze dryer is reduced to-40～-50 ℃ between soak; In the sublimation drying process, under the evacuation condition, with per hour 2～4 ℃ of distillations that heat up, until drying.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2004100138446A CN1555795A (en) | 2004-01-08 | 2004-01-08 | Ondansijiong hydrochleride freeze dried powder ampoule for injection and its preparation method |
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| CNA2004100138446A CN1555795A (en) | 2004-01-08 | 2004-01-08 | Ondansijiong hydrochleride freeze dried powder ampoule for injection and its preparation method |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102125550A (en) * | 2010-12-30 | 2011-07-20 | 江苏奥赛康药业有限公司 | Ondansetron hydrochloride composition for injection and preparation method thereof |
| CN103211771A (en) * | 2012-01-18 | 2013-07-24 | 浙江亚太药业股份有限公司 | Ramosetron hydrochloride freeze-dried powder injection and preparation method thereof |
| CN105769759B (en) * | 2016-04-13 | 2018-06-29 | 山东北大高科华泰制药有限公司 | Ondansetron hydrochloride injecta composition and preparation method |
| CN109464386A (en) * | 2018-12-20 | 2019-03-15 | 江西润泽药业有限公司 | Ondansetron hydrochloride injection and preparation method thereof |
| CN109464404A (en) * | 2018-12-20 | 2019-03-15 | 江西润泽药业有限公司 | Compound hydrochloric acid ondansetron injection and preparation method thereof |
-
2004
- 2004-01-08 CN CNA2004100138446A patent/CN1555795A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102125550A (en) * | 2010-12-30 | 2011-07-20 | 江苏奥赛康药业有限公司 | Ondansetron hydrochloride composition for injection and preparation method thereof |
| CN102125550B (en) * | 2010-12-30 | 2012-10-03 | 江苏奥赛康药业股份有限公司 | Ondansetron hydrochloride composition for injection and preparation method thereof |
| CN103211771A (en) * | 2012-01-18 | 2013-07-24 | 浙江亚太药业股份有限公司 | Ramosetron hydrochloride freeze-dried powder injection and preparation method thereof |
| CN105769759B (en) * | 2016-04-13 | 2018-06-29 | 山东北大高科华泰制药有限公司 | Ondansetron hydrochloride injecta composition and preparation method |
| CN109464386A (en) * | 2018-12-20 | 2019-03-15 | 江西润泽药业有限公司 | Ondansetron hydrochloride injection and preparation method thereof |
| CN109464404A (en) * | 2018-12-20 | 2019-03-15 | 江西润泽药业有限公司 | Compound hydrochloric acid ondansetron injection and preparation method thereof |
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