Dimethylcaine compound preparation and preparation method thereof

Abstract

The invention provides a dimethylcaine compound preparation and a preparation method thereof. Every 100 parts of the compound preparation comprises the following raw materials in parts by weight: 2 to 5 parts of dimethylcaine and 2 to 5 parts of trimethylcaine. The dimethylcaine compound preparation contains chlorhexidine gluconate, Tween 80, oleic acid, polyethylene glycol 400 and purified water, and every 100 parts of the compound preparation is prepared from the following raw materials in parts by weight: 2 to 5 parts of dimethylcaine, 2 to 5 parts of trimethylcaine, 0.1 to 0.3 part of chlorhexidine gluconate, 4 to 6 parts of Tween 80, 4 to 6 parts of oleic acid, 15 to 25 parts of polyethylene glycol 400 and the balance of purified water. Dimethylcaine and trimethylcaine are compounded, so that the blocking effect can be effectively enhanced, the anesthetic effect can be synergistically improved, the anesthetic dosage can be reduced, the side effect can be reduced, and the safety can be improved. Secondly, polyvinylpyrrolidone K90, polyglycerol ester and ascorbic acid in a specific proportion are added, so that the bioavailability of the anesthetic is further improved, the anesthetic effect is enhanced, and meanwhile, the stability of the anesthetic is further improved.

Description

Technical Field

[0001] The present invention relates to the field of anesthetics, and in particular to a dimethocaine compound preparation and a preparation method thereof. Background Art

[0002] Local anesthetics play a vital role in the medical field, especially in surgical operations, dental treatments and other invasive procedures. Effective local anesthesia can significantly improve patient comfort and reduce postoperative pain and discomfort, thereby increasing the success rate of treatment and patient satisfaction. Local anesthetics include lidocaine, bupivacaine, prilocaine, chloroprocaine, dimethocaine, trimecaine, etc.

[0003] Dimethocaine is an aminoester local anesthetic with the advantage of rapid and long-lasting anesthetic effect. However, the relatively high toxicity and potential allergic reactions of dimethocaine limit its widespread clinical application. At the same time, the discomfort and side effects that may be caused by its local application also need to be paid attention to.

[0004] Trimethocaine is a newer local anesthetic with good anesthetic effect and low toxicity, suitable for local anesthesia and topical anesthesia. Compared with dimethocaine, trimethocaine has fewer side effects, but its anesthetic intensity and duration may not be as good as dimethocaine in some cases.

[0005] The physicochemical properties and pharmacological characteristics of dimethocaine and trimecaine are unique. Dimethocaine and trimecaine differ in chemical structure and pharmacological action. When compounding, problems such as compatibility need to be overcome to avoid adverse reactions or affect efficacy.

[0006] At present, there is still a lack of systemic compound preparations for dimethocaine on the market, so the development of a new compound preparation of dimethocaine has important clinical significance and application value. This compound preparation can not only improve the reliability of local anesthesia, but also reduce the pain and anxiety of patients during surgery. In addition, the optimized preparation method will help improve the stability and biocompatibility of the drug, thus providing a safe and effective new option for clinical practice.

[0007] In summary, by developing a dimethocaine compound preparation, better effects can be achieved in local anesthesia, meeting the clinical demand for efficient and safe anesthetic drugs, which is of great significance to improving patients' treatment experience. Summary of the invention

[0008] In view of this, the present invention provides a dimethocaine composite preparation and a preparation method thereof to solve the above problems.

[0009] The invention can provide a rapid and effective anesthetic effect by compounding dimethocaine and trimecaine, and can also reduce toxicity and adverse reactions, thereby improving the safety and effectiveness of local anesthesia.

[0010] The technical solution of the present invention is achieved in this way:

[0011] A dimethocaine compound preparation contains the following raw materials in parts by weight per 100 parts of the compound preparation: 2-5 parts of dimethocaine and 2-5 parts of trimecaine.

[0012] A further technical solution is that the dimethocaine compound preparation contains chlorhexidine gluconate, Tween 80, oleic acid, polyethylene glycol 400, and purified water, and each 100 parts of the compound preparation includes the following raw material components in parts by weight: 2-5 parts of dimethocaine, 2-5 parts of trimecaine, 0.1-0.3 parts of chlorhexidine gluconate, 4-6 parts of Tween 80, 4-6 parts of oleic acid, 15-25 parts of polyethylene glycol 400, and the balance purified water.

[0013] A further technical solution is that the dimethocaine compound preparation also contains a compounding auxiliary agent, and the compounding auxiliary agent is composed of the following components: polyvinyl pyrrolidone K90, polyglycerol ester, and ascorbic acid.

[0014] A further technical solution is that the mass ratio of polyvinyl pyrrolidone K90, polyglycerol ester and ascorbic acid in the compound auxiliary agent is 1:1.5-2.5:6.5-7.5.

[0015] A further technical solution is that every 100 parts of the composite preparation includes the following raw materials in parts by weight: 2-5 parts of dimethocaine, 2-5 parts of trimecaine, 0.1-0.3 parts of chlorhexidine gluconate, 4-6 parts of Tween 80, 4-6 parts of oleic acid, 15-20 parts of polyethylene glycol 400, 1-2 parts of a compounding auxiliary agent, and the balance of purified water.

[0016] The present invention also provides a method for preparing a dimethocaine composite preparation, comprising the following steps:

[0017] (1) Weighing polyethylene glycol 400, oleic acid, Tween 80, and chlorhexidine gluconate according to the prescribed amount, mixing and stirring to obtain solution A;

[0018] (2) Weigh the prescribed amount of dimethocaine and trimecaine, add them to solution A, heat to 35-40° C., and stir for 4-10 minutes to obtain solution B;

[0019] (3) Weigh the prescribed amount of purified water and add it to solution B while stirring. After the purified water is added, adjust the pH value to 6-9 with hydrochloric acid solution to obtain the target anesthetic solution.

[0020] The present invention also provides another method for preparing a dimethocaine composite preparation, comprising the following steps:

[0021] (1) Weighing polyethylene glycol 400, oleic acid, Tween 80, and chlorhexidine gluconate according to the prescribed amount, mixing and stirring to obtain solution A;

[0022] (2) Weigh the prescribed amount of dimethocaine, trimecaine and compounding auxiliary agent, add them to solution A, heat to 35-40° C., and stir for 4-10 minutes to obtain solution B;

[0023] (3) Weigh the prescribed amount of purified water and add it to solution B while stirring. After the purified water is added, adjust the pH value to 6-9 with hydrochloric acid solution to obtain the target anesthetic solution.

[0024] A further technical solution is that the concentration of the hydrochloric acid solution is 0.05-0.2 mol / L.

[0025] Compared with the prior art, the present invention has the following beneficial effects:

[0026] The dimethocaine composite preparation (concentration 2%-5%+2%-5%) prepared by the present invention not only has a rapid anesthetic onset at a lower anesthetic drug concentration, but also can maintain a good anesthetic duration, and has a better comprehensive anesthetic effect.

[0027] The present invention adopts dimethocaine and trimecaine for compounding, which can effectively enhance the blocking effect, synergistically improve the anesthetic effect, reduce the dosage of anesthetic drugs, reduce side effects, and improve safety. Among them, dimethocaine and trimecaine may act on the sodium channel on the nerve cell membrane through different mechanisms, thereby enhancing the blocking effect and prolonging the anesthesia time; because the toxicity of trimecaine is relatively low, when used in combination with dimethocaine, it may help to reduce the dosage of the overall anesthetic drug, thereby reducing the risk of side effects; through synergistic action, dimethocaine and trimecaine may reduce the potential harm to patients while maintaining the anesthetic effect.

[0028] The invention adds polyvinyl pyrrolidone K90, polyglycerol ester and ascorbic acid in a specific ratio, so as to further improve the bioavailability of anesthetic drugs, enhance the anesthetic effect and further improve the stability of anesthetic drugs. DETAILED DESCRIPTION

[0029] In order to better understand the technical content of the present invention, specific embodiments are provided below to further illustrate the present invention.

[0030] Unless otherwise specified, the experimental methods used in the embodiments of the present invention are all conventional methods.

[0031] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial sources.

[0032] Example 1 (concentration 4%+4%)

[0033] A dimethocaine compound preparation, wherein every 100 parts of the compound preparation comprises the following raw materials in parts by weight: 4 parts of dimethocaine, 4 parts of trimecaine, 0.2 parts of chlorhexidine gluconate, 5 parts of Tween 80, 5 parts of oleic acid, 20 parts of polyethylene glycol 400, and the balance of purified water.

[0034] The preparation method of the above-mentioned dimethocaine composite preparation comprises the following steps:

[0035] (1) Weighing polyethylene glycol 400, oleic acid, Tween 80, and chlorhexidine gluconate according to the prescribed amount, mixing and stirring to obtain solution A;

[0036] (2) Weigh the prescribed amount of dimethocaine and trimecaine and add them to solution A, heat to 40°C, and stir for 5 minutes to obtain solution B;

[0037] (3) Weigh the prescribed amount of purified water and add it to solution B while stirring. After the purified water is added, adjust the pH value to 7.0±0.5 with 0.1 mol / L hydrochloric acid solution to obtain the target anesthetic solution.

[0038] Example 2 (concentration 3%+3%)

[0039] A dimethocaine compound preparation comprises, per 100 parts of the compound preparation, the following raw materials in parts by weight: 3 parts of dimethocaine, 3 parts of trimecaine, 0.2 parts of chlorhexidine gluconate, 5 parts of Tween 80, 5 parts of oleic acid, 20 parts of polyethylene glycol 400, and the balance of purified water.

[0040] The preparation method of the above-mentioned dimethocaine composite preparation comprises the following steps:

[0041] (1) Weighing polyethylene glycol 400, oleic acid, Tween 80, and chlorhexidine gluconate according to the prescribed amount, mixing and stirring to obtain solution A;

[0042] (2) Weigh the prescribed amount of dimethocaine and trimecaine and add them to solution A, heat to 40°C, and stir for 5 minutes to obtain solution B;

[0043] (3) Weigh the prescribed amount of purified water and add it to solution B while stirring. After the purified water is added, adjust the pH value to 7.0±0.5 with 0.1 mol / L hydrochloric acid solution to obtain the target anesthetic solution.

[0044] Example 3 (concentration 2%+2%)

[0045] A dimethocaine compound preparation, wherein every 100 parts of the compound preparation comprises the following raw materials in parts by weight: 2 parts of dimethocaine, 2 parts of trimecaine, 0.2 parts of chlorhexidine gluconate, 5 parts of Tween 80, 5 parts of oleic acid, 20 parts of polyethylene glycol 400, and the balance of purified water.

[0046] The preparation method of the above-mentioned dimethocaine composite preparation comprises the following steps:

[0047] (1) Weighing polyethylene glycol 400, oleic acid, Tween 80, and chlorhexidine gluconate according to the prescribed amount, mixing and stirring to obtain solution A;

[0048] (2) Weigh the prescribed amount of dimethocaine and trimecaine and add them to solution A, heat to 40°C, and stir for 5 minutes to obtain solution B;

[0049] (3) Weigh the prescribed amount of purified water and add it to solution B while stirring. After the purified water is added, adjust the pH value to 7.0±0.5 with 0.1 mol / L hydrochloric acid solution to obtain the target anesthetic solution.

[0050] Example 4 (concentration 5%+5%)

[0051] A dimethocaine compound preparation, wherein every 100 parts of the compound preparation comprises the following raw materials in parts by weight: 5 parts of dimethocaine, 5 parts of trimecaine, 0.2 parts of chlorhexidine gluconate, 5 parts of Tween 80, 5 parts of oleic acid, 20 parts of polyethylene glycol 400, and the balance of purified water.

[0052] The preparation method of the above-mentioned dimethocaine composite preparation comprises the following steps:

[0053] (1) Weighing polyethylene glycol 400, oleic acid, Tween 80, and chlorhexidine gluconate according to the prescribed amount, mixing and stirring to obtain solution A;

[0054] (2) Weigh the prescribed amount of dimethocaine and trimecaine and add them to solution A, heat to 40°C, and stir for 5 minutes to obtain solution B;

[0055] (3) Weigh the prescribed amount of purified water and add it to solution B while stirring. After the purified water is added, adjust the pH value to 7.0±0.5 with 0.1 mol / L hydrochloric acid solution to obtain the target anesthetic solution.

[0056] Example 5 (concentration 2%+2%)

[0057] A dimethocaine compound preparation, wherein every 100 parts of the compound preparation comprises the following raw materials in parts by weight: 2 parts of dimethocaine, 2 parts of trimecaine, 0.2 parts of chlorhexidine gluconate, 5 parts of Tween 80, 5 parts of oleic acid, 20 parts of polyethylene glycol 400, 1.5 parts of a compounding auxiliary agent, and the balance of purified water.

[0058] The above-mentioned dimethocaine composite preparation also contains a compounding auxiliary agent, which is composed of the following components: polyvinyl pyrrolidone K90, polyglycerol ester, and ascorbic acid. The mass ratio of polyvinyl pyrrolidone K90, polyglycerol ester, and ascorbic acid in the compounding auxiliary agent is 1:2:7.

[0059] The preparation method of the above-mentioned dimethocaine composite preparation comprises the following steps:

[0060] (1) Weighing polyethylene glycol 400, oleic acid, Tween 80, and chlorhexidine gluconate according to the prescribed amount, mixing and stirring to obtain solution A;

[0061] (2) Weigh the prescribed amount of dimethocaine, trimecaine and compounding auxiliary agent, add them to solution A, heat to 35-40° C., and stir for 4-10 minutes to obtain solution B;

[0062] (3) Weigh the prescribed amount of purified water and add it to solution B while stirring. After the purified water is added, adjust the pH value to 7.0±0.5 with 0.1 mol / L hydrochloric acid solution to obtain the target anesthetic solution.

[0063] Example 6 (concentration 2%+2%)

[0064] A dimethocaine compound preparation, wherein every 100 parts of the compound preparation comprises the following raw materials in parts by weight: 2 parts of dimethocaine, 2 parts of trimecaine, 0.2 parts of chlorhexidine gluconate, 5 parts of Tween 80, 5 parts of oleic acid, 20 parts of polyethylene glycol 400, 1.0 part of a compounding auxiliary agent, and the balance of purified water.

[0065] The above-mentioned dimethocaine composite preparation also contains a compounding auxiliary agent, which is composed of the following components: polyvinyl pyrrolidone K90, polyglycerol ester, and ascorbic acid. The mass ratio of polyvinyl pyrrolidone K90, polyglycerol ester, and ascorbic acid in the compounding auxiliary agent is 1:2:7.

[0066] The preparation method of the above-mentioned dimethocaine composite preparation comprises the following steps:

[0067] (1) Weighing polyethylene glycol 400, oleic acid, Tween 80, and chlorhexidine gluconate according to the prescribed amount, mixing and stirring to obtain solution A;

[0068] (2) Weigh the prescribed amount of dimethocaine, trimecaine and compounding auxiliary agent, add them to solution A, heat to 35-40° C., and stir for 4-10 minutes to obtain solution B;

[0069] (3) Weigh the prescribed amount of purified water and add it to solution B while stirring. After the purified water is added, adjust the pH value to 7.0±0.5 with 0.1 mol / L hydrochloric acid solution to obtain the target anesthetic solution.

[0070] Example 7 (concentration 2%+2%)

[0071] A dimethocaine compound preparation, wherein every 100 parts of the compound preparation comprises the following raw materials in parts by weight: 2 parts of dimethocaine, 2 parts of trimecaine, 0.2 parts of chlorhexidine gluconate, 5 parts of Tween 80, 5 parts of oleic acid, 20 parts of polyethylene glycol 400, 2.0 parts of a compounding auxiliary agent, and the balance of purified water.

[0072] The above-mentioned dimethocaine composite preparation also contains a compounding auxiliary agent, which is composed of the following components: polyvinyl pyrrolidone K90, polyglycerol ester, and ascorbic acid. The mass ratio of polyvinyl pyrrolidone K90, polyglycerol ester, and ascorbic acid in the compounding auxiliary agent is 1:2:7.

[0073] The preparation method of the above-mentioned dimethocaine composite preparation comprises the following steps:

[0074] (1) Weighing polyethylene glycol 400, oleic acid, Tween 80, and chlorhexidine gluconate according to the prescribed amount, mixing and stirring to obtain solution A;

[0075] (2) Weigh the prescribed amount of dimethocaine, trimecaine and compounding auxiliary agent, add them to solution A, heat to 35-40° C., and stir for 4-10 minutes to obtain solution B;

[0076] (3) Weigh the prescribed amount of purified water and add it to solution B while stirring. After the purified water is added, adjust the pH value to 7.0±0.5 with 0.1 mol / L hydrochloric acid solution to obtain the target anesthetic solution.

[0077] Comparative Example 1 (concentration 8%)

[0078] This comparative example is different from Example 1 mainly in that dimethocaine is not added. A trimecaine preparation, wherein every 100 parts of the composite preparation comprises the following raw materials in parts by weight: 8 parts of trimecaine, 0.2 parts of chlorhexidine gluconate, 5 parts of Tween 80, 5 parts of oleic acid, 20 parts of polyethylene glycol 400, and the balance of purified water.

[0079] Comparative Example 2

[0080] A dimethocaine composite preparation, which is mainly different from Example 5 in that the mass ratio of polyvinyl pyrrolidone K90, polyglycerol ester and ascorbic acid in the composite auxiliary agent is 1:1:1.

[0081] Comparative Example 3

[0082] A dimethocaine composite preparation, which is mainly different from Example 5 in that every 100 parts of the composite preparation comprises the following raw material components in parts by weight: 2 parts of dimethocaine, 2 parts of trimecaine, 0.2 parts of chlorhexidine gluconate, 5 parts of Tween 80, 5 parts of oleic acid, 20 parts of polyethylene glycol 400, 3 parts of a compounding auxiliary agent, and the balance of purified water.

[0083] Test Example 1

[0084] Anesthetic: The dimethocaine compound preparations prepared in Example 3, Examples 5-7 and Comparative Examples 2-3 were test groups 1-6; the trimecaine preparation prepared in Comparative Example 1 was the control group.

[0085] 1.1 Test method: The anesthetic effect of the above anesthetics on rats was tested by radiant heat tail-flick latency. The corresponding anesthetics and 0.9% saline samples of the test groups 1-6 and the control group were applied to the tails of the rats and placed in a plastic box. The ventral surface of the distal 5-6 cm of the tail was placed on a 0.5 cm hole, and an infrared radiation bulb was placed under the hole. A cutoff time of 10 s was set (if the rat did not respond to the infrared radiation stimulation within 10 s, the experiment was terminated to avoid excessive exposure that may cause tissue damage); the maximum possible effect (MPE) was calculated, and the baseline latency was calculated as the average of three different measurements taken every 10 min.

[0086] MPE=(test latency-baseline latency) / (cutoff time-baseline latency)×100%.

[0087] 1.2 The test results are shown in Table 1.

[0088] Table 1 Anesthesia test results

[0089]

[0090] The results show that compared with the control group (Comparative Example 1, concentration 8%), the dimethocaine composite preparations (concentration 2% + 2%) prepared by Examples 3 and 5 to 7 have a faster onset of anesthesia and can maintain a good duration of anesthesia at a lower anesthetic concentration, and have a better comprehensive anesthetic effect. The anesthetic effect of Examples 5 to 7 is better.

[0091] Test Example 2-Safety Test

[0092] 2.1 Test methods

[0093] Healthy rabbits weighing 2.3-2.7 kg were selected and randomly divided into test groups 1-2 (corresponding to the dimethocaine compound preparations prepared in Example 3 and Example 5, respectively). Each test group was divided into an intact skin group and a damaged skin group. There were 10 rabbits in each of the intact skin group and the damaged skin group, half of which were male and half were female. The rabbits were depilated on both sides of their backs the day before the test, and the depilation range was 3 cm*3 cm. Intact skin group: The skin of the administration site in the depilated area was intact, undamaged, and normal. Damaged skin group: The administration site in the depilated area was washed with warm water, and after disinfection, a "#" was drawn with a sterile needle and the bleeding was used as the degree.

[0094] Adopt the same body self-left and right comparison experimental method, take the dimethocaine compound preparation prepared by Example 3 and Example 5 and apply 0.5ml to the skin on one side that has been depilated as a test; the other side is given lidocaine hydrochloride gel as a control, and the administration site is covered with 2 layers of gauze (2.5cm*2.5cm) and 1 layer of cellophane, and fixed with a bandage (non-irritating). The test rabbits are raised in a single cage, and the test substance is removed after 24 hours of administration, and the administration site is cleaned with warm water. Observe and record the presence or absence of erythema and edema at the administration site with the naked eye 1h, 24h, 48h, and 72h after the drug is removed. Observe the skin reaction under natural light, score according to the "skin irritation reaction scoring standard", calculate the average score, and score according to the "skin irritation intensity evaluation standard".

[0095] (1) Skin irritation reaction scoring criteria

[0096] Erythema grading: no erythema 0 point; mild erythema (barely visible) 1 point; moderate erythema (clearly visible)

[0097] 2 points; severe erythema 3 points; purple erythema to mild eschar formation 4 points.

[0098] Edema grading: no edema, 0 point; mild edema (barely visible), 1 point; moderate edema (obviously visible), 2 points; severe edema (skin bulge of about 1 mm with clear outline), 3 points; no erythema (skin bulge greater than 1 mm and expanding), 4 points.

[0099] (2) Skin irritation intensity evaluation standards: no irritation (0-0.49 points), mild irritation (0.5-2.99 points), moderate irritation (3.0-5.99 points), and severe irritation (6.0-8.0 points).

[0100] 2.2 Test results

[0101] In the above test, no erythema or edema was observed when the dimethocaine composite preparations prepared in Examples 3 and 5 were used, and there was no irritation to the skin, and there was no significant difference compared with the control.

[0102] Test Example 3-Stability Test

[0103] 3.1 Test method: The dimethicaine compound preparations prepared in Example 3 and Example 5 were subjected to stability tests (accelerated test, long-term test) to investigate the properties of the dimethicaine compound preparations, the content of dimethicaine and trimethicaine, etc., wherein the content of dimethicaine and trimethicaine was determined by HPLC.

[0104] Accelerated test: Place at 40℃±2℃ and relative humidity 75%±5% for 6 months, and take samples for testing at the 0th, 1st, 2nd, 3rd and 6th month.

[0105] Long-term test: Place at 25℃±2℃ and relative humidity 60%±5% for 36 months, and take samples for testing at the 0th, 3rd, 6th, 9th, 12th, 18th, 24th and 36th month.

[0106] 3.2 Test results

[0107] Compared with the data of month 0, after 6 months of accelerated testing, the properties of the dimethocaine composite preparations prepared in Examples 3 and 5 did not change significantly, and there was no significant difference in the contents of dimethocaine and trimecaine.

[0108] Compared with the data of month 0, after 24 months of long-term testing, the properties of the dimethocaine compound preparation prepared in Example 3 did not change significantly, and there was no significant difference in the contents of dimethocaine and trimecaine.

[0109] Compared with the data of month 0, after 36 months of long-term testing, the properties of the dimethocaine compound preparation prepared in Example 5 did not change significantly, and there was no significant difference in the contents of dimethocaine and trimecaine.

[0110] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A dimethocaine compound preparation, characterized in that: Every 100 parts of the composite preparation contains the following raw materials in parts by weight: 2-5 parts of dimethocaine and 2-5 parts of trimecaine.

2. The dimethocaine compound formulation according to claim 1, characterized in that The dimethocaine compound preparation contains chlorhexidine gluconate, Tween 80, oleic acid, polyethylene glycol 400 and purified water. Every 100 parts of the compound preparation comprises the following raw materials in parts by weight: 2-5 parts of dimethocaine, 2-5 parts of trimecaine, 0.1-0.3 parts of chlorhexidine gluconate, 4-6 parts of Tween 80, 4-6 parts of oleic acid, 15-25 parts of polyethylene glycol 400 and the balance of purified water.

3. The dimethocaine compound formulation according to claim 1, characterized in that The invention also contains a compounding auxiliary agent, which is composed of the following components: polyvinyl pyrrolidone K90, polyglycerol ester and ascorbic acid.

4. The dimethocaine compound formulation according to claim 1, characterized in that The mass ratio of polyvinyl pyrrolidone K90, polyglycerol ester and ascorbic acid in the compound auxiliary agent is 1:1.5-2.5:6.5-7.

5.

5. The dimethocaine compound formulation according to claim 3, characterized in that: Every 100 parts of the composite preparation comprises the following raw materials in parts by weight: 2-5 parts of dimethocaine, 2-5 parts of trimecaine, 0.1-0.3 parts of chlorhexidine gluconate, 4-6 parts of Tween 80, 4-6 parts of oleic acid, 15-20 parts of polyethylene glycol 400, 1-2 parts of a compounding auxiliary agent, and the balance of purified water.

6. The method for preparing the dimethocaine compound formulation according to any one of claims 1 to 2, characterized in that: The following steps are involved: (1) Weighing polyethylene glycol 400, oleic acid, Tween 80, and chlorhexidine gluconate according to the prescribed amount, mixing and stirring to obtain solution A; (2) Weigh the prescribed amount of dimethocaine and trimecaine, add them to solution A, heat to 35-40° C., and stir for 4-10 minutes to obtain solution B; (3) Weigh the prescribed amount of purified water and add it to solution B while stirring. After the purified water is added, adjust the pH value to 6-9 with hydrochloric acid solution to obtain the target anesthetic solution.

7. The method for preparing the dimethocaine composite formulation according to claim 6, characterized in that: The concentration of the hydrochloric acid solution is 0.05-0.2 mol / L.

8. The method for preparing the dimethocaine compound formulation according to any one of claims 3 to 5, characterized in that: The following steps are involved: (1) Weighing polyethylene glycol 400, oleic acid, Tween 80, and chlorhexidine gluconate according to the prescribed amount, mixing and stirring to obtain solution A; (2) Weigh the prescribed amount of dimethocaine, trimecaine and compounding auxiliary agent, add them to solution A, heat to 35-40° C., and stir for 4-10 minutes to obtain solution B; (3) Weigh the prescribed amount of purified water and add it to solution B while stirring. After the purified water is added, adjust the pH value to 6-9 with hydrochloric acid solution to obtain the target anesthetic solution.

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