CN118252802A - Tiamulin fumarate soluble powder and preparation method thereof - Google Patents
Tiamulin fumarate soluble powder and preparation method thereof Download PDFInfo
- Publication number
- CN118252802A CN118252802A CN202410346325.9A CN202410346325A CN118252802A CN 118252802 A CN118252802 A CN 118252802A CN 202410346325 A CN202410346325 A CN 202410346325A CN 118252802 A CN118252802 A CN 118252802A
- Authority
- CN
- China
- Prior art keywords
- tiamulin fumarate
- soluble powder
- tiamulin
- fumarate
- cosolvent
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- YXQXDXAHCSEVSD-GCYNEOGWSA-N dynamutilin Chemical compound OC(=O)\C=C\C(O)=O.CCN(CC)CCSCC(=O)O[C@@H]1C[C@@](C)(C=C)[C@@H](O)[C@H](C)[C@@]23CC[C@@H](C)[C@]1(C)[C@@H]2C(=O)CC3 YXQXDXAHCSEVSD-GCYNEOGWSA-N 0.000 title claims abstract description 51
- 229940092292 tiamulin fumarate Drugs 0.000 title claims abstract description 51
- 239000000843 powder Substances 0.000 title claims abstract description 42
- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- 239000006184 cosolvent Substances 0.000 claims abstract description 24
- 239000003381 stabilizer Substances 0.000 claims abstract description 22
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract description 15
- 239000000945 filler Substances 0.000 claims abstract description 14
- 238000000034 method Methods 0.000 claims abstract description 12
- 229920000858 Cyclodextrin Polymers 0.000 claims abstract description 7
- 239000001116 FEMA 4028 Substances 0.000 claims abstract description 7
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 7
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims abstract description 7
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims abstract description 7
- 229960004853 betadex Drugs 0.000 claims abstract description 7
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 7
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 7
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims abstract description 7
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims abstract description 7
- 230000008569 process Effects 0.000 claims abstract description 7
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 6
- 229920002472 Starch Polymers 0.000 claims abstract description 6
- 239000003963 antioxidant agent Substances 0.000 claims abstract description 6
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 6
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 6
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 6
- 235000019698 starch Nutrition 0.000 claims abstract description 6
- 239000008107 starch Substances 0.000 claims abstract description 6
- 239000008363 phosphate buffer Substances 0.000 claims abstract description 5
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims abstract description 4
- 230000003078 antioxidant effect Effects 0.000 claims abstract description 4
- 238000002156 mixing Methods 0.000 claims description 30
- 239000000203 mixture Substances 0.000 claims description 13
- 238000003756 stirring Methods 0.000 claims description 8
- 238000009455 aseptic packaging Methods 0.000 claims description 7
- 230000036512 infertility Effects 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 3
- 238000004806 packaging method and process Methods 0.000 claims description 3
- 238000012216 screening Methods 0.000 claims description 3
- 230000000694 effects Effects 0.000 abstract description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 6
- 239000003814 drug Substances 0.000 description 54
- 229940079593 drug Drugs 0.000 description 36
- 238000004519 manufacturing process Methods 0.000 description 9
- 230000001965 increasing effect Effects 0.000 description 8
- 241001465754 Metazoa Species 0.000 description 5
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 description 4
- 235000006708 antioxidants Nutrition 0.000 description 4
- 238000002347 injection Methods 0.000 description 4
- 239000007924 injection Substances 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 239000000047 product Substances 0.000 description 4
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 description 3
- 208000015181 infectious disease Diseases 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- 241000187747 Streptomyces Species 0.000 description 2
- 229930003427 Vitamin E Natural products 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 230000002708 enhancing effect Effects 0.000 description 2
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 description 2
- 238000011194 good manufacturing practice Methods 0.000 description 2
- 230000002209 hydrophobic effect Effects 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 230000003993 interaction Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 230000033001 locomotion Effects 0.000 description 2
- 239000011159 matrix material Substances 0.000 description 2
- 230000004792 oxidative damage Effects 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 238000012545 processing Methods 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 239000004094 surface-active agent Substances 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 235000019165 vitamin E Nutrition 0.000 description 2
- 229940046009 vitamin E Drugs 0.000 description 2
- 239000011709 vitamin E Substances 0.000 description 2
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 230000001276 controlling effect Effects 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 239000002105 nanoparticle Substances 0.000 description 1
- 239000013618 particulate matter Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000004962 physiological condition Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 206010040872 skin infection Diseases 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention discloses tiamulin fumarate soluble powder and a preparation method thereof, wherein the tiamulin fumarate soluble powder comprises the following components: a) Tiamulin fumarate; b) A cosolvent; c) A filler; d) A stabilizer; e) The pH regulator is characterized in that the cosolvent is at least one selected from polyvinylpyrrolidone, beta-cyclodextrin and polyethylene glycol, the filler is microcrystalline cellulose or starch, the stabilizer is an antioxidant, and the pH regulator is one or more selected from sodium bicarbonate, citric acid and phosphate buffer. The soluble powder is prepared by a specific formula and a specific process, and by adding the cosolvent and the stabilizer, the water solubility of the tiamulin fumarate is obviously improved, the use effect and convenience of the tiamulin fumarate in practical application are improved, and the soluble powder has good solubility, stability and bioavailability and can be conveniently orally taken or injected.
Description
Technical Field
The invention relates to the technical field of veterinary medicine preparations, in particular to tiamulin fumarate soluble powder and a preparation method thereof.
Background
Tiamulin fumarate is a broad-spectrum antibiotic isolated by Thailand scientists in the 80 s of the 20 th century from a strain of Streptomyces (Streptomyces). The medicine can effectively inhibit the growth of gram-positive bacteria and some gram-negative bacteria, so that the medicine is clinically used for treating various infectious diseases, such as respiratory system infection, intestinal tract infection, skin infection and the like. However, although it has a broad antibacterial spectrum and a good therapeutic effect, tiamulin fumarate has a limited application, mainly because of low solubility of the preparation, low bioavailability, inconvenience in administration mode, and the like.
The traditional tiamulin fumarate preparation is mostly powder injection or oral liquid, and the preparation has some problems in clinical application. For example, powder injection needs to be administered by injection, which not only causes pain to animals, but also has high technical requirements for operators and increases the complexity of treatment. The oral liquid is convenient to administer, but is limited by the solubility of the drug, so that a large dosage is often required to achieve the treatment effect, the treatment cost is increased, the drug burden of animals is possibly increased, and the risk of adverse reactions is increased.
In order to solve the above problems, researchers have made extensive researches in an attempt to improve the solubility and bioavailability of tiamulin fumarate by improving the pharmaceutical formulation and preparation process. For example, there is a study to improve wettability and dispersibility of a drug by adding a surfactant, thereby improving its dissolution rate and degree. In addition, there have been studies on the preparation of nanoparticles of tiamulin fumarate using nanotechnology in order to increase the solubility and absorptivity of the drug by increasing its surface area.
Despite the advances made in these studies, there are a number of shortcomings. For example, the use of surfactants may affect the stability of the drug and may even cause allergic reactions in animals. While the nano technology prepared medicine can theoretically improve the solubility and the absorptivity, the production cost in practical application is higher, and potential safety problems can exist.
Therefore, development of the novel tiamulin fumarate soluble powder can not only maintain good antibacterial effect of the medicament, but also improve the solubility and bioavailability of the medicament, and is convenient for administration, so that the tiamulin fumarate soluble powder becomes an important requirement in the field of veterinary medicaments.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides tiamulin fumarate soluble powder and a preparation method thereof, so as to solve the problems in the prior art.
The invention aims at realizing the following technical scheme:
the tiamulin fumarate soluble powder comprises the following components:
a) Tiamulin fumarate;
b) A cosolvent;
c) A filler;
d) A stabilizer;
e) A pH regulator;
Wherein the cosolvent is selected from at least one of polyvinylpyrrolidone, beta-cyclodextrin and polyethylene glycol, the filler is microcrystalline cellulose or starch, the stabilizer is an antioxidant, and the pH regulator is selected from one or more of sodium bicarbonate, citric acid and phosphate buffer.
Preferably, the mass ratio of tiamulin fumarate to cosolvent is 1: (0.5-2), the mass ratio of tiamulin fumarate to the stabilizer is 1: (0.1-0.5).
Preferably, the method comprises the following steps:
(a) Mixing tiamulin fumarate with a cosolvent to obtain a mixture A;
(b) Adding filler, stabilizer and pH regulator into the mixture A, mixing uniformly,
Obtaining a mixture B;
(c) Crushing and screening the mixture B to obtain powder with uniform granularity;
(d) Drying the powder, and packaging to obtain tiamulin fumarate soluble powder.
Preferably, the mixing in step a) is carried out in a stirrer at a stirring speed of 50-100rpm for a mixing time of 10-30 minutes.
Preferably, the mixing in step b) is performed by a three-dimensional mixer for 20-40 minutes.
Preferably, the aseptic packaging in step d) is performed under a laminar flow ultra-clean bench to ensure sterility of the powder.
Compared with the prior art, the invention has the beneficial effects that:
The soluble powder is prepared by a specific formula and a specific process, and by adding the cosolvent and the stabilizer, the water solubility of the tiamulin fumarate is obviously improved, the use effect and convenience of the tiamulin fumarate in practical application are improved, and the soluble powder has good solubility, stability and bioavailability and can be conveniently orally taken or injected for administration. Compared with the existing tiamulin fumarate preparation, the soluble powder has remarkable advantages, the preparation method is simple and feasible, has potential of industrial production, and is expected to be widely applied to the field of veterinary medicines.
Detailed Description
The technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention, and it is apparent that the described embodiments are only some embodiments of the present invention, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
An embodiment of the present invention provides:
the tiamulin fumarate soluble powder comprises the following components:
a) Tiamulin fumarate;
b) A cosolvent;
c) A filler;
d) A stabilizer;
e) A pH regulator;
The cosolvent is selected from at least one of polyvinylpyrrolidone, beta-cyclodextrin and polyethylene glycol, the filler is microcrystalline cellulose or starch, the stabilizer is an antioxidant, the pH regulator is selected from one or more of sodium bicarbonate, citric acid and phosphate buffer, and the cosolvent can improve the solubility of the insoluble drug, so that the bioavailability of the insoluble drug is improved. For example, PVP and beta-cyclodextrin can effectively increase the solubility of drug molecules in water by forming inclusion complexes. Beta-cyclodextrin has an internally hydrophobic, externally hydrophilic character, which allows it to encapsulate drug molecules through hydrophobic interactions, thereby increasing solubility. PEG is used as another cosolvent, the bioavailability of the drug can be improved by increasing the water solubility of the drug, fillers such as microcrystalline cellulose or starch play a role of a carrier in the drug preparation, the fillers can provide a solid matrix, the fluidity and the compressibility of the drug powder are facilitated, the fluidity and the compressibility of the drug powder are crucial to the processing and the forming of the drug, antioxidants such as vitamin E or BHT (butylhydroxytoluene) in a stabilizer can protect the drug from oxidative damage, the shelf life of the drug is prolonged, the activity and the stability of the drug are maintained, and the use of a pH regulator is used for maintaining the acid-base balance of the drug preparation and ensuring that the drug plays an optimal effect under a proper pH condition. For example, sodium bicarbonate and citric acid may be used as buffer pairs to adjust the pH of a drug solution, while phosphate buffers are commonly used to maintain the pH of physiological conditions. The use of these additives in pharmaceutical formulations has the effect of increasing solubility, enhancing stability, adjusting pH and improving processability, thereby enhancing the overall efficacy of the drug and the drug experience of the patient.
Further, the mass ratio of tiamulin fumarate to cosolvent is 1: (0.5-2), the mass ratio of tiamulin fumarate to the stabilizer is 1: (0.1-0.5), the mass ratio of tiamulin fumarate to cosolvent is 1: (0.5-2), and any value within the range of the ratio may be selected as required in the specific implementation. For example, tiamulin fumarate to co-solvent mass ratio of 1 may be selected: 0.5, 1:1. 1:1.5 or 1:2, etc. Also, the mass ratio of tiamulin fumarate to stabilizer is 1: (0.1-0.5), and any value within the range of the ratio may be selected as required in the specific implementation. For example, tiamulin fumarate to stabilizer mass ratio of 1:0.1, 1:0.2, 1:0.3, 1:0.4 or 1:0.5, etc. In the preparation process, tiamulin fumarate and a cosolvent are mixed and stirred uniformly, so that the tiamulin fumarate and the cosolvent are fully contacted and dissolved. Then, a stabilizer was added to the above mixture, and stirring was continued until complete dissolution. Finally, the obtained solution is spray-dried to obtain tiamulin fumarate soluble powder. The conditions of spray drying can be adjusted according to the actual situation to ensure that the obtained soluble powder has good fluidity and stability. The use of a cosolvent such as polyvinylpyrrolidone (PVP), beta-cyclodextrin, polyethylene glycol (PEG) can significantly improve the solubility of tiamulin fumarate. This is because these co-solvents are capable of specific interactions with drug molecules, such as forming inclusion complexes or increasing the water solubility of the drug, thereby making the drug more soluble in water. The use of stabilizers, particularly antioxidants such as vitamin E or BHT, helps to protect the drug from oxidative damage, extend the shelf life of the drug, and maintain the activity and stability of the drug. This is critical to ensure the quality of the drug during storage and transport. By adjusting the use of the pH regulator, the acid-base balance of the pharmaceutical preparation can be maintained, and the pharmaceutical can be ensured to exert the optimal curative effect under the proper pH condition. This is important to improve the bioavailability and therapeutic effect of the drug. The use of fillers such as microcrystalline cellulose or starch not only provides a solid matrix but also aids in the flowability and compressibility of the drug powder, which is critical to the processing and shaping of the drug. Good processability ensures the quality and consistency of the medicament during production. The use of suitable co-solvents and stabilizers can reduce potential irritation and allergic response to animals, thereby improving safety of administration. The solubility is improved, and the absorption of the medicine in the animal body is facilitated, because the medicine in a dissolved state is easier to be absorbed through the biological film, thereby improving the overall curative effect of the medicine.
Further, the preparation method comprises the following steps:
a) Mixing tiamulin fumarate with a cosolvent to obtain a mixture A;
(b) Adding a filler, a stabilizer and a pH regulator into the mixture A, and uniformly mixing to obtain a mixture B;
(c) Crushing and screening the mixture B to obtain powder with uniform granularity;
(d) Drying the powder, and packaging to obtain tiamulin fumarate soluble powder.
Further, the mixing in the step a) is performed in a stirrer, the stirring speed is 50-100rpm, the mixing time is 10-30 minutes, and the uniform mixing between the tiamulin fumarate and the cosolvent can be ensured by using the stirrer for mixing, so that the quality consistency of the final product is ensured. Homogeneous mixing is important for both drug solubility and stability. In the pharmaceutical process, if insufficient mixing is carried out, layering or caking of materials can be caused, and the quality and curative effect of the medicine are affected. By controlling the stirring speed and time, this can be effectively avoided. During the stirring and mixing process, if the speed is too high, powder can fly, influence the production environment and cause material loss. The speed of 50-100rpm can ensure the mixing effect and reduce powder flying. Some pharmaceutical ingredients may decompose or deactivate under high speed agitation. Therefore, the selection of a suitable stirring speed and time is very important for protecting the stability and activity of the pharmaceutical ingredient. By optimizing the stirring speed and time, the production efficiency can be improved on the premise of ensuring the product quality. This is very beneficial for mass production.
Further, the mixing in the step b) is carried out by a three-dimensional mixer, and the mixing time is 20-40 minutes. The three-dimensional mixer is capable of mixing in three dimensions, i.e. adding vertical rotation and other directions of motion in addition to conventional horizontal rotation. The multi-dimensional movement mode can more efficiently realize uniform mixing of materials, and particularly for powdery materials, layering and caking phenomena can be effectively avoided. Due to the efficient mixing capability of the three-dimensional mixer, a desired mixing uniformity can be achieved in a shorter time than in conventional mixing devices. This helps to improve the production efficiency and reduce the production cycle time. The three-dimensional mixer ensures high-efficiency mixing, and meanwhile, the mild mixing acting force can reduce the damage to the medicine components and keep the stability and activity of the medicine. Three-dimensional mixers are often designed to facilitate cleaning and maintenance, which is important to maintain the sanitation of the production environment and to meet GMP (good manufacturing practice) requirements. By using a three-dimensional mixer, the uniform mixing uniformity of each batch of medicines can be ensured, thereby ensuring the consistency of the quality and the curative effect of the product
Further, the aseptic packaging in step d) is performed under a laminar flow ultra-clean bench to ensure sterility of the powder. Before aseptic packaging is performed, it is necessary to ensure that the ultra-clean bench has been sterilized by ultraviolet rays and that only the tools required for the operation at the time are placed on the bench surface, ensuring that the operator can pick up the objects in all directions at considerable distances without shielding. The operator must follow strict aseptic procedures in performing aseptic packaging, including wearing aseptic garments, using aseptic tools and containers. In the aseptic packaging process, the operation flow is strictly controlled, and any action possibly causing pollution is avoided. The quality of the product is proved: the aseptic package carried out on the ultra-clean workbench can effectively prevent microorganism and particle pollution, ensure the sterility and purity of the medicine, and further ensure that the quality of the product meets the standard. The aseptic package is helpful for protecting the medicine from external pollution, is particularly important for the medicine for injection, and can reduce the infection risk of patients in the use process. The production of sterile pharmaceuticals must comply with stringent regulatory requirements, and aseptic packaging is a critical step in meeting these requirements, helping the pharmaceutical to pass quality inspection and market supervision smoothly.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Claims (6)
1. The tiamulin fumarate soluble powder is characterized by comprising the following components:
a) Tiamulin fumarate;
b) A cosolvent;
c) A filler;
d) A stabilizer;
e) A pH regulator;
Wherein the cosolvent is selected from at least one of polyvinylpyrrolidone, beta-cyclodextrin and polyethylene glycol, the filler is microcrystalline cellulose or starch, the stabilizer is an antioxidant, and the pH regulator is selected from one or more of sodium bicarbonate, citric acid and phosphate buffer.
2. The tiamulin fumarate soluble powder according to claim 1, wherein the mass ratio of tiamulin fumarate to cosolvent is 1: (0.5-2), the mass ratio of tiamulin fumarate to the stabilizer is 1: (0.1-0.5).
3. The method for preparing tiamulin fumarate soluble powder according to claim 1, comprising the following steps:
(a) Mixing tiamulin fumarate with a cosolvent to obtain a mixture A;
(b) Adding a filler, a stabilizer and a pH regulator into the mixture A, and uniformly mixing to obtain a mixture B;
(c) Crushing and screening the mixture B to obtain powder with uniform granularity;
(d) Drying the powder, and packaging to obtain tiamulin fumarate soluble powder.
4. The method for preparing tiamulin fumarate soluble powder according to claim 3, wherein the mixing in the step a) is performed in a stirrer at a stirring speed of 50-100rpm for a mixing time of 10-30 minutes.
5. The method for preparing tiamulin fumarate soluble powder according to claim 3, wherein the mixing in the step b) is performed by using a three-dimensional mixer for 20-40 minutes.
6. A process for the preparation of tiamulin fumarate soluble powders according to claim 3, characterized in that the aseptic packaging in step d) is carried out under a laminar flow ultra-clean bench to ensure sterility of the powders.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410346325.9A CN118252802A (en) | 2024-03-26 | 2024-03-26 | Tiamulin fumarate soluble powder and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410346325.9A CN118252802A (en) | 2024-03-26 | 2024-03-26 | Tiamulin fumarate soluble powder and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN118252802A true CN118252802A (en) | 2024-06-28 |
Family
ID=91601766
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202410346325.9A Pending CN118252802A (en) | 2024-03-26 | 2024-03-26 | Tiamulin fumarate soluble powder and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN118252802A (en) |
-
2024
- 2024-03-26 CN CN202410346325.9A patent/CN118252802A/en active Pending
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP3583166B2 (en) | Powder preparation for damaged skin repair | |
| EP0258761B1 (en) | Wound-healing preparations | |
| CN101401787B (en) | Ceftiofur long-acting injection and preparation method thereof | |
| US9345779B2 (en) | Aqueous ophthalmic composition | |
| CN109044970A (en) | A kind of cefquinome sulfate injection and preparation method thereof | |
| CN102048748B (en) | Lincomycin and spectinomycin compound oil suspension injection and preparation method and application thereof | |
| CN105287607A (en) | Compound doxycycline-hydrochloride florfenicol sustained-release microsphere suspension injection for veterinary use | |
| JPH01153625A (en) | Preparation for treating animal | |
| CN118252802A (en) | Tiamulin fumarate soluble powder and preparation method thereof | |
| EP2819699B1 (en) | Controlled release compositions and their methods of use | |
| CN104800229A (en) | Compound sulfadiazine suspension and preparation method thereof | |
| CN115554253B (en) | Aripiprazole freeze-dried preparation for injection capable of stably releasing medicine and preparation method thereof | |
| EP2730292A1 (en) | Aqueous ophthalmic composition | |
| JPH0132210B2 (en) | ||
| US5120711A (en) | Synergistically active veterinary compositions and process for preparing same | |
| CN107789320B (en) | Fulvestrant sustained-release injection and preparation process thereof | |
| CN108403637A (en) | A kind of mouthspray preparation and preparation method thereof | |
| CN109431999B (en) | Nano self-microemulsion, veterinary drug nano self-microemulsion and preparation method and application thereof | |
| CN107126420A (en) | A kind of high-dissolution fenofibrate and preparation method thereof | |
| CN112957481A (en) | Insoluble drug inclusion compound, inclusion method and chlortetracycline hydrochloride soluble powder | |
| DK175335B1 (en) | A veterinary composition | |
| CN104706579A (en) | Fusidic acid eye drop and preparation method thereof | |
| DE69718541T2 (en) | Veterinary compositions with antibacterial agents for intramammary use | |
| JP2002505257A (en) | Fungicidal composition containing benzoylphenylurea | |
| CN102266326B (en) | Imipenem and cilastatin sodium pharmaceutical composition liposome injection |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication |