CN105769757B - A kind of parenteral solution for treating non-Hodgkin lymphoma and preparation method thereof - Google Patents
A kind of parenteral solution for treating non-Hodgkin lymphoma and preparation method thereof Download PDFInfo
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
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- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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Abstract
The invention belongs to pharmaceutical technology fields, and in particular to a kind of parenteral solution for treating non-Hodgkin lymphoma and preparation method thereof.A kind of parenteral solution for treating non-Hodgkin lymphoma (NHL)：Mainly it is made of active ingredient maleic acid Pixantrone, dispersant, Ergol, sodium citrate, pH adjusting agent and water for injection, the parenteral solution stable quality of above-mentioned treatment non-Hodgkin lymphoma (NHL) of the present invention, indices conform to quality requirements, it is simple for process, it is easy to operation.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of parenteral solution for treating non-Hodgkin lymphoma and its preparation
Method.
Background technology
Non-Hodgkin lymphoma (Non-Hodgkin lymphoma, NHL) is one group originating from lymph node and other lymphs
The malignant tumour of tissue is a big type of lymthoma.Worldwide incidence is up to 20/,100,000.The inspection in the U.S.,
Epidemiology survey and the morbidity of final result (surveillance epidemiology and end results, SEER)
Rate statistics indicate that, male is more susceptible to suffer from NHL compared with women.Non-Hodgkin's B cell lymphomas are the main parting of NHL, account for NHL's
85%.The average age that the U.S. is diagnosed to be non-Hodgkin's B cell lymphomas is 67 years old.The statistics of China shows non-Hodgkin's B
Cell lymphoma can betide any age, but more with person between twenty and fifty with children.The morbidity and mortality of China's Coastal Areas
Higher than interior, area that are fairly developed economically is higher than economically underdeveloped area, and age of onset curve peak was at 40 years old or so.
On 2 17th, 2012, European Union's approval pixantrone (trade name Pixuvri) can be used as a kind of single treatment
Method treats more recurrents or refractory aggressive non-Hodgkin's B cell lymphoma adult patients, become European Union by first
It is first kind to the therapeutic regimen of patient in this case and so far in world wide for more recurrents and intractable to invade
The monotherapy drug of attacking property non-Hodgkin's B cell lymphoma treatings.It is how multiple for being treated currently without reliable treatment
For hair property and refractory aggressive non-Hodgkin's B cell lymphoma adult patients, pixantrone adds a kind of important to patient
Therapeutic choice.
Maleic acid Pixantrone, molecular formula are C17H19N5O2. 2C4H4O4, chemical double [(the 2- amino second of entitled 6,9-
Base) amino] benzo [g] isoquinolin -5,10- diketone 2-maleate, structural formula is as follows：
It is mentioned in the injection maleic acid Pixantrone operation instructions that European EMA official websites announce, injection maleic acid
Pixantrone is molten by active ingredient maleic acid Pixantrone, sodium chloride, lactose monohydrate and pH adjusting agent hydrochloric acid solution, sodium hydroxide
Liquid forms.
At present, the formulation patent on injection maleic acid Pixantrone is less, and United States Patent (USP) US2006/0199831 A1 are public
A kind of injection maleic acid Pixantrone of cloth and preparation method thereof, mainly by active ingredient maleic acid Pixantrone and auxiliary material breast
Sugar, dextran and sodium chloride composition.But injection maleic acid Pixantrone freeze-dried powder preparation is there are sterility barrier level is low, it is raw
Produce the shortcomings that cycle is long, and Clinical practice needs to redissolve again.
Chinese patent 201210195910.0 discloses the Liposomal formulation and its preparation process of a kind of maleic acid Pixantrone,
This preparation is established substance by maleic acid Pixantrone, phosphatide, cholesterol and gradient and is prepared.The preparation process includes preparing blank
Liposome, gradient liposome, loading drug and etc..But there are formulation and technologies to answer for the Liposomal formulation of maleic acid Pixantrone
Miscellaneous, the production cycle is long, it is high to equipment requirement the shortcomings that.
The content of the invention
For current deficiency, the present invention provides a kind of parenteral solutions for treating non-Hodgkin lymphoma (NHL)：Mainly by
Active ingredient maleic acid Pixantrone, dispersant, Ergol, sodium citrate, pH adjusting agent and water for injection composition.
Parenteral solution provided by the invention：The dispersant for polysorbate, polyoxyethylene fatty acid ester, polyoxyethylene-
One or more of poiyoxypropylene copolymer and castor oil derivatives further select polyoxyethylene-polyoxy third
PLURONICS F87 in one or several kinds in alkene copolymer, further preferably Pluronic F68.
Parenteral solution provided by the invention：The concentration of the PLURONICS F87 is 50.0mg/ml ~ 60mg/ml, is preferably
55.0mg/ml。
Parenteral solution provided by the invention：The concentration of the Ergol is 0.5mg/ml ~ 1.5mg/ml, is preferably
1.0mg/ml。
Parenteral solution provided by the invention：The concentration of the sodium citrate is 16.0mg/ml ~ 22.0mg/ml, is preferably
19.0mg/ml。
Parenteral solution provided by the invention：The pH value is 5.5.
Parenteral solution provided by the invention：The pH adjusting agent is in hydrochloric acid, acetic acid, phosphoric acid, citric acid or sodium hydroxide
It is a kind of or several, be preferably citric acid or sodium hydroxide.
Parenteral solution provided by the invention：The active ingredient maleic acid Pixantrone concentration is 5.0mg/ml, 10.0mg/
Ml, 15.0mg/ml and 20.0mg/ml are preferably 10.0mg/ml, 15.0mg/ml.
Invention further provides the preparation method of the parenteral solution of above-mentioned treatment non-Hodgkin lymphoma (NHL), mainly
Comprise the following steps：
The dispersant, Ergol and sodium citrate for weighing recipe quantity are dissolved in suitable water for injection, weigh place
The maleic acid Pixantrone just measured is dissolved into above-mentioned solution, is uniformly mixed, and pH value is adjusted with suitable pH adjusting agent, with note
It penetrates and is settled to total amount with water, be uniformly mixed, filter, filling, visual inspection is got product.
The parenteral solution of above-mentioned treatment non-Hodgkin lymphoma (NHL) of the present invention has the following advantages：Present invention system
Standby parenteral solution stable quality, indices conform to quality requirements, simple for process, easy to operation.
Specific embodiment
Embodiment 1：
Prescription
Preparation process
The PLURONICS F87, Ergol and sodium citrate for weighing recipe quantity are dissolved in suitable water for injection,
The maleic acid Pixantrone for weighing recipe quantity is dissolved into above-mentioned solution, is uniformly mixed, with suitable pH adjusting agent
（The citric acid soln of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L）PH value is adjusted, total amount is settled to water for injection,
It is uniformly mixed, filters, filling, visual inspection is got product.
Embodiment 2：
Prescription
Preparation process
The PLURONICS F87, Ergol and sodium citrate for weighing recipe quantity are dissolved in suitable water for injection,
The maleic acid Pixantrone for weighing recipe quantity is dissolved into above-mentioned solution, is uniformly mixed, with suitable pH adjusting agent
（The citric acid soln of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L）PH value is adjusted, total amount is settled to water for injection,
It is uniformly mixed, filters, filling, visual inspection is got product.
Embodiment 3：
Prescription
Preparation process
The PLURONICS F87, Ergol and sodium citrate for weighing recipe quantity are dissolved in suitable water for injection,
The maleic acid Pixantrone for weighing recipe quantity is dissolved into above-mentioned solution, is uniformly mixed, with suitable pH adjusting agent
（The citric acid soln of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L）PH value is adjusted, total amount is settled to water for injection,
It is uniformly mixed, filters, filling, visual inspection is got product.
Embodiment 4：
Prescription
Preparation process
The PLURONICS F87, Ergol and sodium citrate for weighing recipe quantity are dissolved in suitable water for injection,
The maleic acid Pixantrone for weighing recipe quantity is dissolved into above-mentioned solution, is uniformly mixed, with suitable pH adjusting agent
（The citric acid soln of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L）PH value is adjusted, total amount is settled to water for injection,
It is uniformly mixed, filters, filling, visual inspection is got product.
Embodiment 5：
Prescription
Preparation process
The PLURONICS F87, Ergol and sodium citrate for weighing recipe quantity are dissolved in suitable water for injection,
The maleic acid Pixantrone for weighing recipe quantity is dissolved into above-mentioned solution, is uniformly mixed, with suitable pH adjusting agent
（The citric acid soln of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L）PH value is adjusted, total amount is settled to water for injection,
It is uniformly mixed, filters, filling, visual inspection is got product.
Embodiment 6：
Prescription
Preparation process
The PLURONICS F87, Ergol and sodium citrate for weighing recipe quantity are dissolved in suitable water for injection,
The maleic acid Pixantrone for weighing recipe quantity is dissolved into above-mentioned solution, is uniformly mixed, with suitable pH adjusting agent
（The citric acid soln of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L）PH value is adjusted, total amount is settled to water for injection,
It is uniformly mixed, filters, filling, visual inspection is got product.
Comparative example 1：
Prescription
Preparation process
It weighs the Ergol of recipe quantity and sodium citrate is dissolved in suitable water for injection, weigh the horse of recipe quantity
Carry out sour pixantrone to be dissolved into above-mentioned solution, be uniformly mixed, with suitable pH adjusting agent（The citric acid soln of 0.1mol/L
Or the sodium hydroxide solution of 0.1mol/L）PH value is adjusted, total amount is settled to water for injection, is uniformly mixed, is filtered, is filled
Dress, visual inspection are got product.
Comparative example 2：
Prescription
Preparation process
The PLURONICS F87, Ergol and sodium citrate for weighing recipe quantity are dissolved in suitable water for injection,
The maleic acid Pixantrone for weighing recipe quantity is dissolved into above-mentioned solution, is uniformly mixed, with suitable pH adjusting agent
（The citric acid soln of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L）PH value is adjusted, total amount is settled to water for injection,
It is uniformly mixed, filters, filling, visual inspection is got product.
Comparative example 3：
Prescription
Preparation process
It weighs the PLURONICS F87 of recipe quantity and sodium citrate is dissolved in suitable water for injection, weigh recipe quantity
Maleic acid Pixantrone is dissolved into above-mentioned solution, is uniformly mixed, with suitable pH adjusting agent（The citric acid of 0.1mol/L is molten
The sodium hydroxide solution of liquid or 0.1mol/L）PH value is adjusted, total amount is settled to water for injection, is uniformly mixed, is filtered, is filled
Dress, visual inspection are got product.
Comparative example 4：
Prescription
Preparation process
The PLURONICS F87, Ergol and sodium citrate for weighing recipe quantity are dissolved in suitable water for injection,
The maleic acid Pixantrone for weighing recipe quantity is dissolved into above-mentioned solution, is uniformly mixed, with suitable pH adjusting agent
（The citric acid soln of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L）PH value is adjusted, total amount is settled to water for injection,
It is uniformly mixed, filters, filling, visual inspection is got product.
Comparative example 5
Prescription
Preparation process
It weighs the PLURONICS F87 of recipe quantity and Ergol is dissolved in suitable water for injection, weigh recipe quantity
Maleic acid Pixantrone be dissolved into above-mentioned solution, be uniformly mixed, with suitable dilute hydrochloric acid or diluted sodium hydroxide solution tune
PH value is saved, total amount is settled to water for injection, is uniformly mixed, is filtered, filling, visual inspection is got product.
Comparative example 6：
Prescription
Preparation process
The PLURONICS F87, Ergol and sodium citrate for weighing recipe quantity are dissolved in suitable water for injection,
The maleic acid Pixantrone for weighing recipe quantity is dissolved into above-mentioned solution, is uniformly mixed, with suitable pH adjusting agent
（The citric acid soln of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L）PH value is adjusted, total amount is settled to water for injection,
It is uniformly mixed, filters, filling, visual inspection is got product.
Comparative example 7：
Prescription
Preparation process
It weighs the sodium chloride of recipe quantity and lactose is dissolved in suitable water for injection, weigh the maleic acid China fir of recipe quantity
Fine jade is dissolved into above-mentioned solution, is uniformly mixed, and pH value is adjusted with suitable dilute hydrochloric acid or diluted sodium hydroxide solution, with injection
Total amount is settled to water, is uniformly mixed, is filtered, filling, visual inspection is got product.
Verify embodiment
Influence factor experiment investigation
1~6 gained finished product preparation of the embodiment of the present invention and comparison patent 1 ~ 7 are respectively placed in 40 DEG C of climatic chambers,
Its appearance character, visible foreign matters, pH, the variation in relation to substance and content, result of the test are investigated respectively at sampling in the 0th, 5,10 day
It is shown in Table 1.
Finished product preparation obtained by 1 Examples 1 to 6 of table and comparison 1 ~ 7 finished product preparation influence factor experiment investigation result of patent
From experimental result：Preparation made from the embodiment of the present invention 1~6 passes through 40 with 1 ~ 7 gained preparation of comparison patent
DEG C factors influencing, it is formulation aesthetics character made from Examples 1 to 6, visible foreign matters, pH, every in relation to substance and content etc.
Index is significantly better than that comparison 1 ~ 7 gained preparation of patent.
Long term test is investigated
1~6 gained finished product preparation of the embodiment of the present invention and comparison patent 1 ~ 7 are respectively placed in 2-8 DEG C of climatic chamber,
Its appearance character, visible foreign matters, pH, the variation in relation to substance and content, experiment knot are investigated respectively at sampling in the 0th, 6,12 month
Fruit is shown in Table 2.
Finished product preparation obtained by 2 Examples 1 to 6 of table investigates result with 1 ~ 7 finished product preparation long term test of comparison patent
From experimental result：Preparation made from the embodiment of the present invention 1~6 tries for a long time with comparison 1 ~ 7 gained preparation of patent
Investigation is tested, it is formulation aesthetics character made from Examples 1 to 6, visible foreign matters, pH, bright in relation to the indices such as substance and content
Aobvious while embodiment indices meet the quality standard of parenteral solution better than comparison 1 ~ 7 gained preparation of patent, and embodiment 1
Indices are better than other embodiment, are to be worth the prescription carried out in big production.
Claims (8)
1. a kind of parenteral solution for treating non-Hodgkin lymphoma (NHL), which is characterized in that it is by active ingredient maleic acid China fir
Fine jade, dispersant, Ergol, sodium citrate, pH adjusting agent and water for injection composition；The dispersant for polyoxyethylene-
PLURONICS F87 in poiyoxypropylene copolymer；The pH adjusting agent is citric acid or sodium hydroxide.
2. parenteral solution according to claim 1, which is characterized in that the dispersant is polysorbate, polyoxyethylene fat
Fat acid esters, Pluronic F68, Emulsifier EL-60, one kind or at least two classes in above-mentioned four classes substance.
3. the parenteral solution according to claim 1 or claim 2, which is characterized in that the dispersant PLURONICS F87
Concentration be 50.0mg/ml~60mg/ml.
4. parenteral solution according to claim 1, which is characterized in that the concentration of the Ergol for 0.5mg/ml~
1.5mg/ml。
5. parenteral solution according to claim 1, which is characterized in that the concentration of the sodium citrate for 16.0mg/ml~
22.0mg/ml。
6. parenteral solution according to claim 1, which is characterized in that the parenteral solution pH value is 5.5.
7. parenteral solution according to claim 1, which is characterized in that the active ingredient maleic acid Pixantrone concentration is
5.0mg/ml or 10.0mg/ml or 15.0mg/ml or 20.0mg/ml.
8. a kind of parenteral solution for treating non-Hodgkin lymphoma (NHL), preparation method are as follows：Injection as described in claim 7
Liquid, the dispersant, Ergol and sodium citrate for weighing recipe quantity are dissolved in suitable water for injection, weigh recipe quantity
Maleic acid Pixantrone is dissolved into above-mentioned solution, is uniformly mixed, with suitable citric acid soln or sodium hydroxide solution tune
PH value is saved, total amount is settled to water for injection, is uniformly mixed, is filtered, filling, visual inspection is got product.
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| CN201810192120.4A CN108186560A (en) | 2016-03-26 | 2016-03-26 | A kind of parenteral solution for treating non-Hodgkin lymphoma and preparation method thereof |
| CN201610175505.0A CN105769757B (en) | 2016-03-26 | 2016-03-26 | A kind of parenteral solution for treating non-Hodgkin lymphoma and preparation method thereof |
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| CN201610175505.0A CN105769757B (en) | 2016-03-26 | 2016-03-26 | A kind of parenteral solution for treating non-Hodgkin lymphoma and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103479578A (en) * | 2012-06-14 | 2014-01-01 | 沈阳药科大学 | Pixantrone maleate liposome preparation and preparation process thereof |
| CN105288648A (en) * | 2015-10-14 | 2016-02-03 | 东南大学 | Phospholipid compound of hydrophilic drugs as well as pharmaceutical composition and application of phospholipid compound |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| ITMI20021040A1 (en) * | 2002-05-16 | 2003-11-17 | Novuspharma Spa | INJECTABLE PHARMACEUTICAL COMPOSITIONS OF AN ANTHROCENEDIONAL DERIVATIVE WITH ANTI-TUMOR ACTIVITY |
| CN1231209C (en) * | 2002-11-21 | 2005-12-14 | 武汉利元亨药物技术有限公司 | Ursolic acid poly lactic acid nano particle freeze dried powder for ampoule agent and its preparation method |
| WO2013043529A1 (en) * | 2011-09-19 | 2013-03-28 | Emory University | Bone morphogenetic protein pathway activation, compositions for ossification, and methods related thereto |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103479578A (en) * | 2012-06-14 | 2014-01-01 | 沈阳药科大学 | Pixantrone maleate liposome preparation and preparation process thereof |
| CN105288648A (en) * | 2015-10-14 | 2016-02-03 | 东南大学 | Phospholipid compound of hydrophilic drugs as well as pharmaceutical composition and application of phospholipid compound |
Non-Patent Citations (1)
| Title |
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| 原发性中枢神经系统淋巴瘤诊治进展;黄慧强, 林旭滨;《中国神经肿瘤杂志》;20061231;第4卷(第3期);第180-186页 * |
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