Medical defoaming agent and preparation method thereof

Abstract

This invention relates to the field of medical devices, specifically disclosing a medical defoamer and its preparation method. Existing medical defoamers primarily function to lubricate and eliminate gastrointestinal foam, but often have limited functionality or poor synergistic effects, impacting the clarity of gastroscopy, patient comfort, and operational efficiency. The medical defoamer of this invention comprises, by weight percentage: 1-5% dimethyl silicone oil, 0-1% Span 60, 0-0.5% Span 80, 5-10% Tween 80, 5-10% glycerol, 0.5-1% lidocaine hydrochloride, 0-0.5% potassium sorbate, 0.2-1% mono-fatty acid glycerides, and the remainder being purified water. The formulation uses a compound of dimethyl silicone oils of different viscosities and specific proportions as the core lubricating and defoaming matrix; employs a non-ionic composite emulsification system of Span and Tween to ensure stable emulsification of the oil and water phases; introduces mono-fatty acid glycerides as a physical defoaming aid and system stabilizer; and uses lidocaine hydrochloride to achieve surface anesthesia.

Description

Technical Field

[0001] This invention relates to the field of medical device auxiliary preparations technology, and in particular to a medical defoamer and its preparation method. Background Technology

[0002] Gastrointestinal endoscopy (commonly known as gastroscopy or colonoscopy) is the most direct and accurate method for diagnosing diseases of the esophagus, stomach, and duodenum. During the examination, to facilitate the insertion of the endoscopic catheter and reduce patient discomfort, a medical adhesive with lubricating and local anesthetic properties is usually applied to or ingested onto the endoscope or in the patient's throat. Furthermore, mucus and air bubbles present in the gastrointestinal tract can severely interfere with the clarity of the endoscopic field, affecting the observation and diagnosis of lesions. Therefore, an ideal gastroscopy aid should simultaneously possess excellent lubricity, long-lasting surface anesthetic effect, and highly effective defoaming ability.

[0003] Currently, medical defoamers or multifunctional formulations used in clinical practice still have the following shortcomings: 1) Limited Functionality and Poor Synergy: Most products focus on a single function, requiring patients to take two or more preparations sequentially, resulting in a cumbersome process and poor experience. Integrating multiple functions into a single preparation often leads to compatibility issues between components, making it difficult to form a stable system and causing some functions (such as defoaming) to weaken or fail. 2) Inadequate Lubrication and Anesthesia: Traditional lubricants may have poor adhesion and wash away too quickly as they pass through the esophagus, resulting in short-lasting lubrication. Furthermore, improperly formulated anesthetic components may have a slow onset or short duration of action, failing to effectively cover the entire examination process, causing significant discomfort for the patient even in the later stages. 3) Defoaming Efficiency Needs Improvement: Existing defoaming agents often rely solely on chemical defoaming components such as silicone oil. For stubborn foams mixed with mucus in the gastrointestinal tract, their defoaming speed and thoroughness are insufficient, requiring doctors to repeatedly inject water and air to flush during the examination, prolonging the procedure and increasing patient discomfort. 4) Insufficient formulation stability: Medical defoamers are complex emulsion systems containing an oil phase (silicone oil), an aqueous phase, and various surfactants, making their physical stability a key challenge. Common products are prone to layering, oil separation, and precipitation during storage, which not only affects appearance and use but may also lead to uneven composition, impacting their safety and effectiveness.

[0004] Therefore, this invention develops a novel medical defoamer that organically integrates excellent lubrication properties and rapid, efficient defoaming capabilities, while also possessing good physical and chemical stability, to meet the urgent clinical need for efficient, comfortable, and safe gastroscopy. Summary of the Invention

[0005] This invention proposes a medical defoamer and its preparation method, which has the advantages of being multifunctional, stable, and highly efficient in defoaming. It solves the problems of existing products having single functions, making it difficult to simultaneously achieve excellent lubricity, long-lasting surface anesthetic effect, and efficient defoaming ability; poor synergy among components in conventional preparations, resulting in insufficient defoaming efficiency and lubrication durability; poor stability of medical defoamer systems prepared by traditional emulsification processes, which are prone to stratification and oil separation during storage and transportation; slow onset or short duration of action of anesthetic components, failing to effectively reduce patient discomfort throughout the examination process; and the single function of existing products, making it difficult to simultaneously achieve excellent lubricity, long-lasting surface anesthetic effect, and efficient defoaming ability.

[0006] To achieve the aforementioned goals of multifunctional integration, system stability, and high defoaming efficiency, the present invention adopts the following technical solution: A medical defoaming agent, characterized in that, by weight percentage, the defoaming agent comprises: 1%-5% dimethicone, 0.1% Span 60, 0.5% Span 80, 5%-10% Tween 80, 5%-10% glycerol, 1% lidocaine hydrochloride, 0-0.5% potassium sorbate, 0.2%-1% monofatty acid glycerides, and the balance being purified water.

[0007] Preferably, the dimethyl group is one or more of 50cst, 100cst, 300cst, 500cst and 750cst.

[0008] Preferably, the dimethicone oil is 50 cst or 100 cst.

[0009] Preferably, the content of the monoacylglycerol is 0.5%-1%, and the pH value of the medical defoamer is 5-7.

[0010] A method for preparing a medical defoamer, characterized in that: applied to the medical defoamer according to any one of claims 1-4, comprising the following steps: S1. Preparation of oil phase: Mix dimethicone, Span 60, Span 80 and mono-fatty acid glycerides, and heat in an infrared furnace until the mono-fatty acid glycerides and Span 60 are completely dissolved. Add glycerol and Tween 80, and stir for 50 minutes to form a milky white, homogeneous and delicate paste-like oil phase. S2. Preparation of aqueous phase: Dissolve potassium sorbate and lidocaine hydrochloride in purified water to obtain an aqueous phase; S3. Emulsification: The aqueous phase obtained in S2 is added to the paste-like oil phase obtained in S1 in portions, and the mixture is stirred and emulsified to obtain an emulsion.

[0011] Preferably, the final state of the mixture of dimethicone, Span 60, Span 80 and monoacrylic acid glycerides after heating is such that the oil phase is in a state of slight boiling, producing a small amount of bubbles, and stirring is required during the heating process.

[0012] Preferably, after the Span 60 is dissolved, stirring is continued for 50 minutes to form the paste-like oil phase.

[0013] Preferably, the paste-like oil phase is added to the aqueous phase in stages: first, 20% of the aqueous phase is added and stirred for 5-10 minutes; then, 30% of the total aqueous phase is added and stirred for 10-20 minutes; finally, the remaining aqueous phase is added and stirred for 20-40 minutes.

[0014] The beneficial effects of this invention are: By compounding silicone oils of different viscosities as a lubricating and defoaming matrix, and synergistically adding glycerol and mono-fatty acid glycerides, the product simultaneously possesses excellent lubricating properties, reliable surface anesthetic effects, and rapid physical-chemical synergistic defoaming capabilities, thus meeting the comprehensive needs of auxiliary preparations in gastroscopy.

[0015] This invention creatively employs a special process to prepare a "paste-like oil phase" by combining water-soluble components (glycerol, Tween 80) with oil-soluble components. This pre-structuring process forms a uniform and delicate initial matrix, which greatly improves the stability of the final emulsion and effectively solves the technical problems of storage layering and oil separation.

[0016] By introducing mono-fatty acid glycerides as physical defoamers, their porous structure and the chemical defoaming effect of silicone oil produce a synergistic effect, which can eliminate stubborn bubbles in the gastrointestinal tract more quickly and thoroughly, and significantly improve the clarity of vision during operation. Attached Figure Description

[0017] Figure 1 This is a diagram illustrating the defoaming ability of the defoaming agent used in the preparation method of the medical defoamer proposed in this invention. Figure 2 This is a diagram illustrating the stability of the defoamer used in the preparation method of the medical defoamer proposed in this invention. Detailed Implementation

[0018] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0019] Example 1: Refer to Figure 1-2A medical defoaming agent and its preparation method, comprising, by weight percentage: 50 cSt dimethicone: 2%, 100 cSt dimethicone: 3%, Span 60: 0.5%, Span 80: 0.2%, Tween 80: 8%, glycerol: 7%, lidocaine hydrochloride: 1%, potassium sorbate: 0.2%, monoglycerides of fatty acids: 0.6%, and purified water: to 100%. Its preparation method includes the following steps: Preparation of S1 oil phase: Add 50 cst dimethicone, 100 cst dimethicone, Span 60, and Span 80 to a container. Mix thoroughly using a magnetic stirrer, then heat in an infrared furnace to a slight boiling state, generating a small amount of bubbles. Add glycerin and Tween 80, and heat and stir for 50 minutes to obtain a milky white, uniform, fine, and viscous paste-like oil phase.

[0020] S2 Aqueous Phase Preparation: In another container, potassium sorbate and lidocaine hydrochloride are dissolved in purified water and stirred until completely dissolved to obtain a clear aqueous phase, which is then preheated to 75-80℃.

[0021] S3 Emulsification: Under continuous stirring, slowly and in portions add the aqueous phase obtained in step S2 to the paste-like oil phase obtained in step S1. First, add 20% of the aqueous phase and stir for 5-10 minutes, then add 30% of the aqueous phase and stir for 10-20 minutes, and finally add the remaining aqueous phase and stir for 20-40 minutes. Continue until a homogeneous, fine, milky-white medical defoamer emulsion is obtained.

[0022] Example 2: Refer to Figure 1-2 Preparation of a medical defoamer This embodiment provides another medical defoamer, which, by weight percentage, comprises: 50 cst dimethicone: 0.5%, 100 cst dimethicone: 4.5%, Span 60: 0.2%, Span 80: 0.1%, Tween 80: 6%, glycerol: 9%, lidocaine hydrochloride: 1%, potassium sorbate: 0.1%, monoglycerides: 0.3%, and purified water: to 100%. The preparation method is the same as in Example 1.

[0023] Example 3: Preparation of a medical defoamer with modified silicone oil viscosity and dosage This embodiment aims to illustrate the selectivity of silicone oil types, with the following composition: dimethicone 50cst: 1%, dimethicone 100cst: 4%, Span 60: 0.8%, Span 80: 0.4%, Tween 80: 9%, glycerol: 5%, lidocaine hydrochloride: 1%, potassium sorbate: 0.3%, monoglycerides: 1%, purified water: to 100%. The preparation method is the same as in Example 1.

[0024] Comparative Example 1: This comparative example uses the exact same formulation as Example 1, but the preparation process is changed for comparison: S1. Oil phase preparation: Mix only 50 cst dimethicone, 100 cst dimethicone, Span 60, Span 80 and monoacylglycerol, heat until all solids are dissolved, stir for 5 minutes until uniform, and mix all components evenly.

[0025] S2. Aqueous phase preparation: Dissolve glycerol, Tween 80, potassium sorbate and lidocaine hydrochloride in all purified water and heat to 80°C.

[0026] S3. Emulsification: Add the aqueous phase to the oil phase all at once while stirring, and then stir for 60 minutes.

[0027] S4. Post-processing: Same as in Example 1.

[0028] Comparative Example 2: This comparative example uses the exact same process as Example 1, but the formulation is changed for comparison: 5% dimethicone 750cst, 0.5% Span 60, 0.2% Span 80, 8% Tween 80, 7% glycerol, 1% lidocaine hydrochloride, 0.2% potassium sorbate, 0.6% monoglycerides, and purified water to 100%.

[0029] Comparative Example 3: This comparative example uses the same process as Example 1, but the formulation is changed for comparison: 50 cst dimethicone: 2%, 100 cst dimethicone: 3%, Tween 80: 8%, glycerol: 7%, lidocaine hydrochloride: 1%, potassium sorbate: 0.2%, monoglyceride glycerides: 0.6%, purified water: to make up to 100%.

[0030] Comparative Example 4: This comparative example uses the exact same process as Example 1, but with a different formulation for comparison: 50 cSt dimethicone: 2%, 100 cSt dimethicone: 3%, Span 60: 0.5%, Span 80: 0.2%, Tween 80: 8%, Glycerin: 7%, Lidocaine Hydrochloride: 1%, Potassium Sorbate: 0.2%, Purified Water: to 100% Performance testing: 1. Defoaming performance test: Foaming water preparation: Use coconut oil foaming agent to make foaming water. The ratio of coconut oil foaming agent to water is 1:5.

[0031] Defoaming performance test method: Take 10ml of soaking water, shake it up and down 20 times, and record the foam height. Take 0.5ml of the above Examples 1-3 and Comparative Examples 1-4, add it to the foam, and record the height after 30s. The foam amount of the sample without medical defoamer is 100%.

[0032] Depend on Figure 1As can be seen above, Examples 1-3 and Comparative Example 3 had the fastest defoaming speed. After adding the medical defoamer sample, the foam elimination rate was 99% within 30 seconds. Comparative Examples 2 and 4 had the slowest defoaming speed.

[0033] 2. Stability Study Accelerated storage was performed at 54℃ and 60% humidity. Samples were taken at 0, 30, and 60 days to observe sample stability. Figure 2 It can be seen that Examples 1-3 have better stability, while Comparative Examples 1 and 4 have the worst stability.

[0034] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," and "counterclockwise," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0035] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0036] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A medical defoaming agent, characterized in that, The defoamer, by weight percentage, consists of: 1%–5% dimethicone, 0–1% Span 60, 0–0.5% Span 80, 5%–10% Tween 80, 5%–10% glycerol, 1% lidocaine hydrochloride, 0–0.5% potassium sorbate, 0.2%–1% monoglycerides of fatty acids, and the balance being purified water.

2. The medical defoamer according to claim 1, characterized in that: The dimethyl group is one or more of 50cst, 100cst, 300cst, 500cst and 750cst.

3. The medical defoamer according to claim 1, characterized in that: The dimethicone oil is one or more of 50cst, 100cst, and 300cst.

4. The medical defoamer according to claim 1, characterized in that: The pH value of the medical defoamer is 5-7.

5. A method for preparing a medical defoamer, characterized in that: The application of a medical defoamer according to any one of claims 1-4 includes the following steps: S1. Preparation of oil phase: Mix dimethicone, Span 60, Span 80 and mono-fatty acid glycerides, and heat in an infrared furnace until the mono-fatty acid glycerides and Span 60 are completely dissolved. Add glycerol and Tween 80, and stir for 50 minutes to form a milky white, homogeneous and delicate paste-like oil phase. S2. Preparation of aqueous phase: Dissolve potassium sorbate and lidocaine hydrochloride in part of purified water to obtain an aqueous phase; S3. Emulsification: The aqueous phase obtained in S2 is added to the paste-like oil phase obtained in S1 in portions, and the mixture is stirred and emulsified to obtain an emulsion.

6. The method for preparing a medical defoamer according to claim 5, characterized in that: The mixture of dimethicone, Span 60, Span 80, and monoacrylic acid glycerides, when heated, results in an oil phase that is in a state of slight boiling, producing a small number of bubbles. Stirring is required during the heating process.

7. The method for preparing a medical defoamer according to claim 5, characterized in that: After the Span 60 is dissolved, continue stirring for 50 minutes.

8. A method for preparing a medical defoamer according to claim 5, characterized in that: The paste-like oil phase is added to the aqueous phase in several stages: first, 20% of the aqueous phase is added and stirred for 5-10 minutes; then, 30% of the aqueous phase is added and stirred for 10-20 minutes; finally, the remaining aqueous phase is added and stirred for 20-40 minutes.

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