Combined preparation for improving visual field definition of gastroscope

Abstract

The invention relates to the technical field of medicines, in particular to a combined preparation for improving the visual field definition of a gastroscope, which comprises a mucus dissolving component and a defoaming component, the mucus dissolving component is prepared from the following components in parts by weight: 400 to 500 parts of papain and 800 to 1200 parts of sodium bicarbonate; 100 to 130 parts of sucrose polyoxypropylene ether and 40 to 60 parts of polypropylene glycol. The papain disclosed by the invention can efficiently hydrolyze protein and polypeptide substances, and the use pH, temperature and action substrate range of the papain is wider; sodium bicarbonate serves as a pH regulator and is used for regulating the pH of gastric acid, and reduction of the hydrolysis efficacy of an enzyme preparation is avoided; the sucrose polyoxypropylene ether can be used for efficiently breaking foams and inhibiting the generation of foams; and the defoaming capability can be greatly improved by combining polypropylene glycol and sucrose polyoxypropylene ether. The composition has two functions of removing mucus and defoaming, does not need to be combined with other medicines for use, and has mucus dissolving and defoaming capabilities superior to those of similar products on the market.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and specifically relates to a combined preparation for clearing mucus and bubbles in the gastric cavity during gastroscopy examination to improve the endoscopic field of view. Background Art

[0002] There are many types of upper gastrointestinal diseases, but the clinical manifestations of patients are often non-specific. Especially for early upper gastrointestinal cancers (including esophageal cancer and gastric cancer), the early symptoms are not obvious, and most cases are already in the middle and late stages once discovered. The survival rate and prognosis of patients with esophageal cancer and gastric cancer are closely related to the clinical stage. Early-stage patients can undergo minimally invasive treatment, and the 5-year survival rate is over 90%. The survival rate of middle and late-stage patients is less than 30%. Upper gastrointestinal cancer has become a major disease endangering the health of Chinese residents and a health problem that urgently needs to be solved. Gastroesophageal endoscopy (referred to as gastroscopy) can directly observe the mucosal surface of the esophagus and gastric cavity, and biopsy suspicious sites for diagnosis. It is an important means to detect early esophageal cancer and gastric cancer. Since mucus adheres to the surface of the esophagus and stomach cavity, its main components are various proteins and water. The mucus covers the mucosal surface, reducing the clarity of the endoscopic field of view. In addition, the esophagus and stomach cavity introduce air through their own peristalsis, which can generate fine bubbles on the surface of the cavity, thus affecting the detailed observation of the mucosal surface by the endoscopist. This may lead to missed diagnosis or incomplete observation of minor or early lesions. During the operation and observation process, due to the need to comprehensively and carefully observe the entire stomach, when faced with a situation where there are a lot of bubbles or mucus in the gastric cavity of the examinee, that is, when the endoscopic field of view is blocked, the endoscopist needs to wash the surface of the gastric cavity with normal saline, and then use a negative pressure suction device connected to the gastroscope to suck away the normal saline and mucus. This will greatly prolong the operation time of the endoscopist, and the duration of discomfort and pain felt by the patient will increase. Therefore, currently in clinical practice, it is generally required that gastroscopy examinees take defoaming drugs such as dimethicone or simethicone before the examination to treat the bubbles on the surface of the gastric mucosa in advance.

[0003] International and domestic relevant guidelines suggest the use of defoaming drugs before gastroscopy, but do not specify the specific medication regimen and dosage. That is to say, there is currently no unified international and domestic standard. There is a wide variety of drugs on the market in our country, such as dimethicone, simethicone, lidocaine hydrochloride mucilage, dyclonine hydrochloride mucilage, tetracaine hydrochloride mucilage, etc. In addition to different types, dimethicone also includes powder and emulsion, and different dosage forms also lead to different usage effects. For the above-mentioned drugs, the results of multiple clinical controlled experiments are inconsistent, resulting in differences in the choice of medication regimens in different regions and hospitals. In addition, there are also studies indicating that the defoaming ability of single drug use is weak and each has its own disadvantages. For example, dimethicone powder is prone to caking, affecting observation, and has limited cleaning ability for gastric mucus; simethicone causes certain irritation to oral mucosa due to high acidity during application; the main functions of dyclonine hydrochloride mucilage and lidocaine hydrochloride mucilage are local anesthesia, so they need to be used in combination with dimethicone to achieve better defoaming effect. In addition, there is a commonality in the defoaming agents currently used in clinical practice, that is, thickeners, emulsifiers and sugars and other excipients are used in the preparation process to increase the viscosity of the preparation and adjust the taste. However, clinical practice has proved that when defoaming is carried out by endoscopic spraying method, partial drug residues will cause difficulties in cleaning the biopsy channels of the endoscope, resulting in conditions such as conjunctiva and bacterial growth in the biopsy channels.

[0004] Defoaming agents can only remove the already generated bubbles and have no cleaning effect on mucus. Since the substances that increase viscosity and affect the clarity of the field of view in mucus are proteins, enzymatic hydrolysis can be used to reduce the protein content in mucus. The mucus dissolving agents used before gastroscopy mainly include pronase and N-acetylcysteine. Pronase is mostly used in Asian countries, while N-acetylcysteine is mostly used in European and American countries. In our country, N-acetylcysteine is routinely used to treat respiratory diseases, so there is not much clinical and literature data. Japan has routinely used pronase since the 1990s, while our country gradually began to use it after 2010. Although a number of clinical studies have shown that the use of pronase in combination with drugs such as dimethicone and simethicone can improve the clarity of the endoscopic field of view, up to now, the use scope of pronase in our country is still relatively limited. The product name of the drug used in our country is pronase granules (trade name: Deyou), which is the only gastric mucus dissolving agent in China at present. The main component is pronase, which is a proteolytic enzyme that can cut the peptide bond of gastric mucus protein and effectively dissolve gastric mucus, improving the visibility of gastroscopy. Because it is stable and shows activity only in an environment of pH 7-9, sodium bicarbonate needs to be taken simultaneously as an acid neutralizer. The usage method of Deyou is to add 20,000 units of pronase (1 bag) and 1 gram of sodium bicarbonate to 50-80 ml of drinking water (20-40 °C) 15-30 minutes before gastroscopy, shake and dissolve and then take orally. The market price of Deyou is between 70 and 100 yuan.

[0005] Therefore, in view of the deficiencies and dilemmas in the above-mentioned clinical applications: 1. The types of defoamers are complex, and the clinical evaluations are mixed, without a unified medication standard; 2. The products of mucolytic agents are single, without competition from similar products, and cannot be widely used due to price issues; 3. They have a single function, and combined medication increases the economic burden on the examinees. We screened the active ingredients that can be used in gastroscopy from food additives and designed a combined preparation with the functions of removing mucus and defoaming simultaneously, avoiding the influence of mucus and foam on the endoscopic field of view during upper gastrointestinal endoscopy. Food additives have different action directions according to different needs, including defoamers and enzyme preparations used in the food processing process, which can simultaneously meet the two functions of enzymatic hydrolysis and defoaming. And food additives need to meet two key requirements when used: they should not cause any health hazards to the human body and should reduce the usage amount in food as much as possible on the premise of achieving the expected effect. In addition, the production cost of food additives is generally low, so the price of the drug finished product can be effectively reduced. Summary of the Invention

[0006] The purpose of the present invention is to provide a combined preparation of a new type of gastric juice defoaming drug, which not only has the advantages of low dosage, high efficiency, high safety and dual functions, but also has a simple preparation method and low production cost. To solve the above technical problems, the technical solutions provided by the present invention are as follows:

[0007] A combined preparation for improving the clarity of the gastroscopy field of view, comprising a mucus-dissolving component and a defoaming component;

[0008] The mucus-dissolving component includes, by weight: 400-500 parts of papain and 800-1200 parts of sodium bicarbonate;

[0009] The defoaming component includes, by weight: 100-130 parts of sucrose polyoxypropylene ether and 40-60 parts of polypropylene glycol.

[0010] As an improvement, the compositions of the mucus-dissolving component and the defoaming component are as follows:

[0011] Mucus-dissolving component: 500 parts of papain and 1000 parts of sodium bicarbonate;

[0012] Defoaming component: 116.7 parts of sucrose polyoxypropylene ether and 50 parts of polypropylene glycol.

[0013] The present invention discloses a sub-packaging method for two combined preparations for improving the clarity of the gastroscopy field of view.

[0014] One of them includes two independent sub-packaging bottles; both of the sub-packaging bottles are made of light-proof materials;

[0015] The top of the dispensing bottle is provided with a sealing film, and a partition is arranged inside the bottle. The partition divides the dispensing bottle into two sealed and independent sub-chambers;

[0016] The two dispensing bottles are respectively a mucus-dissolving component dispensing bottle and an antifoaming component dispensing bottle; the two sub-chambers in the mucus-dissolving component dispensing bottle store papain and sodium bicarbonate respectively; the antifoaming component dispensing bottle stores sucrose polyoxypropylene ether and polypropylene glycol respectively.

[0017] The usage method based on the above dispensing method is as follows: 10 - 40 minutes before gastroscopy, open the mucus-dissolving component dispensing bottle, add water to the reagents in the two sub-chambers, the water addition amount is 30 mL, and the temperature of the water is 10 - 55 °C. After fully mixing, take orally;

[0018] Then, 0 - 15 minutes before gastroscopy, open the antifoaming component dispensing bottle, add water to the reagents in its two sub-chambers, the water addition amount is 30 mL, and the temperature of the water is 10 - 55 °C. After fully mixing, take orally.

[0019] The second dispensing method of the present invention: includes two aluminum foil bags and a light-shielding centrifuge tube (50 mL);

[0020] The two aluminum foil bags are respectively used to store papain and sodium bicarbonate; the centrifuge tube is used to store the mixture of sucrose polyoxypropylene ether and polypropylene glycol.

[0021] The usage method based on the above dispensing method is: 10 - 40 minutes before gastroscopy, open the two aluminum foil bags, mix the reagents in the two aluminum foil bags, add water, the water addition amount is 30 mL, and the temperature of the water is 10 - 55 °C. After fully mixing, take orally;

[0022] Then, 0 - 15 minutes before gastroscopy, add water to the centrifuge tube, the water addition amount is 30 mL, and the temperature of the water is 10 - 55 °C. After mixing, place it on a high-speed centrifuge, and after centrifugation, shake it thoroughly to mix evenly, and then take orally.

[0023] As an improvement, the rotation speed of the centrifugation is 3000 - 12000 r / min, and the centrifugation time is 10 - 20 minutes.

[0024] The advantages of the present invention are:

[0025] 1. The most important breakthrough of the present invention is that compared with the similar products currently used clinically, the present invention simultaneously has the functions of removing mucus and defoaming, without the need to be used in combination with other drugs, and its ability to dissolve mucus and defoam is superior to that of similar products on the market. Papain in the present invention is an enzyme preparation extracted from papaya, which can efficiently hydrolyze proteins and polypeptide substances. Compared with streptodornase granules, its pH, temperature and substrate range of action are wider; sodium bicarbonate is used as a pH regulator to adjust the pH of gastric acid and improve the hydrolysis efficiency of the enzyme preparation; sucrose polyoxypropylene ether is a high-molecular polyether non-ionic surfactant, which can efficiently break bubbles and inhibit the generation of bubbles; polypropylene glycol is an organic polymer, commonly used as an excipient for medicines. Experiments show that the combination of this substance and polyether defoamers increases the defoaming ability by a multiple level.

[0026] 2. The sequence of drug use in the combined preparation of the present invention is reasonable. The mucus-dissolving component first enters the gastric cavity to lyse substances such as mucin and polypeptides. This process takes time. In addition, the gastric juice hydrolyzed by papain has lost part of its ability to generate bubbles, playing a role in inhibiting the generation of bubbles; then the defoaming component is taken before the examination to eliminate the remaining bubbles, achieving short-term defoaming, which can improve the cleanliness of the gastric cavity surface.

[0027] 3. The preparation and use methods of the present invention are simple, and the combined package itself does not contain water, avoiding the difficulties of packaging and transportation. The first sub-packaging method of the combined package is sufficient to meet the clinical application requirements. However, considering that the low solubility of oily substances in water may cause oil spots to appear after the mixed preparation, and the examinee may take it and adhere to the gastric cavity surface after taking it. Therefore, the second sub-packaging method makes up for the above possible defects. The mixed preparation after high-speed centrifugation is completely emulsified, avoiding the occurrence of the situation where oil spots adhere to the gastric cavity surface, and can improve the solubility of the defoamer, increase its spread in the foaming system, thereby improving the defoaming ability.

[0028] 4. The present invention abandons the idea of adding lubricants, thickeners, emulsifiers and sugars and other components in previous similar products, focuses on studying the optimal ratio of active ingredients, and highlights the improvement of mucus-dissolving and defoaming properties. In addition, the components of dimethicone emulsion, simethicone emulsion and gastroscope mucilage are complex and have high viscosity. There will be some residues after injection through the endoscopic channel. Even after high-level endoscopic disinfection, they cannot be completely removed, and even bacterial growth may lead to the formation of biofilms, causing the occurrence of iatrogenic infections. The present invention avoids the above problems.

[0029] 5. When using dimethicone for defoaming traditionally, usually 60 - 80 mL of water needs to be added. Excessive water volume causes choking cough in the examinee, which may pose a risk of aspiration for the patient. While too little water volume, such as in dyclonine hydrochloride mucilage (10 mL), the drug cannot be fully distributed onto the gastric mucosa, resulting in poor defoaming effect. However, the present invention uses sucrose polyoxypropylene ether and polypropylene glycol, with a moderate water volume used. While avoiding the above-mentioned aspiration problem, it can also achieve sufficient removal of mucus and foam. In addition, the effective doses of sucrose polyoxypropylene ether and polypropylene glycol in the present invention are significantly lower than those of dimethicone powder.

[0030] 6. The components screened and included in the present invention have low production costs, and the raw materials are simple and easily available. Compared with other drugs, it has an obvious advantage of low price. Description of the Drawings

[0031] Figure 1 It is a structural diagram of the dispensing bottle in Example 1.

[0032] Figure 2 It is the composition of the in vitro foaming model.

[0033] Figure 3 It is a contrast diagram of the visibility of pronase granules (left) and the mucus-dissolving component of the present invention (right).

[0034] Figure 4 It is a comparison diagram before and after using the medicine of the present invention (wherein, A1, B1, C1 are before using the medicine; A2, B2, C2 are after using the medicine).

[0035] Labels in the figure:

[0036] 1 - dispensing bottle, 2 - bottle cap, 3 - sealing film, 4 - partition board, 5 - sub-chamber. Detailed Description of the Invention

[0037] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some but not all of the embodiments of the present invention. Usually, the components of the embodiments of the present invention described and illustrated herein can be arranged and designed in various different configurations.

[0038] Example 1

[0039] This example discloses a combined preparation for improving the clarity of the gastroscope vision, including a mucus-dissolving component and a defoaming component.

[0040] Among them, the mucus-dissolving component is: papain 500 mg, sodium bicarbonate 1000 mg;

[0041] The defoaming component is: 116.7 mg of sucrose polyoxypropylene ether and 50 mg of polypropylene glycol.

[0042] The sub-packaging method of this embodiment is as follows:

[0043] Two mutually independent sub-packaging bottles are used; both sub-packaging bottles are made of light-shielding materials.

[0044] As Figure 1 and Figure 2 shown, the top of the sub-packaging bottle 1 is provided with a bottle cap 2 and a sealing film 3, and a partition 4 is arranged inside. The partition 4 divides the sub-packaging bottle 1 into two sealed and mutually independent sub-chambers 5.

[0045] The two sub-packaging bottles are respectively a mucus-dissolving component sub-packaging bottle and a defoaming component sub-packaging bottle; the two sub-chambers in the mucus-dissolving component sub-packaging bottle store papain and sodium bicarbonate respectively; the defoaming component sub-packaging bottle stores sucrose polyoxypropylene ether and polypropylene glycol respectively.

[0046] The usage method of the above sub-packaging method is: 10 - 40 minutes before gastroscopy, open the mucus-dissolving component sub-packaging bottle, add 30 mL of warm water at 10 - 55 °C to the reagents in the two sub-chambers, mix well, and then take orally;

[0047] Then, 0 - 10 minutes before gastroscopy, open the defoaming component sub-packaging bottle, add 30 mL of warm water at 10 - 55 °C to the reagents in its two sub-chambers, mix well, and then take orally.

[0048] Example 2

[0049] This embodiment discloses a combined preparation for improving the clarity of the gastroscopy field of view, including a mucus-dissolving component and a defoaming component.

[0050] Among them, the mucus-dissolving component is: 450 mg of papain and 900 mg of sodium bicarbonate;

[0051] The defoaming component is: 120 mg of sucrose polyoxypropylene ether and 45 mg of polypropylene glycol.

[0052] The sub-packaging method of this embodiment is as follows: Use two aluminum foil bags and a light-shielding centrifuge tube.

[0053] The two aluminum foil bags are respectively used to store papain and sodium bicarbonate; the centrifuge tube is used to store the mixed solution of sucrose polyoxypropylene ether and polypropylene glycol.

[0054] The usage method of the above sub-packaging method is: 10 - 40 minutes before gastroscopy, open the two aluminum foil bags, add 30 mL of warm water at 10 - 55 °C to the reagents in the two aluminum foil bags, mix well, and then take orally;

[0055] Then, 30 mL of warm water at 10 - 55 °C is added to the centrifuge tube 0 - 5 minutes before gastroscopy. After mixing, it is placed in a high-speed centrifuge. After centrifugation, it is shaken thoroughly to mix evenly and then taken orally. The rotation speed is 3000 - 12000 r / min, and the centrifugation time is 10 - 20 minutes.

[0056] The above-mentioned sub-packaging mainly takes into account the following: 1. The dosage of papain and sodium bicarbonate is slightly large, and using a light-proof bag can reduce the cost of drug packaging; 2. The two components of the defoaming agent cannot be completely dissolved in water and will produce oil droplets, which may affect the endoscopist's vision during the fine inspection process. Therefore, considering the above situation, centrifugation technology is used to completely emulsify the two components of the defoaming agent.

[0057] The dosage of the preparations in the above two packages is low, mainly for oral use before the examination, which can remove mucus and bubbles in advance. After taking it, the patient can move appropriately and change positions to make the drug preparation distribute on the surfaces of all parts of the gastric cavity, improving the drug effect. If the endoscope vision is still not clear during the examination, the dosage can also be supplemented by injection or spraying through the endoscopic channel.

[0058] Example 3 Validation test of the effectiveness of the present invention

[0059] 1. In vitro foaming model experiment

[0060] 1.1 Experimental materials

[0061] Foaming model ( Figure 2 ), foaming agent (egg white: water), streptokinase protease granules (produced by Beijing Tide Pharmaceutical Co., Ltd.), dimethicone powder (produced by Sichuan Zigong Honghe Pharmaceutical Co., Ltd.), food-grade papain, sucrose polyoxypropylene ether, polypropylene glycol.

[0062] 1.2 Experimental procedure

[0063] Step 1: Add 50 mL of foaming agent to each of the three glass graduated cylinders. According to different intervention measures, the groups are as follows:

[0064] Group A: 500 mg of papain, dissolved in 2 mL of water;

[0065] Group B: 500 mg of streptokinase protease granules, dissolved in 2 mL of water;

[0066] Group C: 2 mL of water.

[0067] Add different reagents to each glass graduated cylinder, mix thoroughly and let stand for 30 minutes. Observe and record the difference in protein concentration and the difference in visibility for each group.

[0068] Step 2: Add 50 mL of foaming agent to each of the three glass graduated cylinders and stop when the foaming volume reaches 500 mL. According to different intervention measures, the groups are as follows:

[0069] Group A: 116.7 mg of sucrose polyoxypropylene ether and 50 mg of polypropylene glycol are dissolved in 30 mL of water;

[0070] Group B: 2500 mg of dimethicone powder is dissolved in 30 mL of water;

[0071] Group C: 30 mL of water.

[0072] Add 0.5 mL of the above solutions into three glass graduated cylinders respectively, and record the amount of residual bubbles. If the foam can be completely eliminated, record the time taken for the foam to be completely eliminated. Destroy the remaining foam, continue to add the drug, foam, and repeat the above process until the foaming agent can no longer produce foam. Record the dose of the defoaming agent added, which is the minimum anti-foaming amount. Repeat the above two steps for ten experiments.

[0073] 1.3 Test results

[0074] 1.3.1 Comparison of mucolytic agents

[0075] The initial protein concentration is 62.1 mg / mL. The median differences in protein concentration among the three groups are 21.89 mg / mL, 21.54 mg / mL, and 0.16 mg / mL respectively. The differences between Group A and Group B are significantly higher than those of Group C, but there is no significant difference between Group A and Group B. However, the visibility difference of Group A is 9.7 mL, and the visibility difference of Group B is 4.1 mL. Figure 3 For the visibility comparison of the two groups. It can be clearly seen from the figure that the pronase granule solution is relatively turbid, while the mucolytic component in Example 1 is relatively clear, which can effectively improve the visibility and clarity of the examination field during gastroscopy.

[0076] 1.3.2 Comparison of defoaming agents

[0077] The amount of residual bubbles in Group A is 0 mL, and the average defoaming time is 2.54 s. The foams in Group B and Group C are not completely broken. The final results are shown in Table 1.

[0078] Table 1 Comparison of the amount of residual bubbles among the three groups

[0079]

[0080] a: Group A and B P-value<0.05; b: Group A and C P-value<0.05; c: Group B and C P-value<0.05; *P<0.01

[0081] The average minimum amount of defoamer required to suppress bubbles was 5.1 mL for group A. The average values ​​for groups B and C could not be calculated because there were 4 cases in group B and 10 cases in group C where the foam was not completely suppressed after using 30 mL of defoamer.

[0082] 2. In vitro gastric juice experiment

[0083] Gastric juice collection bottle, gastric juice, pronase granules (produced by Beijing Taide Pharmaceutical Co., Ltd.), dimethicone powder (produced by Sichuan Zigong Honghe Pharmaceutical Co., Ltd.), food grade papain, sucrose polyoxypropylene ether, and polypropylene glycol.

[0084] 2.1 Experimental process

[0085] The in vitro gastric juice experiment was approved by the ethics committee. A total of 30 patients were included in the experiment. Each patient signed an informed consent form. The researchers collected their gastric juices separately. The gastric juice collected from each patient was divided into two equal parts. The intervention measures and evaluation indicators were the same as those of the in vitro foam model experiment groups A and B.

[0086] 2.2 Test results

[0087] The median differences of protein concentration between the two groups were 18.62 mg / mL and 17.33 mg / mL, respectively (P<0.05). The difference in visibility was 5.65 (3.13) mL in group A and 4.00 (3.28) mL in group B. The difference was statistically significant (P=0.017).

[0088] Eight gastric juices that could not produce bubbles were eliminated. Therefore, a total of 22 gastric juices were included for analysis. Group A and Group B were able to completely eliminate the foam after adding 0.5 mL of different reagents. The minimum inhibition amount of the defoaming agent on bubbles in Group A was lower than that in Group B, but the difference was still not statistically significant (Table 2).

[0089] Table 2 Comparison of minimum foam inhibition between the two groups

[0090]

[0091] In addition, during the experiment, it was found that the use of papain can dissolve mucus protein and improve visual clarity, but it can also affect the foaming ability of gastric juice itself. Figure 4 Before and after comparison of papain in 3 patients.

[0092] From A1-C1, we can see that before using the combined preparation, the patient's gastric juice was turbid and dark in color, and there was a lot of foam on the surface of the gastric juice. This would affect the visibility during gastroscopy. After using the preparation, the gastric juice became significantly lighter in color, the turbidity decreased, and the foam disappeared, which can effectively improve the visibility and clarity of gastroscopy.

[0093] 3. Safety verification experiment of the preparation

[0094] Taking specific pathogen free (SPF) grade mice as the research object, the acute toxicity effect of the developed drug at different doses on mice was explored, and the median lethal dose (LD50) of the drug and the 95% confidence interval of LD50 were determined. The experiment was divided into two stages: preliminary experiment and formal experiment. The preliminary experiment preliminarily estimated the death dose range of the experimental mice (the dose at which all mice survived and the dose at which all mice died). The formal experiment was carried out according to the requirements of the Karber method.

[0095] The experimental results showed that the LD50 and 95% confidence interval of the combined preparation in Kunming mice by gavage were 17581.28 mg / kg (17286.04 - 17881.57 mg / kg), which was 1582.2 times the clinically recommended dose (taking 60 kg healthy people as an example).

[0096] The above-mentioned efficacy and safety experiments only included papain, sucrose polyoxypropylene ether, and polypropylene glycol for verification. Sodium bicarbonate was only used to adjust the gastric juice pH during clinical application to enable papain to play an effective role in neutral and alkaline environments.

[0097] The main mucus-dissolving and defoaming components used in the present invention were selected from enzyme preparations and defoamers in food additives, which complied with the national food safety standard GB2760-2014 of China and had basic safety guarantees. In addition, the oral acute toxicity experiment of the preparation on mice was carried out in the present invention. The experimental data showed that the clinically recommended dose was far lower than the median lethal dose, and the safety rating was actually non-toxic level.

[0098] The above is only the preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art within the technical scope disclosed by the present invention, according to the technical solution and inventive concept of the present invention, makes equivalent substitutions or changes, and all should be covered within the protection scope of the present invention.

Claims

1. A combined preparation for improving the clarity of gastroscopy, characterized in that: Includes mucolytic and antifoaming components; The mucolytic component comprises, by weight: 400-500 parts of papain and 800-1200 parts of sodium bicarbonate; The defoaming component comprises, by weight: 100-130 parts of sucrose polyoxypropylene ether and 40-60 parts of polypropylene glycol.

2. A combined preparation for improving the clarity of gastroscopic vision according to claim 1, characterized in that: The composition of the mucolytic component and the defoaming component is as follows: Mucolytic component: 500 parts of papain, 1000 parts of sodium bicarbonate; Defoaming components: 116.7 parts of sucrose polyoxypropylene ether and 50 parts of polypropylene glycol.

3. A method for packaging the combined preparation for improving the clarity of gastroscopic vision according to claim 1, characterized in that: It includes two independent sub-packaging bottles; the light-split bottles are made of light-proof materials; The sub-filling bottle is provided with a sealing film on the top and a partition inside, and the partition divides the sub-filling bottle into two sealed and mutually independent sub-chambers; The two sub-bottles are respectively a mucus dissolving component sub-bottle and a defoaming component sub-bottle; the two sub-chambers in the mucus dissolving component sub-bottle respectively store papain and sodium bicarbonate; the defoaming component sub-bottle respectively stores sucrose polyoxypropylene ether and polypropylene glycol.

4. A method of using the packaging method according to claim 3, characterized in that: 10-40 minutes before the gastroscopy, open the bottle of mucolytic component, add 30mL of water to the reagents in the two chambers, the water temperature is 10-55℃, mix thoroughly, and take orally; Then, 0-15 minutes before gastroscopy, open the sub-bottles of the defoaming components, add 30 mL of water to the reagents in the two sub-chambers, the water temperature is 10-55°C, mix thoroughly, and then take orally.

5. A method for packaging the combined preparation for improving the clarity of gastroscopic vision according to claim 1, characterized in that: Includes two aluminum foil bags and a light-protected centrifuge tube (50 mL); The two aluminum foil bags are used to store papain and sodium bicarbonate respectively; the centrifuge tube is used to store a mixed solution of sucrose polyoxypropylene ether and polypropylene glycol.

6. A method of using the packaging method according to claim 5, characterized in that: 10-40 minutes before gastroscopy, open the two aluminum foil bags, mix the reagents in the two aluminum foil bags, add 30 mL of water, the water temperature is 10-55°C, mix thoroughly, and take orally; Then, 0-15 minutes before the gastroscopy, add 30 mL of water to the centrifuge tube, the water temperature is 10-55°C, mix and place in a high-speed centrifuge, shake thoroughly after centrifugation to mix evenly, and then take orally.

7. The method of use according to claim 6, characterized in that: The centrifugal speed is 3000-12000 r / min, and the centrifugal time is 10-20 minutes.

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