A lincomycin spectinomycin soluble powder and its preparation method and application

Abstract

The present application relates to the technical field of drugs, and specifically discloses a lincomycin spectinomycin soluble powder and its preparation method and application. The lincomycin spectinomycin soluble powder disclosed in the present application includes component A and component B; the component A includes: 30-50 parts of lincomycin hydrochloride, 20-30 parts of hydroxypropyl beta-cyclodextrin, 20-30 parts of sucrose monohydrate, 10-20 parts of cosolvents, and 10-20 parts of solubilizers; the component B includes: 40-50 parts of spectinomycin hydrochloride, 10-20 parts of hydroxypropyl beta-cyclodextrin, 10-20 parts of sucrose monohydrate, 10-20 parts of cosolvents, and 10-20 parts of solubilizers. The present application also discloses the preparation method and application of the above-mentioned powder. The soluble powder provided in the present application has a stable pH value and osmotic pressure when used in combination with Marek's vaccine, and the vaccine titer does not decrease; and it can be dissolved in water and oil, and can be used in combination with a variety of oily vaccines without affecting the vaccine titer.

Description

Technical Field

[0001] The present application relates to the technical field of drugs, and in particular to a lincomycin-spectinomycin soluble powder and a preparation method and application thereof. Background Art

[0002] Lincomycin hydrochloride and spectinomycin hydrochloride have a synergistic effect, a broad antibacterial spectrum, rapid action, low toxicity, and good efficacy for piglet diarrhea, mycoplasma pneumonia in pigs, and diseases caused by Mycoplasma synoviae and Mycoplasma gallisepticum. There are many existing lincomycin and spectinomycin compound formulations, but the compound preparations are only soluble in water, not in oil, and cannot be used in combination with oily vaccines, which greatly limits their specific applications.

[0003] Marek's disease (MD) is a highly contagious, highly pathogenic, lymphoproliferative viral tumor disease caused by infection of chickens with pathogenic Marek's disease virus. This disease is widespread around the world. Currently, Marek's disease is mainly prevented by Marek's vaccine, but Marek's vaccine is sensitive to pH value and is easily affected when used in combination with other drugs (mostly acidic, a few alkaline). Currently, it can only be used in combination with cephalosporin antibiotics, but cephalosporin antibiotics are ineffective against mycoplasma, which also limits the effectiveness and promotion of the combination with Marek's vaccine. Summary of the invention

[0004] In order to ensure that lincomycin hydrochloride, spectinomycin hydrochloride and Marek's vaccine are used in combination without affecting the vaccine potency and can be used in combination with oily vaccines, the present application provides a lincomycin and spectinomycin soluble powder and a preparation method and application thereof.

[0005] In a first aspect, the present application provides a lincomycin spectinomycin soluble powder, comprising component A and component B; the component A comprises the following ingredients in parts by weight: 30-50 parts of lincomycin hydrochloride, 20-30 parts of hydroxypropyl β-cyclodextrin, 20-30 parts of sucrose monohydrate, 10-20 parts of cosolvent, and 10-20 parts of solubilizer;

[0006] The component B comprises the following ingredients in parts by weight: 40-50 parts of spectinomycin hydrochloride, 10-20 parts of hydroxypropyl beta-cyclodextrin, 10-20 parts of sucrose monohydrate, 10-20 parts of cosolvent, and 10-20 parts of solubilizer.

[0007] The soluble powder provided in the present application has a stable pH value and osmotic pressure when used in combination with Marek's vaccine, and the vaccine potency is not reduced; and it can be dissolved in water and oil, and does not affect the vaccine potency when used in combination with a variety of oily vaccines.

[0008] Hydroxypropyl β-cyclodextrin is easily soluble in water, has good fluidity, and low viscosity, which can improve the solubility of drugs; it can also increase drug stability and improve drug bioavailability; after hydroxypropyl β-cyclodextrin is encapsulated with drugs, the drugs enter the cavities, which can prevent the volatilization, sublimation, oxidation, and light decomposition of drugs, avoid the influence of other factors, and improve the quality of drugs. Sucrose monohydrate can reduce surface tension, emulsify, moisten, solubilize, moisten, disperse, suspend, adjust viscosity, control crystallization, defoam or foam, starch anti-aging, antibacterial preservation, etc. This application uses these two raw materials as auxiliary ingredients of lincomycin and spectinomycin soluble powders, which have stable pH and osmotic pressure when used in combination with Marek's vaccine, so that the potency of Marek's vaccine does not decrease; and it can be dissolved in water and oil, and will not affect the potency of the vaccine when used in combination with a variety of oily vaccines.

[0009] Preferably, the component A comprises the following ingredients in parts by weight: 30-40 parts of lincomycin hydrochloride, 20-25 parts of hydroxypropyl β-cyclodextrin, 25-30 parts of sucrose monohydrate, 10-15 parts of cosolvent, and 15-20 parts of solubilizer.

[0010] Preferably, the B component comprises the following ingredients in parts by weight: 45-50 parts of spectinomycin hydrochloride, 15-20 parts of hydroxypropyl β-cyclodextrin, 10-15 parts of sucrose monohydrate, 15-20 parts of cosolvent, and 10-15 parts of solubilizer.

[0011] Preferably, in the component A and the component B, the co-solvent is selected from any one or more of sucrose, sodium benzoate and sodium salicylate.

[0012] Furthermore, in the component A, the co-solvent is composed of sucrose and sodium benzoate in a weight ratio of (11-15):(3-7).

[0013] In a specific embodiment, in the component A, the weight ratio of sucrose to sodium benzoate can be 11:3, 11:5, 11:7, 13:3, 13:5, 13:7, 15:3, 15:5, or 15:7.

[0014] In some specific embodiments, in the A component, the weight ratio of sucrose to sodium benzoate can also be (11-13):3, (11-13):5, (11-13):7, (13-15):3, (13-15):5, (13-15):7, 15:(3-5), 15:(3-7), 15:(5-7).

[0015] Through experimental analysis, it can be known that the present application uses sucrose and sodium benzoate in the above weight ratio as the co-solvent of component A, which can further improve the performance of the combined use of lincomycin and spectinomycin soluble powders and vaccines.

[0016] Furthermore, in the B component, the co-solvent is composed of sucrose and sodium salicylate in a weight ratio of (0.5-2.5):(15-19).

[0017] In a specific embodiment, in the component B, the weight ratio of sucrose to sodium salicylate can be 0.5:15, 0.5:17, 0.5:19, 1.5:15, 1.5:17, 1.5:19, 2.5:15, 2.5:17, 2.5:19.

[0018] In some specific embodiments, in the component B, the weight ratio of sucrose and sodium salicylate can also be (0.5-1.5):15, (0.5-1.5):17, (0.5-1.5):19, (1.5-2.5):15, (1.5-2.5):17, (1.5-2.5):19, 2.5:(15-17), 2.5:(17-19), 2.5:(15-19).

[0019] Through experimental analysis, it can be known that the present application uses sucrose and sodium salicylate in the above weight ratio as the co-solvent of component B, which can further improve the performance of the combined use of lincomycin and spectinomycin soluble powders and vaccines.

[0020] Preferably, it is characterized in that, in the component A and the component B, the solubilizing agent is selected from any one or more of Tween 20 and Tween 40.

[0021] On the other hand, the present application provides a method for preparing the above-mentioned lincomycin spectinomycin soluble powder, which specifically comprises the following steps:

[0022] By weight, 30-50 parts of lincomycin hydrochloride are dissolved in 10-30 parts of water, and then 20-30 parts of hydroxypropyl β-cyclodextrin, 20-30 parts of sucrose monohydrate, 10-20 parts of cosolvent A, and 10-20 parts of solubilizer A are added respectively, and the mixture is stirred evenly. After complete emulsification, a pH adjuster is added to adjust the pH value to 6.9-7.0, and the mixture is dried and crushed to obtain component A;

[0023] By weight, 40-50 parts of spectinomycin hydrochloride are dissolved in 10-30 parts of water, and then 10-20 parts of hydroxypropyl β-cyclodextrin, 10-20 parts of sucrose monohydrate, 10-20 parts of cosolvent B and 10-20 parts of solubilizer B are added respectively, and the mixture is fully stirred and emulsified, and then a pH adjuster is added to adjust the pH value to 6.9-7.0. The mixture is vacuum dried and crushed to obtain component B.

[0024] Preferably, the process parameters of the vacuum drying are: temperature of 50-70° C. and time of 3-5 h.

[0025] In a specific embodiment, the temperature may be 50°C, 60°C, or 70°C.

[0026] In some specific embodiments, the temperature may also be 50-60°C or 60-70°C.

[0027] In a third aspect, the present application provides a pharmaceutical composition, comprising any one of an antibacterial drug, an antifungal drug, an anti-pathogenic infection drug, and a vaccine; and the above-mentioned lincomycin and spectinomycin soluble powder.

[0028] In summary, the technical solution of this application has the following effects:

[0029] The lincomycin and spectinomycin soluble powder provided in the present application has a stable pH value and osmotic pressure when used in combination with Marek's vaccine, and the vaccine potency is not reduced; and it can be dissolved in water and oil, and does not affect the vaccine potency when used in combination with a variety of oily vaccines.

[0030] The present application further improves the applicability of lincomycin and spectinomycin soluble powder in vaccines by appropriately screening the cosolvents in components A and B. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 This is the pH value test result when the lincomycin and spectinomycin soluble powders are used in combination with the Marek's vaccine diluent in Example 1. DETAILED DESCRIPTION

[0032] The present application is further described in detail below in conjunction with examples, comparative examples and performance testing experiments. These examples should not be construed as limiting the scope of protection claimed in the present application.

[0033] Example

[0034] Examples 1-5

[0035] Examples 1-5 provide a lincomycin and spectinomycin soluble powder respectively.

[0036] The difference between the above embodiments is that the dosage of each component is different, as shown in Table 1.

[0037] According to the raw materials of component A in Table 1, weigh the raw materials of corresponding weight respectively, dissolve lincomycin hydrochloride with 20g water, add hydroxypropyl β-cyclodextrin, sucrose monohydrate, cosolvent (composed of sucrose and sodium benzoate with a weight ratio of 13:5), and solubilizer Tween 20 respectively, stir well and evenly, and after complete emulsification, add pH regulator phosphate buffer solution to adjust the pH value to 6.9-7.0, vacuum dry at 60°C for 4h, and then use a jet jet mill to ultrafine grind to 400-500 mesh for standby use to obtain component A;

[0038] According to the raw materials of component B in Table 1, weigh the raw materials of corresponding weight respectively, dissolve spectinomycin hydrochloride with 20g water, add hydroxypropyl β-cyclodextrin, sucrose monohydrate, cosolvent (composed of sucrose and sodium salicylate with a weight ratio of 1.5:17), and solubilizer Tween 40 respectively, stir well and evenly, and after complete emulsification, add pH regulator phosphate buffer solution to adjust the pH value to 6.9-7.0, vacuum dry at 60°C for 4h, and then use a jet jet mill to ultrafine grind to 400-500 mesh for standby use to obtain component B;

[0039] The components A and B are uniformly mixed to obtain lincomycin and spectinomycin soluble powder.

[0040] Table 1 The amount of each component in Examples 1-5 and Comparative Examples 1-2

[0041]

[0042] Embodiment 6-11

[0043] Examples 6-11 provide a lincomycin and spectinomycin soluble powder respectively.

[0044] The difference between the above embodiment and embodiment 1 is that the type of the co-solvent in component A is different, as shown below.

[0045] In Example 6: the cosolvent in component A is sucrose.

[0046] In Example 7: the cosolvent in component A is sodium salicylate.

[0047] In Example 8: the co-solvent in component A is composed of sucrose and sodium salicylate in a weight ratio of 13:5.

[0048] In Example 9: the co-solvent in component A is composed of sucrose and sodium benzoate in a weight ratio of 17:3.

[0049] In Example 10: the co-solvent in component A is composed of sucrose and sodium benzoate in a weight ratio of 11:7.

[0050] In Example 11: the co-solvent in component A is composed of sucrose and sodium benzoate in a weight ratio of 15:3.

[0051] The types of other raw materials, the amounts of raw materials used and the preparation method of lincomycin and spectinomycin soluble powders in the above embodiment and embodiment 1 are the same.

[0052] Examples 12-17

[0053] Examples 12-17 provide a lincomycin and spectinomycin soluble powder, respectively.

[0054] The difference between the above embodiment and embodiment 1 is that the type of the co-solvent in component B is different, as shown below.

[0055] In Example 12: the cosolvent in component B is sucrose.

[0056] In Example 13: the cosolvent in component B is sodium benzoate.

[0057] In Example 14: the co-solvent in component B is composed of sucrose and sodium benzoate in a weight ratio of 1.5:17.

[0058] In Example 15: the co-solvent in component B is composed of sucrose and sodium salicylate in a weight ratio of 1.5:13.

[0059] In Example 16: the co-solvent in component B is composed of sucrose and sodium salicylate in a weight ratio of 0.5:19.

[0060] In Example 17: the co-solvent in component B is composed of sucrose and sodium salicylate in a weight ratio of 2.5:15.

[0061] The types of other raw materials, the amounts of raw materials used and the preparation method of lincomycin and spectinomycin soluble powders in the above embodiment and embodiment 1 are the same.

[0062] Comparative Example

[0063] Comparative Example 1-2

[0064] Comparative Examples 1-2 provide a lincomycin and spectinomycin soluble powder respectively.

[0065] The difference between the comparative example and Example 1 is that the dosage of each component is different, as shown in Table 1.

[0066] The types of raw materials and the preparation methods of lincomycin and spectinomycin soluble powders in the comparative example and Example 1 are the same.

[0067] Comparative Examples 3-6

[0068] Comparative Examples 3-6 provide a lincomycin and spectinomycin soluble powder respectively.

[0069] The differences between the above comparative example and Example 1 are specifically as follows:

[0070] In Comparative Example 3, an equal amount of hydroxyethyl β-cyclodextrin was used instead of hydroxypropyl β-cyclodextrin.

[0071] In Comparative Example 4, an equal amount of glucose was used to replace sucrose monohydrate.

[0072] In Comparative Example 5, an equal amount of poloxamer was used to replace sucrose monohydrate.

[0073] In Comparative Example 6, an equal amount of polyethylene glycol 6000 was used to replace sucrose monohydrate.

[0074] Performance testing

[0075] (1) pH value detection

[0076] The pH value of Marek's vaccine diluent is an important factor affecting the potency of Marek's vaccine. Use 25 ml of Marek's vaccine diluent (special diluent for chicken Marek's disease frozen vaccine, provided by Beijing Lingyu Company, packaging: 400 ml / bottle) to dissolve 5 g of lincomycin and spectinomycin soluble powder product, shake for 2-3 minutes to completely dissolve, detect the pH value after dissolution, and conduct 5 parallel tests.

[0077] Test results: Figure 1 The pH value test results in Example 1 are shown (original represents a special diluent for chicken Marek's disease frozen vaccine, 1-5 represents 5 parallel tests of a mixture of a Marek's vaccine diluent and lincomycin spectinomycin soluble powder, and water represents a mixture of deionized water and lincomycin spectinomycin soluble powder); the pH value range of the Marek's vaccine diluent is 6.92-7.00; the test results in Examples 1-17 and Comparative Examples 1-6 are shown in Table 2.

[0078] (2) Osmotic pressure test

[0079] The osmotic pressure of the Marek's vaccine diluent is also one of the main factors affecting the potency of the Marek's vaccine. When the osmotic pressure is between 250-450MOsm / L, the potency is basically unaffected. Dissolve 5g of the finished product of lincomycin and spectinomycin soluble powder with 25ml of Marek's vaccine diluent, shake for 2-3min to completely dissolve, and test the osmotic pressure after dissolution. Perform 5 parallel tests and take the average value. The osmotic pressure is measured using a CM320 freezing point osmotic pressure meter.

[0080] Test results: as shown in Table 2.

[0081] (3) Vaccine potency testing

[0082] The experiment was conducted using a cell viability ratio assay, in which a cell counter was used to precisely and accurately measure the number and viability of cells. Sample analysis was then performed, using trypan blue as a dye to separately mark live cells and dead cells in a bright field. A machine learning algorithm was used to quickly and accurately determine the focus, and to perform cell counting and activity calculations. The ratio of the two cell activities was the cell viability ratio.

[0083] The specific experimental process is:

[0084] S1: Preparation of test solution: Measure 50 ml of Marek's special diluent into a 250 ml conical flask, add 5 g of the accurately weighed test drug (lincomycin and spectinomycin soluble powder provided by the present application), add appropriate amount of Marek's frozen live vaccine (chicken Marek's disease frozen vaccine, CVI 988 Rupens strain, packaging: 2000 doses / bottle), and finally make the cell concentration 10 5 -10 6 / ml, shake well, and measure after 0h and 1h.

[0085] S2: Preparation of reference solution: Measure 50 ml of Marek's special diluent into a 250 ml conical flask, add appropriate amount of Marek's frozen live vaccine, and finally make the cell concentration 10 5 -10 6 / ml, shake well, and measure after 0h and 1h.

[0086] S3: Determination: Take 6ml of the test solution in a centrifuge tube, centrifuge at 2000r / min for 20min, discard the supernatant, add 3ml of Marek's special diluent, shake well, take 10ul and add 10ul of 0.4% trypan blue staining solution, mix well, pipette 10ul of the mixed solution into a disposable counting plate, let it stand horizontally for 30S, insert it into the cell counter to focus, record the reading and save it. Determine the reference solution in the same way.

[0087] S4: The results are calculated as follows: the test solution is measured 6 times and the result is calculated as the average value.

[0088] Cell viability (T h ) = number of viable cells (T h ) / total number of cells (T h )×100%, cell viability ratio (T h ) = cell viability of the test group (T h ) / cell viability of blank group (0 h ).

[0089] Test results: as shown in Table 2.

[0090] (4) Solubility test

[0091] Specific experimental process: dilute 20g of the finished product with nano-dispersion liquid (provided by Ruixiannong Zuohai Company), shake for 2-3 minutes to completely dissolve, and the dissolved solution is allowed to stand for 4 hours without stratification or precipitation;

[0092] Use the diluted solution to extract 22ml and prepare a bottle of 500ml oil seedling. After fully dissolving according to the upside-down method, let it stand for 192h and observe whether there is stratification or precipitation.

[0093] Table 2 Performance test results of Examples 1-17 and Comparative Examples 1-6

[0094]

[0095]

[0096]

[0097] It can be seen from the test results of Table 2 that after the lincomycin spectinomycin soluble powder provided by the present application is mixed with the Marek's vaccine diluent, the pH value of the Marek's vaccine diluent is between 6.92-7.05, the pH value range is suitable and stable, and the osmotic pressure range of the resulting liquid is about 302-406MOsm / L, that is, the lincomycin spectinomycin soluble powder obtained by the present application can provide a suitable and stable pH and osmotic pressure for the Marek's vaccine, avoiding the pH and osmotic pressure of the diluent from affecting the potency of the Marek's vaccine. At the same time, after the lincomycin spectinomycin soluble powder provided by the present application is mixed with the Marek's vaccine diluent and the Marek's frozen live vaccine, the cell viability ratio is 0.95-1.00, and it can also be dissolved in oil, and can be used in combination with a variety of oily vaccines, and the vaccine potency is not affected when used in combination.

[0098] Comparative Example 3 uses hydroxyethyl β-cyclodextrin instead of hydroxypropyl β-cyclodextrin, and Comparative Examples 4-6 use glucose, poloxamer or polyethylene glycol 6000 instead of sucrose monohydrate. After the prepared lincomycin and spectinomycin soluble powder is mixed with the Marek vaccine diluent, the pH value and osmotic pressure of the Marek vaccine diluent are not suitable for the Marek vaccine, which is easy to affect the potency of the Marek vaccine; and after mixing with the oily nanodispersion, stratification or precipitation is prone to occur, which is not suitable for combined use with the oily vaccine, reducing the scope of application of the lincomycin and spectinomycin soluble powder.

[0099] By comparing the test results of Examples 1-5 with those of Comparative Examples 1-2, it can be seen that the dosage of each component raw material in the lincomycin-spectromycin soluble powder has a great influence on the performance of the finished product. The present application screens the appropriate dosage to obtain a lincomycin-spectromycin soluble powder product with better performance.

[0100] By comparing the test results of Examples 1, 6-11, the present application further improves the performance of the finished lincomycin-spectromycin soluble powder by using sucrose and sodium benzoate in a weight ratio of (11-15): (3-7) to form the co-solvent in component A.

[0101] By comparing the test results of Examples 1 and 12-17, the present application further improves the performance of the finished lincomycin-spectromycin soluble powder by using sucrose and sodium salicylate in a weight ratio of (0.5-2.5):(15-19) to form the co-solvent in component B.

[0102] (5) Oil vaccine potency when used in combination with oily vaccines

[0103] Use 1 bottle of nano-dispersion liquid (provided by Ruixiannong Zuohai Company) to dissolve 20g of the finished product of lincomycin and spectinomycin soluble powder provided in Example 1 of the present application, fully oscillate for 3 minutes, and after complete dissolution, obtain about 44ml of liquid medicine; use a syringe to draw 11ml and inject it into 1 bottle of 250ml oil seedling (Xinliu inactivated vaccine and H9 inactivated vaccine) for standby use.

[0104] Experimental grouping: In a standardized white-feather broiler cage farm, 4 rows of chicken cages were selected inside a chicken house, with about 60 chickens (7 days old) in each row of chicken cages. When used, the injection volume was 0.2 ml / feather, and the neck was injected. Blood was collected at 1d, 7d, 14d, 21d, 28d, 35d, and 42d after the injection of the vaccine, and the ND, H9, and H9 HI antibodies were determined using standard antigens. During the experiment, 11ml nanodispersion + 250ml oil seedlings (without the addition of lincomycin and spectinomycin soluble powder) were used as the blank group.

[0105] Test results: as shown in Table 3.

[0106] Table 3 Oil seedling titer when lincomycin spectinomycin soluble powder is used in combination with oily vaccine in Example 1

[0107]

[0108] According to the data in Table 3, it is found that the addition of the lincomycin and spectinomycin soluble powder prepared in this application has no effect on the potency of ND new flow inactivated vaccine and H9 inactivated vaccine, and does not affect the potency of oil seedlings when injected together with oil seedlings. That is, the lincomycin and spectinomycin soluble powder prepared in this application can be used in combination with oil seedlings to reduce the number of injections, thereby reducing stress reactions; and at the same time, it saves the cost of using oil seedling diluents.

[0109] (6) Stress response when used in combination with oily vaccines

[0110] Use 1 bottle of nano-dispersion liquid (provided by Ruixiannong Zuohai Company) to dissolve 20g of the finished product of lincomycin and spectinomycin soluble powder provided in Examples 1-17 of the present application, fully oscillate for 3 minutes, and after complete dissolution, obtain about 44ml of liquid medicine; use a syringe to draw 11ml and inject it into 1 bottle of 250ml oil seedling (Xinliu inactivated vaccine and H9 inactivated vaccine) for standby use.

[0111] Experimental grouping: 18 rows of chicken cages were selected in a standardized white-feathered broiler cage farm, with about 120 chickens (7 days old, average weight 180g) in each row of chicken cages. When used, the injection volume was 0.2ml / feather, and the neck was injected. The average weight of each group of chickens was recorded at 7d, 14d, and 28d after the injection of the vaccine (i.e., 14 days old, 21 days old, and 35 days old), and the weight gain rate of the chickens was calculated (weight gain rate = (average weight of chickens of corresponding age-average weight of chickens of 7 days old) / average weight of chickens of 7 days old × 100%). During the experiment, 11ml of nanodispersion + 250ml of oil seedlings (without adding lincomycin and spectinomycin soluble powder) were used as the blank group.

[0112] Test results: as shown in Table 4.

[0113] Table 4 Stress response when lincomycin spectinomycin soluble powder is used in combination with oily vaccine in the embodiment

[0114]

[0115] Through the data measurement in Table 4, it was found that after the blank group was directly injected with 11ml nanodispersion + 250ml oil seedling (without adding lincomycin and spectinomycin soluble powder) to the chickens, the weight gain rate of the chickens was significantly reduced. This is because after the injection of the vaccine, the chickens had a stress response, diarrhea, decreased appetite and other adverse phenomena; after adding the finished lincomycin and spectinomycin soluble powder prepared by the present application and using it in combination with ND new flow inactivated vaccine and H9 inactivated vaccine, the weight gain rate was significantly higher than that of the blank group; it shows that the use of the lincomycin and spectinomycin soluble powder provided by the technical solution of the present application can significantly reduce the stress response of the chickens, thereby improving the performance of the combined use of lincomycin and spectinomycin soluble powder and vaccines.

[0116] Although the present invention has been described in detail above with general descriptions and specific embodiments, it is obvious to those skilled in the art that some modifications or improvements may be made thereto based on the present invention. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection claimed by the present invention.

Claims

1. A lincomycin spectinomycin soluble powder, characterized in that: It includes component A and component B; The component A comprises the following ingredients in parts by weight: 30-50 parts of lincomycin hydrochloride, 20-30 parts of hydroxypropyl β-cyclodextrin, 20-30 parts of sucrose monohydrate, 10-20 parts of cosolvent, and 10-20 parts of solubilizer; The component B comprises the following ingredients in parts by weight: 40-50 parts of spectinomycin hydrochloride, 10-20 parts of hydroxypropyl β-cyclodextrin, 10-20 parts of sucrose monohydrate, 10-20 parts of cosolvent, and 10-20 parts of solubilizer; In the component A and the component B, the co-solvent is selected from any one or more of sucrose, sodium benzoate, and sodium salicylate; In the component A and the component B, the solubilizing agent is selected from any one or more of Tween 20 and Tween 40.

2. The lincomycin spectinomycin soluble powder according to claim 1, characterized in that The component A comprises the following ingredients in parts by weight: 30-40 parts of lincomycin hydrochloride, 20-25 parts of hydroxypropyl beta-cyclodextrin, 25-30 parts of sucrose monohydrate, 10-15 parts of cosolvent, and 15-20 parts of solubilizer.

3. The lincomycin spectinomycin soluble powder according to claim 1, characterized in that: The component B comprises the following ingredients in parts by weight: 45-50 parts of spectinomycin hydrochloride, 15-20 parts of hydroxypropyl beta-cyclodextrin, 10-15 parts of sucrose monohydrate, 15-20 parts of cosolvent, and 10-15 parts of solubilizer.

4. The lincomycin spectinomycin soluble powder according to claim 1, characterized in that: In the component A, the co-solvent is composed of sucrose and sodium benzoate in a weight ratio of (11-15): (3-7).

5. The lincomycin spectinomycin soluble powder according to claim 1, characterized in that: In the B component, the co-solvent is composed of sucrose and sodium salicylate in a weight ratio of (0.5-2.5):(15-19).

6. The method for preparing the lincomycin-spectromycin soluble powder according to any one of claims 1 to 5, characterized in that: The specific steps include: After dissolving 30-50 parts of lincomycin hydrochloride in 10-30 parts of water by weight, 20-30 parts of hydroxypropyl β-cyclodextrin, 20-30 parts of sucrose monohydrate, 10-20 parts of cosolvent, and 10-20 parts of solubilizer are added respectively, and the mixture is stirred evenly. After complete emulsification, a pH adjuster is added to adjust the pH value to 6.9-7.0, and the mixture is vacuum dried and crushed to obtain component A; By weight, 40-50 parts of spectinomycin hydrochloride are dissolved in 10-30 parts of water, and then 10-20 parts of hydroxypropyl β-cyclodextrin, 10-20 parts of sucrose monohydrate, 10-20 parts of co-solvent and 10-20 parts of solubilizer are added respectively, and the mixture is fully stirred and emulsified, and then a pH adjuster is added to adjust the pH value to 6.9-7.

0. The mixture is vacuum dried and crushed to obtain component B.

7. The method for preparing the lincomycin spectinomycin soluble powder according to claim 6, characterized in that: The process parameters of the vacuum drying are: temperature of 50-70° C. and time of 3-5 h.

8. A pharmaceutical composition, characterized in that The invention comprises any one of antibacterial drugs and antifungal drugs; and the lincomycin and spectinomycin soluble powder according to any one of claims 1 to 5.

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