CN115998686A - Preparation method of tylosin tartrate soluble powder - Google Patents

Preparation method of tylosin tartrate soluble powder Download PDF

Info

Publication number
CN115998686A
CN115998686A CN202111235468.5A CN202111235468A CN115998686A CN 115998686 A CN115998686 A CN 115998686A CN 202111235468 A CN202111235468 A CN 202111235468A CN 115998686 A CN115998686 A CN 115998686A
Authority
CN
China
Prior art keywords
tylosin tartrate
preparation
soluble powder
tartrate
tylosin
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
Application number
CN202111235468.5A
Other languages
Chinese (zh)
Inventor
李阳
李新
逯荷香
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Luoyang Ruihua Animal Health Products Co ltd
Original Assignee
Luoyang Ruihua Animal Health Products Co ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Luoyang Ruihua Animal Health Products Co ltd filed Critical Luoyang Ruihua Animal Health Products Co ltd
Priority to CN202111235468.5A priority Critical patent/CN115998686A/en
Publication of CN115998686A publication Critical patent/CN115998686A/en
Pending legal-status Critical Current

Links

Landscapes

  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention provides a preparation method of tylosin tartrate soluble powder. The preparation comprises the following components: 10-20% of tavancomycin tartrate, 2.5-5% of yellow dextrin, 5-10% of disodium ethylenediamine tetraacetate, 5-10% of acidulant and 5-10% of acacia, and the auxiliary material is anhydrous glucose. The method is prepared through the working procedures of liquid preparation, high-speed shearing and spray drying. The preparation prepared by the method has the advantages of high solubility of about 6.5 ten thousand PPM, good solution clarity, good aqueous solution stability and the like.

Description

Preparation method of tylosin tartrate soluble powder
Technical Field
The invention belongs to the field of veterinary medicines in the field of biological medicine, and in particular relates to a preparation method of tylosin tartrate soluble powder.
Background
The tylosin tartrate is a new generation of macrolide antibiotics, is the antibiotic with the strongest activity of killing mycoplasma at present, and the metabolite of the tylosin tartrate has very strong killing activity on pathogens such as mycoplasma pneumoniae and the like, and can activate macrophages of organisms, so that the number of the macrophages is increased, the phagocytic function is enhanced, the secretion of lysozyme is promoted, and the nonspecific immune function of the organisms is enhanced.
The tylosin tartrate is dissolved in water, and the water solubility of the tylosin tartrate is measured to be about 50000ppm according to the source of the raw materials. In clinical application, because the tylosin tartrate is a raw material obtained through biological fermentation, floccules can appear in a high-concentration aqueous solution of the preparation, and the preparation can be thoroughly dissolved by long-time stirring. The most common mode of administration in large-scale farms is administration through drinking water, and the floccules of the preparation can block the waterline and the drinking water head, so that the clinical application of the product is greatly limited.
Therefore, we consider to find a method which has good water solubility and can eliminate floc of the teicoplanin soluble powder in the aqueous solution so as to solve the problem that the water path is easy to block in clinical use.
In the research process, we find that adding yellow dextrin with a certain proportion can increase the water solubility of the tylosin tartrate, the water solution of the tylosin tartrate at the acidic pH is more stable, and adding disodium edetate enables the tylosin tartrate to form chelate, so that floccules formed in water can be completely eliminated. The acacia can play a role in thickening to ensure the uniformity of materials in the processing process and the uniformity of aqueous solutions in the clinical use process, and can play a certain role in protecting in the spray drying process.
Disclosure of Invention
The invention adopts the following technical scheme:
the invention aims to provide a preparation method of tylosin tartrate soluble powder. The composite material comprises the following components in parts by weight: 10-20% of tavancomycin tartrate, 2.5-5% of yellow dextrin, 5-10% of disodium ethylenediamine tetraacetate, 5-10% of acidulant, 5-10% of acacia and anhydrous glucose.
The invention provides a preparation method of tylosin tartrate soluble powder, wherein the acidulant is aspartic acid or glutamic acid.
The ratio of the telavancin tartrate to the yellow dextrin is 1:0.25
The ratio of the telavancin tartrate to the disodium ethylenediamine tetraacetate is 1:0.5
The ratio of the telavancin tartrate to the acidulant is 1:0.5
The ratio of the telavancin tartrate to the Arabic gum is 1:0.5
The preparation method of the tylosin tartrate soluble powder comprises the following steps:
step 1: mixing telavancin tartrate, yellow dextrin and EDTA-2NA, dissolving in water, adding acidulant, and stirring.
Step 2: adding water into acacia to prepare a mucilage solution for standby.
Step 3: and (3) mixing the solutions obtained in the step (1) and the step (2), uniformly stirring, and adding a proper amount of anhydrous glucose to form uniform suspension liquid.
Step 4: and (3) placing the suspension liquid in the step (3) into a high-speed shearing emulsifying pot, and shearing for later use.
Step 5: and (5) spray drying the liquid obtained in the step (4), and subpackaging with aluminum foil bags.
The preparation method of the tylosin tartrate soluble powder provided by the invention has the advantages that the prepared tylosin tartrate soluble powder has good water solubility and can not generate floccules. The amino acid can be used as an acidulant and can play a role in buffering in aqueous solution so that the aqueous solution of the preparation is more stable, and the amino acid can also provide necessary nutrients for animals.
Detailed Description
The advantages and features of the present invention will become more apparent from the following description of the embodiments. These examples are merely exemplary and do not limit the scope of the invention in any way. It will be understood by those skilled in the art that various changes and substitutions of details and forms of the technical solution of the present invention may be made without departing from the spirit and scope of the present invention, but these changes and substitutions fall within the scope of the present invention.
Example 1: the method for preparing the tylosin tartrate soluble powder
Step 1: taking 20g of telavancin tartrate (calculated by a dry product), 5g of yellow dextrin and 10g of EDTA-2NA, primarily mixing, adding 200ml of water to dissolve, adding 10g of aspartic acid after dissolving, and uniformly stirring to completely dissolve for standby.
Step 2: 10g of Arabic gum is taken, 30ml of water is added to stir the mucilage solution uniformly for standby.
Step 3: mixing the solutions obtained in the step 1 and the step 2, uniformly stirring, adding 36g of anhydrous glucose, and stirring to form uniform suspension liquid.
Step 4: and (3) placing the suspension liquid obtained in the step (3) into a high-speed shearing emulsifying pot, and shearing for 20 minutes at the temperature of 45 ℃.
Step 5: and (3) spray drying the liquid obtained in the step (4), setting the drying stability at 170 ℃, setting the pressure of a high-pressure pump at 16-20mpa, collecting the powder after spray drying, and sub-packaging and sealing the powder by using an aluminum foil bag to obtain the sample 1.
Example 2: tewanocin tartrate soluble powder prepared by common method
Taking 20g (calculated as a dry product) of telavancin tartrate, adding anhydrous glucose to 100g, crushing, uniformly mixing, and then filling in an aluminum foil bag to obtain a sample 2.
Example 3: teleomycin tartrate soluble powder prepared by adding common acidulant
Taking 20g of telavancin tartrate (calculated as a dry product) and 10g of tartaric acid, adding anhydrous glucose to 100g, crushing and uniformly mixing, and then filling the mixture in an aluminum foil bag to obtain a sample 3.
Example 4: teleomycin tartrate soluble powder prepared by adding common acidulant and disodium ethylenediamine tetraacetate
Taking 20g of telavancin tartrate (calculated as a dry product) and 10g of tartaric acid, adding 10g of EDTA-2NA into 100g of anhydrous glucose, crushing and uniformly mixing, and then filling the mixture into an aluminum foil bag to obtain the sample 4.
Example 5:
20g of each was taken and 100ml of water was added thereto, followed by stirring for 1 minute to observe the water solubility.
Figure BDA0003317539100000031
/>
Figure BDA0003317539100000041
The experiment shows that the water solubility of the tylosin tartrate soluble powder prepared by the method is better than that of the tylosin tartrate soluble powder prepared by the common method, the aqueous solution of the tylosin tartrate soluble powder is more stable when the aspartic acid is used as an acidulant in terms of stability, the phenomenon of product floccules in the aqueous solution can be completely eliminated when the disodium edetate is used, and no preparation of the disodium edetate needs to be placed for a long time to eliminate the floccules.
Example 6:
taking 20g of the tavancomycin tartrate raw material and 5g of yellow dextrin, and uniformly mixing for later use. As sample 1.
Taking 20g of the tavancomycin tartrate raw material for standby. As sample 2.
Slowly adding the above two materials into 100ml water, stirring while adding until insoluble substances appear, and recording the addition amount.
Figure BDA0003317539100000042
Figure BDA0003317539100000051
Through experiments, the solubility and the water solubility of the tylosin tartrate added with the yellow dextrin are superior to those of the common tylosin tartrate.

Claims (6)

1. A method for preparing a tylosin tartrate soluble powder, wherein the veterinary formulation comprises: 10-20% of tavancomycin tartrate, 2.5-5% of yellow dextrin, 5-10% of disodium ethylenediamine tetraacetate, 5-10% of acidulant and 5-10% of acacia.
2. The method for preparing the tylosin tartrate soluble powder according to claim 1, wherein the acidulant is aspartic acid, and the use ratio of the acidulant to the tylosin tartrate is 0.5:1.
3. The method for preparing the tylosin tartrate soluble powder according to claim 1, wherein the use ratio of the tylosin tartrate to the yellow dextrin is 1:0.25.
4. The method for preparing the tylosin tartrate soluble powder according to claim 1, wherein the use ratio of the tylosin tartrate to the disodium edetate is 1:1.
5. The method for preparing the tylosin tartrate soluble powder according to claim 1, wherein the use ratio of the tylosin tartrate to the acacia is 1:1.
6. The preparation method of the tylosin tartrate soluble powder comprises the following main process steps and process parameters:
the preparation uses a high-speed shearing emulsification process, wherein the temperature of the intermediate liquid medicine is not more than 45 ℃ in the preparation process, and the shearing time is 20 minutes.
The preparation is prepared by spray drying process, wherein the drying stability is 170deg.C, and the high pressure pump pressure is 16-20mpa.
CN202111235468.5A 2021-10-22 2021-10-22 Preparation method of tylosin tartrate soluble powder Pending CN115998686A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202111235468.5A CN115998686A (en) 2021-10-22 2021-10-22 Preparation method of tylosin tartrate soluble powder

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202111235468.5A CN115998686A (en) 2021-10-22 2021-10-22 Preparation method of tylosin tartrate soluble powder

Publications (1)

Publication Number Publication Date
CN115998686A true CN115998686A (en) 2023-04-25

Family

ID=86027238

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202111235468.5A Pending CN115998686A (en) 2021-10-22 2021-10-22 Preparation method of tylosin tartrate soluble powder

Country Status (1)

Country Link
CN (1) CN115998686A (en)

Similar Documents

Publication Publication Date Title
CN101869188B (en) Preparation method of nosiheptide premix
CN106995502B (en) Bifunctional group modified chitosan derivative and preparation method thereof
JP2023027088A (en) Process for making pullulan
CN102133199A (en) Doxofylline lyophilized preparation for injection and preparation method thereof
CN104857517A (en) Enzalutamide soft capsule and preparation method thereof
CN104721155A (en) Temozolomide lyophilized powder preparation and preparation method thereof
CN113603797B (en) Amino nano-cellulose and preparation method thereof
EP3505156B1 (en) Manufacturing process of cyclosporin eye gel
CN108410928B (en) Preparation method and application of high-concentration small-molecule hyaluronic acid
CN115998686A (en) Preparation method of tylosin tartrate soluble powder
CN110464846A (en) A kind of Meloxicam composition, preparation and the preparation method and application thereof
CN102617643B (en) Riboflavin sodium phosphate compound
CN106467561A (en) A kind of sharp separation, the method for purification Radix Ginseng arginine glycoside
CN109646410A (en) Stable azacitidine lyophilized preparation and preparation method thereof
CN107137360A (en) A kind of injection azacitidine lyophilized formulations
CN105622778A (en) Preparation method of water-soluble chitosan
CN110279658A (en) A kind of oxytocin injection and preparation method thereof
CN102429828B (en) Coenzyme Q10 microcapsule and preparation method and application thereof
CN101822822A (en) Drug composition of pramlintide and preparation method thereof
CN108078931A (en) A kind of bendamustine hydrochloride freeze-dried powder pin and preparation method thereof
CN108743548B (en) Cefprozil granules and preparation method thereof
JPS6363388A (en) Production of low molecular weight chitosan
CN107595769A (en) A kind of preparation method of Fondaparinux sodium injecta composition
CN113952308A (en) Albendazole granules and preparation method thereof
CN109431996B (en) Minoxidil-containing external preparation composition and preparation method thereof

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination