CN110124030A - A kind of Su Jin monoclonal antibody injection and preparation method thereof - Google Patents
A kind of Su Jin monoclonal antibody injection and preparation method thereof Download PDFInfo
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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Abstract
The present invention provides a kind of Su Jin monoclonal antibody injections, it is made of following component: Su Jin monoclonal antibody 50mg/ml-300mg/ml, histidine and histidine hydrochloride 5-50mmol/L, methionine 5-50mmol/L, polyalcohol 150mmol/L-400mmol/L, polyoxyethylene sorbitan monoleate 0.01%-0.02%, remaining ingredient is water for injection, pH5.0-7.0, the Su Jin monoclonal antibody injection proves that the injection quality is stablized by stability test, and stability is better than commercial variety in the market, indices meet the pertinent regulations of Chinese Pharmacopoeia, have a good application prospect.
Description
Technical field
The invention belongs to bio-pharmaceuticals and formulation art, and in particular to a kind of Su Jin monoclonal antibody injection and preparation method thereof.
Technical background
Psoriasis is a kind of skin disease that Chronic immune mediates, global number of patients about 1.25 hundred million, Chinese psoriasis
Patient up to 6,500,000.
Su Jin monoclonal antibody is a kind of anti-IL-17A inflammatory cytokine IgG1 antibody of full Humanized monoclonal, by with IL-17A
In conjunction with the interaction of IL-17A Yu its receptor directly having been blocked, so that changing immune and inflammatory reaction reaches therapeutic purposes.
(active constituent: Secukinumab, Su Jin monoclonal antibody) is first targeting of the whole world of Novartis Co., Ltd's exploitation
The heavy pound biological medicament of IL-17A, it has already been proven that it surmounts the tradition targeting such as Enbrel and Humira in treatment psoriasis curative effect
The biological agent of TNF α, at present temporarily not in Discussion on Chinese Listed, and China lacks corresponding types of drugs.As biological antibody class medicine
Object, the stability of antibody preparation are the key project of drug Quality Control, and applicant has found that original grinds drug in retrieving early period
(CN201580076632.9) trehalose is generallyd use as stabilizer and carries out preparation, other stabilizers are still uncertain at present, make
Few in the types of drugs of international and national at the medicine, substitutability is poor.
Summary of the invention
In order to solve the above technical problems, therefore the present invention provides a kind of Su Jin monoclonal antibody injection, the injection by with
It is lower at being grouped as: Su Jin monoclonal antibody 50mg/ml-300mg/ml, histidine and histidine hydrochloride 5-50mmol/L, methionine 5-
50mmol/L, polyalcohol 150mmol/L-400mmol/L, polyoxyethylene sorbitan monoleate 0.01%-0.02%, remaining ingredient are injection
Water, pH5.0-7.0.
In the present patent application, applicant screens a kind of polyalcohol, preferably glycerine or propylene glycol, in injection field,
Glycerol in injection frequently as being used as solvent and osmotic pressure regulator, typical concentrations range 1%-50%.
Propylene glycol, typical concentrations range 10%-60%, effect is: increasing its stability, is used as stabilizer.When its concentration
When selecting suitable, as injection solvent, has immediate effect or prolongation of effect acts on.Propylene glycol can also be used as antiseptic and inhibiting bacteria function agent use.
Inventor passes through the literature search and a large amount of previous experiments screenings of early period, it was found that and new stabilizer is that is, a kind of more
First alcohol, especially propylene glycol and glycerine.
Above-mentioned this kind of polyalcohol, which is conventionally not intended as stabilizer, to be come using being inventor by expanding screening range, packet
Sugar alcohol, surfactant, excipient etc. are included, carries out stability test respectively, is based on stability indicator: physical stability (SEC-
HPLC (SEC macromolecule protein: 2015 editions general rules of Chinese Pharmacopoeia), the visible particle measured by light blockage method are (with reference to Chinese Pharmacopoeia
2015 editions general rules 0904) and particulate matter (refer to 2015 editions general rules 0903 of Chinese Pharmacopoeia)), chemical stability (CEX-HPLC
Lysine variant, with reference to 2015 editions three annex IIIB of Chinese Pharmacopoeia) obtained from, stability result is shown: polynary being added
After alcohol, the stability of prepared Su Jin monoclonal antibody injection is better than Su Jin monoclonal antibody injection (trehalose conduct in the prior art
Stabilizer, i.e. original grind medicine injection).
Preferably, the present invention provides a kind of Su Jin monoclonal antibody injection, and the injection consists of the following compositions: Su Jin monoclonal antibody
100mg/ml-250mg/ml, histidine and histidine hydrochloride 10-40mmol/L, methionine 5-40mmol/L, polyalcohol
180mmol/L-350mmol/L, polyoxyethylene sorbitan monoleate 0.01%-0.02%, remaining ingredient are water for injection, pH5.5-6.5.
Preferably, the present invention provides a kind of Su Jin monoclonal antibody injection, and the injection consists of the following compositions: Su Jin monoclonal antibody
140mg/ml-200mg/ml, histidine and histidine hydrochloride 10-35mmol/L, methionine 5-30mmol/L, polyalcohol
180mmol/L-300mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.5-6.5.
Preferably, the present invention provides a kind of Su Jin monoclonal antibody injection, and the injection consists of the following compositions: Su Jin monoclonal antibody
140mg/ml-160mg/ml, histidine and histidine hydrochloride 10-30mmol/L, methionine 5-20mmol/L, polyalcohol
210mmol/L-280mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.5-6.5.
Preferably, the present invention provides a kind of Su Jin monoclonal antibody injection, and the injection consists of the following compositions: Su Jin monoclonal antibody
140mg/ml-160mg/ml, histidine and histidine hydrochloride 10-30mmol/L, methionine 5-20mmol/L, polyalcohol
250mmol/L-280mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.5-6.5.
Preferably, in Su Jin monoclonal antibody injection described above, the polyalcohol is propylene glycol or glycerine.
Further preferred polyalcohol is propylene glycol.
Further preferred pH is 5.8.
The present invention further submits a kind of preparation method of above-mentioned Su Jin monoclonal antibody injection, comprises the steps of:
1) buffer
Buffer solution A weighs histidine, methionine, polyalcohol by recipe quantity, is diluted to prescription strength with water for injection,
It is uniformly mixed；
It is dense to be diluted to prescription with water for injection by recipe quantity histidine hydrochloride, methionine, polyalcohol surely for buffer solution B
Degree, is uniformly mixed；
Buffer solution A is added into buffer solution B and is adjusted to final pH, this is final buffer；
2) prepared by finished product
A. Su Jin monoclonal antibody after purification is concentrated by ultrafiltration；
B. protein concentrate concentration mensuration, the protein sample after taking out concentration, measures volume, measures its protein concentration, work as egg
White concentration starts to replace buffer when reaching 100-120mg/ml；
Specimen cup is added in the buffer most in war isometric with the protein liquid volume after concentration by c. replacement operator
In, mixing and being concentrated into protein concentration is 100-120mg/ml, repeatedly replacement operator；
D. the Su Jin monoclonal antibody after displacement buffer is concentrated by ultrafiltration, polyoxyethylene sorbitan monoleate is added, is sterile filtered to obtain the final product.
Further, concrete configuration method are as follows:
Buffer:
Buffer solution A: histidine 10-30mmol/L, methionine 5-20mmol/L, glycerol or propylene glycol are weighed by recipe quantity
210mmol/L-280mmol/L, water for injection is fixed to total volume 7000ml, is uniformly mixed.
Buffer solution B: recipe quantity histidine hydrochloride 10-30mmol/L, methionine 5-20mmol/L, glycerol or the third two are pressed
Alcohol 210mmol/L-280mmol/L, water for injection is fixed to total volume 7000ml, is uniformly mixed.
Buffer solution A is added into buffer solution B and adjusts pH, makes pH to 5.5-6.5, this is final buffer.
Finished product preparation:
A. Su Jin monoclonal antibody after purification is poured into ultrafiltration system specimen cup, starts ultrafiltration system, makes penetration speed in 20-
30ml/min, pressure are not more than 20PSI.PSI (Pounds per square inch),
B. protein concentrate concentration mensuration: the protein sample after taking out concentration measures volume, and uses ultramicrospectrophotometer
Its protein concentration is measured, concentration starts to replace buffer when reaching 100-120mg/ml.
C. it replaces buffer: will be added in specimen cup, mix and dense with the isometric buffer of the albumen volume after concentration
Being reduced to protein concentration is 100-120mg/ml, and above-mentioned replacement operator carries out 8 times；Every time displacement after detection through end liquid pH,
Conductivity, until ultrafiltration system is same or similar with the pH of buffer of preparation and conductivity through end trickle, mark displacement
Buffer terminates.
D. by the Su Jin monoclonal antibody after displacement buffer, then above-mentioned steps progress ultra filtration is concentrated into 170-180mg/ml, receives
Collection sample simultaneously records its volume, rinses ultrafiltration system pipeline with buffer, collects flushing liquor and is added to crossing in the albumen of concentration,
Make protein concentration 140-160mg/ml, volume 1100ml, polyoxyethylene sorbitan monoleate is added, keeps polyoxyethylene sorbitan monoleate final concentration of
0.02%.Gained stoste is used into 0.22 μm of membrane filtration in an aseptic environment and is dispensed into pre-encapsulated injector, volume is dispensed
For 1ml/ branch, totally 1000, label is posted.
The preparation process referenced patent original of the Su Jin monoclonal antibody grinds patent CN101001645A, obtains having identical physics and chemistry
The Su Jin monoclonal antibody product of matter, because Su Jin monoclonal antibody after purification contains acetate salt buffer ingredient, pH value is 5 or so, under this condition
It is unfavorable for preparation stabilization.To guarantee preparation stability, need to replace buffer.
Invention further provides application of the above-mentioned Su Jin monoclonal antibody injection in preparation treatment psoriasis.
In conclusion inventor providing a kind of stable Su Jin monoclonal antibody injection, in the prior art, it is preferred that original grinds medicine
Stabilizer of the trehalose as Su Jin monoclonal antibody injection, substitutability is poor, and inventor passes through sugar alcohol, filler, surface work respectively
Property agent, the screening of osmotic pressure regulator, screening obtained a kind of polyalcohol, especially glycerol and propylene glycol, show respectively
Since original grinds the technological merit of medicine injection, this technical characteristic has obtained the attention of inventor, and prepares corresponding Su Jin
Monoclonal antibody injection, is provided with high industrial applicability at the shortcomings that overcoming the prior art.
Specific embodiment
It the following examples are further illustrations of the invention, is not limitation of the present invention.
Experimental example:
Embodiment 1: buffer
The influence of buffer type (phosphate, histidine, citrate) is evaluated in pre-encapsulated injector.
1: Su Jin monoclonal antibody 150mg/ml of prescription, sodium dihydrogen phosphate and disodium hydrogen phosphate 20mmol/L, methionine 5mmol/
L, trehalose 200mmol/L, polyoxyethylene sorbitan monoleate 0.02%, pH5.8；
2: Su Jin monoclonal antibody 150mg/ml of prescription, histidine and histidine hydrochloride 20mmol/L, methionine 5mmol/L,
Trehalose 200mmol/L, polyoxyethylene sorbitan monoleate 0.02%, pH5.8；
3: Su Jin monoclonal antibody 150mg/ml of prescription, citric acid and sodium citrate 20mmol/L, methionine 5mmol/L, seaweed
Sugared 200mmol/L, polyoxyethylene sorbitan monoleate 0.02%, pH5.8.
Above-mentioned three groups of prescription injections are filled into pre-encapsulated injector, and in long-term (4 DEG C), acceleration (25 DEG C) and height
Stability study is carried out under warm (40 DEG C), evaluates physical stability (SEC-HPLC (SEC macromolecule protein: Chinese Pharmacopoeia 2015 editions
General rule), the visible particle that is measured by light blockage method (with reference to 2015 editions general rules 0904 of Chinese Pharmacopoeia) and particulate matter be (in reference
2015 editions general rules 0903 of state's pharmacopeia)), chemical stability (CEX-HPLC lysine variant, it is attached with reference to Chinese Pharmacopoeia 2015 editions three
Record IIIB).As can be known from the results, histidine buffer salt system variety stability is more excellent, is shown in Table 1-6.
1 SEC-HPLC testing result of table (40 DEG C 4 weeks)
2 CEX-HPLC testing result of table (40 DEG C 4 weeks)
3 SEC-HPLC testing result of table (25 DEG C 12 weeks)
4 CEX-HPLC testing result of table (25 DEG C 12 weeks)
5 SEC-HPLC testing result of table (4 DEG C 16 weeks)
6 CEX-HPLC testing result of table (4 DEG C 16 weeks)
Experimental example 2:pH
With prescription Su Jin monoclonal antibody 150mg/ml, histidine and histidine hydrochloride 20mmol/L, methionine 5mmol/L,
Trehalose 200mmol/L, based on polyoxyethylene sorbitan monoleate 0.02%, adjust pH respectively to 4.5,5.0,5.5,5.8,6.0,6.5,
7.0, investigate influence of the different pH to Su Jin monoclonal antibody stability.Sample is stored under the high temperature conditions 4 weeks, by SEC-HPLC,
CEX-HPLC evaluates Su Jin monoclonal antibody stability.From SEC-HPLC, CEX-HPLC determine albumen aggregation and hydrolyze pH6.0 or so most
It is small.
Experimental example 3: stabilizer
The preliminary recipe development carried out for injection type is dedicated to evaluating different stabilizers in long-term (4 DEG C), acceleration (25
DEG C) and high temperature (40 DEG C) condition of storage under store during to Su Jin monoclonal antibody solubility and insoluble formation of the agglomerates (SEC-HPLC,
DLS, the visible particle and particulate matter measured by light blockage method), the influence of chemical stability (CEX-HPLC).Stabilizer choosing
It is selected as glycerol, propylene glycol, trehalose, prescription is as follows:
1: Su Jin monoclonal antibody 150mg/ml of prescription, histidine and histidine hydrochloride 20mmol/L, methionine 5mmol/L,
Glycerol 270mmol/L, polyoxyethylene sorbitan monoleate 0.02%, pH5.8；
2: Su Jin monoclonal antibody 150mg/ml of prescription, histidine and histidine hydrochloride 20mmol/L, methionine 5mmol/L,
Propylene glycol 271mmol/L, polyoxyethylene sorbitan monoleate 0.02%, pH5.8；
3: Su Jin monoclonal antibody 150mg/ml of prescription, histidine and histidine hydrochloride 20mmol/L, methionine 5mmol/L,
Trehalose 200mmol/L, polyoxyethylene sorbitan monoleate 0.02%, pH5.8.
Its stability experiment of the screening experiment of premenstruum (premenstrua) independent stabilizer concentration, above-mentioned glycerol and propylene glycol is optimal dense
Degree.
(7-12 is shown in Table) by test result, selects glycerol and propylene glycol as the prescription of stabilizer, and stability is equal
It better than prescription 3, and is announced according to the patent formulation that original grinds medicine, the optimization formula that original grinds medicine CN201580076632.9 is prescription 3.
Therefore the present invention overcomes existing technical problems, further improve the stability of injection.
7 SEC-HPLC testing result of table (40 DEG C 4 weeks)
8 CEX-HPLC testing result of table (40 DEG C 4 weeks)
9 SEC-HPLC testing result of table (25 DEG C 6 months)
10 CEX-HPLC testing result of table (25 DEG C 6 months)
11 SEC-HPLC testing result of table (4 DEG C 6 months)
12 CEX-HPLC testing result of table (4 DEG C 6 months)
Embodiment 1
Su Jin monoclonal antibody 150mg/ml, histidine and histidine hydrochloride 20mmol/L, methionine 5mmol/L, glycerol
270mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.8.
Preparation method refers to summary of the invention.
Embodiment 2
Su Jin monoclonal antibody 150mg/ml, histidine and histidine hydrochloride 20mmol/L, methionine 5mmol/L, propylene glycol
271mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.8.
Preparation method refers to summary of the invention.
Embodiment 3
Su Jin monoclonal antibody 150mg/ml, histidine and histidine hydrochloride 20mmol/L, methionine 5mmol/L, propylene glycol
280mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.8.
Preparation method refers to summary of the invention.
Embodiment 4
Su Jin monoclonal antibody 150mg/ml, histidine and histidine hydrochloride 20mmol/L, methionine 5mmol/L, glycerol
210mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.8.
Preparation method refers to summary of the invention.
Embodiment 5
Su Jin monoclonal antibody 150mg/ml, histidine and histidine hydrochloride 20mmol/L, methionine 5mmol/L, glycerol
280mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.8.
Preparation method refers to summary of the invention.
Embodiment 6
Su Jin monoclonal antibody 140mg/ml, histidine and histidine hydrochloride 10mmol/L, methionine 5mmol/L, glycerol
210mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.8.
Preparation method refers to summary of the invention.
Embodiment 7
Su Jin monoclonal antibody 160mg/ml, histidine and histidine hydrochloride 30mmol/L, methionine 20mmol/L, glycerol
280mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.8.Preparation method refers to summary of the invention.
Embodiment 8
Su Jin monoclonal antibody 150mg/ml, histidine and histidine hydrochloride 20mmol/L, methionine 5mmol/L, propylene glycol
210mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.8.Preparation method refers to summary of the invention.
Embodiment 9
Su Jin monoclonal antibody 150mg/ml, histidine and histidine hydrochloride 20mmol/L, methionine 5mmol/L, propylene glycol
280mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.8.
Preparation method refers to summary of the invention.
The above auxiliary material relevant information is as follows:
The embodiments described above only express several embodiments of the present invention, and the description thereof is more specific and detailed, but simultaneously
Limitations on the scope of the patent of the present invention therefore cannot be interpreted as, it is noted that for those skilled in the art,
Without departing from the inventive concept of the premise, several deformations and transformation can also be made, these belong to protection model of the invention
It encloses, therefore, the scope of protection of the patent of the present invention is determined by the appended claims.
Claims (10)
1. a kind of Su Jin monoclonal antibody injection, which is characterized in that the injection consists of the following compositions: Su Jin monoclonal antibody 50mg/ml-
300mg/ml, histidine and histidine hydrochloride 5-50mmol/L, methionine 5-50mmol/L, polyalcohol 150mmol/L-
400mmol/L, polyoxyethylene sorbitan monoleate 0.01%-0.02%, remaining ingredient are water for injection, pH5.0-7.0.
2. Su Jin monoclonal antibody injection according to claim 1, which is characterized in that the injection consists of the following compositions: Soviet Union
It is golden monoclonal antibody 100mg/ml-250mg/ml, histidine and histidine hydrochloride 10-40mmol/L, methionine 5-40mmol/L, more
First alcohol 180mmol/L-350mmol/L, polyoxyethylene sorbitan monoleate 0.01%-0.02%, remaining ingredient are water for injection, pH5.5-
6.5。
3. Su Jin monoclonal antibody injection according to claim 1, which is characterized in that the injection consists of the following compositions: Soviet Union
It is golden monoclonal antibody 140mg/ml-200mg/ml, histidine and histidine hydrochloride 10-35mmol/L, methionine 5-30mmol/L, more
First alcohol 180mmol/L-300mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.5-6.5.
4. Su Jin monoclonal antibody injection according to claim 1, which is characterized in that the injection consists of the following compositions: Soviet Union
It is golden monoclonal antibody 140mg/ml-160mg/ml, histidine and histidine hydrochloride 10-30mmol/L, methionine 5-20mmol/L, more
First alcohol 210mmol/L-280mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.5-6.5.
5. Su Jin monoclonal antibody injection according to claim 1, which is characterized in that the injection consists of the following compositions: Soviet Union
Golden monoclonal antibody 150mg/ml, histidine and histidine hydrochloride 20mmol/L, methionine 5mmol/L, polyalcohol 210mmol/L-
280mmol/L, polyoxyethylene sorbitan monoleate 0.02%, remaining ingredient are water for injection, pH5.5-6.5.
6. Su Jin monoclonal antibody injection described in -5 any claims according to claim 1, which is characterized in that the polyalcohol is sweet
Oil or propylene glycol.
7. Su Jin monoclonal antibody injection according to claim 6, which is characterized in that it is characterized in that, the polyalcohol is the third two
Alcohol.
8. Su Jin monoclonal antibody injection according to claim 6, which is characterized in that the pH is 5.8.
9. the preparation method of Su Jin monoclonal antibody injection described in a kind of claim 1, which comprises the following steps:
1) buffer
Buffer solution A weighs histidine, methionine, polyalcohol by recipe quantity, is diluted to prescription strength with water for injection, stirs
It is uniformly mixed；
Buffer solution B is diluted to prescription strength with water for injection by recipe quantity histidine hydrochloride, methionine, polyalcohol surely,
It is uniformly mixed；
Buffer solution A is added into buffer solution B and is adjusted to final pH, this is final buffer；
2) prepared by finished product
A. Su Jin monoclonal antibody after purification is concentrated by ultrafiltration；
B. protein concentrate concentration mensuration, the protein sample after taking out concentration, measures volume, its protein concentration is measured, when albumen is dense
Degree starts to replace buffer when reaching 100-120mg/ml；
The final buffer isometric with the protein liquid volume after concentration is added in specimen cup, mixes and dense by c. replacement operator
Being reduced to protein concentration is 100-120mg/ml, repeatedly replacement operator；
D. the Su Jin monoclonal antibody after displacement buffer is concentrated by ultrafiltration, polyoxyethylene sorbitan monoleate is added, is sterile filtered to obtain the final product.
10. a kind of application of the Su Jin monoclonal antibody injection described in claim 1 in the drug of preparation treatment psoriasis.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114452383A (en) * | 2022-02-17 | 2022-05-10 | 中国中医科学院中药研究所 | Use of securititumomab in treatment of diabetic ulcers |
| US11634485B2 (en) | 2019-02-18 | 2023-04-25 | Eli Lilly And Company | Therapeutic antibody formulation |
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