Vitamin ADE injection for cattle and preparation method thereof
By preparing stabilizing agents and solubilizers, the stability and pain issues of vitamin ADE injection were resolved, resulting in a clear and transparent solution-type injection, which improved the product's safety and clinical applicability.
Patent Information
- Application Number
- CN202511546306.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-10-28
- Publication Date
- 2025-12-26
AI Technical Summary
Existing vitamin ADE injection solutions have poor stability, are easily oxidized and decomposed, cause injection pain, and have low bioavailability. Traditional solution-type injection solutions have problems with chemical instability and muscle irritation.
A stabilizing synergist was prepared using hydrogenated palm oil glyceride, ethylene oxide, succinic anhydride, and ascorbate palmitate to form micelles that encapsulate the drug. Combined with analgesics and solubilizers, a clear and transparent solution-type injection was prepared, which improves solubility, provides antioxidant protection, and reduces local irritation.
It significantly improved the stability and safety of the injection solution, reduced injection pain, and improved animal tolerance and production performance.
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Abstract
Description
Technical Field
[0001] This invention relates to the field of veterinary medicine technology, specifically to a bovine vitamin ADE injection and its preparation method. Background Technology
[0002] Vitamins A, D, and E are fat-soluble vitamins essential for maintaining cattle health, promoting growth, improving reproductive performance, and enhancing immune function. In intensive farming, due to factors such as feed storage and processing losses, as well as stress on the animals themselves, supplementation via injection is often necessary.
[0003] Currently, most commercially available vitamin A, D, and E injections are oily suspensions or solutions with poor stability. Oily suspensions present problems such as difficulty in injection (needle clogging is common), incomplete absorption, significant differences in bioavailability, and the tendency to form induration at the injection site. While traditional solution-type injections have solved the problem of injection convenience, vitamin A and vitamin E acetates are highly susceptible to oxidative decomposition under the influence of light, oxygen, and metal ions, leading to decreased content, reduced efficacy, and even the formation of irritating degradation products.
[0004] To address the stability issues of injection solutions, large amounts of antioxidants (such as BHT and BHA) are often added. However, this does not fundamentally solve the chemical instability of the drug molecules themselves, and high concentrations of antioxidants may also raise additional safety concerns. Furthermore, high concentrations of oily solvents and the drug itself are highly irritating to muscle tissue, easily causing pain and swelling at the injection site, affecting animal welfare and production performance.
[0005] Based on the above, the present invention provides a bovine vitamin ADE injection and its preparation method to solve the technical problems mentioned above. Summary of the Invention
[0006] The bovine vitamin ADE injection prepared by this invention is clear and transparent, with excellent stability, effectively reducing injection pain and tissue irritation, and significantly improving the product's safety, stability, and clinical applicability.
[0007] To achieve the above objectives, the present invention provides the following technical solution: A bovine vitamin ADE injection solution, each 10L of which consists of: 500-600g vitamin A palmitate, 2-3g vitamin D3, 2800-3200g vitamin E acetate, 10-20g butylated hydroxytoluene, 1800-2200g anhydrous ethanol, 180-220g analgesic, 250-350g solubilizer, 150-250g stabilizer and synergist, with the balance being isopropyl tetradecanoate.
[0008] Furthermore, the preparation method of the stabilizing synergist includes the following steps: Step 1: While stirring, add 25-40% (by mass) of ethylene oxide and 0.5-1% (by mass) of potassium hydroxide to the molten hydrogenated palm oil glyceride, controlling the reaction pressure at 0.2-0.4 MPa, and react at 80-90℃ until the pressure is constant; after cooling the product to 50-60℃, add 3-8% (by mass) of succinic anhydride to the hydrogenated palm oil glyceride, and continue the reaction at 50-60℃ for 2-4 hours. The second step is to add ascorbate palmitate at a mass of 1.2-1.6 times that of succinic anhydride to the resulting reaction product, mix well, and then keep the mixture warm. After the reaction is complete, remove the unreacted reactants and low-boiling-point byproducts from the reaction product by vacuum distillation. The remaining components are the stabilizing synergist.
[0009] Furthermore, the heat preservation reaction temperature in the second step is 60-70℃, and the reaction time is set to 2-3 hours.
[0010] Furthermore, the specific steps of vacuum distillation in the second step are as follows: the reaction product is subjected to vacuum distillation at 70-80℃ and a vacuum degree of not less than -0.095MPa until no fraction flows out, and nitrogen gas is continuously introduced during vacuum distillation to assist distillation by bubbling.
[0011] Furthermore, the analgesic is selected from any one of benzyl alcohol, lidocaine, potassium sorbate, and phenylethanol.
[0012] Furthermore, the solubilizer is selected from any one of polysorbate 80, poloxamer F68, and poloxamer 188.
[0013] A method for preparing a bovine vitamin ADE injection solution includes the following steps: Step 1: Weigh out the following ingredients according to the prescription: Vitamin A palmitate, Vitamin D3, Vitamin E acetate, butylated hydroxytoluene, anhydrous ethanol, analgesics, solubilizers, and stabilizing agents. Step 2: Under nitrogen protection throughout the process, add 3000 mL of isopropyl myristate to the mixing tank. While stirring, raise the temperature to 45-55℃ and maintain the temperature. Then, add the weighed vitamin A palmitate, vitamin D3, vitamin E acetate, and butylated hydroxytoluene to the tank in sequence. Continue stirring for 20-30 minutes, then add the remaining raw materials and add isopropyl myristate to bring the total volume to 10 L. Mix and stir for 20-30 minutes, then take a sample for intermediate analysis. Step 3: After the intermediates pass the test, the obtained drug solution is subjected to double-stage filtration, and then the filling machine is turned on to fill the drug solution; after filling is completed, each injection sample is sterilized by flowing steam. Step 4: After sterilization, the injection samples pass the light inspection and are labeled, packaged, and stored as required.
[0014] Furthermore, the microporous pleated filter elements used in the dual-stage filtration process are all made of hydrophobic PTFE material, and the pore sizes of the filter elements are 0.45μm and 0.22μm, respectively.
[0015] Furthermore, during filling, 2L of the drug solution is dispensed into 10ml ampoules and then sealed; the other 8L of the drug solution is dispensed into 100ml vials and then sealed with rubber stoppers and aluminum caps.
[0016] Furthermore, the temperature of the steam sterilization is 100°C, and the sterilization time is 30-40 minutes.
[0017] Compared with the prior art, the beneficial effects of the present invention are: 1. This invention uses hydrogenated palm oil glyceride, ethylene oxide, succinic anhydride, and ascorbyl palmitate as raw materials to prepare a stabilizing synergist with the following effects through relevant chemical reactions: A. Its molecule has both strong hydrophilic and lipophilic structures, which enable it to form micelles with a variety of poorly soluble drug molecules or to encapsulate them through intermolecular forces, significantly improving the solubility of drugs in the aqueous phase, thereby preparing a clear and transparent solution-type injection, avoiding the problems of inconvenient injection, absorption differences and local irritation that may be caused by suspensions. B. The covalently linked ascorbate palmitate group can effectively neutralize free radicals generated by the drug during storage due to factors such as light and oxygen, prevent the degradation of easily oxidized active ingredients, and strictly ensure the stability of the content and the constant efficacy of the injection solution throughout the entire cycle from production to use. C. Naturally derived lipid skeletons have good biocompatibility and can form a mild protective layer at the injection site, effectively reducing adverse reactions such as local muscle pain and tissue induration caused by certain high concentrations or irritating drugs, and improving animal tolerance. In summary, the stabilizing and enhancing agent prepared by this invention significantly improves the product quality, therapeutic safety, and clinical applicability of veterinary injections through multiple synergistic effects of solubilization, anti-oxidation, and irritation reduction.
[0018] 2. The injection solution contains analgesics that effectively block nerve conduction, reducing pain during injection. The stable microemulsion system, formed by stabilizers, solubilizers, and ethanol, facilitates diffusion and absorption of the medication within tissues, reducing accumulation and retention at the injection site, thereby minimizing chemical irritation and tissue damage caused by oily injection solutions. Furthermore, isopropyl myristate, as a solvent, is characterized by low viscosity, good tissue compatibility, and easy absorption. Detailed Implementation
[0019] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.
[0020] Example 1 A bovine vitamin ADE injection solution, each 10L of which consists of: 500g vitamin A palmitate, 2g vitamin D3, 2800g vitamin E acetate, 10g butylated hydroxytoluene, 1800g anhydrous ethanol, 180g benzyl alcohol, 250g polysorbate 80, 150g stabilizer and synergist, with the balance being isopropyl tetradecanoate.
[0021] The preparation method of the stabilizing synergist includes the following steps: Step 1: While stirring, add 25% by mass of ethylene oxide and 0.5% by mass of potassium hydroxide to the molten hydrogenated palm oil glyceride, control the reaction pressure at 0.2 MPa, and react at 80°C until the pressure is constant; after cooling the product to 50°C, add 3% by mass of succinic anhydride to the hydrogenated palm oil glyceride, and continue the reaction at 50°C for 4 hours. Step 2: After the reaction is complete, add ascorbate palmitate at a mass of 1.2 times that of succinic anhydride to the obtained reaction product, mix well and carry out the reaction at a constant temperature; after the reaction is complete, distill off the unreacted reactants and low-boiling-point byproducts in the reaction product by vacuum distillation, and the remaining components are the stabilizing synergist; the temperature of the reaction is 60℃ and the reaction time is set to 3h. The specific steps of vacuum distillation are as follows: the reaction product is subjected to vacuum distillation at 70°C and a vacuum degree of not less than -0.095MPa until no fraction flows out, and nitrogen gas is continuously introduced during vacuum distillation to assist distillation by bubbling.
[0022] A method for preparing a bovine vitamin ADE injection solution includes the following steps: Step 1: Weigh out the following ingredients according to the prescription: Vitamin A palmitate, Vitamin D3, Vitamin E acetate, butylated hydroxytoluene, anhydrous ethanol, analgesics, solubilizers, and stabilizing agents. Step 2: Under nitrogen protection throughout the process, add 3000 mL of isopropyl myristate to the mixing tank, raise the temperature to 45°C with stirring, and then maintain the temperature. Add the weighed vitamin A palmitate, vitamin D3, vitamin E acetate, and butylated hydroxytoluene to the tank in sequence, continue stirring for 20 min, add the remaining raw materials, and add isopropyl myristate to bring the total volume to 10 L. Mix and stir for 20 min, and then take a sample for intermediate analysis. Step 3: After the intermediates pass the test, the obtained drug solution is subjected to double-stage filtration, and then the filling machine is turned on to fill the drug solution; after filling is completed, each injection sample is sterilized by flowing steam. The microporous pleated filter elements used in the dual-stage filtration process are all made of hydrophobic PTFE material, and the pore sizes of the filter elements are 0.45μm and 0.22μm, respectively. During filling, 2L of the medicine solution is dispensed into 10ml ampoules and then sealed; the other 8L of the medicine solution is dispensed into 100ml vials and then sealed with rubber stoppers and aluminum caps. The temperature for steam sterilization is 100℃, and the sterilization time is 30 minutes. Step 4: After sterilization, the injection samples pass the light inspection and are labeled, packaged, and stored as required.
[0023] Example 2 A bovine vitamin ADE injection solution, each 10L of which consists of: 550g vitamin A palmitate, 2.5g vitamin D3, 3000g vitamin E acetate, 15g butylated hydroxytoluene, 2000g anhydrous ethanol, 200g lidocaine, 300g poloxamer F68, 200g stabilizer and synergist, with the balance being isopropyl myristate.
[0024] The preparation method of the stabilizing synergist includes the following steps: Step 1: While stirring, add 30% by mass of ethylene oxide and 0.8% by mass of potassium hydroxide to the molten hydrogenated palm oil glyceride, control the reaction pressure at 0.3 MPa, and react at 85°C until the pressure is constant; after cooling the product to 55°C, add 5% by mass of succinic anhydride to the hydrogenated palm oil glyceride, and continue the reaction at 55°C for 3 hours. Step 2: After the reaction is complete, add ascorbate palmitate at a mass of 1.4 times that of succinic anhydride to the obtained reaction product, mix well and carry out the reaction at a constant temperature; after the reaction is complete, distill off the unreacted reactants and low-boiling-point byproducts in the reaction product by vacuum distillation, and the remaining components are the stabilizing synergist; the temperature of the reaction is 65℃ and the reaction time is set to 3h. The specific steps of vacuum distillation are as follows: the reaction product is subjected to vacuum distillation at 75°C and a vacuum degree of not less than -0.095MPa until no fraction flows out, and nitrogen gas is continuously introduced during vacuum distillation to assist distillation by bubbling.
[0025] A method for preparing a bovine vitamin ADE injection solution includes the following steps: Step 1: Weigh out the following ingredients according to the prescription: Vitamin A palmitate, Vitamin D3, Vitamin E acetate, butylated hydroxytoluene, anhydrous ethanol, analgesics, solubilizers, and stabilizing agents. Step 2: Under nitrogen protection throughout the process, add 3000 mL of isopropyl myristate to the mixing tank, raise the temperature to 50°C with stirring, and then maintain the temperature. Add the weighed vitamin A palmitate, vitamin D3, vitamin E acetate, and butylated hydroxytoluene to the tank in sequence, continue stirring for 25 min, add the remaining raw materials, and add isopropyl myristate to bring the volume to 10 L. Mix and stir for 25 min, and then take a sample for intermediate testing. Step 3: After the intermediates pass the test, the obtained drug solution is subjected to double-stage filtration, and then the filling machine is turned on to fill the drug solution; after filling is completed, each injection sample is sterilized by flowing steam. The microporous pleated filter elements used in the dual-stage filtration process are all made of hydrophobic PTFE material, and the pore sizes of the filter elements are 0.45μm and 0.22μm, respectively. During filling, 2L of the medicine solution is dispensed into 10ml ampoules and then sealed; the other 8L of the medicine solution is dispensed into 100ml vials and then sealed with rubber stoppers and aluminum caps. The temperature for steam sterilization is 100℃, and the sterilization time is 35 minutes. Step 4: After sterilization, the injection samples pass the light inspection and are labeled, packaged, and stored as required.
[0026] Example 3 A bovine vitamin ADE injection solution, each 10L of which consists of: 600g vitamin A palmitate, 3g vitamin D3, 3200g vitamin E acetate, 20g butylated hydroxytoluene, 2200g anhydrous ethanol, 220g potassium sorbate, 350g poloxamer 188, 250g stabilizer and synergist, with the balance being isopropyl tetradecanoate.
[0027] The preparation method of the stabilizing synergist includes the following steps: Step 1: While stirring, add 40% by mass of ethylene oxide and 1% by mass of potassium hydroxide to the molten hydrogenated palm oil glyceride, control the reaction pressure at 0.4 MPa, and react at 90°C until the pressure is constant; after cooling the product to 60°C, add 3-8% by mass of succinic anhydride to the hydrogenated palm oil glyceride, and continue the reaction at 60°C for 2 hours. Step 2: After the reaction is complete, add ascorbate palmitate at a mass of 1.6 times that of succinic anhydride to the obtained reaction product, mix well and carry out the reaction at a constant temperature; after the reaction is complete, distill off the unreacted reactants and low-boiling-point byproducts in the reaction product by vacuum distillation, and the remaining components are the stabilizing synergist; the temperature of the reaction is 70℃ and the reaction time is set to 2h. The specific steps of vacuum distillation are as follows: the reaction product is subjected to vacuum distillation at 80°C and a vacuum degree of not less than -0.095MPa until no fraction flows out, and nitrogen gas is continuously introduced during vacuum distillation to assist distillation by bubbling.
[0028] A method for preparing a bovine vitamin ADE injection solution includes the following steps: Step 1: Weigh out the following ingredients according to the prescription: Vitamin A palmitate, Vitamin D3, Vitamin E acetate, butylated hydroxytoluene, anhydrous ethanol, analgesics, solubilizers, and stabilizing agents. Step 2: Under nitrogen protection throughout the process, add 3000 mL of isopropyl myristate to the mixing tank, raise the temperature to 55°C with stirring, and then maintain the temperature. Add the weighed vitamin A palmitate, vitamin D3, vitamin E acetate, and butylated hydroxytoluene to the tank in sequence, continue stirring for 30 min, add the remaining raw materials, and add isopropyl myristate to bring the total volume to 10 L. Mix and stir for 30 min, and then take a sample for intermediate analysis. Step 3: After the intermediates pass the test, the obtained drug solution is subjected to double-stage filtration, and then the filling machine is turned on to fill the drug solution; after filling is completed, each injection sample is sterilized by flowing steam. The microporous pleated filter elements used in the dual-stage filtration process are all made of hydrophobic PTFE material, and the pore sizes of the filter elements are 0.45μm and 0.22μm, respectively. During filling, 2L of the medicine solution is dispensed into 10ml ampoules and then sealed; the other 8L of the medicine solution is dispensed into 100ml vials and then sealed with rubber stoppers and aluminum caps. The temperature for steam sterilization is 100℃, and the sterilization time is 40 minutes. Step 4: After sterilization, the injection samples pass the light inspection and are labeled, packaged, and stored as required.
[0029] Comparative Example: The difference between this comparative example and Example 1 is that this comparative example does not contain a stabilizing synergist.
[0030] Performance testing: The relevant performance of the bovine vitamin ADE injection samples provided in Examples 1-3 and the comparative examples were tested as follows, and the test data are recorded in the table below: I. Properties and stability test of the injection solution Experimental Methods: Initial properties (clarity) of each group of injection samples were observed, and observation was performed again after centrifugation at 5000 r / min for 30 min. Subsequently, accelerated stability tests were conducted on each group of injection samples. The specific experimental procedure was as follows: each injection sample was placed at 40℃ and 75% relative humidity for 6 months. After 6 months, samples were taken, and the properties of each injection sample were observed. At the same time, the initial contents and contents of vitamin A palmitate, vitamin E acetate, and vitamin D3 in each injection sample were determined by HPLC, and their respective content retention rates were calculated (content retention rate / % = content in injection after 6 months / initial content in injection × 100%). The chromatographic column used in the HPLC method was a C18 column; the mobile phase was phosphate buffer (pH=3.0)-acetonitrile (75:25); the detection wavelength was 210 nm; and the flow rate was 1.0 mL / min. The test results are recorded in the table below:
[0031] II. Stimulation Test (Muscle Stimulation Index) Experimental Methods: Forty healthy New Zealand white rabbits (weighing 2.0-2.5 kg) were randomly divided into four groups of ten each. After grouping, each rabbit received an intramuscular injection of the solutions provided in Examples 1, 2, 3, and the comparative example (1.0 ml / side) in its hind leg for three consecutive days. Forty-eight hours after the last injection, the animals were euthanized, and the quadriceps femoris muscle was dissected. The muscle stimulation response (congestion, swelling, induration, necrosis) was observed, and the muscle stimulation index was calculated based on the stimulation response level; a higher index indicated stronger stimulation. Stimulus response grading criteria: Level 0: No visible reaction; Level 1: Mild congestion, localized area; Grade 2: Moderate congestion, accompanied by mild redness or induration; Grade 3: Severe congestion, accompanied by obvious redness, swelling, induration, or a small amount of necrosis; Grade 4: Extensive congestion, severe redness and swelling, induration, or large-area necrosis.
[0032] The muscle stimulation index is calculated as: the sum of stimulation levels for all animals in each group / the total number of animals.
[0033] The test data obtained above is recorded in the table below:
[0034] III. Behavioral Observation of Localized Pain (Bovine Experiment) Experimental Methods: Forty healthy growing cattle (weighing 300±50kg) were randomly divided into four groups of 10 each, designated as Example 1, Example 2, Example 3, and the comparative group. A single-blind method was used. The corresponding drug solution was injected deep into the neck muscles of the cattle at a dose of 10mL / 100kg body weight. Professional breeders and veterinarians, unaware of the group assignments, observed and recorded the cattle's pain behaviors 2 hours after injection. The mean behavioral scores and standard deviations for each group were calculated. Pain behaviors include: Neck retraction: A reaction of momentary or persistent stiffness of the neck muscles after injection.
[0035] Avoidance of touch: Shows obvious avoidance or resistance to touching the injection site and surrounding area.
[0036] Limping or head shaking: Mild limping of the forelimb due to pain (if the injection side is near the forelimb) or frequent head shaking.
[0037] Feed intake and rumination: Observe whether the amount of feed intake and the frequency of rumination are significantly reduced within a certain period of time after injection.
[0038] Each behavioral indicator is scored according to severity (0 points: no response; 1 point: mild response; 2 points: moderate response; 3 points: severe response). The test data obtained above is recorded in the table below:
[0039] By comparing and analyzing the relevant data in the table, it can be seen that the bovine vitamin ADE injection prepared by this invention is clear and transparent, has excellent stability, effectively reduces injection pain and tissue irritation, and significantly improves the product's safety, stability, and clinical applicability. This indicates that the bovine vitamin ADE injection and its preparation method provided by this invention have a broader market prospect and are more suitable for promotion.
[0040] In the description of this specification, references to terms such as "an embodiment," "example," "specific example," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.
[0041] The preferred embodiments of the present invention disclosed above are merely illustrative of the invention. These preferred embodiments do not exhaustively describe all details, nor do they limit the invention to the specific implementations described. Clearly, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to better understand and utilize the invention. The invention is limited only by the claims and their full scope and equivalents.
Claims
1. A bovine vitamin ADE injection solution, characterized in that, The composition of each 10L injection solution is as follows: 500-600g vitamin A palmitate, 2-3g vitamin D3, 2800-3200g vitamin E acetate, 10-20g butylated hydroxytoluene, 1800-2200g anhydrous ethanol, 180-220g analgesic, 250-350g solubilizer, 150-250g stabilizer and synergist, with the balance being isopropyl tetradecanoate.
2. The bovine vitamin ADE injection solution according to claim 1, characterized in that, The preparation method of the stabilizer includes the following steps: Step 1: While stirring, add 25-40% (by mass) of ethylene oxide and 0.5-1% (by mass) of potassium hydroxide to the molten hydrogenated palm oil glyceride, controlling the reaction pressure at 0.2-0.4 MPa, and react at 80-90℃ until the pressure is constant; after cooling the product to 50-60℃, add 3-8% (by mass) of succinic anhydride to the hydrogenated palm oil glyceride, and continue the reaction at 50-60℃ for 2-4 hours. The second step is to add ascorbate palmitate at a mass of 1.2-1.6 times that of succinic anhydride to the resulting reaction product, mix well, and then keep the mixture warm. After the reaction is complete, remove the unreacted reactants and low-boiling-point byproducts from the reaction product by vacuum distillation. The remaining components are the stabilizing synergist.
3. The bovine vitamin ADE injection solution according to claim 2, characterized in that: The heat preservation reaction temperature in the second step is 60-70℃, and the reaction time is set to 2-3 hours.
4. The bovine vitamin ADE injection solution according to claim 2, characterized in that, The specific steps of vacuum distillation in the second step are as follows: the reaction product is subjected to vacuum distillation at 70-80℃ and a vacuum degree of not less than -0.095MPa until no fraction flows out, and nitrogen gas is continuously introduced during vacuum distillation to assist distillation by bubbling.
5. The bovine vitamin ADE injection solution according to claim 1, characterized in that: The analgesic is selected from any one of benzyl alcohol, lidocaine, potassium sorbate, and phenylethanol.
6. The bovine vitamin ADE injection solution according to claim 1, characterized in that: The solubilizer is selected from any one of polysorbate 80, poloxamer F68, and poloxamer 188.
7. A method for preparing a bovine vitamin ADE injection solution according to any one of claims 1-6, characterized in that, Includes the following steps: Step 1: Weigh out the following ingredients according to the prescription: Vitamin A palmitate, Vitamin D3, Vitamin E acetate, butylated hydroxytoluene, anhydrous ethanol, analgesics, solubilizers, and stabilizing agents. Step 2: Under nitrogen protection throughout the process, add 3000 mL of isopropyl myristate to the mixing tank. While stirring, raise the temperature to 45-55℃ and maintain the temperature. Then, add the weighed vitamin A palmitate, vitamin D3, vitamin E acetate, and butylated hydroxytoluene to the tank in sequence. Continue stirring for 20-30 minutes, then add the remaining raw materials and add isopropyl myristate to bring the total volume to 10 L. Mix and stir for 20-30 minutes, then take a sample for intermediate analysis. Step 3: After the intermediates pass the test, the obtained drug solution is subjected to double-stage filtration, and then the filling machine is turned on to fill the drug solution; after filling is completed, each injection sample is sterilized by flowing steam. Step 4: After sterilization, the injection samples pass the light inspection and are labeled, packaged, and stored as required.
8. The method for preparing a bovine vitamin ADE injection solution according to claim 7, characterized in that: The microporous pleated filter elements used in the dual-stage filtration process are all made of hydrophobic PTFE material, and the pore sizes of the filter elements are 0.45μm and 0.22μm, respectively.
9. The method for preparing a bovine vitamin ADE injection solution according to claim 7, characterized in that: During filling, 2L of the medicine solution is dispensed into 10ml ampoules and then sealed; the other 8L of the medicine solution is dispensed into 100ml vials and then sealed with rubber stoppers and aluminum caps.
10. The method for preparing a bovine vitamin ADE injection solution according to claim 7, characterized in that: The temperature for steam sterilization is 100℃, and the sterilization time is 30-40 minutes.