Compound lidocaine hydrochloride mucilage composition for endoscopic anesthesia as well as preparation method and application of compound lidocaine hydrochloride mucilage composition

Abstract

The invention provides a compound lidocaine hydrochloride mucilage composition for endoscopic anesthesia. The compound lidocaine hydrochloride mucilage composition comprises water and the following raw materials in parts by weight: 2 parts of lidocaine hydrochloride; 2 parts of simethicone; 10 thousand to 30 thousand units of streptavidin; 1-4 parts of a cellulose derivative; 0.1 to 0.5 part of xanthan gum; 0.001 to 0.05 part of 2, 6-di-tert-butyl p-cresol; 0.01 to 0.1 part of methylparaben; 0.01 to 0.1 part of propyl hydroxybenzoate; 0.1 to 1.5 parts of polysorbate 80; 0.1 to 2 parts of ethanol; 0.01 to 0.1 part of a flavoring agent; 0.01-2 parts of an aromatic agent; and 0.01 to 0.015 part of a pH regulator. The product disclosed by the invention can play roles in relieving pain, defoaming and eliminating gastric mucus at the same time, and provides a clearer endoscope view field; meanwhile, the viscosity of the preparation can be increased, the residence time of the medicine acting on the mucosa surface is delayed, the local anesthesia action time is prolonged, and the medication frequency is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical preparations, and in particular to a compound lidocaine hydrochloride mucilage composition for endoscopic anesthesia, a preparation method thereof, and an application thereof. Background Art

[0002] With the continuous improvement of people's living standards, the dietary structure is also constantly changing, resulting in an increasing number of gastric diseases. Gastroscopy is a commonly used diagnostic method for gastrointestinal diseases at the present stage, which can greatly improve the early detection rate of cancer. The quality of gastroscopy is affected by various factors, such as the experience of the operating physician, the cooperation of the examined patient, the clarity of the endoscope, etc. Among them, the clarity of the endoscope is the key factor affecting the quality of gastroscopy. Excessive bubbles and mucus in the patient's gastrointestinal tract affect the vision, resulting in missed diagnosis or misdiagnosis of lesions. Taking an antifoaming agent before gastroscopy can avoid the occurrence of the above phenomena (Yin Min, Li Qiulu, Dong Zibo, Fu Mian. Determination of lidocaine hydrochloride content in gastroscope antifoaming agent by HPLC [J]. Contemporary Chemical Industry, 2023, 52(11): 2698-2701, 2766).

[0003] Common drugs for improving visual field clarity include acetylcysteine, pronase, and simethicone, etc. Simethicone is a stable surfactant that can change the surface tension of bubbles in digestive tract mucus and decompose them. Since simethicone is not absorbed after oral administration and is excreted from the body in its original form, no toxic or side effects have been reported so far. As an anti-foaming agent, there have been many studies on the digestive tract preparation before adult endoscopic examination (Wu Jie, Wang Shengnan, Ding Junjie, Huang Ying. Randomized parallel control trial on the clarity of gastroscope visual field with or without oral simethicone at different time points before pediatric gastroscopy [J]. Chinese Journal of Evidence-Based Pediatrics, 2015, 10(4): 245-249). Pronase is a mixture of non-specific proteolytic enzymes that can cut the mucin peptide bonds in gastric mucus and dissolve mucin, thus truly decomposing and removing gastric mucus and improving the clarity of endoscopic examination. Weng Jing et al. found that lidocaine mucilage is mostly used as an anti-foaming agent in routine gastroscopy, but the actual application effect is not ideal. In comparison, dimethicone has a better effect in removing foam on the mucosal surface. For some patients with thick mucosa in the stomach and esophagus, it is difficult to clean with dimethicone. Streptomyces griseus can be used in combination with dimethicone to improve the cleaning quality. The component of pronase is derived from Streptomyces griseus, which can decompose gastric and esophageal mucus and make the mucosal layer thinner. Compared with the conventional anti-foaming method, the combined use of dimethicone and pronase has a relatively ideal effect ([1] Weng Jing, Chen Feng, Li Rucan, etc. Efficacy study on the combined application of pronase and simethicone before gastroscopy [J]. Northern Pharmacy, 2022, 19(02): 27-29+46.). Li Ke et al. found that preoperative preparation with lidocaine mucilage combined with pronase before gastroscopy can effectively remove gastric mucus, improve the clarity of the visual field, shorten the operation time, and also help to improve the diagnostic rate of gastric mucosal micro-lesions ([1] Li Ke, Chen Zhulin. Application value of lidocaine mucilage combined with pronase in gastroscopy [J]. Chinese Journal of Convalescent Medicine, 2018, 27(12): 1307-1309. DOI: 10.13517 / j.cnki.ccm.2018.12.031.).

[0004] Therefore, the combined use of simethicone, pronase, and lidocaine hydrochloride mucilage is a good combination, which has a good pharyngeal anesthetic effect and can also achieve the ideal effect of removing gastric foam and mucus and maintaining the clear visibility of the gastric mucosa, and is worthy of further clinical research (Wu Yunlin, Chen Lina, Wang Chunlan, Qu Qing, Cheng Shidan, Zhang Shu, Chen Ying, Ma Wenfang. Value of simethicone in the observation of the gastric body and fundus by endoscopy [J]. Chinese Journal of Gastroenterology and Hepatology, 2006, 15(3): 300-302).

[0005] Currently, simethicone (dimethyl polysiloxane) preparations and lidocaine hydrochloride mucilage have been widely used in combination clinically as adjuvant medications before gastroscopy. However, proteolytic enzyme preparations are less available on the market, and there are no relevant invention patents reporting compound preparations of the three. To reduce the complexity of patients' medication and improve compliance, the present invention provides a compound lidocaine hydrochloride mucilage, which contains both simethicone with defoaming ability and proteolytic enzyme with mucus-eliminating effect, as well as lidocaine hydrochloride with anesthetic effect; it can not only more effectively eliminate the bubbles and mucus in the stomach, but also play an anesthetic role, significantly reducing the discomfort in the patient's pharynx. Summary of the Invention

[0006] In view of this, the technical problem to be solved by the present invention is to provide a compound lidocaine hydrochloride mucilage composition for endoscopic anesthesia. The above composition provided by the present invention can more effectively eliminate the bubbles and mucus in the stomach, and also play an anesthetic role, significantly reducing the discomfort in the patient's pharynx.

[0007] The present invention provides a compound lidocaine hydrochloride mucilage composition for endoscopic anesthesia, comprising water and the following raw materials in parts by weight:

[0008]

[0009]

[0010] In some embodiments of the present invention, the compound lidocaine hydrochloride mucilage preparation comprises water and the following raw materials in parts by weight:

[0011]

[0012] In some embodiments of the present invention, the cellulose derivative is one of sodium carboxymethylcellulose, hydroxyethyl cellulose or hydroxypropyl cellulose.

[0013] In some embodiments of the present invention, the flavoring agent is sodium saccharin;

[0014] The flavoring agent is grape essence.

[0015] In some embodiments of the present invention, the pH regulator is sodium hydroxide or citric acid.

[0016] In some embodiments of the present invention, the viscosity of the compound lidocaine hydrochloride mucilage preparation is 50 - 300 mPa·s, and the pH value is 6.5 - 7.0.

[0017] The present invention provides a preparation method of the compound lidocaine hydrochloride mucilage composition according to any one of the above technical solutions, comprising the following steps:

[0018] A) Add methylparaben and propylparaben to water and mix to obtain a first solution;

[0019] The cellulose derivative and xanthan gum are added to water and mixed to obtain a second dissolution solution;

[0020] The first dissolution solution and the second dissolution solution are mixed to obtain a third dissolution solution;

[0021] B) 2,6-Di-tert-butyl-p-cresol is dissolved in ethanol to obtain a 2,6-di-tert-butyl-p-cresol ethanol solution;

[0022] Lidocaine hydrochloride, pronase, flavoring agent, and aromatic agent are dissolved in water to obtain a fourth dissolution solution;

[0023] C) Simethicone, polysorbate 80, and the third dissolution solution are mixed and emulsified, then the 2,6-di-tert-butyl-p-cresol ethanol solution and the fourth dissolution solution are added and emulsified continuously. After the emulsification is completed, the pH value is adjusted with a pH regulator, the volume is fixed, and filtration is carried out to obtain the product.

[0024] In some embodiments of the present invention, the volume percentage of water in the first dissolution solution is 40% - 50%;

[0025] The volume percentage of water in the second dissolution solution is 20% - 30%; the dissolution temperature of the second dissolution solution is 30 - 40 °C;

[0026] The volume percentage of water in the fourth dissolution solution is 5%;

[0027] The emulsification time is 30 min; the continuous emulsification time is 30 min; the pH value is adjusted to 6.5 - 7.0;

[0028] The filtration is carried out using a stainless steel filter element with a pore size of 50 - 75 μm.

[0029] The present invention provides the application of the compound lidocaine hydrochloride mucilage composition as described in the above technical solution in the preparation of an endoscopic anesthetic preparation.

[0030] The present invention provides an endoscopic anesthetic compound lidocaine hydrochloride mucilage product, comprising the compound lidocaine hydrochloride mucilage composition as described in any one of the above technical solutions or the compound lidocaine hydrochloride mucilage composition prepared by the preparation method as described in the above technical solution.

[0031] Compared with the prior art, the present invention provides a compound lidocaine hydrochloride mucilage composition for endoscopic anesthesia, which comprises water and raw materials in the following parts by weight: 2 parts of lidocaine hydrochloride; 2 parts of simethicone; 10,000 - 30,000 units of pronase; 1 - 4 parts of cellulose derivative; 0.1 - 0.5 part of xanthan gum; 0.001 - 0.05 part of 2,6 - di - tert - butyl - p - cresol (BHT); 0.01 - 0.1 part of methylparaben; 0.01 - 0.1 part of propylparaben; 0.1 - 1.5 parts of polysorbate 80; 0.1 - 2 parts of ethanol; 0.01 - 0.1 part of flavoring agent; 0.01 - 2 parts of fragrance; 0.01 - 0.015 part of pH regulator. The compound lidocaine hydrochloride mucilage for endoscopic anesthesia of the present invention contains lidocaine hydrochloride, simethicone and pronase. The combined use of lidocaine hydrochloride, simethicone and pronase can simultaneously play the roles of analgesia, defoaming and removing gastric mucus, providing a clearer endoscopic view; in the prescription, the defoaming agent simethicone and pronase are used in combination to enhance the defoaming ability; the sodium cellulose derivative and xanthan gum in the prescription can increase the viscosity of the preparation, delay the residence time of the drug action on the mucosal surface, prolong the local anesthetic action time, reduce the number of drug administrations, and when using the cellulose derivative alone, its viscosity stability is poor. In the present invention, the novel thickener xanthan gum is used in combination, and the viscosity stability is better. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 It is a preparation process flow chart of a compound lidocaine hydrochloride mucilage for endoscopic anesthesia. DETAILED DESCRIPTION OF THE INVENTION

[0033] The present invention provides a compound lidocaine hydrochloride mucilage composition for endoscopic anesthesia, its preparation method and application. Those skilled in the art can draw on the content of this article and appropriately modify the process parameters to achieve it. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art, and they all fall within the scope of protection of the present invention. The method and application of the present invention have been described through preferred embodiments. Relevant personnel can obviously make changes or appropriate modifications and combinations to the methods and applications in this article without departing from the content, spirit and scope of the present invention to implement and apply the technology of the present invention.

[0034] It should be understood that the expression "one or more of..." individually includes each of the objects recited after the expression and various different combinations of two or more of the recited objects, unless otherwise understood from the context and usage. The expression "and / or" in combination with three or more recited objects should be understood to have the same meaning, unless otherwise understood from the context.

[0035] The terms "comprising", "having", or "including", including the use of their grammatical synonyms, should generally be understood as open-ended and non-limiting, for example, not excluding other unrecited elements or steps, unless specifically stated otherwise or understood from the context.

[0036] In this application, the term "and / or" describes the relationship between related objects and indicates that three relationships can exist. For example, A and / or B can represent: A exists alone, A and B exist simultaneously, and B exists alone. Where A and B can be singular or plural.

[0037] The present invention provides a compound lidocaine hydrochloride mucilage composition for endoscopic anesthesia, comprising water and the following raw materials in parts by weight:

[0038]

[0039]

[0040] In some embodiments of the present invention, the compound lidocaine hydrochloride mucilage comprises water and the following raw materials in parts by weight:

[0041]

[0042] In some embodiments of the present invention, the compound lidocaine hydrochloride mucilage comprises water and the following raw materials in parts by weight:

[0043]

[0044]

[0045] In some embodiments of the present invention, the compound lidocaine hydrochloride mucilage comprises the following raw materials:

[0046] In some embodiments of the present invention, the compound lidocaine hydrochloride mucilage comprises the following raw materials:

[0047]

[0048]

[0049] In some embodiments of the present invention, the compound lidocaine hydrochloride mucilage comprises the following raw materials:

[0050]

[0051] In some embodiments of the present invention, the cellulose derivative comprises one of sodium carboxymethyl cellulose, hydroxyethyl cellulose, or hydroxypropyl cellulose.

[0052] In some embodiments of the present invention, the flavoring agent is sodium saccharin;

[0053] The flavoring agent is grape essence.

[0054] In some embodiments of the present invention, the pH regulator is sodium hydroxide or citric acid.

[0055] In some embodiments of the present invention, the viscosity of the compound lidocaine hydrochloride mucilage is 50 - 300 mPa·s, and the pH value is 6.5 - 7.0.

[0056] The present invention provides a preparation method of the compound lidocaine hydrochloride mucilage composition according to any one of the above technical solutions, comprising the following steps:

[0057] A) Add methylparaben and propylparaben to water and mix to obtain a first solution;

[0058] Add a cellulose derivative and xanthan gum to water and mix to obtain a second solution;

[0059] Mix the first solution and the second solution to obtain a third solution;

[0060] B) Dissolve 2,6 - di - tert - butyl - p - cresol in ethanol to obtain a 2,6 - di - tert - butyl - p - cresol ethanol solution;

[0061] Dissolve lidocaine hydrochloride, streptokinase, flavoring agent, and flavoring agent in water to obtain a fourth solution;

[0062] C) Mix simethicone, polysorbate 80 and the third solution, emulsify, then add the 2,6 - di - tert - butyl - p - cresol ethanol solution and the fourth solution and continue to emulsify. After the emulsification is completed, adjust the pH value with a pH regulator, make up the volume, and filter to obtain the compound lidocaine hydrochloride mucilage composition.

[0063] The preparation method of the compound lidocaine hydrochloride mucilage composition provided by the present invention first adds methylparaben and propylparaben to water and mixes to obtain a first solution.

[0064] In some embodiments of the present invention, the volume percentage of water in the first solution is 40% - 50%; specifically, it can be 40%, 42%, 45%, 47%, 49%, 50%; or the range value between any two of the above.

[0065] The above water is preferably purified water; the temperature of the purified water is preferably 70 - 80 °C.

[0066] The above mixing is preferably stirring and mixing. The present invention does not limit the specific manner of mixing, and it can be stirred with a stirrer.

[0067] Mix the cellulose derivative and xanthan gum with water to obtain a second dissolution solution. Use a disperser to disperse and dissolve simultaneously until complete dissolution.

[0068] In the second dissolution solution of the present invention, the volume percentage of water is 20% - 30%; specifically, it can be 20%, 22%, 25%, 27%, 29%, 30%; or the range value between any two of the above.

[0069] The above water is preferably purified water; the temperature of the purified water is preferably 30 - 40 °C.

[0070] Mix the first dissolution solution and the second dissolution solution to obtain a third dissolution solution.

[0071] Dissolve 2,6 - di - tert - butyl - p - cresol in ethanol to obtain a 2,6 - di - tert - butyl - p - cresol alcohol solution;

[0072] Dissolve lidocaine hydrochloride, pronase, flavoring agent, and fragrance in water to obtain a fourth dissolution solution; the volume percentage of water in the fourth dissolution solution is 5%.

[0073] Mix simethicone, polysorbate 80 and the third dissolution solution and emulsify. The emulsification time in the present invention is 30 min; the emulsification is carried out using an emulsifier, and the present invention does not limit this, and those well - known to those skilled in the art can be used.

[0074] Then add the 2,6 - di - tert - butyl - p - cresol alcohol solution and the fourth dissolution solution and continue emulsifying, and the time for the continued emulsification is 30 min.

[0075] After the emulsification is completed, adjust the pH value using a pH regulator, and the pH value is adjusted to 6.5 - 7.0.

[0076] The pH regulator in the present invention is preferably an alkali solution; the alkali solution is preferably a sodium hydroxide solution; the concentration of the sodium hydroxide solution is 1% - 4%.

[0077] Add the remaining purified water to a sufficient amount, mix evenly, filter, fill the obtained oral solution into containers, cap them, and pack them into boxes.

[0078] The filtration in the present invention is carried out using a stainless - steel filter element with a pore size of 50 - 75 μm.

[0079] The packaging material used in the filling step of the present invention is a 15 - ml glass bottle.

[0080] The present invention provides the application of the compound lidocaine hydrochloride mucilage composition described in the above technical solution in the preparation of an endoscopic anesthetic preparation.

[0081] The present invention provides a compound lidocaine hydrochloride mucilage product for endoscopic anesthesia, including the compound lidocaine hydrochloride mucilage composition described in any one of the above technical solutions or the compound lidocaine hydrochloride mucilage composition prepared by the preparation method described in the above technical solution.

[0082] This product combines the anesthetic effect of lidocaine and the defoaming effects of simethicone and pronase, and can simultaneously achieve the effects of analgesia, relaxation of connective tissues, and effective elimination of gastric bubbles and mucus. In clinical practice, it is used in combination more frequently. After being made into a compound preparation, it can simplify the clinical usage steps, improve the usage efficiency, reduce the dosage of excipients, and reduce adverse reactions. This product has a simple process and wide application, and has a broad market prospect.

[0083] The present invention provides a compound lidocaine hydrochloride mucilage composition for endoscopic anesthesia, including water and the following raw materials in parts by weight: 2 parts of lidocaine hydrochloride; 2 parts of simethicone; 10,000 to 30,000 units of pronase; 1 to 4 parts of cellulose derivative; 0.1 to 0.5 part of xanthan gum; 0.001 to 0.05 part of 2,6-di-tert-butyl-p-cresol (BHT); 0.01 to 0.1 part of methylparaben; 0.01 to 0.1 part of propylparaben; 0.1 to 1.5 parts of polysorbate 80; 0.1 to 2 parts of ethanol; 0.01 to 0.1 part of flavoring agent; 0.01 to 2 parts of fragrance; 0.01 to 0.015 part of pH regulator. The compound lidocaine hydrochloride mucilage for endoscopic anesthesia of the present invention contains lidocaine hydrochloride, simethicone, and pronase. The combined use of lidocaine hydrochloride, simethicone, and pronase can simultaneously achieve the effects of analgesia, defoaming, and elimination of gastric mucus, providing a clearer endoscopic vision; in the prescription, the defoaming agent simethicone and pronase are used in combination to enhance the defoaming ability; the cellulose sodium derivative and xanthan gum in the prescription can increase the viscosity of the preparation, delay the residence time of the drug action on the mucosal surface, prolong the local anesthetic action time, reduce the number of drug administrations, and the viscosity stability of the cellulose derivative alone is poor. In the present invention, the novel thickener xanthan gum is used in combination, and the viscosity stability is better.

[0084] It should be understood that as long as the present invention is still operable, the order of steps or the order of performing certain actions is not important. In addition, two or more steps or actions can be performed simultaneously.

[0085] The use of any and all examples or exemplary language such as "for example" or "including" in this article is only intended to better illustrate the present invention, and unless a claim is made, it does not limit the scope of the present invention. Any language in this specification should not be construed as indicating that any unclaimed element is essential for the practice of the present invention.

[0086] In addition, the numerical ranges and parameters used to define the present invention are approximate values. The relevant numerical values in the specific embodiments have been presented as precisely as possible herein. However, any numerical value inherently and inevitably contains standard deviations caused by individual testing methods. Therefore, unless otherwise clearly stated, it should be understood that all ranges, quantities, numerical values, and percentages used in this disclosure are modified by "about". Herein, "about" generally means that the actual numerical value is within plus or minus 10%, 5%, 1%, or 0.5% of a specific numerical value or range.

[0087] It should be understood that in various embodiments of the present application, the magnitudes of the serial numbers of the above processes do not mean the order of execution. Some or all of the steps can be executed in parallel or sequentially. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation to the implementation process of the embodiments of the present application.

[0088] Some cases are described in the embodiments and comparative examples of the present invention, and some implementation manners of the present invention are shown in the embodiments. However, this does not mean that the effects of the present invention can only be achieved in these cases.

[0089] To further illustrate the present invention, the following describes in detail a compound lidocaine hydrochloride mucilage composition for endoscopic anesthesia provided by the present invention, its preparation method, and its application in combination with embodiments.

[0090] Example 1: Preparation of a compound lidocaine hydrochloride mucilage for endoscopic anesthesia

[0091] Prescription:

[0092]

[0093]

[0094] Preparation process:

[0095] (1) Weighing: Weigh the prescribed amounts of lidocaine hydrochloride, simethicone, streptokinase, sodium carboxymethylcellulose, xanthan gum, 2,6-di-tert-butyl-p-cresol (BHT), methylparaben, propylparaben, polysorbate, ethanol, saccharin sodium, grape essence, and sodium hydroxide for standby;

[0096] (2) Dissolve methylparaben and propylparaben: Add methylparaben and propylparaben to 40 - 50% of the total volume of purified water (temperature control range 70 - 80 °C), and stir with a stirrer until completely dissolved;

[0097] (3) Dissolve sodium carboxymethylcellulose and xanthan gum: Add 20 - 30% of the total volume of purified water to the solution in step (1), control the water temperature in the range of 30 - 40 °C, add sodium carboxymethylcellulose and xanthan gum, and disperse and dissolve with a disperser until completely dissolved;

[0098] (4) Mix the materials in (2) and (3) evenly and then cool to room temperature for standby.

[0099] (5) Dissolve 2,6 - di - tert - butyl - p - cresol (BHT): Crush 2,6 - di - tert - butyl - p - cresol (BHT) into powder and dissolve it with the prescribed amount of ethanol to form a homogeneous ethanol solution for standby.

[0100] (6) Dissolve lidocaine hydrochloride, pronase, sodium saccharin and grape essence: Stir and dissolve lidocaine hydrochloride, sodium saccharin and grape essence with 5% of the total volume of purified water to form a homogeneous solution for standby.

[0101] (7) Stir and mix the prescribed amount of simethicone and polysorbate 80 evenly, and then add them together with the mixed solution in step (4) into an emulsifier for emulsification for 30 minutes.

[0102] (8) Pour the solutions prepared in step (5) and step (6) into the emulsifier and continue emulsification for 30 minutes.

[0103] (9) Adjust the pH value: After the emulsification is completed, prepare a 1.0% (w / v) sodium hydroxide solution by adding an appropriate amount of sodium hydroxide to freshly prepared sterile injection water, and adjust the pH value to 6.5 - 7.0.

[0104] (10) Make up the volume: Add the remaining purified water to the full amount, mix evenly, filter through a 50 - um stainless - steel filter element, fill the obtained oral solution into 15 - ml glass bottles, cap them, and after passing the finished - product inspection, pack them into boxes and cases.

[0105] Quality inspection:

[0106] Table 1 Quality inspection results of Example 1

[0107]

[0108]

[0109] Example 2: Preparation formula of a compound lidocaine hydrochloride mucilage for endoscopic anesthesia:

[0110]

[0111]

[0112] Preparation process: The concentration of the prepared sodium hydroxide solution is 2%, and other steps are the same as those in Example 1. Quality inspection:

[0113] Table 2 Quality inspection results of Example 2

[0114]

[0115]

[0116] Example 3: Preparation Prescription of Compound Lidocaine Hydrochloride Mucilage for Endoscopic Anesthesia:

[0117]

[0118]

[0119] Preparation Process: The concentration of the sodium hydroxide solution prepared is 4%, and other steps are the same as those in Example 1. Quality Inspection:

[0120] Table 3 Quality Inspection Results of Example 3

[0121]

[0122]

[0123] Example 4

[0124] 1. Stability Investigation

[0125] According to the stability test guiding principle of the 2020 Pharmacopoeia, the stability of the experimental samples (Example 1, Example 2, and Example 3) under high-temperature conditions (investigation condition: 40°C) was investigated. The main investigation results are as follows:

[0126] Table 4 High-Temperature Investigation Results of Examples 1 - 3

[0127]

[0128]

[0129] Comparative Example 1

[0130] Prescription:

[0131]

[0132] Preparation Process: The concentration of the sodium hydroxide solution prepared is 4%, and other steps are the same as those in Example 3.

[0133] Comparative Example 2

[0134]

[0135]

[0136] Preparation Process: The concentration of the sodium hydroxide solution prepared is 4%, and other steps are the same as those in Example 3.

[0137] Comparison Test of Defoaming Ability between Examples and Comparative Examples:

[0138] The defoaming ability of the above Example 3 and Comparative Example 1 was investigated, and the defoaming ability was checked after being placed at a high temperature (40 °C) for 30 days. The main investigation results are as follows:

[0139] Table 5 Comparison results of defoaming ability (high temperature)

[0140]

[0141] The viscosity stability of the above Example 3 and Comparative Example 2 was investigated, and the viscosity stability was checked after being placed at a high temperature (40 °C) for 30 days. The main investigation results are as follows:

[0142] Table 6 Comparison results of viscosity stability (high temperature)

[0143]

[0144] The above experimental results show that: during the investigation of the experimental samples at a high temperature of 40 °C, the key quality indicators all meet the regulations, indicating that a product with stable quality can be prepared according to the present invention. The results of the defoaming ability comparison test and the viscosity stability comparison test show that the compound lidocaine hydrochloride mucilage of the present invention has a short defoaming time, and its defoaming ability is significantly better than that of Comparative Example 1, and its viscosity stability is significantly better than that of Comparative Example 2.

[0145] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A compound lidocaine hydrochloride mucilage composition for endoscopic anesthesia, characterized in that, It comprises water and raw materials in the following parts by weight:

2. The compound lidocaine hydrochloride mucilage composition according to claim 1, wherein The compound lidocaine hydrochloride mucilage comprises water and raw materials in the following parts by weight:

3. The compound lidocaine hydrochloride mucilage composition according to claim 1, wherein The cellulose derivative is one of sodium carboxymethylcellulose, hydroxyethyl cellulose or hydroxypropyl cellulose.

4. The compound lidocaine hydrochloride mucilage composition according to claim 1, wherein The flavoring agent is sodium saccharin; The fragrance is grape essence.

5. The compound lidocaine hydrochloride mucilage composition according to claim 1, wherein The pH regulator is sodium hydroxide or citric acid.

6. The compound lidocaine hydrochloride mucilage composition according to claim 1, wherein The viscosity of the compound lidocaine hydrochloride mucilage is 50 - 300 mPa·s, and the pH value is 6.5 - 7.

0.

7. A method for preparing the compound lidocaine hydrochloride mucilage composition according to any one of claims 1 to 6, characterized in that, It comprises the following steps: A) Add methylparaben and propylparaben to water and mix to obtain a first solution; Add the cellulose derivative and xanthan gum to water and mix to obtain a second solution; Mix the first solution and the second solution to obtain a third solution; B) Dissolve 2,6 - di - tert - butyl - p - cresol in ethanol to obtain a 2,6 - di - tert - butyl - p - cresol ethanol solution; Dissolve lidocaine hydrochloride, streptomyces protease, flavoring agent and fragrance in water to obtain a fourth solution; C) Mix simethicone, polysorbate 80 and the third solution, emulsify, then add the 2,6 - di - tert - butyl - p - cresol ethanol solution and the fourth solution and continue to emulsify. After the emulsification is completed, adjust the pH value with a pH regulator, make up the volume, and filter to obtain the product.

8. The preparation method according to claim 7, characterized in that, The volume percentage of water in the first solution is 40% - 50%; The volume percentage of water in the second solution is 20% - 30%; the dissolution temperature of the second solution is 30 - 40 °C; The volume percentage of water in the fourth solution is 5%; The emulsification time is 30 min; the continued emulsification time is 30 min; the pH value is adjusted to 6.5 - 7.0; The filtration is carried out using a stainless - steel filter element with a pore size of 50 - 75 μm.

9. Use of the compound lidocaine hydrochloride mucilage composition according to any one of claims 1 - 6 in the preparation of an endoscopic anesthetic preparation.

10. A compound lidocaine hydrochloride mucilage product for endoscopic anesthesia, characterized in that, It comprises the compound lidocaine hydrochloride mucilage composition according to any one of claims 1 - 6 or the compound lidocaine hydrochloride mucilage composition prepared by the preparation method according to claims 7 - 8.

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