CN1522691A - Nucleic acid, protein polypeptide and vaccine emulsion preparation method - Google Patents
Nucleic acid, protein polypeptide and vaccine emulsion preparation method Download PDFInfo
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- CN1522691A CN1522691A CNA031403999A CN03140399A CN1522691A CN 1522691 A CN1522691 A CN 1522691A CN A031403999 A CNA031403999 A CN A031403999A CN 03140399 A CN03140399 A CN 03140399A CN 1522691 A CN1522691 A CN 1522691A
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Abstract
The method for preparing nucleic acid, protein polypeptide and vaccine emulsion includes the following steps: (1). injecting original or prepared nucleic acid, protein polypeptide and vaccine water phase or oil phase liquid and another prepared oil phase or water phase liquid into one or respectively injecting them into two syringes at the same time; (2). connecting one syringe in which the water phase and oil phase liquid are held with another identical empty syringe or two syringes in which the water phase and oil phase liquids are respectively held on one two-way or multiway pipe; and (3) making two syringes be communicated, reciprocating and vibrating two syringes until the water phase liquid and oil phase liquid are fully mixed and converted to emulsion.
Description
The present invention relates to prepare the method for nucleic acid, protein polypeptide and vaccine Emulsion, more particularly, the present invention relates to prepare before a kind of more simple and practical use the method for the aseptic nucleic acid of better quality, protein polypeptide and vaccine Emulsion temporarily.
Nucleic acid, protein polypeptide and vaccine Emulsion are expected to demonstrate its superiority, the report of existing many animal oil emulsion vaccine successful Application at present by prolonging increase curative effect, reduction toxic and side effects, targeted therapy etc.However, the key issue that still exists some to solve in nucleic acid, protein polypeptide and the preparation of vaccine Emulsion, mainly be: 1, physical agitation or oscillation intensity are big, can cause nucleic acid, protein polypeptide and vaccine activity loss; 2, liquid nucleic acid, protein polypeptide and vaccine Emulsion storage life are short, easily layering, breakdown of emulsion etc.; 3, owing to the factor of equipment and technical process, output is little; 4, in sterilization or the sterile working, heat sterilization causes nucleic acid, protein polypeptide, vaccine activity loss and influences emulsion stability, radiation sterilization also may cause nucleic acid, protein polypeptide and vaccine degeneration, loss of activity, and whole preparation process all requires the sterile working then must cause cost rising, output to descend.
The object of the present invention is to provide the preceding method that just can prepare the aseptic nucleic acid of better quality, protein polypeptide and vaccine Emulsion temporarily of a kind of simple, economic, practical use.
For achieving the above object, the present invention prepares the method for nucleic acid, protein polypeptide and vaccine Emulsion, successively according to the following steps:
1, product is only with the production and sales of semi-finished product mode, preparation of water, oil phase and preparation comprise: when a. water is preparation with add or not the waterborne liquid of adding water soluble emulsifying agent mix or in nucleic acid, protein polypeptide, vaccine liquid, add when dissolving nucleic acid, protein polypeptide, vaccine or preparation or adding water soluble emulsifying agent not, oil phase is formulated by the oil-based liquid that adds or do not add the oil-soluble emulsifying agent; B. water is by adding or the waterborne liquid of adding water soluble emulsifying agent is not formulated, mixes with the oil-based liquid that adds or do not add the oil-soluble emulsifying agent when oil phase is preparation or nucleic acid, protein polypeptide, vaccine directly is dissolved in the oil-based liquid that adds or do not add the oil-soluble emulsifying agent when dissolving nucleic acid, protein polypeptide, vaccine or preparation; C. as will be prepared into the W/O/W breast, then increase the amount of original aqueous phase liquid preparation or preparation will add again or not the adding water soluble emulsifying agent another kind of waterborne liquid preparation or be mixed with outer water; D. as will be prepared into the O/W/O emulsion, increase then that original oil phase liquid system is equipped with or the amount of preparation or will add or not add the another kind of oil-based liquid preparation of oil-soluble emulsifying agent again or be mixed with outer oil phase;
2, a. is the original or water for preparing and oil phase be respectively in syringe of suction, and all be connected on one or two logical or many siphunculus; B. be connected in original or the water for preparing and syringe of oil phase suction simultaneously on two logical or many siphunculus, another empty syringe is connected on another interface of two logical or many siphunculus;
3, two syringes are communicated, move back and forth by manpower or machine power and vibrate two syringes, be mixed into emulsion fully until water and oil phase, this moment, the preparation of Water-In-Oil or oil in water emulsion was finished;
4, as being prepared into emulsion, then take off the syringe of one of them no emulsion, an amount of with this syringe or another sky syringe suction: a. original or the water or the outer water that prepare; B. original or prepare oil phase or outer oil phase are connected on two logical or many siphunculus again, and repeating step 3 can be prepared into the emulsion preparation.
Waterborne liquid in the above-mentioned steps 1 can be water, single substance solution, many materials mixed liquor or water sample solvent.
Oil-based liquid in the above-mentioned steps 1 can be single fluid, two or the mixed oil liquid of the mixed oil liquid of multiple oil, oil and oil soluble material.
Logical or the many siphunculus of in the above-mentioned steps 2 and 4 two are a kind of connection tube, and two logically can connect two syringes, manyly logically can connect two or more syringes, preferred microporous tee T in two logical or many siphunculus.
The manpower that passes through in the above-mentioned steps 3 moves back and forth and vibrates two syringes, is meant by the people to promote the motion of two syringes back and forth.
The machine power of passing through in the above-mentioned steps 3 moves back and forth and vibrates two syringes, be meant that driving two syringes by electromotor or motor by machine driven system moves back and forth, its meaning is to make the preparation condition standardization, simultaneously machine power can obviously improve reciprocating motion speed, makes Emulsion microgranule littler and even than the manpower preparation.
Adopt sterile manner to be loaded in the sterile chamber or directly be loaded on back sterilization treatment in the container as the preparation of product in the above-mentioned step 1, preparation in the step 1 is by the sterile working, above-mentioned steps 2,3,4 adopt asepsis injector, aseptic two logical or many siphunculus, and by the sterile working, then water and oil phase are in fully and move back and forth mixing under a kind of airtight aseptic condition, the Emulsion for preparing like this can reach aseptic requirement, wherein can reach 2 to 3 microns with the prepared Emulsion mean diameter of the artificial promotion of micropore tee T, 96% microgranule is less than 10 microns, and the Emulsion good reproducibility of preparation, except that direct intravenous injection, almost can be used for various occupation modes.
The present invention compares the advantage or the good effect that are had with prior art:
1, preparation technology is very simple, and cost is low, and need not increase emulsifying device.
2, owing to before application, be prepared into Emulsion temporarily, use at once after having prepared, do not have phenomenons such as breakdown of emulsion, layering, flocculation during the application substantially, therefore fundamentally solved the problem of dosage form stability difference.
3, owing to nucleic acid, protein polypeptide or vaccine can be stored with stable stock solution or dry powder mode, therefore consistent with the storage life of existing nucleic acid, protein polypeptide and vaccine.
4, the micropore tee T can make microgranule conventional two logical or many siphunculus preparations littler and even in the prepared Emulsion, has improved the quality and the stability of dosage form, and good reproducibility.
5, manpower back and forth promote time of two syringes short, that mechanical strength is little, liquid heats up is little, the established technology condition is quite gentle, does not cause that nucleic acid, protein polypeptide and vaccine activity loss or loss of activity are minimum.
6, short time low-intensity machine power back and forth promotes two syringes, can not cause that also nucleic acid, protein polypeptide and vaccine activity loss or loss of activity are minimum, also can make the preparation condition standardization simultaneously.
7, the prepared Emulsion of the present invention can reach aseptic requirement, has solved the problem that nucleic acid, protein polypeptide and vaccine Emulsion can not be sterilized or is difficult to sterilize.
8, because nucleic acid, protein polypeptide or vaccine can be stored transportation with stable stock solution or dry powder mode, therefore can save the storage transport space, reduce corresponding cost.
The invention will be further described for following examples.
Embodiment 1: the preparation of hepatitis B emulsion vaccine
The oil phase preparation: originally 80 be made into oil phase by 98 parts of refined soybean oils, 2 parts of departments, the packing sterilization is standby behind the mixing.
The preparation of Water-In-Oil vaccine: extract 2 parts of oil phase liquids with a syringe, another syringe extracts 1 part of hepatitis B vaccine liquid, two syringes all are connected on the micropore tee T, two syringes are communicated, move back and forth by manpower and to vibrate two syringes, be mixed into emulsion fully until vaccine liquid and oil phase liquid, this moment, hepatitis B water in oil emulsion vaccine production was finished.
Embodiment 2: the preparation of Interferon Alfa-2a Emulsion
The oil phase preparation: originally 80 be made into oil phase by 98 parts of refined soybean oils, 2 parts of departments, the packing sterilization is standby behind the mixing.
Interferon Alfa-2a water: with 1 milliliter of solvent solubilization, 3,000,000 Interferon Alfa-2a injectable powder.
The preparation of Interferon Alfa-2a water in oil emulsion: extract 2 parts of oil phase liquids with a syringe, another syringe extracts 1 part of Interferon Alfa-2a liquid, two syringes all are connected on the micropore tee T, two syringes are communicated, move back and forth by manpower and to vibrate two syringes, be mixed into emulsion fully until Interferon Alfa-2a liquid and oil phase liquid, this moment, the preparation of Interferon Alfa-2a water in oil emulsion was finished.
Embodiment 3: the preparation of Progesterone Emulsion
The water preparation: be made into water by 98 parts of normal saline, 2 parts of Tween 80s, the packing sterilization is standby behind the mixing.
The preparation of Progesterone oil in water emulsion: extract 2 parts of water liquid with a syringe, another syringe extracts 1 part of Progesterone oil solution, two syringes all are connected on the micropore tee T, two syringes are communicated, above-mentioned micropore tee T and syringe are fixed on a kind of vibration homogenizer structure (application number 02227690.4), move back and forth by machine power and to vibrate two syringes, be mixed into emulsion fully until Progesterone oil solution and water liquid, this moment, the preparation of Progesterone oil in water emulsion was finished.
Embodiment 4: the preparation of Interferon Alfa-2a W/O/W emulsion
The oil phase preparation: originally 80 be made into oil phase by 98 parts of refined soybean oils, 2 parts of departments, the packing sterilization is standby behind the mixing.
Interferon Alfa-2a water: with 1 milliliter of solvent solubilization, 3,000,000 Interferon Alfa-2a injectable powder.
Outer water: be made into outer water by 98 parts of normal saline, 2 parts of Tween 80s, the packing sterilization is standby behind the mixing.
The preparation of Interferon Alfa-2a W/O/W emulsion: extract 1.5 milliliters of oil phase liquids with 5 milliliters of syringe, another 5 milliliters of syringes extract 1 milliliter of Interferon Alfa-2a liquid, two syringes all are connected on the micropore tee T, two syringes are communicated, move back and forth by manpower and to vibrate two syringes, be mixed into emulsion fully until Interferon Alfa-2a liquid and oil phase liquid, this moment, the preparation of Interferon Alfa-2a water in oil emulsion was finished.Take off the syringe of one of them no emulsion,, be connected to again on the micropore tee T, repeat the step of front, can be prepared into W/O/W emulsion preparation with 2.5 milliliters of outer waters of this syringe suction.
Claims (8)
1, a kind of method for preparing nucleic acid, protein polypeptide and vaccine Emulsion, successively according to the following steps:
(1) product is only with the production and sales of semi-finished product mode, preparation of water, oil phase and preparation comprise: when a. water is preparation with add or not the waterborne liquid of adding water soluble emulsifying agent mix or in nucleic acid, protein polypeptide, vaccine liquid, add when dissolving nucleic acid, protein polypeptide, vaccine or preparation or adding water soluble emulsifying agent not, oil phase is formulated by the oil-based liquid that adds or do not add the oil-soluble emulsifying agent; B. water is by adding or the waterborne liquid of adding water soluble emulsifying agent is not formulated, mixes with the oil-based liquid that adds or do not add the oil-soluble emulsifying agent when oil phase is preparation or nucleic acid, protein polypeptide, vaccine directly is dissolved in the oil-based liquid that adds or do not add the oil-soluble emulsifying agent when dissolving nucleic acid, protein polypeptide, vaccine or preparation; C. as will be prepared into the W/O/W emulsion, then increase the amount of original aqueous phase liquid preparation or preparation will add again or not the adding water soluble emulsifying agent another kind of waterborne liquid preparation or be mixed with outer water; D. as will be prepared into the O/W/O emulsion, increase then that original oil phase liquid system is equipped with or the amount of preparation or will add or not add the another kind of oil-based liquid preparation of oil-soluble emulsifying agent again or be mixed with outer oil phase;
(2) a. is the original or water for preparing and oil phase be respectively in syringe of suction, and all be connected on one or two logical or many siphunculus; B. be connected in original or the water for preparing and syringe of oil phase suction simultaneously on two logical or many siphunculus, another empty syringe is connected on another interface of two logical or many siphunculus;
(3) two syringes are communicated, move back and forth by manpower or machine power and vibrate two syringes, be mixed into emulsion fully until water and oil phase, this moment, the preparation of Water-In-Oil or oil in water emulsion was finished;
(4) as being prepared into emulsion, then take off the syringe of one of them no emulsion, an amount of with this syringe or another sky syringe suction: a. original or the water or the outer water that prepare; B. original or prepare oil phase or outer oil phase are connected on two logical or many siphunculus again, and repeating step 3 can be prepared into the emulsion preparation.
2,, it is characterized in that described waterborne liquid can be water, single substance solution, many materials mixed liquor or water sample solvent according to the preparation method of the described nucleic acid of claim 1, protein polypeptide and vaccine Emulsion.
3,, it is characterized in that described oil-based liquid can be single fluid, two or the mixed oil liquid of the mixed oil liquid of multiple oil, oil and oil soluble material according to the preparation method of the described nucleic acid of claim 1, protein polypeptide and vaccine Emulsion.
4, according to the preparation method of the described nucleic acid of claim 1, protein polypeptide and vaccine Emulsion, it is characterized in that described two siphunculus is a kind of connection tube, it has two interfaces can connect two syringes.
5, according to the preparation method of the described nucleic acid of claim 1, protein polypeptide and vaccine Emulsion, it is characterized in that described many siphunculus are a kind of connection tube, it has three or above interface, wherein has at least two interfaces can connect syringe.
6,, it is characterized in that in described two logical and many siphunculus the preferred microporous tee T according to the preparation method of the described nucleic acid of claim 1, protein polypeptide and vaccine Emulsion.
7, according to the preparation method of the described nucleic acid of claim 1, protein polypeptide and vaccine Emulsion, it is characterized in that described moving back and forth by manpower vibrate two syringes, be meant by the people to promote the motion of two syringes back and forth.
8, according to the preparation method of the described nucleic acid of claim 1, protein polypeptide and vaccine Emulsion, it is characterized in that described moving back and forth by machine power vibrate two syringes, be meant that driving two syringes by electromotor or motor by machine driven system moves back and forth.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031403999A CN1522691A (en) | 2003-09-05 | 2003-09-05 | Nucleic acid, protein polypeptide and vaccine emulsion preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031403999A CN1522691A (en) | 2003-09-05 | 2003-09-05 | Nucleic acid, protein polypeptide and vaccine emulsion preparation method |
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| CN1522691A true CN1522691A (en) | 2004-08-25 |
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| CNA031403999A Pending CN1522691A (en) | 2003-09-05 | 2003-09-05 | Nucleic acid, protein polypeptide and vaccine emulsion preparation method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105311629A (en) * | 2007-04-20 | 2016-02-10 | 葛兰素史密丝克莱恩生物有限公司 | Oil-in-water emulsion influenza vaccine |
-
2003
- 2003-09-05 CN CNA031403999A patent/CN1522691A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105311629A (en) * | 2007-04-20 | 2016-02-10 | 葛兰素史密丝克莱恩生物有限公司 | Oil-in-water emulsion influenza vaccine |
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