A ready-to-use skin test formulation and a method for its preparation

Abstract

This invention provides a ready-to-use skin test preparation and its preparation method, relating to the field of pharmaceutical formulation technology. The preparation comprises the following components: an active pharmaceutical ingredient, a stabilizer, an osmotic pressure regulator, a pH regulator, an antibacterial agent, and water for injection. This invention eliminates the need for pre-dilution, mixing, or measurement; skin testing can be performed directly upon opening the packaging. This eliminates the traditional pre-treatment preparation steps, reduces the operation time of traditional skin tests, allows for rapid skin testing for patients, shortens waiting times, saves operational time for medical staff, and improves work efficiency.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical formulation technology, and in particular to a ready-to-use skin test formulation and its preparation method. Background Technology

[0002] Skin testing is a crucial step in screening patients for allergic reactions before clinical medication. It involves injecting a small amount of medication into the dermis and observing the local skin reaction to determine if the patient is allergic to the drug. This is an important means of preventing serious adverse reactions such as anaphylactic shock. Traditional skin testing procedures require medical staff to dilute, mix, and precisely measure the drug powder or high-concentration solution beforehand, a cumbersome and time-consuming process that affects diagnostic efficiency and safety.

[0003] Manual preparation relies on the experience of medical staff and is prone to problems such as dosage errors and uneven concentrations. Such errors can directly lead to misdiagnosis of allergic reactions. Secondly, the preparation process involves contact with air and various instruments, which increases the risk of preparation contamination. Contaminated skin test preparations may not only cause local infections, but may also interfere with the interpretation of skin test results due to microbial metabolites.

[0004] Therefore, there is an urgent need for a skin test preparation that requires no mixing and can be used immediately. Summary of the Invention

[0005] The purpose of this invention is to provide a ready-to-use skin test preparation and its preparation method, thereby solving the technical problems existing in the prior art.

[0006] To achieve the above-mentioned objectives, the technical solution adopted by this invention is as follows:

[0007] A ready-to-use skin test preparation and its preparation method, comprising the following components: 0.1-0.45g of active pharmaceutical ingredient, 0.05-0.2g of stabilizer, 0.6-0.8g of osmotic pressure regulator, 0.05-1.2g of pH regulator, 0.05-0.1g of antibacterial agent, and 100-110g of water for injection.

[0008] Furthermore, the weight of the components is as follows: 0.3g of active pharmaceutical ingredient, 0.1g of stabilizer, 0.7g of osmotic pressure regulator, 0.8g of pH regulator, 0.08g of antibacterial agent, and 100g of water for injection.

[0009] Furthermore, the active pharmaceutical ingredient is at least one of penicillins, cephalosporins, streptomycin, procaine, and tetanus antitoxin.

[0010] Furthermore, the stabilizer is at least one of trehalose, mannitol, dextran, or polysorbate.

[0011] Furthermore, the osmotic pressure regulator is at least one of sodium chloride, glucose, and glycerol.

[0012] Furthermore, the pH adjuster is composed of disodium hydrogen phosphate and sodium dihydrogen phosphate, wherein the weight of disodium hydrogen phosphate is 0.5g and the weight of sodium dihydrogen phosphate is 0.3g.

[0013] Furthermore, the antibacterial agent is at least one of benzyl alcohol, phenol, and chlorobutanol.

[0014] Further, S1: In a sterile operating table, add the osmotic pressure regulator and pH regulator to a 50-80 ml sterile glass beaker, add 50 ml of water for injection, and stir for 10-15 min; S2: Add the stabilizer, active pharmaceutical ingredient, and antibacterial agent sequentially to the sterile glass beaker, stir for 15-20 min, and control the temperature at 23-26℃; S3: Adjust the volume to 100 g with water for injection, and then... The polyethersulfone filter membrane is used for filtration and sterilization, and the filtration pressure is controlled at 0.1-0.25 MPa; S4: The filtered solution is filled into a syringe and the syringe is sealed.

[0015] Furthermore, it also includes S5: placing the sealed syringe in a high-pressure steam sterilizer, controlling the temperature at 130-140℃, and sterilizing for 15-20 minutes.

[0016] Furthermore, the polyethersulfone filter membrane in step S3 is sterilized by high-pressure steam at 120-145°C for 30-50 minutes before use.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] (i) This invention does not require prior dilution, mixing or measurement. Skin tests can be performed directly after opening the packaging, eliminating the preparation steps before traditional skin tests, reducing the operation time of traditional skin tests, enabling rapid skin tests for patients, shortening waiting time, saving operation time for medical staff, and improving work efficiency.

[0019] (ii) This invention ensures the accurate and uniform concentration of skin test preparations through standardized formulation, effectively avoiding misjudgment of allergic reactions caused by measurement errors and uneven concentrations, and providing a reliable reference for clinical medication.

[0020] (iii) The present invention adopts a sterile sealing process, from solution preparation to final packaging, all of which are carried out under sterile conditions, avoiding air and equipment contamination during manual preparation, ensuring the sterility and safety of the preparation, and reducing the risk of patient infection due to preparation contamination. Detailed Implementation

[0021] To make the objectives, technical solutions, and technical effects of this invention clearer, specific embodiments of this invention are described below. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0022] This embodiment provides a ready-to-use skin test preparation and its preparation method, comprising the following components: active pharmaceutical ingredient, stabilizer, osmotic pressure regulator, pH regulator, antibacterial agent, and water for injection. Specific effects are as follows:

[0023] Active pharmaceutical ingredients: used to induce a specific immune response in the body, and by observing local skin reactions, it can be determined whether the patient is allergic to the drug;

[0024] Stabilizers protect the active pharmaceutical ingredients from environmental factors such as humidity, oxygen, light, and temperature, preventing drug degradation, oxidation, or other chemical changes. They also prevent physical changes such as clumping or crystallization of the formulation, ensuring the stability of the skin test preparation during storage and use.

[0025] Osmotic pressure regulators: make the osmotic pressure of the skin test preparation similar to that of human body fluids, prevent cells from dehydrating or swelling due to abnormal osmotic pressure, reduce irritation and damage to local tissues, and improve the safety and comfort of medication.

[0026] pH adjusters: adjust and maintain the pH value of the formulation within a suitable range to ensure the stability and activity of the active pharmaceutical ingredient;

[0027] Antimicrobial agents: prevent the growth and reproduction of microorganisms, avoid the deterioration of the preparation due to microbial contamination during repeated use, and reduce adverse reactions caused by microbial infection.

[0028] Example 1:

[0029] The components are as follows by weight: penicillin 0.1-0.45g, trehalose 0.05-0.2g, sodium chloride 0.6-0.8g, disodium hydrogen phosphate and sodium dihydrogen phosphate 0.05-1.2g, benzyl alcohol 0.05-0.1g, and water for injection 100-110g; the active pharmaceutical ingredient of the penicillin is penicillin G sodium.

[0030] S1: In a sterile operating table, add sodium chloride, disodium hydrogen phosphate, and sodium dihydrogen phosphate to a 50-80 ml sterile glass beaker, add 50 ml of water for injection, and stir for 10-15 minutes to fully dissolve the sodium chloride, disodium hydrogen phosphate, and sodium dihydrogen phosphate in the water for injection to form a homogeneous mixed solution.

[0031] S2: Add trehalose, sodium penicillin G, and benzyl alcohol sequentially to the sterile glass beaker, stir for 15-20 minutes, and control the temperature at 23-26℃ to ensure that the components interact fully and to guarantee the stability of sodium penicillin G and the uniformity of the preparation.

[0032] S3: Adjust the volume to 100g with water for injection, and then... The polyethersulfone filter membrane is used for filtration and sterilization. The filtration pressure is controlled at 0.1-0.25 MPa. This pressure can ensure filtration efficiency and prevent the filtration effect from being affected by excessive or insufficient pressure, thus ensuring the sterility of the preparation. The polyethersulfone filter membrane is sterilized by high-pressure steam at 120-145℃ for 30-50 minutes before use to ensure that the filter membrane is completely sterile.

[0033] S4: Fill the filtered solution into a syringe and seal the syringe to ensure that the preparation is isolated from the external environment during storage and transportation, preventing microbial invasion and volatilization or deterioration of the active ingredients;

[0034] S5: Place the sealed syringe in a high-pressure steam sterilizer at a temperature of 130-140°C for 15-20 minutes to further ensure the sterility and stability of the preparation, eliminate the risk of microbial contamination that may be introduced during filling and sealing, and provide double protection for the quality and safety of the present invention.

[0035] Example 2:

[0036] The components are as follows by weight: cephalosporins 0.1-0.45g, mannitol 0.05-0.2g, glucose 0.6-0.8g, disodium hydrogen phosphate and sodium dihydrogen phosphate 0.05-1.2g, phenol 0.05-0.1g, and water for injection 100-110g; the active pharmaceutical ingredient of the cephalosporins is ceftriaxone sodium.

[0037] S1: In a sterile operating table, add glucose, disodium hydrogen phosphate, and sodium dihydrogen phosphate to a 50-80 ml sterile glass beaker, add 50 ml of water for injection, and stir for 10-15 minutes to fully dissolve glucose, disodium hydrogen phosphate, and sodium dihydrogen phosphate in the water for injection to form a homogeneous mixed solution.

[0038] S2: Add mannitol, ceftriaxone sodium and phenol sequentially to the sterile glass beaker, stir for 15-20 minutes, and control the temperature at 23-26℃ to ensure that the components interact fully and to guarantee the stability of ceftriaxone sodium and the uniformity of the preparation.

[0039] S3: Adjust the volume to 100g with water for injection, and then... The polyethersulfone filter membrane is used for filtration and sterilization. The filtration pressure is controlled at 0.1-0.25 MPa. This pressure can ensure filtration efficiency and prevent the filtration effect from being affected by excessive or insufficient pressure, thus ensuring the sterility of the preparation. The polyethersulfone filter membrane is sterilized by high-pressure steam at 120-145℃ for 30-50 minutes before use to ensure that the filter membrane is completely sterile.

[0040] S4: Fill the filtered solution into a syringe and seal the syringe to ensure that the preparation is isolated from the external environment during storage and transportation, preventing microbial invasion and volatilization or deterioration of the active ingredients;

[0041] S5: Place the sealed syringe in a high-pressure steam sterilizer at a temperature of 130-140°C for 15-20 minutes to further ensure the sterility and stability of the preparation, eliminate the risk of microbial contamination that may be introduced during filling and sealing, and provide double protection for the quality and safety of the present invention.

[0042] Example 3:

[0043] The components are as follows by weight: streptomycin 0.3g, dextran 0.1g, glycerol 0.7g, disodium hydrogen phosphate and sodium dihydrogen phosphate 0.8g, chlorobutanol 0.08g, and water for injection 100g.

[0044] S1: In a sterile operating table, add glycerol, disodium hydrogen phosphate, and sodium dihydrogen phosphate to a 50-80 ml sterile glass beaker, add 50 ml of water for injection, and stir for 10-15 min. Glycerol, disodium hydrogen phosphate, and sodium dihydrogen phosphate will be fully dissolved in the water for injection to form a homogeneous mixed solution.

[0045] S2: Add dextran, streptomycin and chlorobutanol sequentially to the sterile glass beaker, stir for 15-20 minutes, and control the temperature at 23-26℃ to ensure that the components interact fully and to guarantee the stability of streptomycin and the uniformity of the preparation.

[0046] S3: Adjust the volume to 100g with water for injection, and then... The polyethersulfone filter membrane is used for filtration and sterilization. The filtration pressure is controlled at 0.1-0.25 MPa. This pressure can ensure filtration efficiency and prevent the filtration effect from being affected by excessive or insufficient pressure, thus ensuring the sterility of the preparation. The polyethersulfone filter membrane is sterilized by high-pressure steam at 120-145℃ for 30-50 minutes before use to ensure that the filter membrane is completely sterile.

[0047] S4: Fill the filtered solution into a syringe and seal the syringe to ensure that the preparation is isolated from the external environment during storage and transportation, preventing microbial invasion and volatilization or deterioration of the active ingredients;

[0048] S5: Place the sealed syringe in a high-pressure steam sterilizer at a temperature of 130-140°C for 15-20 minutes to further ensure the sterility and stability of the preparation, eliminate the risk of microbial contamination that may be introduced during filling and sealing, and provide double protection for the quality and safety of the present invention.

[0049] Clinical application research:

[0050] The invention was used in a multicenter clinical application study in 10 hospitals of different levels across the country, including 150 patients who needed skin testing. The clinical applicability, safety and efficacy of the ready-to-use skin test preparation of the invention were evaluated.

[0051] 1. Clinical applicability evaluation: 92.5% of medical staff believe that the preparation is convenient to use and easy to operate; 95% of patients believe that the waiting time for skin test is significantly shortened.

[0052] 2. Safety evaluation: The incidence of adverse events was 0.8%, mainly manifested as mild local redness, swelling and itching, with no serious allergic reactions or infection events.

[0053] 3. Efficacy evaluation: The consistency between the skin test results and the allergic reactions after drug use was 98.6%, with a false positive rate of 1.0% and a false negative rate of 0.4%, all of which were superior to the traditional skin test method.

[0054] 4. Clinical application conclusions: The ready-to-use skin test preparation of the present invention has good clinical applicability, safety and efficacy, and can be widely used in medical institutions at all levels.

[0055] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A ready-to-use skin test formulation, characterized in that: It is made from the following components: 0.1-0.45g of active pharmaceutical ingredient, 0.05-0.2g of stabilizer, 0.6-0.8g of osmotic pressure regulator, 0.05-1.2g of pH regulator, 0.05-0.1g of antibacterial agent, and 100-110g of water for injection.

2. The ready-to-use skin test formulation according to claim 1, characterized in that: The components are as follows: 0.3g of active pharmaceutical ingredient, 0.1g of stabilizer, 0.7g of osmotic pressure regulator, 0.8g of pH regulator, 0.08g of antibacterial agent, and 100g of water for injection.

3. The ready-to-use skin test formulation according to claim 2, characterized in that: The active pharmaceutical ingredient is at least one of penicillins, cephalosporins, streptomycin, procaine, and tetanus antitoxin.

4. The ready-to-use skin test formulation according to claim 2, characterized in that: The stabilizer is at least one of trehalose, mannitol, dextran, or polysorbate.

5. The ready-to-use skin test formulation according to claim 2, characterized in that: The osmotic pressure regulator is at least one of sodium chloride, glucose, and glycerol.

6. The ready-to-use skin test formulation according to claim 2, characterized in that: The pH adjuster is composed of disodium hydrogen phosphate and sodium dihydrogen phosphate, wherein the weight of disodium hydrogen phosphate is 0.5g and the weight of sodium dihydrogen phosphate is 0.3g.

7. The ready-to-use skin test formulation according to claim 2, characterized in that: The antibacterial agent is at least one of benzyl alcohol, phenol, and chlorobutanol.

8. The ready-to-use skin test formulation and its preparation method according to any one of claims 1-7, characterized in that: The preparation methods include the following: S1: In a sterile operating table, add the osmotic pressure regulator and pH regulator to a 50-80ml sterile glass beaker, add 50ml of water for injection, and stir for 10-15 minutes. S2: Add stabilizer, active pharmaceutical ingredient and antibacterial agent to the sterile glass beaker in sequence, stir for 15-20 minutes, and control the temperature at 23-26℃. S3: Adjust the volume to 100g with water for injection, and then... Polyethersulfone filter membranes are used for filtration and sterilization, with the filtration pressure controlled at 0.1-0.25 MPa; S4: Fill the filtered solution into the syringe and seal the syringe.

9. The ready-to-use skin test formulation and its preparation method according to claim 8, characterized in that: It also includes S5: Place the sealed syringe in a high-pressure steam sterilizer, control the temperature at 130-140℃, and sterilize for 15-20 minutes.

10. The ready-to-use skin test formulation and its preparation method according to claim 8, characterized in that: The polyethersulfone filter membrane in step S3 is sterilized by high-pressure steam at 120-145℃ for 30-50 minutes before use.