A cefodizime sodium preparation for injection and a preparation method thereof

Abstract

The application provides a cefodizime sodium injection preparation and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The cefodizime sodium injection preparation comprises the following components in parts by weight: cefodizime sodium 5 parts, traditional Chinese medicine water-alcohol extract 0.2-0.4 parts, pH regulator 0.3-0.8 parts, suspending agent 0.5-1 part, and injection 15-20 parts. The traditional Chinese medicine water-alcohol extract is obtained by water extraction and alcohol extraction of Linzhi spore powder and Belamcanda chinensis powder in sequence, and the mass ratio of the Linzhi spore powder and the Belamcanda chinensis powder is 1-3:1. The suspending agent is prepared by mixing tragacanth gum, gum arabic and hydroxyethyl cellulose at a mass ratio of 1:1:0.8-2. When used, the cefodizime sodium injection preparation is diluted with the injection according to actual conditions. The antibacterial activity and long-acting property of the prepared cefodizime sodium injection preparation are obviously enhanced.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparation technology, specifically relating to an injectable cefoperazone sodium preparation and its preparation method. Background Technology

[0002] Cefoperazone sodium is a third-generation injectable cephalosporin antibiotic, developed by Hoechst AG of Germany and Taiho Co., Ltd. of Japan. It was launched in Japan in May 1990 under the brand name "Neucef". In 1994, Hoechst-Russel AG of Germany obtained registration in my country for injectable cefoperazone sodium (Modi).

[0003] Cefoperazone sodium exhibits antibacterial activity against both Gram-positive and Gram-negative bacteria. It is stable against β-lactamases and extremely stable against cephalosporinase and penicillinase. Compared to other similar drugs, cefoperazone sodium not only possesses highly effective and broad-spectrum antibacterial activity but also enhances immunity. Clinically, it is mainly used for pneumonia, bronchitis, pharyngitis, tonsillitis, pyelonephritis, urinary tract infections, gonococcal urethritis, cholecystitis, cholangitis, gynecological infections, sepsis, and otitis media caused by susceptible bacteria such as Streptococcus spp. and Pneumococcus.

[0004] Currently, the main cefoperazone sodium formulations on the market are injectable cefoperazone sodium formulations. The strength of their antibacterial activity and duration of action directly determines their actual therapeutic efficacy. Therefore, improving the antibacterial activity and duration of action of injectable cefoperazone sodium formulations is a worthy research direction in this field. Summary of the Invention

[0005] To address the problems existing in the background art, the present invention provides an injectable cefoperazone sodium preparation and its preparation method, so as to significantly enhance the antibacterial activity and long-lasting effect of the prepared injectable cefoperazone sodium preparation.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] A cefotaxime sodium injection preparation, by weight, comprises the following components: 5 parts cefotaxime sodium, 0.2-0.4 parts aqueous and alcoholic extract of traditional Chinese medicine, 0.3-0.8 parts pH adjuster, 0.5-1 parts suspending agent, and 15-20 parts injection solution;

[0008] The herbal water-alcohol extract is obtained by successively extracting Linzhi spore powder and Belamcanda chinensis powder with water and alcohol, and the mass ratio of Linzhi spore powder to Belamcanda chinensis powder is 1-3:1.

[0009] The suspending agent is prepared by mixing tragacanth gum, gum arabic and hydroxyethyl cellulose in a mass ratio of 1:1:0.8-2;

[0010] When using, the injectable cefoperazone sodium preparation should be diluted with the injection solution according to the actual situation.

[0011] Furthermore, by weight, it includes the following components: 5 parts cefoperazone sodium, 0.3 parts traditional Chinese medicine alcohol extract, 0.3-0.8 parts pH stabilizer, 0.7 parts suspending agent, and 15-20 parts injection solution.

[0012] Furthermore, by weight, it includes the following components: 5 parts cefoperazone sodium, 0.3 parts traditional Chinese medicine alcohol extract, 0.5 parts pH stabilizer, 0.7 parts suspending agent, and 15 parts injection solution.

[0013] Furthermore, the mass ratio of the Ganoderma lucidum spore powder to the Belamcanda chinensis powder is 2:1.

[0014] Furthermore, the preparation method of the aqueous and alcoholic extract of the traditional Chinese medicine is as follows:

[0015] A1. Add Ganoderma lucidum spore powder and Belamcanda chinensis powder to a multi-functional extraction tank, add 12 times and 10 times the amount of purified water respectively, extract twice, turn on steam heating each time, keep the whole process in a gentle boiling state, filter the two extracts and put them into a concentrator, turn on the circulating cooling water of the concentrator, turn on the vacuum pump, turn on the steam, reduce pressure and concentrate to obtain water-concentrated material.

[0016] A2. Using ethanol, the water extract concentrate obtained in A1 is subjected to multiple alcohol precipitation and evaporation treatments to obtain alcohol extract;

[0017] A3. The alcohol extract obtained in A2 is concentrated in a single-effect concentrator until the relative density is 1.05-1.08, thus obtaining the water-alcohol extract of traditional Chinese medicine.

[0018] Furthermore, in A1, the vacuum is controlled at 0.06 MPa, the steam pressure is within 0.1 MPa, and the temperature is 80±5℃, concentrating the extract to a relative density of 1.11-1.14 to obtain the water extract concentrate.

[0019] Furthermore, in A2, alcohol precipitation and evaporation are performed three times consecutively using an alcohol precipitation tank and a single-effect concentrator, as detailed below:

[0020] First, 85% ethanol was added under stirring to make the alcohol content 70%, and the mixture was allowed to settle for 48 hours. Then, the ethanol was recovered completely within a steam pressure of 0.09 MPa, and the mixture was further concentrated to a relative density of 1.09-1.1.

[0021] The second time, 90% ethanol was added under stirring to make the alcohol content 75%, and the mixture was allowed to settle for 48 hours. Then, the ethanol was recovered completely under a steam pressure of less than 0.09 MPa.

[0022] The third time, 95% ethanol was added under stirring to make the alcohol content 80%, and the mixture was allowed to settle for 48 hours. Then, the ethanol was recovered completely under a steam pressure of less than 0.09 MPa.

[0023] Furthermore, the suspending agent is prepared by mixing tragacanth gum, gum arabic and hydroxyethyl cellulose in a mass ratio of 1:1:1.

[0024] Furthermore, the pH adjuster is prepared as follows: equal volumes of 1% sodium dihydrogen phosphate solution and 0.8% disodium hydrogen phosphate solution are mixed to obtain the pH adjuster.

[0025] A method for preparing an injectable cefoperazone sodium formulation, comprising the following steps:

[0026] S1. Mix the water-alcohol extract of traditional Chinese medicine, the suspending agent and the injection solution evenly to obtain a mixture;

[0027] S2. First, add a pH adjuster to the mixture obtained in S1 and mix well. Then add cefoperazone sodium and mix well to obtain cefoperazone sodium preparation for injection.

[0028] This application has the following beneficial effects:

[0029] 1. This invention uses cefoperazone sodium and water-alcohol extracts of traditional Chinese medicine as raw materials to prepare an injectable cefoperazone sodium preparation. The combination of traditional Chinese and Western medicines has a synergistic effect, which aims to enhance the antibacterial activity and long-lasting effect of the injectable cefoperazone sodium preparation. Among them, the traditional Chinese medicine raw materials are selected from Ganoderma lucidum spore powder and Belamcanda chinensis powder. The special functional components are extracted by water extraction and alcohol extraction process, which have the function of effectively inhibiting the oxidation caused by reactive oxygen species, which is of great benefit to enhancing the drug activity and the duration of efficacy. At the same time, the addition of suspending agents can reduce the sedimentation speed of particles or increase the hydrophilicity of particles, which is conducive to the uniform mixing and dispersion of various components in the preparation, and at the same time assists in the synergistic performance of various components in the preparation.

[0030] 2. In the preparation process of the water-alcohol extract of traditional Chinese medicine, the alcohol is continuously subjected to three alcohol precipitation and evaporation treatments. The concentration of ethanol used increases gradually with each treatment, and the alcohol content in the mixture also increases gradually to ensure that the alcohol extract from which special functional components can be extracted is obtained. Attached Figure Description

[0031] Figure 1 The control group and Examples 1-7 of this invention show the bactericidal curves against Escherichia coli.

[0032] Figure 2 The images show the bactericidal curves of Escherichia coli in Example 5 and Comparative Examples 1-7 of this invention.

[0033] Figure 3The above are the bactericidal curves of Escherichia coli in Examples 5, 6, and 8-11 of the present invention. Detailed Implementation

[0034] The present application will be further described in detail below with reference to the embodiments.

[0035] Unless otherwise specified, the raw materials used in the embodiments and comparative examples of this application are all commercially available. Example 1

[0036] The aqueous and alcoholic extract of traditional Chinese medicine was obtained by sequentially extracting Linzhi spore powder and Belamcanda chinensis powder with water and alcohol, respectively. The mass ratio of Linzhi spore powder to Belamcanda chinensis powder was 2:1. The specific preparation method is as follows:

[0037] A1. Add Ganoderma lucidum spore powder and Belamcanda chinensis powder to a multi-functional extraction tank, and add 12 times and 10 times the amount of purified water respectively. Extract twice, with steam heating on each time, and keep the process at a slight boil. After filtering both extracts, put them into a concentrator, turn on the circulating cooling water of the concentrator, turn on the vacuum pump, turn on the steam, and concentrate under reduced pressure. The vacuum is controlled at 0.06MPa, the steam pressure is within 0.1MPa, and the temperature is 80±5℃. Concentrate the extract to a relative density of 1.13 (measured at a temperature of about 80℃), which is the water-extracted concentrate.

[0038] A2. Using ethanol, the water extract concentrate obtained in A1 is subjected to three consecutive alcohol precipitation and evaporation treatments to obtain alcohol extract, as detailed below;

[0039] The first step involves starting the pneumatic diaphragm pump to pump the water-extracted concentrate into an alcohol precipitation tank that has been purged with ethylene glycol coolant. 85% ethanol is added while stirring to bring the alcohol content to 70%. The mixture is then allowed to settle for 48 hours. Vacuum filtration is performed, and the filtrate is pumped into a single-effect concentrator. The evaporator cooling water system is turned on, and the steam heating valve is opened. The steam pressure is controlled to be below 0.09 MPa, and all ethanol is recovered. The vacuum system is then activated, and the mixture is further concentrated to a relative density of 1.1 (measured at approximately 80°C).

[0040] The second step involves adding 90% ethanol to an alcohol precipitation tank with ethylene glycol coolant already turned on, while stirring, to achieve an alcohol content of 75%. After 48 hours of cold precipitation, the mixture is vacuum-filtered, and the filtrate is pumped into a single-effect concentrator. The evaporator cooling water system is then turned on, and the steam heating valve is opened, maintaining the steam pressure below 0.09 MPa to recover all the ethanol.

[0041] The third step involves adding 95% ethanol to an alcohol precipitation tank with ethylene glycol coolant already turned on, while stirring, to achieve an alcohol content of 80%. After 48 hours of cold precipitation, the mixture is vacuum-filtered, and the filtrate is pumped into a single-effect concentrator. The evaporator cooling water system is turned on, the steam heating valve is opened, and the steam pressure is controlled to be below 0.09 MPa. Ethanol is recovered completely, yielding the alcohol extract.

[0042] A3. The alcohol extract obtained in A2 is concentrated in a single-effect concentrator until the relative density is 1.06 (measured at a temperature of about 80℃), thus obtaining the water-alcohol extract of traditional Chinese medicine.

[0043] The suspending agent was prepared by mixing tragacanth gum, gum arabic and hydroxyethyl cellulose in a mass ratio of 1:1:1.

[0044] The pH adjuster is prepared by mixing equal volumes of 1% sodium dihydrogen phosphate solution and 0.8% disodium hydrogen phosphate solution.

[0045] The injection solution used is 0.9% sodium chloride injection.

[0046] This embodiment provides a cefotaxime sodium injection preparation, which, by weight, comprises the following components: 5 parts cefotaxime sodium, 0.4 parts water-alcohol extract of traditional Chinese medicine, 0.8 parts pH adjuster, 1 part suspending agent, and 20 parts injection solution.

[0047] The specific preparation method steps are as follows:

[0048] S1. Mix the water-alcohol extract of traditional Chinese medicine, the suspending agent and the injection solution evenly to obtain a mixture;

[0049] S2. First, add a pH adjuster to the mixture obtained in S1 and mix well. Then add cefoperazone sodium and mix well to obtain cefoperazone sodium preparation for injection.

[0050] When using, the prepared cefoperazone sodium preparation for injection shall be diluted with the injection solution according to the actual situation. Example 2

[0051] The only difference between this embodiment and Embodiment 1 is that:

[0052] This embodiment provides a cefotaxime sodium injection preparation, which, by weight, comprises the following components: 5 parts cefotaxime sodium, 0.2 parts water-alcohol extract of traditional Chinese medicine, 0.3 parts pH adjuster, 0.5 parts suspending agent, and 15 parts injection solution. Example 3

[0053] The only difference between this embodiment and Embodiment 1 is that:

[0054] This embodiment provides a cefotaxime sodium injection preparation, which, by weight, comprises the following components: 5 parts cefotaxime sodium, 0.3 parts water-alcohol extract of traditional Chinese medicine, 0.3 parts pH adjuster, 1 part suspending agent, and 15 parts injection solution. Example 4

[0055] The only difference between this embodiment and Embodiment 1 is that:

[0056] This embodiment provides a cefotaxime sodium injection preparation, which, by weight, comprises the following components: 5 parts cefotaxime sodium, 0.3 parts traditional Chinese medicine alcohol extract, 0.8 parts pH stabilizer, 0.7 parts suspending agent, and 20 parts injection solution. Example 5

[0057] The only difference between this embodiment and Embodiment 1 is that:

[0058] This embodiment provides a cefotaxime sodium injection preparation, which, by weight, comprises the following components: 5 parts cefotaxime sodium, 0.3 parts traditional Chinese medicine alcohol extract, 0.5 parts pH stabilizer, 0.7 parts suspending agent, and 15 parts injection solution. Example 6

[0059] The only difference between this embodiment and Embodiment 1 is that:

[0060] The water-alcohol extract of traditional Chinese medicine is obtained by water extraction and alcohol extraction of Ganoderma lucidum spore powder and Belamcanda chinensis powder, respectively, with a mass ratio of 1:1. Example 7

[0061] The only difference between this embodiment and Embodiment 1 is that:

[0062] The suspending agent was prepared by mixing tragacanth gum, gum arabic and hydroxyethyl cellulose in a mass ratio of 1:1:2. Comparative Example 1

[0063] The only difference between this comparative example and Example 5 is that the raw materials of the Chinese herbal water-alcohol extract do not include Belamcanda chinensis powder, that is, the Chinese herbal water-alcohol extract is made from a single raw material, Ganoderma lucidum spore powder, and the preparation method is the same as that described in Example 1. Comparative Example 2

[0064] The only difference between this comparative example and Example 5 is that the raw materials of the Chinese herbal water-alcohol extract do not include Ganoderma lucidum spore powder. That is, the Chinese herbal water-alcohol extract is made from a single raw material, Belamcanda chinensis powder, and the preparation method is the same as that described in Example 1. Comparative Example 3

[0065] The only difference between this comparative example and Example 5 is that in the raw materials of the Chinese herbal water-alcohol extract, Panax notoginseng powder is used instead of Ganoderma lucidum spore powder. That is, the Chinese herbal water-alcohol extract is prepared by mixing Panax notoginseng powder and Belamcanda chinensis powder in a mass ratio of 2:1. The preparation method is the same as that described in Example 1. Comparative Example 4

[0066] The only difference between this comparative example and Example 5 is that in the raw materials of the Chinese herbal water-alcohol extract, Panax notoginseng powder is used instead of Belamcanda chinensis powder. That is, the Chinese herbal water-alcohol extract is prepared by mixing Ganoderma lucidum spore powder and Panax notoginseng powder in a mass ratio of 2:1. The preparation method is the same as that described in Example 1. Comparative Example 5

[0067] The only difference between this comparative example and Example 5 is that in the preparation of the herbal aqueous alcohol extract, a single alcohol precipitation and evaporation treatment (using 85% ethanol) is performed to directly obtain the alcohol extract with the desired relative density. The specific steps are as follows:

[0068] A1. Add Ganoderma lucidum spore powder and Belamcanda chinensis powder to a multi-functional extraction tank, and add 12 times and 10 times the amount of purified water respectively. Extract twice, with steam heating on each time, and keep the process at a slight boil. After filtering both extracts, put them into a concentrator, turn on the circulating cooling water of the concentrator, turn on the vacuum pump, turn on the steam, and concentrate under reduced pressure. The vacuum is controlled at 0.06MPa, the steam pressure is within 0.1MPa, and the temperature is 80±5℃. Concentrate the extract to a relative density of 1.13 (measured at a temperature of about 80℃), which is the water-extracted concentrate.

[0069] A2. Turn on the pneumatic diaphragm pump and pump the water extract concentrate into the alcohol precipitation tank that has been purged with ethylene glycol coolant. Add 85% ethanol while stirring to make the alcohol content 70%. Allow it to settle for 48 hours. Vacuum filter the filtrate and pump it into a single-effect concentrator. Turn on the evaporator cooling water system and open the steam heating valve. Control the steam pressure to within 0.09 MPa and recover all the ethanol. Turn on the vacuum system and continue to concentrate until the relative density is 1.1 (measured at around 80°C). This yields the alcohol extract.

[0070] A3. The alcohol extract obtained in A2 is concentrated in a single-effect concentrator until the relative density is 1.06 (measured at a temperature of about 80℃), thus obtaining the water-alcohol extract of traditional Chinese medicine. Comparative Example 6

[0071] The only difference between this comparative example and Example 5 is that the raw materials used to prepare the injectable cefoperazone sodium preparation do not contain the water-alcohol extract of traditional Chinese medicine. That is, this comparative example provides an injectable cefoperazone sodium preparation, which, by weight, includes the following components: 5 parts cefoperazone sodium, 0.5 parts pH stabilizer, 0.7 parts suspending agent, and 15 parts injection solution. Comparative Example 7

[0072] The only difference between this comparative example and Example 5 is that the antioxidant vitamin E is used instead of the traditional Chinese medicine alcohol extract in the raw materials for preparing the cefoperazone sodium injection. That is, this comparative example provides a cefoperazone sodium injection preparation, which, by weight, includes the following components: 5 parts cefoperazone sodium, 0.3 parts antioxidant vitamin E, 0.5 parts pH stabilizer, 0.7 parts suspending agent, and 15 parts injection solution. Comparative Example 8

[0073] The only difference between this comparative example and Example 5 is that the suspending agent is prepared by mixing tragacanth gum and gum arabic in a 1:1 mass ratio. Comparative Example 9

[0074] The only difference between this comparative example and Example 5 is that the suspending agent used is a single-component hydroxyethyl cellulose. Comparative Example 10

[0075] The only difference between this comparative example and Example 5 is that the raw materials used to prepare the cefoperazone sodium injection do not contain a suspending agent. That is, this comparative example provides a cefoperazone sodium injection, which, by weight, includes the following components: 5 parts cefoperazone sodium, 0.3 parts traditional Chinese medicine alcohol extract, 0.5 parts pH stabilizer, and 15 parts injection solution. Comparative Example 11

[0076] The only difference between this comparative example and Example 5 is that the raw materials used to prepare the injectable cefoperazone sodium preparation do not contain the traditional Chinese medicine water-alcohol extract and suspending agent. That is, this comparative example provides an injectable cefoperazone sodium preparation, which, by weight, includes the following components: 5 parts cefoperazone sodium, 0.5 parts pH stabilizer, and 15 parts injection solution.

[0077] Test case

[0078] Test items: antibacterial activity and long-lasting effect.

[0079] Experiment content:

[0080] Clinically isolated *Escherichia coli* (NO. 22, β-lactamase-producing bacterium) was cultured overnight, diluted, and mixed with the test drug to achieve a final bacterial concentration of approximately 10⁻⁶. 5 -10 6 cfu.mL -1 ;

[0081] The cefoperazone sodium injection formulations prepared using Examples 1-7 and Comparative Examples 1-11 all had a final concentration of 0.28 μg / mL, based on the content of the cefoperazone sodium component. -1 Meanwhile, a control group was set up, which used only ordinary physiological saline without cefoperazone sodium or any other antibiotics.

[0082] The cells were incubated at 37 °C, and samples were taken at 0, 2, 4, 6, 8, and 12 h for colony counting and sterilization curve plotting.

[0083] Experimental results: The bactericidal curve was plotted, as shown below. Figure 1-3 As shown.

[0084] Results analysis: Analysis of the control group and Examples 1-7, combined with... Figure 1 It can be seen that the cefdinir sodium injection of the present invention has good bactericidal activity and long-lasting effect against Escherichia coli, and the bactericidal rate reaches more than 99.9% after 8 hours. Although the bactericidal curves of Examples 1-7 have a high degree of overlap, after careful comparison, it can still be seen that Example 5 is the best example.

[0085] Analysis of Example 5, Comparative Examples 1-4 and Comparative Examples 6-7, and in conjunction with Figure 2 It can be seen that the addition of the water-alcohol extract of traditional Chinese medicine in the formulation components is beneficial to enhancing the bactericidal activity and long-lasting effect of the cefoperazone sodium injection preparation of the present invention against Escherichia coli. Among them, the water-alcohol extract of traditional Chinese medicine is obtained by water extraction and alcohol extraction of Ganoderma lucidum spore powder and Belamcanda chinensis powder respectively. The two raw materials are extracted together, and the effect is synergistic. The absence of one of them will weaken the enhancement effect. Moreover, the simple replacement of ordinary traditional Chinese medicine of the same type (such as Panax notoginseng) cannot bring about the same enhancement effect. Furthermore, this enhancement effect depends on the antioxidant properties of the water-alcohol extract of traditional Chinese medicine, but it does not rely solely on this single property. The simple replacement of the water-alcohol extract of traditional Chinese medicine with ordinary antioxidants (such as vitamin E) cannot bring about the same enhancement effect.

[0086] Analysis of Example 5 and Comparative Example 5, combined with Figure 2 It can be seen that the preparation process of water-alcohol extracts of traditional Chinese medicine requires three consecutive alcohol precipitation and evaporation treatments. Furthermore, the concentration of ethanol used increases gradually with each treatment, and the alcohol content in the mixture also increases gradually to ensure that the extract yields the key active ingredients. Otherwise, a single alcohol extraction, which completes the process in one step, may reduce the number of steps but will lead to the loss of active ingredients and affect the efficacy.

[0087] Analysis of Example 5 and Comparative Examples 6-11 and in conjunction with Figure 3 It can be seen that the addition of the suspending agent in the formulation is beneficial to enhancing the bactericidal activity and long-lasting effect of the cefdinir sodium injection of the present invention against Escherichia coli. Its synergistic effect is mainly reflected in the increased effect on the water-alcohol extract of traditional Chinese medicine. Furthermore, the suspending agent is a mixture of tragacanth gum, gum arabic and hydroxyethyl cellulose. Neither the single synthetic polymeric suspending agent hydroxyethyl cellulose nor the mixture of natural polymeric suspending agents tragacanth gum and gum arabic can achieve the synergistic effect of the three.

[0088] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present invention will not describe the various possible combinations separately.

[0089] Furthermore, various different embodiments of the present invention can be combined in any way, as long as they do not violate the spirit of the present invention, they should also be regarded as the content disclosed by the present invention.

Claims

1. A cefotaxime sodium injection formulation, characterized in that, By weight, it includes the following components: 5 parts cefoperazone sodium, 0.2-0.4 parts aqueous alcohol extract of traditional Chinese medicine, 0.3-0.8 parts pH adjuster, 0.5-1 part suspending agent, and 15-20 parts 0.9% sodium chloride injection. The aqueous and alcoholic extract of the traditional Chinese medicine is obtained by mixing Ganoderma lucidum spore powder and Belamcanda chinensis powder in a mass ratio of 1-3:1, followed by water extraction and three alcohol extractions. The preparation method includes the following steps: A1. Add the Ganoderma lucidum spore powder and Belamcanda chinensis powder to a multi-functional extraction tank, add 12 times and 10 times the amount of purified water respectively, and extract twice. Each time, turn on the steam heating and keep the whole process at a slight boil. After filtering the two extracts, put them into a concentrator, turn on the circulating cooling water of the concentrator, turn on the vacuum pump, and turn on the steam. The vacuum is controlled at 0.06MPa, the steam pressure is within 0.1MPa, and the temperature is 80±5℃. Concentrate under reduced pressure to concentrate the extract to a relative density of 1.11-1.14 to obtain the water extract concentrate. A2. Using ethanol, the water extract concentrate described in A1 is subjected to three consecutive alcohol precipitation and evaporation treatments using an alcohol precipitation tank and a single-effect concentrator: First, 85% ethanol is added under stirring to make the alcohol content 70%, and the mixture is cooled and precipitated for 48 hours. Then, the ethanol is recovered completely within a steam pressure of 0.09 MPa, and the mixture is further concentrated to a relative density of 1.09-1.

1. The second time, 90% ethanol was added under stirring to make the alcohol content 75%, and the mixture was allowed to settle for 48 hours. Then, the ethanol was recovered completely at a steam pressure of 0.09 MPa. The third time, 95% ethanol was added under stirring to make the alcohol content 80%, and the mixture was allowed to settle for 48 hours. Then, the ethanol was recovered completely at a steam pressure of 0.09 MPa. A3. The alcohol extract obtained in A2 is concentrated in a single-effect concentrator until the relative density is 1.05-1.08, thus obtaining the water-alcohol extract of traditional Chinese medicine. The suspending agent is prepared by mixing tragacanth gum, gum arabic and hydroxyethyl cellulose in a mass ratio of 1:1:0.8-2; The pH adjuster is prepared by mixing equal volumes of 1% sodium dihydrogen phosphate solution and 0.8% disodium hydrogen phosphate solution; When using, the cefotaxime sodium for injection should be diluted with the 0.9% sodium chloride injection solution according to the actual situation.

2. The cefoperazone sodium preparation for injection according to claim 1, characterized in that, By weight, it includes the following components: 5 parts cefoperazone sodium, 0.3 parts traditional Chinese medicine alcohol extract, 0.3-0.8 parts pH stabilizer, 0.7 parts suspending agent, and 15-20 parts 0.9% sodium chloride injection.

3. The cefoperazone sodium preparation for injection according to claim 2, characterized in that, By weight, it includes the following components: 5 parts cefoperazone sodium, 0.3 parts traditional Chinese medicine alcohol extract, 0.5 parts pH stabilizer, 0.7 parts suspending agent, and 15 parts injection solution.

4. The cefoperazone sodium preparation for injection according to claim 1, characterized in that, The mass ratio of the Ganoderma lucidum spore powder to the Belamcanda chinensis powder is 2:

1.

5. The cefoperazone sodium preparation for injection according to claim 1, characterized in that, The suspending agent is prepared by mixing tragacanth gum, gum arabic and hydroxyethyl cellulose in a mass ratio of 1:1:

1.

6. A method for preparing a cefoperazone sodium injection formulation, characterized in that, The preparation of the cefoperazone sodium formulation for injection as described in any one of claims 1-5 specifically includes the following steps: S1. Mix the water-alcohol extract of traditional Chinese medicine, the suspending agent and the injection solution evenly to obtain a mixture; S2. First, add a pH adjuster to the mixture obtained in S1 and mix well. Then add cefoperazone sodium and mix well to obtain cefoperazone sodium preparation for injection.

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