A kind of tedizolid phosphate powder injection for injection and preparation method thereof

Abstract

The present invention provides a tedizolid phosphate powder injection for injection and a preparation method thereof. In terms of mass percentage, the tedizolid phosphate powder injection for injection includes 45% to 55% of tedizolid phosphate, 22% to 35% of a filler, and 18% to 25% of a stabilizer; wherein the stabilizer is a composition of xylitol and glycine, and the mass ratio of xylitol to the glycine is 1: (5 to 10). The present invention uses a composite composition of xylitol and glycine as a stabilizer, combined with component optimization, so that the storage stability of the tedizolid phosphate powder injection for injection can be improved, thereby extending its shelf life. Furthermore, combined with a spray drying process, the moisture content is reduced, the particle fluidity is improved, the production time is shortened, the quality is improved, and the production cost is reduced, which is more conducive to large-scale commercial production.

Description

Technical Field

[0001] The invention belongs to the technical field of pharmaceutical preparation preparation, and particularly relates to a tedizolid phosphate powder injection for injection and a preparation method thereof. Background Art

[0002] The chemical name of tedizolid phosphate is (R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyloxazolidin-2-one phosphate, and its structural formula is as follows:

[0003]

[0004] Tedizolid phosphate is a new type of drug for antibacterial infection. During the development of Tedizolid phosphate for injection, it was found that the reference preparation Tedizolid phosphate injection (lyophilized powder injection) had relatively poor stability in long-term and accelerated stability tests, with high water content and impurities.

[0005] At present, the preparation method of tedizolid phosphate injection (lyophilized powder injection) is based on freeze drying process, such as patents CN112957333A, CN115245488A, CN114246832A, CN112826801B and CN102439006A, all record the preparation method of injection about tedizolid phosphate, and the tedizolid phosphate injection recorded in the above patents is the freeze dried powder injection prepared by freeze drying process. It is well known that freeze drying process is often faced with large required equipment investment, high energy consumption, high product cost, complex production process, long production time, and low output. And often face the production process water content in freeze drying process, the appearance is unqualified (the appearance is not full or shrinks into granules), the wall hanging phenomenon is prone to occur in the filling process, the powder moisture is unevenly dried in the sublimation drying process, and the spray bottle phenomenon and the process disadvantages of the product cold violent bottoming phenomenon are prone to occur during decompression.

[0006] Therefore, the production process of tedizolid phosphate for injection needs to be further developed and enriched and improved, so as to overcome the above-mentioned process shortcomings and reduce the preparation cost while improving product stability, so as to be more conducive to large-scale commercial production. Summary of the invention

[0007] The purpose of the present invention is to provide a tedizolid phosphate powder injection with better storage stability and higher quality.

[0008] Another object of the present invention is to provide a method for preparing the above-mentioned tedizolid phosphate powder injection, which has a simple process and high production efficiency.

[0009] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0010] A tedizolid phosphate powder for injection comprises, by mass percentage, 45% to 55% of tedizolid phosphate, 22% to 35% of a filler, and 18% to 25% of a stabilizer; wherein the stabilizer is a composition of xylitol and glycine, and the mass ratio of the xylitol to the glycine is 1:(5-10).

[0011] Preferably, the tedizolid phosphate powder for injection comprises 47% to 52% of tedizolid phosphate, 25% to 30% of filler, and 20% to 25% of stabilizer in terms of mass percentage.

[0012] Preferably, the mass ratio of the xylitol to the glycine is 1:(5.3-8).

[0013] More preferably, the mass ratio of the xylitol to the glycine is 1:(6-8).

[0014] Preferably, the filler is one or more of mannitol, trehalose and sorbitol.

[0015] According to some preferred embodiments, the filler is mannitol.

[0016] Preferably, the particle size D90 of the tedizolid phosphate powder for injection is 100-120 μm.

[0017] Preferably, the angle of repose of the tedizolid phosphate powder for injection is 25 to 35°.

[0018] Preferably, the Carle coefficient of the tedizolid phosphate powder for injection is 20% to 30%.

[0019] Preferably, the tedizolid phosphate powder for injection is prepared by spray drying.

[0020] At present, sterile powder for injection is often prepared by freeze drying process and aseptic filling technology. However, since the raw material of tedizolid phosphate is insoluble in water and its simple disodium salt is easily hygroscopic and unstable and the powder fluidity is poor, it is difficult to directly adopt aseptic filling technology for filling production. The present invention finds that the aseptic spray drying method can improve the fluidity of tedizolid phosphate sterile powder while ensuring the sterility of tedizolid phosphate, overcome the complexity of freeze drying process and the process disadvantages of freeze drying process itself, and can also reduce the moisture content, which has a certain positive effect on the stability of the product.

[0021] The present invention also provides a preparation method of the tedizolid phosphate powder injection, which comprises adding the tedizolid phosphate into water for injection, then slowly adding a sodium hydroxide solution to dissolve the tedizolid phosphate and adjusting the pH value to 7.5-8.0, adding the stabilizer and the filler to obtain a tedizolid phosphate mother solution, microfiltering the tedizolid phosphate mother solution and spray drying to obtain a tedizolid phosphate sterile powder for injection, and packaging the tedizolid phosphate powder for injection to obtain the tedizolid phosphate powder for injection.

[0022] Preferably, the amount of water for injection required for every 200 g of tedizolid phosphate is 1800-2000 mL.

[0023] Preferably, the pH of the prepared tedizolid phosphate solution is adjusted to a range of 7.6 to 7.8.

[0024] Preferably, hydrochloric acid and / or sodium hydroxide are used to adjust the pH value.

[0025] Preferably, the sterile tedizolid phosphate for injection powder is dispensed into vials by a screw dispenser.

[0026] According to some embodiments, the spray drying parameters are: inlet air temperature 120-160°C, outlet air temperature 80-110°C, inlet air frequency 32-40Hz, atomizer frequency 37-45Hz, tower pressure 0.15-0.30kPa, air delivery frequency 32-40Hz, and air delivery temperature 40-60°C.

[0027] Compared with the prior art, the present invention has the following advantages:

[0028] The present invention uses a composite composition of xylitol and glycine as a stabilizer and combines component optimization to improve the storage stability of the tedizolid phosphate powder for injection, thereby extending its shelf life. Furthermore, combined with a spray drying process, the moisture content is reduced, the particle fluidity is improved, the production time is shortened, the quality is improved, and the production cost is reduced, which is more conducive to large-scale commercial promotion and production. DETAILED DESCRIPTION

[0029] The present invention is further described below in conjunction with the examples. However, the present invention is not limited to the following examples. The implementation conditions used in the examples can be further adjusted according to the different requirements of specific use, and the implementation conditions not specified are conventional conditions in the industry. The technical features involved in each embodiment of the present invention can be combined with each other as long as they do not conflict with each other.

[0030] In order to further improve the storage stability of tedizolid phosphate powder for injection, extend its shelf life and improve its safety, the inventors have conducted a lot of research and experimental verification on the formula of tedizolid phosphate powder for injection, and developed a tedizolid phosphate powder for injection, which includes 45% to 55% of tedizolid phosphate, 22% to 35% of filler, and 18% to 25% of stabilizer, calculated by mass percentage; wherein the stabilizer is a combination of xylitol and glycine, and the mass ratio of xylitol to glycine is 1:(5 to 10).

[0031] Furthermore, in order to overcome the problems that the existing pure disodium tedizolid phosphate salt is easy to absorb moisture and is unstable and has poor powder fluidity, making it difficult to directly use aseptic packaging technology for packaging production, the current production efficiency of the corresponding freeze-dried preparations is low, and the product quality is uneven, and in order to further reduce the moisture content of the powder, the inventors proposed to use a spray drying process instead of a freeze drying process.

[0032] The tedizolid phosphate powder for injection of the present invention has the following advantages:

[0033] (1) By adding a stabilizer (a composition of xylitol and glycine in a ratio of 1:(5-10)), the storage stability of the drug is improved, the product quality is improved, and the safety during use is further ensured;

[0034] (2) The drug powder particle size D90 is 100-120 μm, which is uniform and loose, with appropriate particle size and significantly improved particle fluidity, and can be directly packaged and produced through aseptic packaging technology;

[0035] (3) The drug is dried and formed instantly (heating time is extremely short), which can further avoid the potential impact of long-term drying on product stability. In addition, the spray drying process is short in time, high in efficiency, and simple in process operation. Compared with the freeze drying (lyophilization) process, it greatly shortens the product production time, simplifies the production process operation flow, and improves production efficiency, which is conducive to achieving cost control and large-scale commercial production of the product.

[0036] (4) The aseptic spray drying process improves the drying efficiency and controls the moisture content of the drug below 1.5%, which is beneficial to improving the stability of the drug. At the same time, compared with the freeze-drying process for preparing drug powder, the drug powder is more dispersed and loose, which helps to shorten the dissolution time (redissolution time) of the drug before injection.

[0037] The technical scheme and technical effects of the present invention are further described below in conjunction with embodiments and comparative examples.

[0038] In the following examples and comparative examples, the raw materials, reagents, etc. used were all commercially available.

[0039] In the following examples and comparative examples, unless otherwise specified, "%" refers to mass percentage.

[0040] Example 1 (Prescription 1): Trial production batch of 1000 bottles (200 mg / bottle), the dosage of ingredients is shown in Table 1.

[0041] Table 1

[0042]

[0043] Preparation method:

[0044] (1) Preparation of feed solution: 200 g of tedizolid phosphate was added to 2000 mL of water for injection while stirring, 1.0 mol / L sodium hydroxide solution was added dropwise to dissolve it, and an appropriate amount of 0.1 ml / L hydrochloric acid solution was added dropwise to adjust the pH value to 7.7, and then 11 g of xylitol, 77 g of glycine and 112 g of mannitol were added in sequence, and stirring was continued until it was clear to obtain tedizolid phosphate mother solution. The whole batch of tedizolid phosphate mother solution was filtered through a 0.22 μm PES filter, and the filtrate was collected in a sterile collection bucket.

[0045] (2) Spray drying: Turn on the sterile spray dryer and set the parameters: inlet air temperature 140°C, outlet air temperature 95°C, inlet air frequency 38Hz, atomizer frequency 40Hz, tower pressure 0.25kPa, air delivery frequency 37Hz, and air delivery temperature 48°C. First spray water for injection until each parameter reaches the above control range. After the parameters are stable, switch to spraying and start spray drying the filtered tedizolid phosphate mother liquid to obtain tedizolid phosphate sterile powder. After the spraying is completed, switch to spraying water for injection and stop spraying after about 10 minutes. Collect the tedizolid phosphate sterile powder into a sterile aggregate barrel. The particle size of the tedizolid phosphate sterile powder D90 ≤ 115μm; the drying loss is 1.08%.

[0046] (3) Packaging:

[0047] Sterilization of vials, rubber stoppers and aluminum caps: After the vials are untangled, they are immersed in circulating water for ultrasonic initial washing. Then they are finely washed by alternating air and water backwashing. Cleaning parameters: bottle washing machine speed ≤ 25Hz, circulating water pressure ≥ 0.3Mpa, injection water pressure ≥ 0.4Mpa, injection water temperature 40-65℃, compressed air pressure ≥ 0.3Mpa, ultrasonic power ≥ 0.4kW. After washing, the vials are sterilized in a tunnel oven to remove endotoxins, and the tunnel oven belt speed is ≤ 220mm / min. Sterilization parameters: high temperature section 1: 270-300℃, high temperature section 2: 305-325℃, high temperature section 3: 285-305℃. After sterilization, the vials are used for subpackaging. The rubber stoppers are sucked into the rubber stopper cleaning machine by vacuum suction for strong spraying, slow tumbling stirring, fully automatic rough washing and fine washing until the visible foreign matter inspection is qualified. Cleaning parameters: Rough washing time 5-10min, injection water rinsing time 5-10min, injection water rinsing speed 2-5rpm, injection water fine washing speed 2-5rpm, injection water fine washing temperature 80℃, injection water fine washing time 20-30min. After washing, the rubber stopper is sterilized by wet heat (121℃, 30min), and then vacuum dried. The rubber stopper is packed into a double-layer sterile PE bag for standby use. The aluminum cap is sterilized by wet heat (121℃, 30min), and then vacuum dried. The aluminum cap is packed into a single-layer sterile PE bag for standby use.

[0048] Aseptic filling: Add sterile powder of tedizolid phosphate into the screw filling machine, use sterilized 20mL borosilicate molded vials and brominated coated butyl rubber stoppers, set the filling speed to 125rpm, adjust the filling amount to the specified range (≤±3.5%), control the nitrogen flow rate until the residual oxygen content is qualified (residual oxygen content ≤2.0%), test the machine until it is stable, and then fill and add stoppers. The filling amount should be monitored regularly during the filling process. Standard filling amount per bottle (g) = labeled amount of tedizolid phosphate / (tedizolid phosphate% × (1-water %)) (1+5%); filling amount control range: standard filling amount × (1±4.0%).

[0049] After packaging, the product is conveyed to the capping machine through a conveyor belt to add the aluminum-plastic composite cap and tighten it. The frequency of the main machine shall not exceed 30Hz, and the tightness and sealing of the capping shall be checked regularly.

[0050] Capping tightness: Check 3 times after starting the machine, rotate clockwise with three fingers, if it cannot turn, it is qualified. Capping tightness: 100% of the sealing is qualified.

[0051] Light inspection: The semi-finished products after capping are subjected to light inspection. The illumination of the light inspection operation surface is: 1000~2000lx, and unqualified semi-finished products are strictly selected.

[0052] Labeling: Check the product name, batch number, expiration date, etc. on the label, and affix the product label to each vial.

[0053] Packaging: Pack the product into boxes and cartons to obtain tedizolid phosphate powder for injection.

[0054] Example 2 (Prescription 2): Trial production batch of 1000 bottles (200 mg / bottle), ingredient dosage see Table 2.

[0055] Table 2

[0056]

[0057] Preparation method:

[0058] (1) Preparation of feed solution: 200 g of tedizolid phosphate was added to 2000 mL of water for injection while stirring, 1.0 mol / L sodium hydroxide solution was added dropwise to dissolve it, and an appropriate amount of 0.1 ml / L hydrochloric acid solution was added dropwise to adjust the pH value to 7.8, and then 15 g of xylitol, 80 g of glycine and 105 g of mannitol were added in sequence, and stirring was continued until it was clear to obtain tedizolid phosphate mother solution. The whole batch of tedizolid phosphate mother solution was filtered through a 0.22 μm PES filter, and the filtrate was collected in a sterile collection bucket.

[0059] (2) Spray drying: The operation of this step is basically the same as that of Example 1, except that the parameters are set as follows: air inlet temperature 143° C., air outlet temperature 98° C., air inlet frequency 36 Hz, atomizer frequency 42 Hz, tower pressure 0.27 kPa, air delivery frequency 36 Hz, and air delivery temperature 45° C. The obtained sterile tedizolid phosphate powder has a particle size D90 ≤ 109 μm and a drying loss of 1.05%.

[0060] (3) Packaging: This step is the same as in Example 1.

[0061] Example 3 (Prescription 3): Trial production batch of 1000 bottles (200 mg / bottle), ingredient dosage see Table 3.

[0062] Table 3

[0063]

[0064] Preparation method:

[0065] (1) Preparation of feed solution: 200 g of tedizolid phosphate was added to 2000 mL of water for injection while stirring, 1.0 mol / L sodium hydroxide solution was added dropwise to dissolve it, and an appropriate amount of 0.1 ml / L hydrochloric acid solution was added dropwise to adjust the pH value to 7.8, and then 14 g of xylitol, 70 g of glycine and 116 g of mannitol were added in sequence, and stirring was continued until it was clear to obtain tedizolid phosphate mother solution. The whole batch of tedizolid phosphate mother solution was filtered through a 0.22 μm PES filter, and the filtrate was collected in a sterile collection bucket.

[0066] (2) Spray drying: The operation of this step is basically the same as that of Example 1, except that the parameters are set as follows: air inlet temperature 138° C., air outlet temperature 93° C., air inlet frequency 35 Hz, atomizer frequency 39 Hz, tower pressure 0.28 kPa, air delivery frequency 37 Hz, and air delivery temperature 43° C. The obtained sterile tedizolid phosphate powder has a particle size D90 ≤ 118 μm and a drying loss of 1.17%.

[0067] (3) Packaging: This step is the same as in Example 1.

[0068] Comparative Example 1 (Prescription 4): Trial production batch of 1000 bottles (200 mg / bottle), ingredient dosage see Table 4.

[0069] Table 4

[0070]

[0071] Preparation method:

[0072] (1) Preparation of feed solution: Add 200 g of tedizolid phosphate to 2000 mL of water for injection while stirring, add 1.0 mol / L sodium hydroxide solution dropwise to dissolve it, and simultaneously add an appropriate amount of 0.1 ml / L hydrochloric acid solution dropwise to adjust the pH value to 7.75, then add 100 g of mannitol while stirring, and continue stirring until it becomes clear. Filter the entire batch of tedizolid phosphate feed solution through a 0.22 μm PES filter, and collect the filtrate into a sterile collection bucket.

[0073] (2) Filling and stoppering: Under sterile conditions, a filling machine is used to fill the target amount of solution (overfilling is about 5%) into a 20 mL vial and half-stopper is completed.

[0074] (3) Freeze drying: Use a freeze dryer to perform freeze drying and complete the nitrogen filling and plugging process.

[0075] (4) Capping: After freeze-drying, the product is conveyed to the capping machine through a conveyor belt and covered with an aluminum-plastic composite cap, which is then rolled tightly. The frequency of the main machine shall not exceed 30 Hz, and the tightness and sealing of the capping shall be checked regularly.

[0076] Comparative Example 2 (Prescription 5): A trial batch of 1000 bottles (200 mg / bottle) was prepared, and the dosage of the ingredients was the same as that of Comparative Example 1.

[0077] Preparation method:

[0078] (1) Preparation of feed liquid: 200 g of tedizolid phosphate was added to 2000 mL of water for injection while stirring, 1.0 mol / L sodium hydroxide solution was added dropwise to dissolve it, and an appropriate amount of 0.1 ml / L hydrochloric acid solution was added dropwise to adjust the pH value to 7.8, and then 100 g of mannitol was added while stirring, and stirring was continued until it was clear to obtain tedizolid phosphate feed liquid. The entire batch of tedizolid phosphate feed liquid was filtered through a 0.22 μm PES filter, and the filtrate was collected in a sterile collection barrel.

[0079] (2) Spray drying: The operation of this step is basically the same as that of Example 1.

[0080] (3) Packaging: This step is the same as in Example 1.

[0081] Comparative Example 3 (Prescription 6): Trial production batch of 1000 bottles (200 mg / bottle), ingredient dosage see Table 5.

[0082] Table 5

[0083]

[0084]

[0085] Preparation method:

[0086] (1) Preparation of liquid: 200 g of tedizolid phosphate was added to 2000 mL of water for injection while stirring, 1.0 mol / L sodium hydroxide solution was added dropwise to dissolve it, and an appropriate amount of 0.1 ml / L hydrochloric acid solution was added dropwise to adjust the pH value to 7.7, 10 g of sucrose, 70 g of lysine and 120 g of mannitol were added in sequence, and stirring was continued until the solution was clear to obtain tedizolid phosphate mother solution.

[0087] The whole batch of tedizolid phosphate mother liquor was filtered through a 0.22 μm PES filter, and the filtrate was collected in a sterile collection bucket.

[0088] (2) Spray drying: This step is carried out in the same manner as in Example 1.

[0089] (3) Packaging: This step is the same as in Example 1.

[0090] A quality comparison study was conducted between the tedizolid phosphate powder for injection of the above-mentioned examples and comparative examples and the original commercially available tedizolid phosphate lyophilized powder for injection (specification: 200 mg; trade name: Sivextro; batch number: 19TE2; manufacturer: Patheon Italia SpA).

[0091] The distribution of particle size and powder properties is shown in Table 6. The long-term stability test was carried out at 25°C, and samples were taken for inspection on day 0, the third month, and the sixth month, respectively. The key quality indicators were tested, and the properties, related substances, and content and other test items were examined. The detailed results are shown in Table 7. The high-temperature test was carried out at 60°C, and samples were taken for inspection on day 0, the fifth day, and the tenth day, respectively. The key quality indicators were tested, and the properties, related substances, and content and other test items were examined, respectively. The detailed results are shown in Table 8.

[0092] Table 6

[0093]

[0094] As shown in Table 6, the tedizolid phosphate powder produced by the aseptic spray drying process has an appropriate particle size and significantly improved fluidity, and can be directly aseptically packaged; in addition, compared with the lyophilized preparation (Comparative Example 1 / Sivextro), the particles are more dispersed and loose, which is conducive to the rapid dissolution of the sterile powder before injection.

[0095] Table 7

[0096]

[0097]

[0098] Table 8 (Accelerated stability test)

[0099]

[0100]

[0101] The appearance was determined by visual inspection; the alkalinity test was based on the general rules of the fourth part of the Chinese Pharmacopoeia 2020 edition 0631; the loss on drying test was based on the general rules of the fourth part of the Chinese Pharmacopoeia 2020 edition 0661; the content test was based on HPLC, and the 17 H 16 FN6O6P) should be 95.0%-105.0% of the labeled amount; the total impurities were detected by HPLC; in addition, insoluble particles, bacterial endotoxins and sterility were also tested, referring to the General Rules of Part Four of the Chinese Pharmacopoeia 2020 Edition 0903, 1143 and 1101, respectively. Since they all met the requirements and there was basically no difference, they were not recorded in Tables 7 and 8.

[0102] Table 7 shows that after being stored at 25° C. for 6 months, the impurity content of the tedizolid phosphate for injection of the embodiment is lower than that of the comparative example and Sivextro, and the use of aseptic spray drying technology to trial-produce samples can significantly reduce the moisture control level of the product (to control the moisture content below 1.5%).

[0103] Since the shelf life of lyophilized injection is usually 1 to 3 years, in order to reasonably anticipate the long-term stability or shelf life of lyophilized injection, accelerated stability tests are usually carried out. The lower the increase in impurity content under more severe temperature conditions, the better the stability and longer the shelf life can be directly inferred. In this paper, 60 ° C was used for accelerated stability experiments. The results are shown in Table 8. The addition of a composition of xylitol and glycine as a stabilizer slowed down the growth of related substances in the product, thereby significantly improving the stability of the product and improving the safety of the product. If a composition of sucrose and lysine is added as a stabilizer, the effect of improving product stability is weakened. Furthermore, when the mass ratio of xylitol and glycine is not appropriate, the effect of improving product stability is also weakened. When the composition of xylitol and glycine is adjusted to a composition of sucrose and lysine, the growth of related substances is accelerated and the product stability is relatively reduced. In addition, under the premise that the product prescription remains consistent, the sample product produced by aseptic spray drying technology has lower moisture content, which helps to improve product stability to a certain extent.

[0104] The above detailed description of the present invention is intended to enable persons familiar with the art to understand the contents of the present invention and implement them. It does not limit the protection scope of the present invention. Any equivalent changes or modifications made according to the spirit of the present invention should be included in the protection scope of the present invention.

Claims

1. A tedizolid phosphate powder for injection, characterized in that: Calculated by mass percentage, the tedizolid phosphate powder for injection comprises 45% to 55% of tedizolid phosphate, 22% to 35% of a filler, and 18% to 25% of a stabilizer; Wherein, the stabilizer is a combination of xylitol and glycine, and the mass ratio of the xylitol to the glycine is 1:(5-10), The tedizolid phosphate powder for injection is prepared by spray drying.

2. The tedizolid phosphate powder for injection according to claim 1, characterized in that: Calculated by mass percentage, the tedizolid phosphate powder for injection includes 47% to 52% of tedizolid phosphate, 25% to 30% of a filler, and 20% to 25% of a stabilizer.

3. The tedizolid phosphate powder for injection according to claim 1, characterized in that: The mass ratio of the xylitol to the glycine is 1:(5.3-8).

4. The tedizolid phosphate powder for injection according to claim 1, characterized in that: The filler is one or more of mannitol, trehalose and sorbitol.

5. The tedizolid phosphate powder for injection according to claim 1, characterized in that: The particle size D90 of the tedizolid phosphate powder for injection is 100-120 μm; and / or the angle of repose of the tedizolid phosphate powder for injection is 25-35°; and / or the Carr coefficient of the tedizolid phosphate powder for injection is 20%-30%.

6. The method for preparing the tedizolid phosphate powder for injection according to any one of claims 1 to 5, characterized in that: The tedizolid phosphate is added to water for injection while stirring, sodium hydroxide solution is slowly added to dissolve the tedizolid phosphate, the pH value is adjusted to 7.5-8.0, the stabilizer and the filler are added to obtain a tedizolid phosphate mother solution, the tedizolid phosphate mother solution is microfiltered and spray-dried to obtain a sterile tedizolid phosphate powder for injection, and the tedizolid phosphate powder for injection is obtained by subpackaging.

7. The preparation method according to claim 6, characterized in that: The amount of water for injection required for every 200 g of tedizolid phosphate is 1800-2200 mL; and / or, the sterile tedizolid phosphate for injection powder is dispensed into vials by a screw dispenser.

8. The preparation method according to claim 6, characterized in that: The pH is adjusted with hydrochloric acid and / or sodium hydroxide.

9. The preparation method according to claim 6, characterized in that: The spray drying parameters are: inlet air temperature 120~160℃, outlet air temperature 80~110℃, inlet air frequency 32~40Hz, atomizer frequency 37~45Hz, tower pressure 0.15~0.30kPa, air delivery frequency 32~40Hz, and air delivery temperature 40~60℃.

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