A compound emulsion and a preparation method thereof

Abstract

The present application belongs to the field of preparation, and particularly relates to a compound emulsion and a preparation method thereof. The compound emulsion provided by the present application comprises the following components: simethicone, procaine hydrochloride, polyoxyl 40 stearate, glycerin monostearate, sodium carboxymethyl cellulose, a bacteriostatic agent, a pH regulator, a flavoring agent and water; wherein the content of the simethicone is 4 g%, the content of the procaine hydrochloride is 0.3%, the content of the polyoxyl 40 stearate is 0.8-1%, the content of the glycerin monostearate is 0.8-1%, and the content of the sodium carboxymethyl cellulose is 0.6-1.6%; the pH of the compound emulsion is 4.8-5.2, the emulsion droplet particle size D 10 is 1-3 microns, the emulsion droplet particle size D 50 is 3-6 microns, and the emulsion droplet particle size D 90 is 6-20 microns. The compound emulsion contains both the simethicone with defoaming capacity and the procaine hydrochloride with local anesthetic effect, and the emulsion has suitable particle size distribution and stable quality.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparations, and particularly relates to a compound emulsion and its preparation method. Background Technology

[0002] Simethicone is a complex of dimethyl polysiloxane and silica. It is also a stable surfactant that can change the surface tension of foam, causing it to break and release, and finally be excreted through intestinal peristalsis. It is mainly used as a routine adjuvant medication before gastroscopy and to treat discomfort symptoms caused by excessive gas accumulation in the gastrointestinal tract, such as bloating.

[0003] Procaine hydrochloride is a local anesthetic widely used clinically for various anesthetic methods, including infiltration anesthesia, nerve block anesthesia, subarachnoid anesthesia, and epidural anesthesia. It blocks the generation and transmission of nerve impulses, thus temporarily eliminating local pain sensation. However, some adverse reactions may occur during use, such as allergic reactions in some patients. Additionally, in certain surgical settings, such as gastrointestinal surgery, the surgical field may be interfered with by factors such as gas and mucus within the gastrointestinal tract.

[0004] Currently, simethicone and procaine hydrochloride are widely used in clinical practice as routine adjuvant medications before gastroscopy. However, the use of the two separately has certain limitations in terms of ease of operation and synergistic effect, and there are no reports of compound preparations combining the two. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to provide a compound emulsion and its preparation method, wherein the compound emulsion contains both simethicone oil with defoaming ability and procaine hydrochloride with local anesthetic effect, and the emulsion has a suitable particle size distribution and stable quality.

[0006] This invention provides a compound emulsion comprising the following components: simethicone, procaine hydrochloride, polyoxyethylene stearate 40, glyceryl monostearate, sodium carboxymethyl cellulose, an antibacterial agent, a pH adjuster, a flavoring agent, and water; wherein the simethicone has a mass-volume percentage of 4g, the procaine hydrochloride has a mass-volume percentage of 0.3%, the polyoxyethylene stearate 40 has a mass-volume percentage of 0.8-1%, the glyceryl monostearate has a mass-volume percentage of 0.8-1%, and the sodium carboxymethyl cellulose has a mass-volume percentage of 0.6-1.6%.

[0007] The compound emulsion has a pH of 4.8–5.2 and a droplet size D. 10 1–3 μm, D 50 3–6 μm, D 90 Its size is 6–20 μm.

[0008] Preferably, the antibacterial agent is one or more of sorbic acid, potassium sorbate, benzoic acid, and sodium benzoate.

[0009] Preferably, the antibacterial agent has a mass-volume percentage of 0.02% to 0.2%.

[0010] Preferably, the pH adjuster is one or more of sodium hydroxide, potassium hydroxide, and triethanolamine.

[0011] Preferably, the flavoring agent is one or more of sorbitol, acesulfame potassium, sodium saccharin, and flavoring.

[0012] Preferably, the flavoring agent has a mass-volume percentage of 0.01% to 0.1%.

[0013] Preferably, the viscosity of the compound emulsion at 25°C is 150–300 mPa·s.

[0014] This invention provides a method for preparing the compound emulsion described above, comprising the following steps:

[0015] a) Mix sodium carboxymethyl cellulose, antibacterial agent and water to obtain an aqueous mixture;

[0016] b) Mix polyoxyethylene stearate 40, glyceryl monostearate and simethicone oil and heat to 75-80°C, keep warm and mix until melted to obtain an oil phase mixture;

[0017] There is no specific order between steps a) and b).

[0018] c) Take a portion of the aqueous phase mixture, heat it to 75-80°C, and then mix it with the oil phase mixture, homogenize it, and obtain the primary emulsion;

[0019] d) Mix procaine hydrochloride and flavoring agent with the remaining aqueous mixture, then mix with the colostrum, then add pH adjuster, and finally add water to make up to volume and mix to obtain compound emulsion.

[0020] Preferably, in step a), the amount of water used is 75-85 wt% of the total water content of the compound emulsion; in step c), the amount of the aqueous phase mixture used is 8-15 wt% of the total amount of the aqueous phase mixture.

[0021] Preferably, in step c), the mixing speed is 1000-1500 rpm, the mixing time is 5-15 min, the homogenization pressure is 200-500 bar, and the homogenization time is 20-40 min; in step d), the stirring speed for constant volume mixing is 300-1000 rpm, and the mixing time for constant volume mixing is 5-15 min.

[0022] Compared with the prior art, the present invention provides a compound emulsion and its preparation method. The compound emulsion provided by the present invention comprises the following components: simethicone, procaine hydrochloride, polyoxyethylene stearate 40, glyceryl monostearate, sodium carboxymethyl cellulose, antibacterial agent, pH adjuster, flavoring agent, and water; wherein the mass-volume percentage of simethicone is 4g, the mass-volume percentage of procaine hydrochloride is 0.3%, the mass-volume percentage of polyoxyethylene stearate 40 is 0.8-1%, the mass-volume percentage of glyceryl monostearate is 0.8-1%, and the mass-volume percentage of sodium carboxymethyl cellulose is 0.6-1.6%; the pH of the compound emulsion is 4.8-5.2, and the droplet particle size D... 10 1–3 μm, D 50 3–6 μm, D 90 The particle size is 6–20 μm. This invention optimizes the composition and preparation method of a simethicone-procaine hydrochloride compound emulsion, resulting in a compound emulsion with suitable particle size distribution, stable quality, and a simple preparation process suitable for industrial application. The compound emulsion provided by this invention contains both simethicone with defoaming properties and procaine hydrochloride with local anesthetic effects, showing broad application prospects, including but not limited to:

[0023] (1) Anesthesia and visual field improvement in gastrointestinal surgery: In gastrointestinal surgery, on the one hand, procaine hydrochloride can play a local anesthetic role and reduce the pain caused by surgical operation; on the other hand, simethicone can effectively eliminate foam and mucus in the gastrointestinal tract, reduce gas interference, create a clear visual field for surgery, and facilitate the smooth progress of surgery.

[0024] (2) Endoscopic examination related anesthesia and field of vision optimization: When performing endoscopic examinations (such as gastroscopy, colonoscopy, etc.) and local anesthesia is required, this emulsion can simultaneously meet the needs of anesthesia and removal of interfering objects in the field of vision, thereby improving the accuracy of the examination and the patient's comfort. Detailed Implementation

[0025] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0026] This invention provides a compound emulsion comprising the following components: simethicone, procaine hydrochloride, polyoxyethylene stearate 40, glyceryl monostearate, sodium carboxymethyl cellulose, antibacterial agent, pH adjuster, flavoring agent, and water.

[0027] In the compound emulsion provided by the present invention, the mass-volume percentage of simethicone oil is 4%, i.e., 4g / 100mL; and the mass-volume percentage of procaine hydrochloride is 0.3%, i.e., 0.3g / 100mL.

[0028] In the compound emulsion provided by this invention, the mass-volume percentage of stearic acid polyoxyethylene 40 ester is 0.8% to 1%, i.e., 0.8 g / 100 mL to 1 g / 100 mL, specifically 0.8%, 0.81%, 0.82%, 0.83%, 0.84%, 0.85%, 0.86%, 0.87%, 0.88%, 0.89%, 0.9%, 0.91%, 0.92%, 0.93%, 0.94%, 0.95%, 0.96%, 0.97%, 0.98%, 0.99%, or 1%.

[0029] In the compound emulsion provided by this invention, the content of glyceryl monostearate is 0.8% to 1%, that is, 0.8g / 100mL to 1g / 100mL, specifically 0.8%, 0.81%, 0.82%, 0.83%, 0.84%, 0.85%, 0.86%, 0.87%, 0.88%, 0.89%, 0.9%, 0.91%, 0.92%, 0.93%, 0.94%, 0.95%, 0.96%, 0.97%, 0.98%, 0.99%, or 1%.

[0030] In the compound emulsion provided by this invention, the content of sodium carboxymethyl cellulose is 0.6% to 1.6%, that is, 0.6g / 100mL to 1.6g / 100mL, specifically 0.6%, 0.65%, 0.7%, 0.75%, 0.8%, 0.85%, 0.9%, 0.95%, 1%, 1.05%, 1.1%, 1.15%, 1.2%, 1.25%, 1.3%, 1.35%, 1.4%, 1.45%, 1.5%, 1.55%, or 1.6%.

[0031] In the compound emulsion provided by this invention, the antibacterial agent is preferably one or more selected from sorbic acid, potassium sorbate, benzoic acid, and sodium benzoate. The content of the antibacterial agent is preferably 0.02-0.2%, i.e., 0.02 g / 100 mL to 0.2 g / 100 mL, specifically 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.11%, 0.12%, 0.13%, 0.14%, 0.15%, 0.16%, 0.17%, 0.18%, 0.19%, or 0.2%.

[0032] In the compound emulsion provided by this invention, the pH adjuster is preferably one or more of sodium hydroxide, potassium hydroxide, and triethanolamine. The pH adjuster controls the pH value of the compound emulsion to be between 4.8 and 5.2, specifically 4.8, 4.9, 5, 5.1, or 5.2.

[0033] In the compound emulsion provided by this invention, the flavoring agent is preferably one or more of sorbitol, acesulfame potassium, sodium saccharin, and flavoring. The content of the flavoring agent is preferably 0.01-0.1%, i.e., 0.01g / 100mL-0.1g / 100mL, specifically 0.01%, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0.04%, 0.045%, 0.05%, 0.055%, 0.06%, 0.065%, 0.07%, 0.075%, 0.08%, 0.085%, 0.09%, 0.095%, or 0.1%.

[0034] In the compound emulsion provided by the present invention, the droplet size D of the compound emulsion is... 10 Preferably, the droplet size is 1–3 μm, specifically 1 μm, 1.1 μm, 1.2 μm, 1.3 μm, 1.4 μm, 1.5 μm, 1.6 μm, 1.7 μm, 1.8 μm, 1.9 μm, 2 μm, 2.1 μm, 2.2 μm, 2.3 μm, 2.4 μm, 2.5 μm, 2.6 μm, 2.7 μm, 2.8 μm, 2.9 μm, or 3 μm; the droplet size D of the compound emulsion is... 50 3 to 6 μm, specifically 3 μm, 3.1 μm, 3.2 μm, 3.3 μm, 3.4 μm, 3.5 μm, 3.6 μm, 3.7 μm, 3.8 μm, 3.9 μm, 4 μm, 4.1 μm, 4.2 μm, 4.3 μm, 4.4 μm, 4.5 μm, 4.6 μm, 4.7 μm, 4.8 μm, 4.9 μm, 5 μm, 5.1 μm, 5.2 μm, 5.3 μm, 5.4 μm, 5.5 μm, 5.6 μm, 5.7 μm, 5.8 μm, 5.9 μm or 6 μm; the emulsion droplet size D of the compound emulsion 90 The micrometer size ranges from 6 to 20 μm, specifically 6 μm, 6.5 μm, 7 μm, 7.5 μm, 8 μm, 8.5 μm, 9 μm, 9.5 μm, 10 μm, 10.5 μm, 11 μm, 11.5 μm, 12 μm, 12.5 μm, 13 μm, 13.5 μm, 14 μm, 14.5 μm, 15 μm, 15.5 μm, 16 μm, 16.5 μm, 17 μm, 17.5 μm, 18 μm, 18.5 μm, 19 μm, 19.5 μm, or 20 μm.

[0035] In the compound emulsion provided by this invention, the viscosity of the compound emulsion at 25°C is preferably 150–300 mPa·s, specifically 150 mPa·s, 155 mPa·s, 160 mPa·s, 165 mPa·s, 170 mPa·s, 175 mPa·s, 180 mPa·s, 185 mPa·s, 190 mPa·s, 195 mPa·s, 200 mPa·s, 205 mPa·s, 210 mPa·s. 215mPa.s, 220mPa.s, 225mPa.s, 230mPa.s, 235mPa.s, 240mPa.s, 245mPa.s, 250mPa.s, 255mPa.s, 260mPa.s, 265mPa.s, 270mPa.s, 275mPa.s, 280mPa.s, 285mPa.s, 290mPa.s, 295mPa.s or 300mPa.s.

[0036] This invention also provides a method for preparing the compound emulsion described above, comprising the following steps:

[0037] a) Mix sodium carboxymethyl cellulose, antibacterial agent and water to obtain an aqueous mixture;

[0038] b) Mix polyoxyethylene stearate 40, glyceryl monostearate and simethicone oil and heat to 75-80°C, keep warm and mix until melted to obtain an oil phase mixture;

[0039] There is no specific order between steps a) and b).

[0040] c) Take a portion of the aqueous phase mixture, heat it to 75-80°C, and then mix it with the oil phase mixture, homogenize it, and obtain the primary emulsion;

[0041] d) Mix procaine hydrochloride and flavoring agent with the remaining aqueous mixture, then mix with the colostrum, then add pH adjuster, and finally add water to make up to volume and mix to obtain compound emulsion.

[0042] In the preparation method provided by the present invention, in step a), the amount of water used is preferably 75-85 wt% of the total water content of the compound emulsion, specifically 75 wt%, 76 wt%, 77 wt%, 78 wt%, 79 wt%, 80 wt%, 81 wt%, 82 wt%, 83 wt%, 84 wt%, or 85 wt%; the aqueous phase mixture is a clear viscous liquid.

[0043] In the preparation method provided by the present invention, in step b), the heating temperature can specifically be 75°C, 76°C, 77°C, 78°C, 79°C or 80°C.

[0044] In the preparation method provided by the present invention, in step c), the amount of the aqueous phase mixture is preferably 8 to 15 wt% of the total amount of the aqueous phase mixture, specifically 8 wt%, 9 wt%, 10 wt%, 11 wt%, 12 wt%, 13 wt%, 14 wt%, or 15 wt%.

[0045] In the preparation method provided by the present invention, in step c), the heating temperature can specifically be 75°C, 76°C, 77°C, 78°C, 79°C or 80°C.

[0046] In the preparation method provided by the present invention, in step c), the stirring speed for mixing is preferably 1000-1500 rpm, specifically 1000 rpm, 1050 rpm, 1100 rpm, 1150 rpm, 1200 rpm, 1250 rpm, 1300 rpm, 1350 rpm, 1400 rpm, 1450 rpm or 1500 rpm; the mixing time is preferably 5-15 min, specifically 5 min, 6 min, 7 min, 8 min, 9 min, 10 min, 11 min, 12 min, 13 min, 14 min or 15 min.

[0047] In the preparation method provided by the present invention, in step c), the homogenization is carried out in a homogenizer in a cyclic manner; the homogenization pressure is preferably 200-500 bar, specifically 200 bar, 230 bar, 250 bar, 270 bar, 300 bar, 320 bar, 350 bar, 370 bar, 400 bar, 420 bar, 450 bar, 470 bar or 500 bar; the homogenization time is preferably 20-40 min, specifically 20 min, 21 min, 22 min, 23 min, 24 min, 25 min, 26 min, 27 min, 28 min, 29 min, 30 min, 31 min, 32 min, 33 min, 34 min, 35 min, 36 min, 37 min, 38 min, 39 min or 40 min.

[0048] In the preparation method provided by the present invention, in step d), the mixing with the primary emulsion is preferably carried out in an emulsifier; the processing time of the emulsifier is preferably 5 to 15 min, specifically 5 min, 6 min, 7 min, 8 min, 9 min, 10 min, 11 min, 12 min, 13 min, 14 min or 15 min.

[0049] In the preparation method provided by the present invention, in step d), the stirring speed for volumetric mixing is preferably 300-1000 rpm, specifically 300 rpm, 350 rpm, 400 rpm, 450 rpm, 500 rpm, 550 rpm, 600 rpm, 650 rpm, 700 rpm, 750 rpm, 800 rpm, 850 rpm, 900 rpm, 950 rpm, or 1000 rpm; the mixing time for volumetric mixing is preferably 5-15 min, specifically 5 min, 6 min, 7 min, 8 min, 9 min, 10 min, 11 min, 12 min, 13 min, 14 min, or 15 min.

[0050] For clarity, the following examples will be used to provide a detailed description.

[0051] Example 1

[0052] Simethicone-procaine hydrochloride compound emulsion, formulation shown in Table 1:

[0053] Table 1. Formulation of Simethicone Hydrochloride Compound Emulsion in Example 1

[0054]

[0055]

[0056] This embodiment uses Table 1 as the formula and prepares the pharmaceutical preparation using the following method:

[0057] (1) Weigh out the formula amount of sodium carboxymethyl cellulose and antibacterial agent (sorbic acid), add them to 80wt% of purified water, and stir until a uniform, clear, viscous liquid is formed to obtain an aqueous phase;

[0058] (2) Weigh out the formula amount of emulsifiers stearic acid polyoxyethylene 40 ester and glyceryl monostearate, add the formula amount of simethicone oil, heat to 75°C, stir until melted, and obtain an oil phase emulsifier mixture.

[0059] (3) Take 10wt% of the aqueous phase, heat it to 75℃, add it to the oil phase emulsifier mixture, stir and mix it for 10min with an electric mixer at 1000rpm, and then circulate it for 30min with a homogenizer at 200bar to obtain the initial emulsion.

[0060] (4) Weigh out the formula amount of procaine hydrochloride and flavoring agent (sodium saccharin) and add them to the remaining aqueous phase. After stirring and mixing evenly, add all the initial milk and process it in an emulsifier for 10 minutes. Add pH adjuster to adjust the pH of the solution to about 5.0.

[0061] (5) Add purified water to make up to the total volume, and mix with an electric mixer at 300 rpm for 10 minutes to obtain the final product.

[0062] Example 2

[0063] Simethicone-procaine hydrochloride compound emulsion, formulation shown in Table 2:

[0064] Table 2. Formulation of Simethicone Hydrochloride Compound Emulsion in Example 2

[0065] raw materials Dosage mass-volume percentage Simethicone 80g 4％ Procaine hydrochloride 6g 0.3％ Poly(hydroxyl) stearate 40 18g 0.9％ Glyceryl monostearate 18g 0.9％ Sodium carboxymethyl cellulose 24g 1.2％ Sorbic acid 2g 0.1％ Sodium hydroxide Appropriate amount Appropriate amount Sodium saccharin 0.8g 0.04％ Purified water Up to 2000mL Up to 2000mL

[0066] The preparation method in this embodiment is the same as in Embodiment 1.

[0067] Example 3

[0068] Simethicone-procaine hydrochloride compound emulsion, formulation shown in Table 3:

[0069] Table 3. Formulation of Simethicone Hydrochloride Compound Emulsion in Example 3

[0070] raw materials Dosage mass-volume percentage Simethicone 80g 4％ Procaine hydrochloride 6g 0.3％ Poly(hydroxyl) stearate 40 18g 0.9％ Glyceryl monostearate 18g 0.9％ Sodium carboxymethyl cellulose 26g 1.3％ Sorbic acid 2g 0.1％ Sodium hydroxide Appropriate amount Appropriate amount Sodium saccharin 0.8g 0.04％ Purified water Up to 2000mL Up to 2000mL

[0071] The preparation method in this embodiment is the same as in Embodiment 1.

[0072] Example 4

[0073] Simethicone-procaine hydrochloride compound emulsion, the formula is shown in Table 4:

[0074] Table 4. Formulation of Simethicone Hydrochloride Compound Emulsion in Example 4

[0075] raw materials Dosage mass-volume percentage Simethicone 80g 4％ Procaine hydrochloride 6g 0.3％ Poly(hydroxyl) stearate 40 16g 0.8％ Glyceryl monostearate 16g 0.8％ Sodium carboxymethyl cellulose 24g 1.2％ Sorbic acid 2g 0.1％ Sodium hydroxide Appropriate amount Appropriate amount Sodium saccharin 0.8 0.04％ Purified water Up to 2000mL Up to 2000mL

[0076] The preparation method in this embodiment is the same as in Embodiment 1.

[0077] Example 5

[0078] Simethicone-procaine hydrochloride compound emulsion, formulation shown in Table 5:

[0079] Table 5. Formulation of Simethicone Hydrochloride Compound Emulsion in Example 5

[0080]

[0081]

[0082] The preparation method in this embodiment is the same as in Embodiment 1.

[0083] Performance Evaluation

[0084] (1) Product quality testing was conducted on the simethicone-procaine hydrochloride compound emulsions prepared in Examples 1-5. The test items included viscosity, particle size distribution, pH value, emulsion stability, and defoaming ability. The test results are shown in Table 6:

[0085] Table 6. Quality test results of the simethicone-procaine hydrochloride compound emulsion products prepared in Examples 1-5.

[0086]

[0087] Comparing the results of Examples 1-3 in Table 6, it can be seen that the thickener dosage (mass-volume percentage) of the three batches of samples was 1.1%, 1.2%, and 1.3%, which led to significant differences in the viscosity of the samples, but all were within the target range, i.e., they met the viscosity quality requirements. At the same time, the quality indicators of the three batches of samples, such as pH value, particle size distribution, emulsion stability, defoaming ability, simethicone content, and procaine hydrochloride content, all met the requirements, and no significant differences or gradient changes were found. This indicates that the current preparation process has good universality and is conducive to the smooth progress of production scale-up.

[0088] Comparing the results of Examples 2, 4, and 5 in Table 6, it can be seen that the total emulsifier content (mass-volume percentage) of the three batches of samples was 1.8%, 1.6%, and 2.0%, respectively. The mass ratio of poly(hydroxyl) stearate 40 ester to glyceryl monostearate was 1:1. There was no difference in mass among the three batches of samples, and all indicators met the requirements. This indicates that the dosage of poly(hydroxyl) stearate 40 ester and glyceryl monostearate emulsifiers in the range of 0.8% to 1.0% can meet the preparation requirements of the current process, further proving the rationality and good adaptability of the current process.

[0089] (2) The simethicone hydrochloride compound emulsions prepared in Examples 1-5 were placed at 60°C for 30 days, and the product quality was tested. The test results are shown in Table 7.

[0090] Table 7. Quality test results of simethicone-procaine hydrochloride compound emulsion products prepared in Examples 1-5 during the stability study at 60℃ for 30 days.

[0091] Testing items Target Example 1 Example 2 Example 3 Example 4 Example 5 pH value 4.8-5.2 5.0 5.0 5.0 5.0 5.0 Emulsion stability Centrifugation without stratification No layering No layering No layering No layering No layering Defoaming ability No less than 80% 99.8％ 99.6％ 99.2％ 98.9％ 99.5％ Simethicone content 90％-110％ 102.2％ 102.4％ 101.9％ 101.5％ 101.8％ Procaine hydrochloride content 97％-103％ 98.7％ 98.9％ 99.7％ 99.5％ 99.3％

[0092] The experimental results in Table 7 show that after one month of accelerated testing, all quality indicators of the samples in Examples 1 to 5 met the quality requirements, and there was no significant change compared with the results on day 0 (Table 6), indicating that the simethicone hydrochloride procaine compound defoaming emulsion prepared according to the formulation process of this invention has stable quality.

[0093] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A compound emulsion, characterized in that, The product comprises the following ingredients: simethicone, procaine hydrochloride, polyoxyethylene stearate 40, glyceryl monostearate, sodium carboxymethyl cellulose, antibacterial agent, pH adjuster, flavoring agent, and water; wherein the simethicone has a mass-volume percentage of 4g, the procaine hydrochloride has a mass-volume percentage of 0.3%, the polyoxyethylene stearate 40 has a mass-volume percentage of 0.8-1%, the glyceryl monostearate has a mass-volume percentage of 0.8-1%, and the sodium carboxymethyl cellulose has a mass-volume percentage of 0.6-1.6%. The pH of the compound emulsion is 4.8-5.2, the droplet size D 10 is 1-3 μm, D 50 is 3-6 μm, D 90 is 6-20 μm.

2. The compound emulsion according to claim 1, characterized in that, The antibacterial agent is one or more of sorbic acid, potassium sorbate, benzoic acid, and sodium benzoate.

3. The compound emulsion according to claim 2, characterized in that, The antibacterial agent has a mass-volume percentage of 0.02% to 0.2%.

4. The compound emulsion according to claim 1, characterized in that, The pH adjuster is one or more of sodium hydroxide, potassium hydroxide, and triethanolamine.

5. The compound emulsion according to claim 1, characterized in that, The flavoring agent is one or more of sorbitol, acesulfame potassium, sodium saccharin, and flavoring.

6. The compound emulsion according to claim 5, characterized in that, The flavoring agent has a mass-volume percentage of 0.01% to 0.1%.

7. The compound emulsion according to claim 1, characterized in that, The viscosity of the compound emulsion at 25°C is 150–300 mPa·s.

8. A method for preparing the compound emulsion according to any one of claims 1 to 7, characterized in that, Includes the following steps: a) Mix sodium carboxymethyl cellulose, antibacterial agent and water to obtain an aqueous mixture; b) Mix polyoxyethylene stearate 40, glyceryl monostearate and simethicone oil and heat to 75-80°C, keep warm and mix until melted to obtain an oil phase mixture; There is no specific order between steps a) and b). c) Take a portion of the aqueous phase mixture, heat it to 75-80°C, and then mix it with the oil phase mixture, homogenize it, and obtain the primary emulsion; d) Mix procaine hydrochloride and flavoring agent with the remaining aqueous mixture, then mix with the colostrum, then add pH adjuster, and finally add water to make up to volume and mix to obtain compound emulsion.

9. The preparation method according to claim 8, characterized in that, In step a), the amount of water used is 75-85 wt% of the total water content of the compound emulsion; in step c), the amount of the aqueous phase mixture used is 8-15 wt% of the total amount of the aqueous phase mixture.

10. The preparation method according to claim 8, characterized in that, In step c), the mixing speed is 1000-1500 rpm, the mixing time is 5-15 min, the homogenization pressure is 200-500 bar, and the homogenization time is 20-40 min; in step d), the stirring speed for constant volume mixing is 300-1000 rpm, and the mixing time for constant volume mixing is 5-15 min.

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