Preparation method and application of injection for needle-free injection

Abstract

The invention provides a preparation method and application of an injection for needleless injection, and relates to the field of preparation methods and application of needleless injections. The injection for needleless injection is in the form of freeze-dried powder, is composed of a vaccine, a medicine adjuvant, salvianolic acid B and a pharmacologically acceptable pH regulator, and does not contain other excipients, the addition amount of the pH regulator enables the pH of a freeze-dried system to be 5-6, the injection is in the form of powder, and the size of powder particles is 60-120 microns, preferably 80-100 microns. According to the invention, the needle-free powder injection technology is adopted for skin administration, the first-pass effect can be avoided through transdermal absorption, the bioavailability is high, cross infection can be effectively avoided, the needle-free and painless effects are realized, the administration efficiency is high, the self-operation can be realized, and the injection is particularly suitable for patients needing long-term administration treatment, children and patients with fear of fear of needles.

Description

Technical Field

[0001] The present invention relates to a preparation method and application field of a needle-free injection, and specifically to a preparation method and application of an injection for needle-free injection. Background Art

[0002] Biological products are drugs used for the prevention, treatment and diagnosis of human diseases, which are prepared from common biological materials or microorganisms, cells, and various animal and human tissues and fluids obtained through biotechnology such as genetic engineering, cell engineering, protein engineering, and fermentation engineering. At present, biological products for human use in my country include bacterial vaccines (including toxoids), viral vaccines, antitoxins and immune sera, blood products, cytokines, in vivo and in vitro diagnostic products, and other active preparations.

[0003] The active components of most biological products are large molecular life substances (such as proteins, peptides, nucleic acids, polysaccharides, etc.). Their relative molecular mass is large, and they are not easy to penetrate the gastrointestinal barrier to be absorbed by the body. They are also easily decomposed and inactivated by digestive juices. Therefore, they are not suitable for oral administration. In most cases, intravenous injection, intramuscular injection, subcutaneous injection, etc. are required.

[0004] However, there are many problems with the ordinary injection method of drug administration. For example, it may cause bleeding and there is a risk of cross-infection; it causes great tissue damage. Some patients with chronic diseases such as diabetes need to inject insulin for a long time, which often causes lesions such as hardening and agglomeration of tissues at the injection site; the pain is intense and the patient's compliance is poor. It is even more difficult for children and people with needle phobia to adapt, as the pain of needle pricks is unbearable for them; and it usually requires professional personnel to complete the operation, so it is not suitable for self-administration.

[0005] Therefore, those skilled in the art provide a method for preparing an injection for needle-free injection and its application to solve the problems raised in the above background technology. Summary of the invention

[0006] 1. Technical issues to be resolved

[0007] In view of the deficiencies in the prior art, the present invention provides a method for preparing an injection for needle-free injection and its application, which adopts needle-free powder injection technology to administer the drug through the skin. Transdermal absorption can avoid the first-pass effect, has high bioavailability, can effectively avoid cross-infection, is needle-free, painless, has high drug administration efficiency, and can be self-operated. It is particularly suitable for patients who need long-term drug administration, children, and patients with needle phobia, and solves many problems existing in ordinary injection drug administration methods.

[0008] (II) Technical solution

[0009] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0010] An injection for needle-free injection is in the form of a freeze-dried powder, which is composed of a vaccine, a drug adjuvant, salvianolic acid B and a pharmacologically acceptable pH regulator, and does not contain other excipients. The pH regulator is added in an amount such that the pH of the system before freeze-drying is 5-6. The injection is in the form of a powder, and the size of the powder particles is between 60-120 microns, preferably between 80-100 microns.

[0011] Preferably, the vaccine is selected from one of hepatitis B vaccine, tetanus toxoid vaccine, mumps vaccine, measles vaccine, pertussis vaccine, rubella vaccine, typhoid vaccine, type B influenza vaccine, plague vaccine, anthrax vaccine, Japanese encephalitis vaccine and hepatitis A vaccine.

[0012] Preferably, the drug adjuvant consists of a traditional Chinese medicine adjuvant and an aluminum adjuvant, and the mass ratio of the traditional Chinese medicine adjuvant to the aluminum adjuvant is 1:2-3, preferably 1:2.

[0013] Preferably, the Chinese medicine adjuvant is selected from saponins, polysaccharides and flavonoids, the saponins are selected from one of ginsenosides, notoginseng saponins, gynostemma saponins, clematis saponins and diosgenin, the polysaccharides are selected from one of astragalus polysaccharides, ginseng polysaccharides, rhodiola rosea polysaccharides and jujube polysaccharides, and the flavonoids are selected from one of epimedium flavonoids, kumquat flavonoids, soybean flavonoids and seabuckthorn flavonoids.

[0014] Preferably, the pH value of the system before freeze-drying is 5.5.

[0015] Preferably, the pH regulator is an inorganic base, an alkaline buffer salt or an alkaline amino acid, the inorganic base is one of sodium hydroxide, potassium hydroxide, sodium phosphate, sodium bicarbonate and potassium bicarbonate, the alkaline buffer salt is one of dipotassium hydrogen phosphate, disodium hydrogen phosphate, tripotassium phosphate and trisodium phosphate, and the alkaline amino acid is one of lysine, arginine, valine and isoleucine.

[0016] Preferably, the method comprises the following steps:

[0017] Step S1. Firstly, dissolve part of the pH regulator in water for injection, then dissolve the salvianolic acid B in the above solution, and add the pH regulator to adjust the pH value of the system to 5-6;

[0018] Step S2. Add 0.01-0.5% activated carbon injection to remove heat source, stir at 50°C for 20 minutes, filter and obtain particulate matter;

[0019] Step S3. The granular material obtained in the above step is fully mixed with the vaccine and the Chinese medicine adjuvant in a liquid environment according to a mass ratio, and after drying, a powder having a particle size between 60 and 120 microns is collected to obtain an injection 1;

[0020] Step S4. In a liquid environment, the particulate matter and the vaccine are adsorbed onto the aluminum adjuvant according to the mass ratio, and after drying, the powder with a particle size between 60 and 120 microns is collected, and then the Chinese medicine adjuvant powder with a particle size between 60 and 120 microns is added according to the mass ratio, and the mixture is evenly mixed to obtain the second injection;

[0021] Step S5. In a liquid environment, the particulate matter is mixed and adsorbed with the vaccine, aluminum adjuvant and traditional Chinese medicine adjuvant according to the mass ratio, and after drying and mixing, a powder with a particle size between 60 and 120 microns is collected to obtain a vaccine injection III;

[0022] Step S6. Prepare an aluminum adsorption column with aluminum hydroxide as the carrier, slowly flow the vaccine solution and the traditional Chinese medicine adjuvant solution through the aluminum adsorption column respectively, and dry the aluminum adsorption column to collect powder with a particle size between 60-120 microns to obtain vaccine injection four.

[0023] Preferably, the injection for needle-free injection is used to prepare a drug for preventing or treating a disease.

[0024] Preferably, the use of the injection for needle-free injection includes the following diseases for treating hepatitis B, tetanus, mumps, measles, whooping cough, rubella, typhoid fever, influenza type B, plague, anthrax, Japanese encephalitis and hepatitis A.

[0025] Preferably, the method for needle-free injection of the injection for needle-free injection specifically comprises: loading 10-50 micrograms of the needle-free injection into a medicine box of a needle-free syringe, and administering through the needle-free syringe.

[0026] (III) Beneficial effects

[0027] The present invention provides a method for preparing an injection for needle-free injection and its application. It has the following beneficial effects:

[0028] 1. The present invention provides a method for preparing and use of an injection for needle-free injection. The injection is a lyophilized powder, and a suitable pH range is selected to ensure the stability of the injection and the physiological acceptability of the injection. The injection can be used safely in clinical practice without causing adverse effects such as hemolysis. The injection has good safety and is suitable for self-administration. The injection has stable quality and can be stored for a long time. Its stability and safety fully meet the requirements for injection preparation and clinical use.

[0029] 2. The present invention provides a method for preparing and using an injection for needle-free injection. The injection is used by adsorption with a traditional Chinese medicine adjuvant and an aluminum adjuvant. Aluminum hydroxide particles as aluminum adjuvants have a relatively high surface energy and can adsorb substances such as proteins, thereby combining the vaccine on the surface of the aluminum hydroxide particles and finally forming a relatively stable powder system. In addition to being an immune adjuvant, aluminum hydroxide itself also has flocculation and adsorption effects. The matrix of a solid vaccine developed based on the adsorption effect can give full play to its pharmaceutical advantages. Traditional Chinese medicine adjuvants have certain adsorption and carrying capacities, which can play an auxiliary solidification role, making up for the insufficient adsorption capacity of aluminum adjuvants and achieving better use effects.

[0030] 3. The present invention provides a method for preparing and using an injection for needle-free injection, which adopts needle-free powder injection technology to administer the drug through the skin. Transdermal absorption can avoid the first-pass effect, has high bioavailability, can effectively avoid cross-infection, is needle-free and painless, has high drug administration efficiency, and can be self-operated. It is particularly suitable for patients who need long-term drug administration, children, and patients with needle phobia. Therefore, the vaccine injection suitable for needle-free injection technology is particularly suitable for medical prevention and protection under conditions such as major emergencies and remote areas and large-scale field operations, and has broader application prospects. DETAILED DESCRIPTION

[0031] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] Embodiment 1:

[0033] The embodiment of the present invention provides an injection for needle-free injection, which is prepared by directly mixing a solution and a traditional Chinese medicine adjuvant, and includes the following steps:

[0034] Step S1. Firstly, dissolve part of the pH regulator in water for injection, then dissolve the salvianolic acid B in the above solution, and add the pH regulator to adjust the pH value of the system to 5.5;

[0035] Step S2. Add 0.3% activated carbon injection to remove heat source, stir at 50°C for 20 min, filter and obtain particulate matter;

[0036] Step S3. In a liquid environment, the granular material obtained in the above step is fully mixed with the hepatitis B vaccine and the traditional Chinese medicine adjuvant according to the mass ratio. After drying, the powder with a particle size of 80 microns is collected to obtain the needle-free injection of the hepatitis B vaccine.

[0037] Embodiment 2:

[0038] The embodiment of the present invention provides an injection for needle-free injection, which adopts a solution dispersion adsorption method and a Chinese medicine adjuvant powder mixing method to prepare a needle-free injection containing a tetanus toxoid vaccine, comprising the following steps:

[0039] Step S1. Firstly, dissolve part of the pH regulator in water for injection, then dissolve the salvianolic acid B in the above solution, and add the pH regulator to adjust the pH value of the system to 5.5;

[0040] Step S2. Add 0.3% activated carbon injection to remove heat source, stir at 50°C for 20 min, filter and obtain particulate matter;

[0041] Step S3. In a liquid environment, the particulate matter and the tetanus toxoid vaccine are adsorbed onto an aluminum adjuvant according to a mass ratio. After drying, a powder with a particle size of 80 microns is collected, and then a Chinese medicine adjuvant powder with a particle size of 80 microns is added according to a mass ratio. After mixing evenly, a needle-free injection of a tetanus toxoid vaccine is obtained.

[0042] Embodiment 3:

[0043] The embodiment of the present invention provides an injection for needle-free injection, which adopts a solution dispersion adsorption method, and an aluminum adjuvant and a traditional Chinese medicine adjuvant powder are mixed and adsorbed to prepare a needle-free injection containing a mumps vaccine, comprising the following steps:

[0044] Step S1. Firstly, dissolve part of the pH regulator in water for injection, then dissolve the salvianolic acid B in the above solution, and add the pH regulator to adjust the pH value of the system to 5;

[0045] Step S2. Add 0.4% activated carbon injection to remove heat source, stir at 50°C for 20 minutes, filter and obtain particulate matter;

[0046] Step S3. In a liquid environment, the particulate matter is mixed and adsorbed with the mumps vaccine, aluminum adjuvant and traditional Chinese medicine adjuvant according to the mass ratio. After drying and mixing, the powder with a particle size of 100 microns is collected to obtain a needle-free injection of the mumps vaccine.

[0047] Embodiment 4:

[0048] The embodiment of the present invention provides an injection for needle-free injection, which is prepared by an aluminum column adsorption method and includes the following steps:

[0049] Step S1. Firstly, dissolve part of the pH regulator in water for injection, then dissolve the salvianolic acid B in the above solution, and add the pH regulator to adjust the pH value of the system to 6;

[0050] Step S2. Add 0.5% activated carbon injection to remove heat source, stir at 50°C for 20 minutes, filter and obtain particulate matter;

[0051] Step S3. In a liquid environment, the particulate matter is mixed and adsorbed with the measles vaccine, aluminum adjuvant and traditional Chinese medicine adjuvant according to the mass ratio. After drying and mixing, powder with a particle size of 90 microns is collected to obtain a needle-free injection of measles vaccine.

[0052] Embodiment 5:

[0053] The embodiment of the present invention provides an injection for needle-free injection, which is prepared by directly mixing a solution and a traditional Chinese medicine adjuvant, and includes the following steps:

[0054] Step S1. Firstly, dissolve part of the pH regulator in water for injection, then dissolve the salvianolic acid B in the above solution, and add the pH regulator to adjust the pH value of the system to 5.5;

[0055] Step S2. Add 0.3% activated carbon injection to remove heat source, stir at 50°C for 20 min, filter and obtain particulate matter;

[0056] Step S3. The granular material obtained in the above step is fully mixed with the pertussis vaccine and the traditional Chinese medicine adjuvant in a liquid environment according to the mass ratio. After drying, the powder with a particle size of 80 microns is collected to obtain the needle-free injection of the pertussis vaccine.

[0057] Embodiment 6:

[0058] The embodiment of the present invention provides an injection for needle-free injection, which adopts a solution dispersion adsorption method and a Chinese medicine adjuvant powder mixing method to prepare a needle-free injection containing a rubella vaccine, comprising the following steps:

[0059] Step S1. Firstly, dissolve part of the pH regulator in water for injection, then dissolve the salvianolic acid B in the above solution, and add the pH regulator to adjust the pH value of the system to 5.5;

[0060] Step S2. Add 0.3% activated carbon injection to remove heat source, stir at 50°C for 20 min, filter and obtain particulate matter;

[0061] Step S3. In a liquid environment, the particulate matter and the rubella vaccine are adsorbed onto the aluminum adjuvant according to the mass ratio. After drying, the powder with a particle size of 80 microns is collected, and then the Chinese medicine adjuvant powder with a particle size of 80 microns is added according to the mass ratio. After mixing evenly, the needle-free injection of the rubella vaccine is obtained.

[0062] Embodiment 7:

[0063] The embodiment of the present invention provides an injection for needle-free injection, which adopts a solution dispersion adsorption method, and an aluminum adjuvant and a traditional Chinese medicine adjuvant powder are mixed and adsorbed together to prepare a needle-free injection containing a typhoid vaccine, comprising the following steps:

[0064] Step S1. Firstly, dissolve part of the pH regulator in water for injection, then dissolve the salvianolic acid B in the above solution, and add the pH regulator to adjust the pH value of the system to 5;

[0065] Step S2. Add 0.4% activated carbon injection to remove heat source, stir at 50°C for 20 minutes, filter and obtain particulate matter;

[0066] Step S3. In a liquid environment, the particulate matter is mixed and adsorbed with the typhoid vaccine, aluminum adjuvant and traditional Chinese medicine adjuvant according to the mass ratio. After drying and mixing, powder with a particle size of 100 microns is collected to obtain a needle-free injection of the typhoid vaccine.

[0067] Embodiment 8:

[0068] The embodiment of the present invention provides an injection for needle-free injection, which is prepared by an aluminum column adsorption method and includes the following steps:

[0069] Step S1. Firstly, dissolve part of the pH regulator in water for injection, then dissolve the salvianolic acid B in the above solution, and add the pH regulator to adjust the pH value of the system to 6;

[0070] Step S2. Add 0.5% activated carbon injection to remove heat source, stir at 50°C for 20 minutes, filter and obtain particulate matter;

[0071] Step S3. In a liquid environment, the particulate matter is mixed and adsorbed with the influenza B vaccine, aluminum adjuvant and traditional Chinese medicine adjuvant according to the mass ratio. After drying and mixing, powder with a particle size of 90 microns is collected to obtain a needle-free injection of influenza B vaccine.

[0072] Embodiment 9:

[0073] The embodiment of the present invention provides an injection for needle-free injection, which adopts a solution dispersion adsorption method and a Chinese medicine adjuvant powder mixing method to prepare a needle-free injection containing a plague vaccine, comprising the following steps:

[0074] Step S1. Firstly, dissolve part of the pH regulator in water for injection, then dissolve the salvianolic acid B in the above solution, and add the pH regulator to adjust the pH value of the system to 5.5;

[0075] Step S2. Add 0.3% activated carbon injection to remove heat source, stir at 50°C for 20 min, filter and obtain particulate matter;

[0076] Step S3. In a liquid environment, the particulate matter and the plague vaccine are adsorbed onto the aluminum adjuvant according to the mass ratio. After drying, the powder with a particle size of 80 microns is collected, and then the Chinese medicine adjuvant powder with a particle size of 80 microns is added according to the mass ratio. After mixing evenly, the needle-free injection of the plague vaccine is obtained.

[0077] Embodiment 10:

[0078] The embodiment of the present invention provides an injection for needle-free injection, which is prepared by directly mixing a solution and a traditional Chinese medicine adjuvant, comprising the following steps:

[0079] Step S1. Firstly, dissolve part of the pH regulator in water for injection, then dissolve the salvianolic acid B in the above solution, and add the pH regulator to adjust the pH value of the system to 5.5;

[0080] Step S2. Add 0.3% activated carbon injection to remove heat source, stir at 50°C for 20 min, filter and obtain particulate matter;

[0081] Step S3. The granular material obtained in the above step is fully mixed with the anthrax vaccine and the traditional Chinese medicine adjuvant in a liquid environment according to the mass ratio. After drying, the powder with a particle size of 80 microns is collected to obtain the needle-free injection of the anthrax vaccine.

[0082] Embodiment 11:

[0083] The embodiment of the present invention provides an injection for needle-free injection, which adopts a solution dispersion adsorption method, and an aluminum adjuvant and a traditional Chinese medicine adjuvant powder are mixed and adsorbed to prepare a needle-free injection containing Japanese encephalitis vaccine, comprising the following steps:

[0084] Step S1. Firstly, dissolve part of the pH regulator in water for injection, then dissolve the salvianolic acid B in the above solution, and add the pH regulator to adjust the pH value of the system to 5;

[0085] Step S2. Add 0.4% activated carbon injection to remove heat source, stir at 50°C for 20 minutes, filter and obtain particulate matter;

[0086] Step S3. In a liquid environment, the particulate matter is mixed and adsorbed with the Japanese encephalitis vaccine, aluminum adjuvant and traditional Chinese medicine adjuvant according to the mass ratio. After drying and mixing, powder with a particle size of 100 microns is collected to obtain a needle-free injection of the Japanese encephalitis vaccine.

[0087] Embodiment 12:

[0088] The embodiment of the present invention provides an injection for needle-free injection, and the needle-free injection containing hepatitis A vaccine is prepared by an aluminum column adsorption method, comprising the following steps:

[0089] Step S1. Firstly, dissolve part of the pH regulator in water for injection, then dissolve the salvianolic acid B in the above solution, and add the pH regulator to adjust the pH value of the system to 6;

[0090] Step S2. Add 0.5% activated carbon injection to remove heat source, stir at 50°C for 20 minutes, filter and obtain particulate matter;

[0091] Step S3. In a liquid environment, the particulate matter is mixed and adsorbed together with the hepatitis A vaccine, aluminum adjuvant and traditional Chinese medicine adjuvant according to the mass ratio. After drying and mixing, powder with a particle size of 90 microns is collected to obtain a needle-free injection of the hepatitis A vaccine.

[0092] The methods of using the needle-free injections of the various vaccines prepared above are as follows:

[0093] When in use, the prepared needle-free injection is matched with an automatic needle-free powder injector, and the prepared powder injection is loaded into the medicine box of the needle-free injector. Through the gas storage device, excitation device, and emission device of the needle-free injector, the powder injection loaded in the medicine box is transmitted into the skin tissue cells through the needle-free injector, and enters the intradermal, subcutaneous or mucosal tissue to release the drug components.

[0094] The needle-free injection powder of the present invention has the advantages of uniform particle size, high drug loading, firm drug adsorption, high bioavailability, stable and safe properties, etc. It adopts needle-free powder injection technology to administer the drug through the skin, transdermal absorption can avoid the first-pass effect, has high bioavailability, can effectively avoid cross infection, is needle-free, painless, has high drug administration efficiency, can be self-operated, and is particularly suitable for patients who need long-term drug administration, children and patients with needle phobia.

[0095] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. An injection for needle-free injection, characterized in that: The injection is in the form of a lyophilized powder, which consists of a vaccine, a drug adjuvant, salvianolic acid B and a pharmacologically acceptable pH regulator, and does not contain other excipients. The amount of the pH regulator added is such that the pH of the system before lyophilization is 5 to 6. The injection is in the form of a powder, and the size of the powder particles is between 60 and 120 microns, preferably between 80 and 100 microns.

2. The injection for needle-free injection according to claim 1, characterized in that: The vaccine is selected from one of hepatitis B vaccine, tetanus toxoid vaccine, mumps vaccine, measles vaccine, pertussis vaccine, rubella vaccine, typhoid vaccine, type B influenza vaccine, plague vaccine, anthrax vaccine, Japanese encephalitis vaccine and hepatitis A vaccine.

3. The injection for needle-free injection according to claim 1, characterized in that: The drug adjuvant is composed of a traditional Chinese medicine adjuvant and an aluminum adjuvant, and the mass ratio of the traditional Chinese medicine adjuvant to the aluminum adjuvant is 1:2-3, preferably 1:

2.

4. The injection for needle-free injection according to claim 1, characterized in that: The Chinese medicine adjuvant is selected from saponins, polysaccharides and flavonoids. The saponins are selected from one of ginsenosides, notoginseng saponins, gynostemma saponins, clematis saponins and diosgenin saponins. The polysaccharides are selected from one of astragalus polysaccharides, ginseng polysaccharides, rhodiola rosea polysaccharides and jujube polysaccharides. The flavonoids are selected from one of epimedium flavonoids, kumquat flavonoids, soybean flavonoids and seabuckthorn flavonoids.

5. The injection for needle-free injection according to claim 1, characterized in that: The pH value of the system before freeze-drying is 5.

5.

6. The injection for needle-free injection according to claim 1, characterized in that: The pH regulator is an inorganic base, an alkaline buffer salt or an alkaline amino acid, the inorganic base is one of sodium hydroxide, potassium hydroxide, sodium phosphate, sodium bicarbonate and potassium bicarbonate, the alkaline buffer salt is one of dipotassium hydrogen phosphate, disodium hydrogen phosphate, tripotassium phosphate and trisodium phosphate, and the alkaline amino acid is one of lysine, arginine, valine and isoleucine.

7. The method for preparing the injection for needle-free injection according to any one of claims 1 to 6, characterized in that: The steps include: Step S1. Firstly, dissolve part of the pH regulator in water for injection, then dissolve the salvianolic acid B in the above solution, and add the pH regulator to adjust the pH value of the system to 5-6; Step S2. Add 0.01-0.5% activated carbon injection to remove heat source, stir at 50°C for 20 minutes, filter and obtain particulate matter; Step S3. The granular material obtained in the above step is fully mixed with the vaccine and the Chinese medicine adjuvant in a liquid environment according to a mass ratio, and after drying, a powder having a particle size between 60 and 120 microns is collected to obtain an injection 1; Step S4. In a liquid environment, the particulate matter and the vaccine are adsorbed onto the aluminum adjuvant according to the mass ratio, and after drying, the powder with a particle size between 60 and 120 microns is collected, and then the Chinese medicine adjuvant powder with a particle size between 60 and 120 microns is added according to the mass ratio, and the mixture is evenly mixed to obtain the second injection; Step S5. In a liquid environment, the particulate matter is mixed and adsorbed with the vaccine, aluminum adjuvant and traditional Chinese medicine adjuvant according to the mass ratio, and after drying and mixing, a powder with a particle size between 60 and 120 microns is collected to obtain a vaccine injection III; Step S6. Prepare an aluminum adsorption column with aluminum hydroxide as the carrier, slowly flow the vaccine solution and the traditional Chinese medicine adjuvant solution through the aluminum adsorption column respectively, and dry the aluminum adsorption column to collect powder with a particle size between 60-120 microns to obtain vaccine injection four.

8. Use of the injection for needle-free injection according to any one of claims 1 to 6 for preparing a medicament for preventing or treating a disease.

9. The use of the injection for needle-free injection as described in claim 8, wherein the diseases to be treated include hepatitis B, tetanus, mumps, measles, whooping cough, rubella, typhoid, influenza type B, plague, anthrax, Japanese encephalitis and hepatitis A.

10. A method for needle-free injection using the injection for needle-free injection according to claims 1 to 6, comprising: 10-50 micrograms of the needle-free injection is loaded into a cartridge of a needle-free syringe and administered through the needle-free syringe.