Targeted drug for acquired infertility of dairy cow and preparation method thereof

Abstract

The invention relates to the technical field of biological pharmacy, and discloses a target drug for acquired infertility of dairy cows and a preparation method of the target drug. The feed comprises the following components in percentage by mass: 15%-17% of buserelin, 1.5%-2.5% of penicillin, 18%-20% of vitamin A, 14%-16% of vitamin E, 10%-12% of vitamin D, 3%-6% of calcium, 4%-5% of phosphorus, 4%-5% of magnesium, 2%-3% of zinc, 3%-6% of lysine, 3%-5% of linolenic acid and an additive, the problems that in the feeding process of part of dairy cows, in order to increase the milk yield, the dairy cows are fed too early, the milk yield is increased too quickly, a large amount of nutrition is discharged through the milk, and nutritional ingredients are seriously overdraft, so that the dairy cows suffer from postnatal infertility conditions such as nutrient insufficiency of reproductive systems and ovarian function decline infertility are solved.

Description

Technical Field

[0001] This invention relates to the field of biopharmaceutical technology, specifically to a targeted drug for acquired infertility in dairy cows and its preparation method. Background Technology

[0002] Veterinary drugs refer to substances (including medicated feed additives) used to prevent, treat, or diagnose animal diseases or to purposefully regulate animal physiological functions. Veterinary drugs mainly include: serum products, vaccines, diagnostic products, microecological products, Chinese medicinal materials, prepared Chinese medicines, chemical drugs, antibiotics, biochemical drugs, radioactive drugs, and external insecticides and disinfectants.

[0003] Milk and dairy products contain a large number of substances that are beneficial to the human body. As a result, people's demand for milk and dairy products has been increasing year by year. In order to increase milk production, some dairy cows are fed too early and milk production is increased too quickly. A large amount of nutrients are excreted through milk, and the nutritional components are severely depleted. This leads to acquired infertility in dairy cows, such as insufficient nutrition of the reproductive system and ovarian dysfunction. Summary of the Invention

[0004] The purpose of this invention is to provide a targeted drug for acquired infertility in dairy cows and its preparation method, so as to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a targeted drug for acquired infertility in dairy cows, comprising the following components in the following mass ratio: 15%-17% buserelline, 1.5%-2.5% penicillin, 18%-20% vitamin A, 14%-16% vitamin E, 10%-12% vitamin D, 3%-6% calcium, 4%-5% phosphorus, 4%-5% magnesium, 2%-3% zinc, 3%-6% lysine, 3%-5% linolenic acid, and additives.

[0006] Preferably, the additive is a stabilizer, a solubilizer, a preservative, a buffer, a suspending agent, and a diluent.

[0007] Preferably, the stabilizer has a mass ratio of 0.4%, the cosolvent has a mass ratio of 2%, the preservative has a mass ratio of 0.6%, the buffer has a mass ratio of 0.4%, the suspending agent has a mass ratio of 0.4%, and the diluent has a mass ratio of 25%.

[0008] Preferably, the stabilizer is ascorbic acid, the solubilizer is β-cyclodextrin, the preservative is benzyl alcohol, the buffer is disodium hydrogen phosphate, the suspending agent is methylcellulose, and the diluent is physiological saline.

[0009] This invention also provides a method for preparing a targeted drug for acquired infertility in dairy cows, comprising the following steps;

[0010] S1. Raw material preparation: Prepare raw materials that meet pharmaceutical production standards in terms of quality and purity, and weigh them according to the specified weight ratio.

[0011] S2. Dissolution and pretreatment: Select appropriate solvents to dissolve solid components, and dissolve and adjust the concentration of liquid components;

[0012] S3. Mixing and stirring: Mixing and processing the dissolved solid and liquid components;

[0013] S4. Filtration and Clarification: Filtrate and clarify the mixture to remove insoluble particles and impurities;

[0014] S5. Sterilization and disinfection: Sterilize the treated mixture.

[0015] S6. Filling and Packaging: Packing the drug into a syringe;

[0016] S7. Quality control and inspection: Inspect the finished drug product and conduct stability tests on it.

[0017] Preferably, in step S2, a compatibilizer needs to be added when dissolving the fixed component, and a suspending agent needs to be added after sterilization in step S5.

[0018] Preferably, in step S1, when preparing the raw materials, it is necessary to conduct necessary inspections and quality control on the raw materials. In step S2, the solid components are dissolved in distilled water, and the mixture is stirred during the dissolution process.

[0019] Preferably, in step S2, penicillin requires aseptic processing, and in step S3, a stirrer is required to mix the solid component solution and the liquid component solution.

[0020] Preferably, a centrifuge and a filter are used in step S4, and a heat sterilizer is used in step S5 to sterilize the mixture.

[0021] Preferably, in step S7, a spectrophotometer and a high-performance liquid chromatograph are used to detect the chemical and physical properties of the drug.

[0022] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0023] This invention, by adding busherin, can inhibit estrus and ovulation in dairy cows by suppressing the release of luteinizing hormone, thus enabling artificial insemination at specific times and improving reproductive efficiency. Simultaneously, it can regulate the cow's endocrine system, promoting mammary gland development and increasing milk production. With the aid of penicillin, it can treat inflammation in the cow's body, preventing infertility caused by reproductive system infections. The addition of vitamins A, E, and D, essential nutrients for the cow's reproductive system, provides additional benefits. Vitamin A maintains the health of the reproductive organs, vitamin E has antioxidant properties that protect the integrity of reproductive cells, and vitamin D aids in the absorption and utilization of calcium and phosphorus, ensuring optimal reproductive health. The health of dairy cows' bones and reproductive capacity can be improved by adding calcium, phosphorus, magnesium, and zinc. Calcium and phosphorus are the main components of dairy cow bones and teeth and can maintain the normal function of the dairy cow's reproductive system. By adding lysine, which participates in the synthesis and metabolism of proteins in dairy cows, the normal function and reproductive capacity of dairy cow reproductive cells can be maintained. By adding linolenic acid, which participates in the metabolism of fat in dairy cows and the formation of cell membranes, the integrity and function of dairy cow reproductive cells can be improved. This solves the problem of some dairy cows being fed too early and too quickly to increase milk production, resulting in a large amount of nutrients being excreted through milk, a serious over-depletion of nutrients, and thus, insufficient nutrition of the reproductive system and acquired infertility such as ovarian dysfunction. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of a preferred embodiment of the method for preparing a targeted drug for acquired infertility in dairy cows provided by the present invention. Detailed Implementation

[0025] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. 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 skilled in the art without creative effort are within the scope of protection of the present invention.

[0026] Please see Figure 1As shown, a targeted drug for acquired infertility in dairy cows comprises the following components in the indicated mass ratios: 15%–17% buserelline, 1.5%–2.5% penicillin, 18%–20% vitamin A, 14%–16% vitamin E, 10%–12% vitamin D, 3%–6% calcium, 4%–5% phosphorus, 4%–5% magnesium, 2%–3% zinc, 3%–6% lysine, 3%–5% linolenic acid, and additives. Buserelin can promote the secretion of reproductive hormones in dairy cows, thereby improving ovarian function and increasing conception rates. Penicillin is a broad-spectrum antibiotic that can effectively prevent and treat reproductive system infections in dairy cows. By eliminating the source of infection, penicillin helps restore the reproductive health of dairy cows. Vitamins A and E are antioxidants that help maintain the normal structure and function of the reproductive system in dairy cows and reduce the damage of oxidative stress to the reproductive system. Calcium is an essential mineral for maintaining normal reproductive function, while vitamin D can promote calcium absorption and ensure the reproductive health of dairy cows. Calcium, phosphorus, and magnesium minerals can maintain the normal physiological function of the reproductive system in dairy cows. Lysine is one of the essential amino acids and helps improve the reproductive health of dairy cows. Linolenic acid may ensure the normal reproductive function of dairy cows by reducing inflammation and oxidative stress in the reproductive system.

[0027] The additives include stabilizers, solubilizers, preservatives, buffers, suspending agents, and diluents.

[0028] The stabilizer has a mass ratio of 0.4%, the cosolvent has a mass ratio of 2%, the preservative has a mass ratio of 0.6%, the buffer has a mass ratio of 0.4%, the suspending agent has a mass ratio of 0.4%, and the diluent has a mass ratio of 25%.

[0029] The stabilizer is ascorbic acid, the solubilizer is β-cyclodextrin, the preservative is benzyl alcohol, the buffer is disodium hydrogen phosphate, the suspending agent is methylcellulose, and the diluent is physiological saline. Adding stabilizers to the mixed drugs extends their shelf life and ensures they maintain their original efficacy during storage and use. Preservatives inhibit the growth of bacteria and mold, thus ensuring the hygienic quality of the drugs. Buffers maintain the acid-base balance of the drug solution, preventing changes in pH from affecting its stability and efficacy during storage and use. Suspending agents increase the viscosity of the drug suspension, allowing drug particles to disperse better in the liquid and preventing precipitation and stratification. Dissolving or suspending the drug in physiological saline reduces its concentration, making it easier for dairy cows to absorb.

[0030] This invention also provides a method for preparing a targeted drug for acquired infertility in dairy cows, comprising the following steps:

[0031] S1. Raw material preparation: Prepare raw materials that meet the quality and purity standards for pharmaceutical production, and weigh them according to the weight ratio; weigh and mix the bisereline, penicillin, vitamin A, vitamin E, vitamin D, calcium, phosphorus, magnesium, zinc, lysine, linolenic acid, and additives according to the standards, pharmaceutical quality requirements, and purity requirements.

[0032] S2. Dissolution and Pretreatment: Select appropriate solvents to dissolve solid components and dissolve and adjust the concentration of liquid components; add the solid components in the raw materials to the corresponding solvents, where methanol is used as the solvent for buserelin, physiological saline is used as the solvent for penicillin, ethanol is used as the solvent for vitamins A, E, and D, water is used as the solvent for calcium, phosphorus, magnesium, zinc, and lysine, and ethanol is used as the solvent for linolenic acid. Co-solvents can also be added to assist in the process.

[0033] S3. Mixing and Stirring: Mixing and processing the dissolved solid and liquid components; mixing the dissolved solutions of busereline, penicillin, vitamin A, vitamin E, vitamin D, calcium, phosphorus, magnesium, zinc, lysine, and linolenic acid, while adding stabilizers and buffers to prevent the drugs from being affected by the external environment.

[0034] S4. Filtration and Clarification: Filter and clarify the mixture to remove insoluble particles and impurities; then filter the mixed solution to remove impurities and insoluble substances.

[0035] S5. Sterilization and disinfection: Sterilize the treated mixture; add preservatives to the sterilized mixture to ensure drug efficacy.

[0036] S6. Filling and Packaging: Packing the drug into a syringe;

[0037] S7. Quality Control and Inspection: Inspect the finished drug product and conduct stability tests. In S2, a compatibilizer needs to be added when dissolving the fixed components, and a suspending agent needs to be added after sterilization in S5.

[0038] In S1, when preparing raw materials, necessary inspections and quality control are required. In S2, solid components are dissolved in distilled water, and the mixture is stirred during the dissolution process.

[0039] In S2, penicillin requires aseptic handling, and in S3, a stirrer is needed to mix the solid and liquid components.

[0040] S4 requires the use of a centrifuge and a filter, while S5 requires the use of a heat sterilizer to sterilize the mixture.

[0041] In S7, spectrophotometers and high-performance liquid chromatographs are required to detect the chemical and physical properties of the drug. This is to monitor the quality and properties of the drug and prevent changes in its properties that could lead to a loss of efficacy.

[0042] Example 1

[0043] According to the weight ratio, take 15% Buserelin, 1.5% Penicillin, 18% Vitamin A, 14% Vitamin E, 10% Vitamin D, 3% Calcium, 4% Phosphorus, 4% Magnesium, 2% Zinc, 3% Lysine, 3% Linolenic Acid, and additives.

[0044] Stabilizer 0.4%, solubilizer 2%, preservative 0.6%, buffer 0.4%, suspending agent 0.4%, diluent 25%.

[0045] The stabilizer is sodium bisulfite, the solubilizer is β-cyclodextrin, the preservative is methylparaben, the buffer is potassium dihydrogen phosphate, the suspending agent is xanthan gum, and the diluent is glucose injection.

[0046] Example 2

[0047] According to the weight ratio, take 16% Buserelin, 2% Penicillin, 19% Vitamin A, 15% Vitamin E, 11% Vitamin D, 4% Calcium, 4.5% Phosphorus, 4.5% Magnesium, 2.5% Zinc, 4% Lysine, 4% Linolenic Acid, and additives.

[0048] Stabilizer 0.4%, solubilizer 2%, preservative 0.6%, buffer 0.4%, suspending agent 0.4%, diluent 25%.

[0049] The stabilizer is ascorbic acid, the solubilizer is β-cyclodextrin, the preservative is benzyl alcohol, the buffer is disodium hydrogen phosphate, the suspending agent is methylcellulose, and the diluent is physiological saline.

[0050] Example 3

[0051] According to the weight ratio, it consists of 17% Buserelin, 2.5% Penicillin, 20% Vitamin A, 16% Vitamin E, 12% Vitamin D, 6% Calcium, 5% Phosphorus, 5% Magnesium, 3% Zinc, 6% Lysine, 5% Linolenic Acid, and additives.

[0052] Stabilizer 0.4%, solubilizer 2%, preservative 0.6%, buffer 0.4%, suspending agent 0.4%, diluent 25%.

[0053] The stabilizer is ascorbic acid, the solubilizer is β-cyclodextrin, the preservative is benzyl alcohol, the buffer is disodium hydrogen phosphate, the suspending agent is methylcellulose, and the diluent is physiological saline.

[0054] As can be seen from the above embodiments, the drug prepared in Example 2 has better effects. It can support the reproductive health of dairy cows from multiple perspectives and treat acquired infertility caused by excessive lactation in dairy cows.

[0055] Working principle: Buserreline stimulates the secretion of gonadotropins in dairy cows, thereby promoting their reproductive capacity. Penicillin helps prevent acquired infertility caused by inflammation and infection of the reproductive organs. The addition of vitamins A, E, and D, along with minerals, provides nutritional supplementation, promoting normal physical and skeletal development, thus improving the health of the reproductive organs and overall health, ultimately enhancing reproductive capacity. Solubilizers and stabilizers improve drug stability and solubility, preventing deterioration or precipitation during storage and use. Preservatives prevent microbial contamination, ensuring safety and efficacy. Buffers maintain the drug's acid-base balance, protecting it from environmental influences. Suspending agents and diluents improve suspension and flowability, facilitating administration. When preparing the mixed drug, it is necessary to first determine the appropriate weight ratio. The drug meets the required purity standards. The solid and liquid components are then dissolved using appropriate solvents and co-solvents to ensure complete dissolution. After dissolution, the concentrations of the solid and liquid solutions are adjusted separately to prevent drug interactions and thus avoid affecting the efficacy of the mixed drug. The solid and liquid solutions are then thoroughly mixed and stirred to ensure uniform distribution. Stabilizers and suspending agents are added to stabilize the drug components. The mixture is then filtered to remove particulate matter and insoluble substances, improving its purity. After preparation, the mixture is sterilized to prevent external bacteria from affecting its purity. It is then sealed and stored. After a specified storage period, quality and stability tests are conducted to control the quality of the mixed drug and prevent reduced efficacy, thus ensuring its proper use.

[0056] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0057] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A targeted drug for acquired infertility in dairy cows, characterized in that, It consists of the following components by weight: 15%–17% buserelline, 1.5%–2.5% penicillin, 18%–20% vitamin A, 14%–16% vitamin E, 10%–12% vitamin D, 3%–6% calcium, 4%–5% phosphorus, 4%–5% magnesium, 2%–3% zinc, 3%–6% lysine, 3%–5% linolenic acid, and additives.

2. The targeted drug for acquired infertility in dairy cows according to claim 1, characterized in that: The additives are stabilizers, solubilizers, preservatives, buffers, suspending agents, and diluents.

3. A targeted drug for acquired infertility in dairy cows according to claim 2, characterized in that: The stabilizer has a mass ratio of 0.4%, the cosolvent has a mass ratio of 2%, the preservative has a mass ratio of 0.6%, the buffer has a mass ratio of 0.4%, the suspending agent has a mass ratio of 0.4%, and the diluent has a mass ratio of 25%.

4. A targeted drug for acquired infertility in dairy cows according to claim 2, characterized in that: The stabilizer is ascorbic acid, the solubilizer is β-cyclodextrin, the preservative is benzyl alcohol, the buffer is disodium hydrogen phosphate, the suspending agent is methylcellulose, and the diluent is physiological saline.

5. A method for preparing a targeted drug for acquired infertility in dairy cows, characterized in that: Includes the following steps: S1. Raw material preparation: Prepare raw materials whose quality and purity meet the pharmaceutical production standards, and weigh them according to the weight ratio. S2. Dissolution and pretreatment: Select appropriate solvents to dissolve solid components, and dissolve and adjust the concentration of liquid components; S3. Mixing and stirring: Mixing and processing the dissolved solid and liquid components; S4. Filtration and Clarification: Filtrate and clarify the mixture to remove insoluble particles and impurities; S5. Sterilization and disinfection: Sterilize the treated mixture. S6. Filling and Packaging: Packing the drug into a syringe; S7. Quality control and inspection: Inspect the finished drug product and conduct stability tests on it.

6. The method for preparing a targeted drug for acquired infertility in dairy cows according to claim 5, characterized in that: In step S2, a compatibilizer needs to be added when dissolving the fixed component, and a suspending agent needs to be added after sterilization in step S5.

7. The method for preparing a targeted drug for acquired infertility in dairy cows according to claim 5, characterized in that: In step S1, when preparing raw materials, it is necessary to conduct necessary inspections and quality control on the raw materials. In step S2, the solid components are dissolved in distilled water, and the mixture is stirred during the dissolution process.

8. The method for preparing a targeted drug for acquired infertility in dairy cows according to claim 5, characterized in that: In step S2, penicillin requires aseptic processing, and in step S3, a stirrer is required to mix the solid component solution and the liquid component solution.

9. A method for preparing a targeted drug for acquired infertility in dairy cows according to claim 5, characterized in that: In step S4, a centrifuge and a filter are required, and in step S5, a heat sterilizer is required to sterilize the mixture.

10. A method for preparing a targeted drug for acquired infertility in dairy cows according to claim 5, characterized in that: In step S7, a spectrophotometer and a high-performance liquid chromatograph are required to detect the chemical and physical properties of the drug.

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