CN108113967A - A kind of freeze-dried composition for treating non-Hodgkin lymphoma and preparation method thereof - Google Patents
A kind of freeze-dried composition for treating non-Hodgkin lymphoma and preparation method thereof Download PDFInfo
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- CN108113967A CN108113967A CN201810192123.8A CN201810192123A CN108113967A CN 108113967 A CN108113967 A CN 108113967A CN 201810192123 A CN201810192123 A CN 201810192123A CN 108113967 A CN108113967 A CN 108113967A
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- maleic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- 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
- A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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Abstract
The invention belongs to pharmaceutical technology fields, and in particular to a kind of freeze-dried composition for treating non-Hodgkin lymphoma (NHL) and preparation method thereof.A kind of freeze-dried composition for treating non-Hodgkin lymphoma (NHL) is mainly made of active ingredient maleic acid Pixantrone, sodium chloride, lactose, sodium acetate and pH adjusting agent, the freeze-dried composition stable quality for the treatment of non-Hodgkin lymphoma (NHL) of the present invention, indices conform to quality requirements, in Clinical practice, facilitate medical staff's preparation, drug after preparation can be with the storage of long period, while also improves the security that patient uses.
Description
The application is entitled：A kind of freeze-dried composition for treating non-Hodgkin lymphoma and preparation method thereof, application number
For：201610175504.6, the applying date be：The divisional application of the application for a patent for invention of on 03 26th, 2016.
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of freeze-dried composition for treating non-Hodgkin lymphoma and its
Preparation method.
Background technology
Non-Hodgkin lymphoma（non-Hodgkin’slymphoma,NHL）It is one group of height heterogeneity tumor disease.
It is widely distributed due to the difference of the lymphocyte function of clonal expansion, and in human body, any one internal device can be involved
Official, therefore it shows variform feature, immunophenotype, biological behaviour, clinical manifestation, different therapeutic response and pre-
Afterwards.Its major clinical feature shows as whole body superficial or deep lymph node enlargement, the hyperblastosis of knot perilymph, internal other organs
Involvement and constitutional symptom occur.The course advancement speed of NHL differs, and Most patients morbidity is rendered as the pernicious increasing of more lesions
It is raw or initially its originating from one group of lymph node or the outer a certain internal organs of knot, but often in great-jump-forward send out to other lymph nodes with/
Or the outer organ of knot.With Hodgkin's disease（Hodgkin’sdisease,HD）Compare, NHL easily invades outside the organization, disease progression compared with
Soon.This disease incidence is 19.1/100,000, accounts for the 4% of all tumor invasions, it is seen that in any age, with green grass or young crops in 20-50 Sui
Year is most commonly seen, and men and women's Proportion of patients is more than 1.53:1.
Injection maleic acid Pixantrone is suitable for the more recurrents of single therapy adult or refractory aggressive B cell is non-suddenly
Strange gold lymthoma (NHL).The active ingredient of injection maleic acid Pixantrone is maleic acid Pixantrone, and molecular formula is
C17H19N5O2.C4H4O4, entitled 6, the 9- of chemistry two horse of double [(2- amino-ethyls) amino] benzo [g] isoquinolin -5,10- diketone
Carry out hydrochlorate, structural formula is as follows：
At present, the formulation patent on injection maleic acid Pixantrone is less, and United States Patent (USP) US2006/0199831A1 is disclosed
A kind of injection maleic acid Pixantrone and preparation method thereof, mainly by active ingredient maleic acid Pixantrone and auxiliary material lactose, the right side
The sugared acid anhydride of rotation and sodium chloride composition.
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.
But inventor in experiments it is found that, when injection maleic acid Pixantrone Clinical practice, need to use 0.9% sodium chloride solution
Intravenous drip after dilution, solution visible foreign matters become larger with the extension of standing time after dilution, this just faces to medical staff
Bed compounding medicine brings great inconvenience, while also increases the application risk of patient, and inventor is by examining current technology
Discovery is examined, current technology cannot solve the problems, such as this.
The content of the invention
For current deficiency, the present invention provides a kind of freeze-dried compositions for treating non-Hodgkin lymphoma (NHL)：It is main
It to be made of active ingredient maleic acid Pixantrone, sodium chloride, lactose, sodium acetate and pH adjusting agent.
Freeze-dried composition provided by the invention：The active ingredient maleic acid Pixantrone and the mass ratio of lactose are 1：
1.4 ~ 1.8, it is preferably 1:1.6.
Freeze-dried composition provided by the invention：The active ingredient maleic acid Pixantrone and the mass ratio of sodium acetate are 1：
0.8 ~ 1.4, it is preferably 1:1.1.
Freeze-dried composition provided by the invention：PH value range is 5.0 ~ 6.0 after the freeze-dried composition redissolves, and is preferably
5.5。
The freeze-dried composition for the treatment of non-Hodgkin lymphoma (NHL) provided by the invention：The pH adjusting agent for hydrochloric acid,
It is a kind of or several in acetic acid, phosphoric acid, citric acid, benzene sulfonic acid or sodium hydroxide, it is preferably hydrochloric acid or sodium hydroxide.
Invention further provides the preparation method of the freeze-dried composition of above-mentioned treatment non-Hodgkin lymphoma (NHL),
It mainly includes the following steps that：
The sodium chloride, lactose and sodium acetate for weighing recipe quantity are dissolved in suitable water for injection, weigh the maleic acid of recipe quantity
Pixantrone is dissolved into above-mentioned solution, is uniformly mixed, and is adjusted pH value with suitable dilute hydrochloric acid or diluted sodium hydroxide solution, is used
Water for injection is settled to total amount, is uniformly mixed, filtering, filling, and freeze-drying, visual inspection is got product.
The freeze-dried composition of above-mentioned treatment non-Hodgkin lymphoma (NHL) of the present invention has the following advantages：This hair
The freeze-dried composition stable quality of bright preparation, indices conform to quality requirements, preparation with 0.9% sodium chloride solution redissolve with
The intravenous drip solution prepared afterwards, visible foreign matters do not find significantly to change within twenty four hours, convenient in Clinical practice
Medical staff's preparation, the drug after preparation can be with the storage of long period, while also improve the security that patient uses.
Specific embodiment
Embodiment 1：
Prescription
Preparation process
The sodium chloride, lactose and sodium acetate for weighing recipe quantity are dissolved in suitable water for injection, weigh the maleic acid of recipe quantity
Pixantrone is dissolved into above-mentioned solution, is uniformly mixed, and is adjusted pH value with suitable dilute hydrochloric acid or diluted sodium hydroxide solution, is used
Water for injection is settled to total amount, is uniformly mixed, filtering, filling, and freeze-drying, visual inspection is got product.
Embodiment 2：
Prescription
Preparation process：
The sodium chloride, lactose and sodium acetate for weighing recipe quantity are dissolved in suitable water for injection, weigh the maleic acid of recipe quantity
Pixantrone is dissolved into above-mentioned solution, is uniformly mixed, and is adjusted pH value with suitable dilute hydrochloric acid or diluted sodium hydroxide solution, is used
Water for injection is settled to total amount, is uniformly mixed, filtering, filling, and freeze-drying, visual inspection is got product.
Embodiment 3：
Prescription
Preparation process：
The sodium chloride, lactose and sodium acetate for weighing recipe quantity are dissolved in suitable water for injection, weigh the maleic acid of recipe quantity
Pixantrone is dissolved into above-mentioned solution, is uniformly mixed, and is adjusted pH value with suitable dilute hydrochloric acid or diluted sodium hydroxide solution, is used
Water for injection is settled to total amount, is uniformly mixed, filtering, filling, and freeze-drying, visual inspection is got product.
Embodiment 4：
Prescription
Preparation process：
The sodium chloride, lactose and sodium acetate for weighing recipe quantity are dissolved in suitable water for injection, weigh the maleic acid of recipe quantity
Pixantrone is dissolved into above-mentioned solution, is uniformly mixed, and is adjusted pH value with suitable dilute hydrochloric acid or diluted sodium hydroxide solution, is used
Water for injection is settled to total amount, is uniformly mixed, filtering, filling, and freeze-drying, visual inspection is got product.
Embodiment 5：
Prescription
Preparation process：
The sodium chloride, lactose and sodium acetate for weighing recipe quantity are dissolved in suitable water for injection, weigh the maleic acid of recipe quantity
Pixantrone is dissolved into above-mentioned solution, is uniformly mixed, and is adjusted pH value with suitable dilute hydrochloric acid or diluted sodium hydroxide solution, is used
Water for injection is settled to total amount, is uniformly mixed, filtering, filling, and freeze-drying, visual inspection is got product.
Embodiment 6：
Prescription
Preparation process：
The sodium chloride, lactose and sodium acetate for weighing recipe quantity are dissolved in suitable water for injection, weigh the maleic acid of recipe quantity
Pixantrone is dissolved into above-mentioned solution, is uniformly mixed, and is adjusted pH value with suitable dilute hydrochloric acid or diluted sodium hydroxide solution, is used
Water for injection is settled to total amount, is uniformly mixed, filtering, filling, and freeze-drying, visual inspection is got product.
Embodiment 7：
Prescription
Preparation process：
The sodium chloride, lactose and sodium acetate for weighing recipe quantity are dissolved in suitable water for injection, weigh the maleic acid of recipe quantity
Pixantrone is dissolved into above-mentioned solution, is uniformly mixed, and is adjusted pH value with suitable dilute hydrochloric acid or diluted sodium hydroxide solution, is used
Water for injection is settled to total amount, is uniformly mixed, filtering, filling, and freeze-drying, visual inspection is got product.
Comparative example 1：
Prescription
Preparation process
It weighs the sodium chloride of recipe quantity and lactose is dissolved in suitable water for injection, the maleic acid Pixantrone for weighing recipe quantity is molten
Solution is uniformly mixed into above-mentioned solution, is adjusted pH value with suitable dilute hydrochloric acid or diluted sodium hydroxide solution, is used water for injection
Total amount is settled to, is uniformly mixed, is filtered, filling, freeze-drying, visual inspection is got product.
Comparative example 2：
Prescription
Preparation process：
The sodium chloride, lactose and sodium acetate for weighing recipe quantity are dissolved in suitable water for injection, weigh the maleic acid of recipe quantity
Pixantrone is dissolved into above-mentioned solution, is uniformly mixed, and is adjusted pH value with suitable dilute hydrochloric acid or diluted sodium hydroxide solution, is used
Water for injection is settled to total amount, is uniformly mixed, filtering, filling, and freeze-drying, visual inspection is got product.
Comparative example 3：
Prescription
Preparation process：
The sodium chloride, Dextran 40 and sodium acetate 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, and is adjusted with suitable dilute hydrochloric acid or diluted sodium hydroxide solution
PH value is settled to total amount with water for injection, is uniformly mixed, filtering, filling, and freeze-drying, visual inspection is got product.
Comparative example 4：
Prescription
Preparation process
It weighs the sodium chloride of recipe quantity and lactose is dissolved in suitable water for injection, the maleic acid Pixantrone for weighing recipe quantity is molten
Solution is uniformly mixed into above-mentioned solution, is adjusted pH value with suitable dilute hydrochloric acid or diluted sodium hydroxide solution, is used water for injection
Total amount is settled to, is uniformly mixed, is filtered, filling, freeze-drying, visual inspection is got product.
Comparative example 5：
Prescription
Preparation process
It weighs the sodium chloride of recipe quantity and sodium acetate is dissolved in suitable water for injection, weigh the maleic acid Pixantrone of recipe quantity
It is dissolved into above-mentioned solution, is uniformly mixed, adjust pH value with suitable dilute hydrochloric acid or diluted sodium hydroxide solution, use injection
Water is settled to total amount, is uniformly mixed, filtering, filling, and freeze-drying, visual inspection is got product.
Comparative example 6：
Prescription
Preparation process
The sodium chloride, lactose and sodium acetate for weighing recipe quantity are dissolved in suitable water for injection, weigh the maleic acid of recipe quantity
Pixantrone is dissolved into above-mentioned solution, is uniformly mixed, and is adjusted pH value with suitable dilute hydrochloric acid or diluted sodium hydroxide solution, is used
Water for injection is settled to total amount, is uniformly mixed, filtering, filling, and freeze-drying, visual inspection is got product.
Verify embodiment
Influence factor experiment investigation
1~7 gained finished product preparation of the embodiment of the present invention and comparison patent 1 are respectively placed in 40 DEG C of climatic chambers, respectively at
Its appearance character, pH, moisture, the variation in relation to substance and content are investigated in sampling in 0th, 5,10 day, and result of the test is shown in Table 1
1 Examples 1 to 7 of table and comparison 1 finished product preparation influence factor experiment investigation result of patent
From experimental result：Preparation made from the embodiment of the present invention 1~7 is with 1 gained preparation of comparative example in influence factor
Under experimental condition, appearance character, pH, moisture, conform to quality requirements in relation to the indices such as substance and content.
The embodiment of the present invention 1~7 and 1~6 gained finished product preparation of comparative example are first used to 0.9% sodium chloride of 5ml respectively
Parenteral solution redissolve, be then transferred to 250ml 0.9% sodium chloride injection further dilute preparation become intravenous drip it is molten
Liquid, with reference to Chinese Pharmacopoeia the 4th the first method of visible foreign matters inspection technique of version in 2015（Lamp test）, when 0,6,12,24 is small
Its visible foreign matters is measured, result of the test is shown in Table 2
2 Examples 1 to 7 of table prepares intravenous drip solution visible foreign matters with 1~6 preparation of comparative example and investigates result
From experimental result：It is quiet with being prepared into after the dilution of 0.9% sodium chloride injection that preparation is made in the embodiment of the present invention 1~7
Arteries and veins instillation solution quality stablizes visible foreign matters and is substantially better than comparative example 1 ~ 6, and embodiment 1 more embodies the excellent of the present invention
More property.
Claims (7)
1. a kind of freeze-dried composition for treating non-Hodgkin lymphoma, which is characterized in that it is by active ingredient maleic acid China fir
Fine jade, sodium chloride, lactose, sodium acetate and pH adjusting agent composition；The active ingredient maleic acid Pixantrone and the mass ratio of lactose
For 1:1.6；The active ingredient maleic acid Pixantrone and the mass ratio of sodium acetate are 1:1.1；The freeze-dried composition is answered
PH value range is 5.0~6.0 after molten；The pH adjusting agent is citric acid or benzene sulfonic acid or pH adjusting agent is citric acid and benzene sulphur
Acid.
2. a kind of freeze-dried composition for treating non-Hodgkin lymphoma, which is characterized in that it is by active ingredient maleic acid China fir
Fine jade, sodium chloride, lactose, sodium acetate and pH adjusting agent composition；The active ingredient maleic acid Pixantrone and the mass ratio of lactose
For 1:1.6；The active ingredient maleic acid Pixantrone and the mass ratio of sodium acetate are 1：(0.8~1.4)；Described lyophilized group
It is 5.5 to close pH value range after object redissolves；The pH adjusting agent is citric acid or benzene sulfonic acid or pH adjusting agent is citric acid and benzene
Sulfonic acid.
3. a kind of freeze-dried composition for treating non-Hodgkin lymphoma, which is characterized in that it is by active ingredient maleic acid China fir
Fine jade, sodium chloride, lactose, sodium acetate and pH adjusting agent composition；The active ingredient maleic acid Pixantrone and the mass ratio of lactose
For 1：(1.4~1.8)；The active ingredient maleic acid Pixantrone and the mass ratio of sodium acetate are 1：1.1；Described lyophilized group
It is 5.5 to close pH value range after object redissolves；The pH adjusting agent is citric acid or benzene sulfonic acid or pH adjusting agent is citric acid and benzene
Sulfonic acid.
4. a kind of freeze-dried composition for treating non-Hodgkin lymphoma, which is characterized in that it is by active ingredient maleic acid China fir
Fine jade, sodium chloride, lactose, sodium acetate and pH adjusting agent composition；The active ingredient maleic acid Pixantrone and the mass ratio of lactose
For 1：1.6；The active ingredient maleic acid Pixantrone and the mass ratio of sodium acetate are 1：1.1；The freeze-dried composition is answered
PH value range is 5.0~6.0 after molten；The pH adjusting agent is sodium hydroxide.
5. a kind of freeze-dried composition for treating non-Hodgkin lymphoma, which is characterized in that it is by active ingredient maleic acid China fir
Fine jade, sodium chloride, lactose, sodium acetate and pH adjusting agent composition；The active ingredient maleic acid Pixantrone and the mass ratio of lactose
For 1：1.6；The active ingredient maleic acid Pixantrone and the mass ratio of sodium acetate are 1：(0.8~1.4)；Described lyophilized group
It is 5.5 to close pH value range after object redissolves；The pH adjusting agent is sodium hydroxide.
6. a kind of freeze-dried composition for treating non-Hodgkin lymphoma, which is characterized in that it is by active ingredient maleic acid China fir
Fine jade, sodium chloride, lactose, sodium acetate and pH adjusting agent composition；The active ingredient maleic acid Pixantrone and the mass ratio of lactose
For 1：(1.4~1.8)；The active ingredient maleic acid Pixantrone and the mass ratio of sodium acetate are 1：1.1；Described lyophilized group
It is 5.5 to close pH value range after object redissolves；The pH adjusting agent is sodium hydroxide.
7. a kind of freeze-dried composition for treating non-Hodgkin lymphoma, preparation method are as follows：According to claim 1 to claim
The sodium chloride, lactose and sodium acetate that recipe quantity is weighed described in 6 any one are dissolved in suitable water for injection, weigh recipe quantity
Maleic acid Pixantrone be dissolved into above-mentioned solution, be uniformly mixed, with suitable diluted sodium hydroxide solution adjust pH value, use
Water for injection is settled to total amount, is uniformly mixed, filtering, filling, and freeze-drying, visual inspection is got product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810192123.8A CN108113967A (en) | 2016-03-26 | 2016-03-26 | A kind of freeze-dried composition for treating non-Hodgkin lymphoma and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610175504.6A CN105769776B (en) | 2016-03-26 | 2016-03-26 | A kind of freeze-dried composition for treating non-Hodgkin lymphoma and preparation method thereof |
| CN201810192123.8A CN108113967A (en) | 2016-03-26 | 2016-03-26 | A kind of freeze-dried composition for treating non-Hodgkin lymphoma and preparation method thereof |
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| CN201610175504.6A Division CN105769776B (en) | 2016-03-26 | 2016-03-26 | A kind of freeze-dried composition for treating non-Hodgkin lymphoma and preparation method thereof |
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| CN201810192123.8A Pending CN108113967A (en) | 2016-03-26 | 2016-03-26 | A kind of freeze-dried composition for treating non-Hodgkin lymphoma and preparation method thereof |
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| CN106176630B (en) * | 2016-08-03 | 2019-01-04 | 湖北丽益医药科技有限公司 | A kind of preparation method of injection maleic acid Pixantrone aseptic powdery |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060199831A1 (en) * | 2002-05-16 | 2006-09-07 | Cell Therapeutics Europe S.R.I. | Injectable pharmaceutical compositions of an anthracenedione derivative with anti-tumoral activity |
| CN101439181A (en) * | 2008-12-31 | 2009-05-27 | 广东天普生化医药股份有限公司 | Stable water injection medicament composition containing Ulinastatin |
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| CN103479578B (en) * | 2012-06-14 | 2016-08-03 | 沈阳药科大学 | The Liposomal formulation of a kind of maleic acid Pixantrone and preparation technology thereof |
| CN105288648B (en) * | 2015-10-14 | 2018-11-06 | 东南大学 | A kind of phosphatide cpd of hydrophilic medicament, its pharmaceutical composition and application |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060199831A1 (en) * | 2002-05-16 | 2006-09-07 | Cell Therapeutics Europe S.R.I. | Injectable pharmaceutical compositions of an anthracenedione derivative with anti-tumoral activity |
| CN101439181A (en) * | 2008-12-31 | 2009-05-27 | 广东天普生化医药股份有限公司 | Stable water injection medicament composition containing Ulinastatin |
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| CN105769776A (en) | 2016-07-20 |
| CN105769776B (en) | 2018-05-11 |
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