A stomach-strengthening and digestion-promoting oral gel and preparation method thereof

Abstract

The invention provides a stomach-strengthening and digestion-promoting oral gel and a preparation method thereof, and relates to the field of medical technology. The stomach-strengthening and digestion-promoting oral gel of the invention comprises components by weight fraction: 0.5-2% compound glue, 0.05-0.2% potassium chloride, 5-20% sucrose, 0.05-0.25% citric acid, 0.025-0.075% antibacterial agent, 2.5-4% fruit powder and 73.475-91.875% liquid; in the liquid, the concentration of the Chinese medicine extract is 0.19-0.51g crude drug / mL; in the compound glue, the mass ratio of carrageenan, locust bean gum and xanthan gum is 1-5:0.3-3:0.5-2.5; the prepared stomach-strengthening and digestion-promoting oral gel has moderate elasticity and hardness, is convenient to chew, has a good taste, can meet the needs of different groups of people, improve the compliance of people with chewing and swallowing difficulties, can also significantly reduce the relative residual rate of pigment in the stomach, and significantly accelerate the pigment propulsion movement in the small intestine.

Description

Technical Field

[0001] The invention belongs to the technical field of medicines, and in particular relates to a stomach-strengthening and digestion-promoting oral gel and a preparation method thereof. Background Art

[0002] Symptoms of indigestion include abdominal distension, belching, early satiety, decreased appetite, nausea, and vomiting. Functional indigestion caused by weak spleen and stomach is becoming more and more common. Traditional Chinese medicine for treating such diseases is mainly Chinese patent medicine for strengthening the stomach and digestion, and most of these Chinese patent medicines are in the form of tablets. The classic formula Jianwei Xiaoshi Tablets comes from the 2005 edition of the Chinese Pharmacopoeia. It is made of five Chinese medicines: Radix Pseudostellariae, dried tangerine peel, Chinese yam, stir-fried malt, and hawthorn. It has the effects of strengthening the spleen and replenishing qi, digesting food and removing stagnation, and is used to treat symptoms such as weak spleen and stomach and indigestion. Radix Pseudostellariae has the effects of strengthening the spleen and replenishing qi; Chinese yam replenishes spleen qi and benefits stomach yin, and is a medicine for replenishing the middle qi; with dried tangerine peel, it replenishes and deficiencies, promotes qi and aids digestion, and hawthorn and malt have the effects of digesting food, removing stagnation, and removing bloating. Jianwei Xiaoshi Tablets are swallowed after chewing, and the effect is good. However, the stomachic and digestive drugs in tablets have a strong medicinal taste, which children tend to reject. At the same time, tablets are not suitable for people who have difficulty chewing and swallowing, especially some special groups and the elderly and children who have chewing and swallowing disorders, who find it difficult to swallow tablets.

[0003] Chinese invention patent application CN104146197A discloses a jelly powder for strengthening the stomach and promoting digestion in children and a preparation method thereof. The jelly powder comprises a Chinese medicine composition and other auxiliary materials, which are prepared into a powder or granule preparation together: the powder or granule is dissolved in water, stirred, and cooled to form a jelly; wherein the Chinese medicine composition comprises chicken gizzard lining, hawthorn, tangerine peel, malt or barley malt. The jelly powder prepared by the invention has both the effect of strengthening the stomach and promoting digestion, and has the unique taste of ordinary jelly.

[0004] Chinese invention patent application CN101185733A discloses a stomach-strengthening and digestion-promoting orally disintegrating tablet and a preparation method thereof, which is made of the following raw materials in percentage by weight: 5-20% Chinese herbal extract, 40-80% filler, 5-30% disintegrant, 0.5-5% flavoring agent, 0.5-3% glidant, and 0.3-2% lubricant. The disintegrating tablet has a simple preparation process and high bioavailability. It can quickly disintegrate when encountering saliva in the mouth and is easy to take. It is particularly suitable for the elderly with poor swallowing function, infants and children, and people who have difficulty in getting water.

[0005] For children, some modified dosage forms still have great swallowing difficulties, and children do not cooperate with the consumption due to the strong odor of the medicine. Oral gel dosage forms have controllable drug release and soft and smooth texture, which can reduce the risk of throat choking and suffocation and improve the safety of medication for children. Oral gel dosage forms also form a physical barrier to unpleasant tastes such as bitter, astringent, and spicy, and have good taste masking and flavor correction functions, which can reduce the addition of flavor correctors while improving patient compliance with medication.

[0006] At present, most of the research on oral gels stays on the effect of using a single matrix, and there are few studies on the synergistic enhancement between multiple gel matrices; it is also unclear what effect the excipients have on the smell, taste and tissue morphology of traditional Chinese medicine. In view of this, the present invention provides a stomach-strengthening and digestion-promoting oral gel and a preparation method thereof, and deeply studies the effects of the type of gel matrix and the amount of gel matrix added on the gel hardness, elasticity, taste, smell and tissue morphology. Summary of the invention

[0007] The invention aims at the problems existing in the prior art and provides a stomachic and digestive oral gel and a preparation method thereof. After five Chinese medicinal herbs including Radix Pseudostellariae, dried tangerine peel, Chinese yam, roasted malt and hawthorn are extracted with water, a Chinese medicinal extract is obtained; the Chinese medicinal extract is used to soak and dissolve a compound gum composed of carrageenan, locust bean gum and xanthan gum, which is helpful for the formation of the gel; the addition of citric acid, sucrose, fruit powder and the compound gum can not only enhance the flavor of the gel, but also cover up the bitterness of the Chinese medicinal ingredients; the preparation method of the invention can ensure the formation of the gel and improve the bad Chinese medicinal taste of the stomachic and digestive oral gel.

[0008] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0009] First, the present invention provides a stomach-strengthening and digestion-promoting oral gel, which comprises the following components by weight: 0.5-2% compound gel, 0.05-0.2% potassium chloride, 5-20% sucrose, 0.05-0.25% citric acid, 0.025-0.075% antibacterial agent, 2.5-4% fruit powder and 73.475-91.875% liquid;

[0010] The liquid is a Chinese medicine extract and water; in the Chinese medicine extract, the concentration of the drug is 0.19-0.51 g crude drug / mL;

[0011] The compound gum consists of carrageenan, locust bean gum and xanthan gum, and the mass ratio of carrageenan, locust bean gum and xanthan gum is 1-5:0.3-3:0.5-2.5.

[0012] Preferably, the stomachic and digestive oral gel comprises the following components by weight: 0.8-1.5% compound gel, 0.08-0.15% potassium chloride, 10-16% sucrose, 0.1-0.2% citric acid, 0.03-0.06% antibacterial agent, 2.8-3.5% fruit powder and 78.59-86.19% liquid.

[0013] Further preferably, the stomachic and digestive oral gel comprises the following components by weight: 1% compound gel, 0.1% potassium chloride, 15% sucrose, 0.15% citric acid, 0.04% antibacterial agent, 3% fruit powder and 80.71% liquid.

[0014] Preferably, the concentration of the drug in the traditional Chinese medicine extract is 0.35 g crude drug / mL.

[0015] Preferably, in the compound gum, the mass ratio of carrageenan, locust bean gum and xanthan gum is 2-4:0.8-2.4:0.8-2.

[0016] Further preferably, in the compound gum, the mass ratio of carrageenan, locust bean gum and xanthan gum is 3:1:1.

[0017] Preferably, the antibacterial agent is a conventional antibacterial agent used in the field of pharmaceutical preparations, and is not limited to potassium sorbate, sodium benzoate or methylparaben.

[0018] Preferably, the fruit powder is any edible fruit powder, not limited to sweet orange fruit powder, blueberry fruit powder or strawberry fruit powder.

[0019] Preferably, the Chinese medicine extract is made from the following Chinese medicine raw materials in parts by weight: 150-280 parts of Pseudostellaria heterophylla, 18-26 parts of dried tangerine peel, 130-215 parts of yam, 130-215 parts of roasted malt and 75-140 parts of hawthorn.

[0020] Further preferably, the Chinese medicine extract is made from the following Chinese medicine raw materials in parts by weight: 200-240 parts of Pseudostellaria heterophylla, 20-24 parts of dried tangerine peel, 150-190 parts of yam, 150-190 parts of roasted malt and 100-120 parts of hawthorn.

[0021] More preferably, the Chinese medicine extract is made from the following Chinese medicine raw materials in parts by weight: 228.6 parts of Pseudostellaria heterophylla, 22.9 parts of dried tangerine peel, 171.4 parts of yam, 171.4 parts of roasted malt and 114.3 parts of hawthorn.

[0022] Preferably, the Chinese medicine extract is prepared according to the following preparation method: boiling the Chinese medicine raw material with water for 2-4 times, filtering and concentrating the decoction to obtain the Chinese medicine extract.

[0023] Further preferably, the Chinese medicine extract is prepared according to the following preparation method: soak the Chinese medicine raw material in water for 10-40 minutes, decoct it twice, the first decoction is 1-3 hours, and the second decoction is 0.5-2 hours, the decoction is filtered and concentrated to obtain the Chinese medicine extract.

[0024] More preferably, the Chinese medicine extract is prepared according to the following preparation method: soak the Chinese medicine raw material components in water for 30 minutes, decoct them twice, the first decoction is 2 hours, and the second decoction is 1 hour, the decoction is filtered, concentrated, and centrifuged to obtain the Chinese medicine extract.

[0025] Then, the present invention provides a method for preparing the above-mentioned stomach-strengthening and digestion-promoting oral gel, comprising the steps of:

[0026] (1) Preparation of Chinese medicine extracts;

[0027] (2) mixing the compound glue, potassium chloride and part of sucrose, and then adding the mixture into a 70-90° C. traditional Chinese medicine extract in 1-4 portions to obtain a mixed glue solution;

[0028] (3) Under heat preservation conditions, the mixed gel solution is mixed with citric acid, preservatives, fruit powder, and remaining sucrose, and water is added to obtain a stomachic and digestive oral gel.

[0029] Preferably, step (1) is specifically as follows: soaking the Chinese medicinal raw material components of Radix Pseudostellariae, dried tangerine peel, yam, roasted malt and hawthorn in water for 10-40 minutes and then decocting them twice, the first decoction is 1-3 hours, and the second decoction is 0.5-2 hours, the decoction is filtered and concentrated to obtain a Chinese medicinal extract.

[0030] Further preferably, step (1) is specifically as follows: soaking the Chinese medicinal raw material components of Radix Pseudostellariae, dried tangerine peel, yam, roasted malt and hawthorn in water for 30 minutes and then decocting them twice, the first decoction is for 2 hours and the second decoction is for 1 hour, filtering, concentrating and centrifuging the decoction to obtain a Chinese medicinal extract.

[0031] Preferably, in step (2), the partial sucrose is 30-60% by weight of the total sucrose; further preferably, the partial sucrose is 50% by weight of the total sucrose.

[0032] Preferably, in step (2), the temperature of the Chinese medicine extract is 75-85°C; further preferably, the temperature of the Chinese medicine extract is 80°C.

[0033] Preferably, in step (3), the temperature of the insulation condition is 70-90°C; further preferably, the temperature of the insulation condition is 75-85°C; further preferably, the temperature of the insulation condition is 80°C.

[0034] Compared with the prior art, the present invention has the following beneficial effects:

[0035] 1. The oral gel of the present invention uses a composite gel obtained by mixing carrageenan, locust bean gum and xanthan gum as a gel matrix, controls the dosage of carrageenan, locust bean gum and xanthan gum, and significantly improves the molding performance of the gel. The gel has moderate elasticity and hardness, low dehydration rate, good taste and is convenient to chew. The present invention also controls the concentration of the Chinese medicine extract, and each component synergizes and enhances the effect. The use of citric acid, sucrose and fruit powder can not only enhance the flavor, taste and tissue morphology of the gel, but also cover up the bitterness of the Chinese medicine ingredients.

[0036] 2. The oral gel of the present invention can meet the needs of different groups of people. It not only has a good taste, but also can improve the compliance of patients with dysphagia, and can be used in emergency or water-unavailable environments. The preparation method of the oral gel of the present invention is simple and has a high comprehensive sensory evaluation score.

[0037] 3. The stomach-strengthening and digestion-promoting oral gel of the present invention can significantly reduce the relative residual rate of pigment in the stomach and significantly accelerate the propulsion movement of pigment in the small intestine. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 It is a comparison diagram of the tissue morphology of the stomach-strengthening and digestion-promoting oral gels prepared in the present application; from left to right, they are respectively: the stomach-strengthening and digestion-promoting oral gel of Comparative Example 8, the stomach-strengthening and digestion-promoting oral gel of Example 5, and the stomach-strengthening and digestion-promoting oral gel of Example 4. DETAILED DESCRIPTION

[0039] The following non-limiting examples can enable those skilled in the art to more fully understand the present invention, but do not limit the present invention in any way. The following content is merely an exemplary description of the scope of the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, which should also fall within the scope of the present invention.

[0040] When the embodiments give numerical ranges, it should be understood that, unless otherwise specified in the present invention, both endpoints of each numerical range and any numerical value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meanings as those generally understood by those of ordinary skill in the art to which the present invention belongs.

[0041] The present invention is further described below by way of specific examples. Unless otherwise specified, the various chemical reagents used in the examples of the present invention are obtained through conventional commercial channels.

[0042] In the following examples, carrageenan was purchased from Azelis International Trading (Shanghai) Co., Ltd., with a product number of 400-C; locust bean gum was purchased from Azelis International Trading (Shanghai) Co., Ltd., with a product number of RL-200; and xanthan gum was purchased from Wilder (Beijing) Flavor Co., Ltd., with a product number of 174931. Products from different manufacturers have no significant effect on the effect.

[0043] In the following embodiments, the mass fraction of the compound glue in the digestive oral gel is 0.5-2%. The mass fraction of this amount includes any range, real number and endpoint value within the numerical range. The mass fraction is exemplified but not limited to 0.5-2%, 0.5-1%, 0.5-1.2%, 1-1.5%, 1-2%, 0.8-1.2%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.8%, and 2%.

[0044] In the following embodiments, in the Chinese medicine extract, the concentration of the drug is 0.19-0.51 g crude drug / mL Chinese medicine extract; the concentration of the drug includes any range, real number and endpoint value within the numerical range, and the drug concentration (g crude drug / mL Chinese medicine extract) is exemplified but not limited to: 0.19-0.51 g / mL, 0.19-0.35 g / mL, 0.35-0.51 g / mL, 0.2-0.4 g / mL, 0.19 g / mL, 0.2 g / mL, 0.25 g / mL, 0.28 g / mL, 0.3 g / mL, 0.35 g / mL, 0.38 g / mL, 0.4 g / mL, 0.45 g / mL, 0.5 g / mL, 0.51 g / mL.

[0045] Example 1

[0046] A stomachic and digestive oral gel, comprising the following components by weight: 0.5% compound gel, 0.1% potassium chloride, 15% sucrose, 0.15% citric acid, 0.04% antibacterial agent (potassium sorbate), 3% fruit powder (sweet orange fruit powder) and the remainder liquid;

[0047] The liquids are: Chinese herbal medicine extract (the concentration of the drug is 0.19 g crude drug / mL) and water.

[0048] In the compound gum, the mass ratio of carrageenan, locust bean gum and xanthan gum is 3:1:1.

[0049] The preparation method of the oral gel for strengthening stomach and digestion is as follows:

[0050] (1) Preparation method of Chinese medicine extract: 228.6g of Pseudostellaria heterophylla, 22.9g of dried tangerine peel, 171.4g of Chinese yam, 171.4g of roasted malt, and 114.3g of hawthorn are decocted twice with water. For the first decoction, 10 times the total weight of the medicinal materials are added, soaked for 30 minutes, and decocted for 2 hours; for the second decoction, 8 times the total weight of the medicinal materials are added, decocted for 1 hour, the decoction is filtered, and the filtrate is concentrated under reduced pressure at 60°C. The concentrate is centrifuged to remove the residue, and the supernatant is taken to prepare a Chinese medicine extract with a drug concentration of 0.19g crude drug / mL;

[0051] (2) The Chinese medicine extract is heated in a constant temperature water bath at 80°C, and compound glue, potassium chloride and a portion of sucrose accounting for 50% of the total weight of sucrose are added in two portions, uniformly dispersed, and dissolved to obtain a mixed glue solution;

[0052] (3) Under the condition of keeping warm at 80℃, add the prescribed amount of citric acid, preservatives, fruit powder and the remaining sucrose, add distilled water to the prescribed weight, stir evenly, keep warm at 80℃ for 20 minutes to sterilize, and fill to obtain the oral gel for strengthening stomach and digestion.

[0053] Example 2

[0054] Different from Example 1, the drug concentration of the Chinese medicine extract is 0.35 g crude drug / mL.

[0055] A stomachic and digestive oral gel, comprising the following components by weight: 0.5% compound gel, 0.1% potassium chloride, 15% sucrose, 0.15% citric acid, 0.04% antibacterial agent (potassium sorbate), 3% fruit powder (sweet orange fruit powder) and the remainder liquid;

[0056] The liquids are: Chinese herbal medicine extract (the concentration of the drug is 0.35 g crude drug / mL) and water.

[0057] In the compound gum, the mass ratio of carrageenan, locust bean gum and xanthan gum is 3:1:1.

[0058] The preparation method of the oral gel for strengthening stomach and digestion is as follows:

[0059] (1) Preparation method of Chinese medicine extract: 228.6g of Pseudostellaria heterophylla, 22.9g of dried tangerine peel, 171.4g of Chinese yam, 171.4g of roasted malt, and 114.3g of hawthorn are decocted twice with water. For the first decoction, 10 times the total weight of the medicinal materials are added, soaked for 30 minutes, and decocted for 2 hours; for the second decoction, 8 times the total weight of the medicinal materials are added, decocted for 1 hour, the decoction is filtered, and the filtrate is concentrated under reduced pressure at 60°C. The concentrate is centrifuged to remove the residue, and the supernatant is taken to prepare a Chinese medicine extract with a drug concentration of 0.35g crude drug / mL;

[0060] Step (2) to step (3) are the same as in Example 1.

[0061] Example 3

[0062] Different from Example 1, the drug concentration of the Chinese medicine extract is 0.51 g crude drug / mL.

[0063] A stomachic and digestive oral gel, comprising the following components by weight: 0.5% compound gel, 0.1% potassium chloride, 15% sucrose, 0.15% citric acid, 0.04% antibacterial agent (potassium sorbate), 3% fruit powder (sweet orange fruit powder) and the remainder liquid;

[0064] The liquids are: Chinese herbal medicine extract (the concentration of the drug is 0.51 g crude drug / mL) and water.

[0065] The preparation method of the oral gel for strengthening stomach and digestion is as follows:

[0066] (1) Preparation method of Chinese medicine extract: 228.6g of Pseudostellaria heterophylla, 22.9g of dried tangerine peel, 171.4g of Chinese yam, 171.4g of roasted malt and 114.3g of hawthorn are decocted twice with water. For the first decoction, 10 times the total weight of the medicinal materials are added, soaked for 30 minutes and decocted for 2 hours. For the second decoction, 8 times the total weight of the medicinal materials are added and decocted for 1 hour. The decoction is filtered, and the filtrate is concentrated under reduced pressure at 60°C. The concentrate is centrifuged to remove the residue, and the supernatant is taken to prepare a Chinese medicine extract with a drug concentration of 0.51g crude drug / mL.

[0067] Step (2) to step (3) are the same as in Example 1.

[0068] Example 4

[0069] An oral gel for strengthening the stomach and promoting digestion, comprising the following components by weight: 1% compound gel, 0.1% potassium chloride, 15% sucrose, 0.15% citric acid, 0.04% antibacterial agent (potassium sorbate), 3% fruit powder (sweet orange fruit powder) and the remainder liquid;

[0070] The liquids are: Chinese herbal medicine extract (the concentration of the drug is 0.35 g crude drug / mL) and water.

[0071] In the compound gum, the mass ratio of carrageenan, locust bean gum and xanthan gum is 3:1:1.

[0072] The preparation method of the oral gel for strengthening stomach and digestion is as follows:

[0073] (1) Preparation method of Chinese medicine extract: 228.6g of Pseudostellaria heterophylla, 22.9g of dried tangerine peel, 171.4g of Chinese yam, 171.4g of roasted malt, and 114.3g of hawthorn are decocted twice with water. For the first decoction, 10 times the total weight of the medicinal materials are added, soaked for 30 minutes, and decocted for 2 hours; for the second decoction, 8 times the total weight of the medicinal materials are added, decocted for 1 hour, the decoction is filtered, and the filtrate is concentrated under reduced pressure at 60°C. The concentrate is centrifuged to remove the residue, and the supernatant is taken to prepare a Chinese medicine extract with a drug concentration of 0.35g crude drug / mL;

[0074] (2) The Chinese medicine extract is heated in a constant temperature water bath at 80°C, and compound glue, potassium chloride and a portion of sucrose accounting for 50% of the total weight of sucrose are added in two portions, uniformly dispersed, and dissolved to obtain a mixed glue solution;

[0075] (3) Under the condition of keeping warm at 80℃, add the prescribed amount of citric acid, preservatives, fruit powder and the remaining sucrose, add distilled water to the prescribed weight, stir evenly, keep warm at 80℃ for 20 minutes to sterilize, and fill to obtain the oral gel for strengthening stomach and digestion. The mass fraction of the compound gel is 1%.

[0076] Example 5

[0077] Different from Example 4, the amount of the compound glue added to the stomachic and digestive oral gel is different, and the mass fraction of the compound glue is 1.5%.

[0078] An oral gel for strengthening the stomach and promoting digestion, comprising the following components by weight: 1.5% compound gel, 0.1% potassium chloride, 15% sucrose, 0.15% citric acid, 0.04% antibacterial agent (potassium sorbate), 3% fruit powder (sweet orange fruit powder) and the remainder of liquid;

[0079] The liquids are: Chinese herbal medicine extract (the concentration of the drug is 0.35 g crude drug / mL) and water.

[0080] The rest is the same as Example 4.

[0081] Example 6

[0082] Different from Example 4, the amount of the compound glue added to the stomachic and digestive oral gel is different, and the mass fraction of the compound glue is 2.0%.

[0083] An oral gel for strengthening the stomach and promoting digestion, comprising the following components by weight: 2.0% compound gel, 0.1% potassium chloride, 15% sucrose, 0.15% citric acid, 0.04% antibacterial agent (potassium sorbate), 3% fruit powder (sweet orange fruit powder) and the remainder of liquid;

[0084] The liquids are: Chinese herbal medicine extract (the concentration of the drug is 0.35 g crude drug / mL) and water.

[0085] The rest is the same as Example 4.

[0086] Example 7

[0087] The difference from Example 4 is that the ratio of the compounded rubber is different. In the compounded rubber, the mass ratio of carrageenan, locust bean gum and xanthan gum is 3:0.8:0.8.

[0088] The rest is the same as Example 4.

[0089] Example 8

[0090] The difference from Example 4 is that the ratio of the compounded rubber is different. In the compounded rubber, the mass ratio of carrageenan, locust bean gum and xanthan gum is 3:1.8:1.5.

[0091] The rest is the same as Example 4.

[0092] Example 9

[0093] The difference from Example 4 is that the ratio of the compounded rubber is different. In the compounded rubber, the mass ratio of carrageenan, locust bean gum and xanthan gum is 1:0.3:0.5.

[0094] The rest is the same as Example 4.

[0095] Comparative Example 1

[0096] The difference from Example 4 is that the compounded gel is different. In this comparative example, the compounded gel is replaced with only one component, carrageenan, and the mass fraction of carrageenan in the stomachic and digestive oral gel is 1%.

[0097] Comparative Example 2

[0098] The difference from Example 4 is that the compounded glue is different. In this comparative example, the compounded glue used is 0.6% carrageenan and 0.4% locust bean gum. The rest is the same as Example 4.

[0099] Comparative Example 3

[0100] The difference from Example 4 is that the compounded rubber is different. In this comparative example, the compounded rubber used is 0.6% carrageenan and 0.4% xanthan gum. The rest is the same as Example 4.

[0101] Comparative Example 4

[0102] The difference from Example 4 is that the compound glue is different, and xanthan gum is replaced by gelatin. The compound glue is 0.6% carrageenan, 0.2% locust bean gum and 0.2% gelatin.

[0103] The rest is the same as Example 4.

[0104] Comparative Example 5

[0105] The difference from Example 4 is that the ratio of the compounded rubber is different. The compounded rubber is 0.3% carrageenan, 0.3% locust bean gum and 0.4% xanthan gum.

[0106] The rest are the same as in Example 4.

[0107] Comparative Example 6

[0108] Different from Example 4, the compound gum is replaced with only one component, xanthan gum, and the mass fraction of xanthan gum in the stomachic and digestive oral gel is 1%.

[0109] The rest is the same as Example 4.

[0110] Comparative Example 7

[0111] The difference from Example 4 is that the compound gel is replaced with only one component, locust bean gum, and the mass fraction of locust bean gum in the stomachic and digestive oral gel is 1%.

[0112] The rest are the same as in Example 4.

[0113] Comparative Example 8

[0114] Different from Example 4, the preparation method of the stomach-strengthening and digestion-promoting oral gel is different, specifically:

[0115] (1) Preparation method of Chinese medicine extract: same as Example 4;

[0116] (2) The Chinese medicine extract is heated in a constant temperature water bath at 60°C, and the compound glue, potassium chloride and part of the sucrose accounting for 50% of the total weight of the sucrose (not added in batches) are added, and the mixture is evenly dispersed and dissolved to obtain a mixed glue solution;

[0117] (3) Under the condition of keeping warm at 60℃, add the prescribed amount of citric acid, preservatives, fruit powder and the remaining sucrose, add distilled water to the prescribed weight, stir evenly, keep warm at 80℃ for 20 minutes to sterilize, and fill to obtain the oral gel for strengthening the stomach and digestion.

[0118] Comparative Example 9

[0119] The difference from Example 4 is that the ingredients of the compound glue are different. Locust bean gum is replaced by konjac gum. The compound glue is 0.6% carrageenan, 0.2% konjac gum and 0.2% xanthan gum.

[0120] The rest is the same as Example 4.

[0121] Comparative Example 10

[0122] The difference from Example 4 is that the compound glue has different ingredients, including 0.3% carrageenan, 0.2% locust bean gum, 0.2% xanthan gum and 0.3% konjac gum.

[0123] The rest is the same as Example 4.

[0124] Test 1 Quality Assessment

[0125] The hardness, elasticity, dehydration rate and sensory evaluation of the stomachic and digestive oral gel samples of Examples 1 to 9 of the present invention and Comparative Examples 1 to 10 were respectively tested.

[0126] The hardness and elasticity data of the stomachic and digestive oral gel were obtained by using a texture analyzer.

[0127] The formula for calculating the dehydration rate is: dehydration rate = weight of precipitated water after refrigeration for 24 hours (g) / total weight of gel (g) × 100%.

[0128] The sensory evaluation was obtained by a human food tasting evaluation experiment: 20 screened and trained evaluators were selected to conduct a sensory evaluation on the taste and tissue morphology of the stomachic and digestive oral gels of Examples 1 to 9 and Comparative Examples 1 to 10.

[0129] Evaluation method: After evaluating one group of samples, rinse your mouth with clean water and then evaluate the next group of samples after a 30-second interval.

[0130] The sensory evaluation items were scored on a 10-point scale, and the taste and texture of the samples were scored according to the sensory evaluation scoring criteria shown in Table 1. The overall sensory evaluation score = taste evaluation × 0.6 + texture evaluation × 0.4.

[0131] Table 1 Sensory scoring criteria

[0132]

[0133] The quality evaluation comparison results of the stomachic and digestive oral gels of the embodiments and comparative examples are shown in Table 2.

[0134] Table 2 Quality evaluation comparison results

[0135]

[0136] Table 2 shows the data on hardness, elasticity and dehydration rate, and the parallel experiments were conducted with n=6.

[0137] As can be seen from Table 2, compared with Example 4, the comparative sample gel is softer or harder, has a high dehydration rate, and has a low sensory evaluation comprehensive score. The example samples have a low dehydration rate, moderate hardness and elasticity, and a good sensory evaluation comprehensive score.

[0138] from Figure 1It can be seen from the tissue morphology comparison diagram that the gels prepared in Examples 4 and 5 have better tissue morphology, more uniform texture and smoother surface than the gel in the comparative example; the gel in Example 4 has no bubbles, the gel in Example 5 has a small amount of bubbles, and the gel in Comparative Example 8 has a large amount of bubbles.

[0139] Experiment 2 Pharmacodynamic study

[0140] A comparative study on the efficacy of Example 4 and Jianwei Xiaoshi Tablets (purchased from Jiangzhong Pharmaceutical Co., Ltd., item number 23080002, specification 0.5 g / tablet) was carried out.

[0141] 1. Effects on gastrointestinal motility in normal mice

[0142] 50 KM mice (batch number: JZDWNO: 2023-0085) were purchased, half male and half female, and randomly divided into 5 groups, 10 mice in each group, namely the control group, the Jianwei Xiaoshi tablet group, and the high, medium and low dose groups of the Jianwei Xiaoshi oral gel of Example 4.

[0143] The mice in the control group were given an equal amount of normal saline every day, and the mice in the other groups were given the corresponding drugs 0.1 mL / 10 g body weight by gavage every day, once a day, for 7 consecutive days. Before the last administration, all mice were fasted but not watered for 18 h. 30 min after administration, mice in each group were given 0.4 mL / mouse of 2% dextran blue-2000 solution. After 20 min, the mice were killed by cervical dislocation, and the stomach was removed by laparotomy and cut open along the greater curvature of the stomach. The pigment residue in the stomach was fully washed in 4 mL of deionized water.

[0144] Subsequently, the washing solution was centrifuged at 3500 r / min for 15 min, the supernatant filtrate was taken, and the absorbance was measured at 620 nm, which was the residual pigment in the stomach.

[0145] The percentage of the residual amount of pigment in the stomach of each sample to the mean value of the control group is the relative residual rate of pigment in the stomach of each sample.

[0146] At the same time, the intestinal tube from the upper end of the small intestine (pylorus) to the lower end (ileocecal part) was cut and gently spread on a glass plate. The length of the intestinal tube was measured as the total length of the small intestine. The distance from the pylorus to the blue front was measured as the "dextran advancement distance in the intestine" and the small intestine advancement percentage was calculated based on this. Effects of each drug on gastric emptying (relative residual rate of pigment in the stomach) and small intestinal advancement (small intestinal advancement rate) in mice ( )The results are shown in Table 3.

[0147] ;

[0148] As shown in Table 3, both Example 4 and the Jianweixiaoshi Tablets group can significantly reduce the relative residual rate of pigment in the stomach, significantly accelerate the propulsion movement of pigment in the small intestine, and increase the propulsion rate of the small intestine; compared with the control group, the relative residual rate of pigment and the propulsion rate of the small intestine in the Example 4 group are significantly different (*P<0.05, **P<0.01). There is no difference between the medium and high dose groups of the Jianweixiaoshi oral gel and the Jianweixiaoshi Tablets group.

[0149] Table 3 Effects of gastric emptying and small intestinal propulsion in mice ( , n=10) Results

[0150]

[0151] In Table 3, compared with the control group: *P<0.05, **P<0.01; "-" in Table 3 means no intragastric administration of drugs.

[0152] In summary, the stomachic and digestive oral gel of the present invention has a simple preparation method, good taste and high quality. The efficacy study shows that it has no difference compared with the stomachic and digestive tablets, and can improve the compliance of patients with chewing and swallowing difficulties.

[0153] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A stomach-strengthening and digestion-promoting oral gel, characterized in that: According to weight fraction, the components include 1% compound glue, 0.1% potassium chloride, 15% sucrose, 0.15% citric acid, 0.04% antibacterial agent, 3% fruit powder and 80.71% liquid; The liquid is a Chinese medicine extract and water; in the Chinese medicine extract, the concentration of the drug is 0.35 g crude drug / mL; The compound gum is composed of carrageenan, locust bean gum and xanthan gum, and the mass ratio of carrageenan, locust bean gum and xanthan gum is 3:1:1; The stomach-strengthening and digestion-promoting oral gel is prepared by the following steps: (1) Preparation of Chinese medicine extracts; (2) mixing the compound glue, potassium chloride and part of sucrose, and then adding the mixture into a 70-90° C. traditional Chinese medicine extract in 2-4 portions to obtain a mixed glue solution; (3) Under heat preservation conditions, the mixed gel solution is mixed with citric acid, preservatives, fruit powder, and remaining sucrose, and water is added to obtain a stomachic and digestive oral gel; The Chinese medicine extract is prepared from the following Chinese medicine raw materials in parts by weight: 150-280 parts of Pseudostellaria heterophylla, 18-26 parts of dried orange peel, 130-215 parts of Chinese yam, 130-215 parts of roasted malt and 75-140 parts of hawthorn.

2. The stomach-strengthening and digestion-promoting oral gel according to claim 1, characterized in that: The Chinese medicine extract is prepared according to the following preparation method: the Chinese medicine raw material is boiled in water for 2-4 times, and the decoction is filtered and concentrated to obtain the Chinese medicine extract.

3. The method for preparing the stomachic and digestive oral gel according to any one of claims 1 to 2, characterized in that: Includes steps: (1) Preparation of Chinese medicine extracts; (2) Mixing the compound glue, potassium chloride and part of sucrose, and then adding the mixture into a 70-90° C. traditional Chinese medicine extract in 2-4 portions to obtain a mixed glue solution; (3) Under heat preservation conditions, the mixed gel solution is mixed with citric acid, preservatives, fruit powder, and remaining sucrose, and water is added to obtain a stomachic and digestive oral gel.

4. The preparation method according to claim 3, characterized in that: In step (2), the partial sucrose is 30-60% of the total sucrose weight; the temperature of the Chinese medicine extract is 75-85°C; In step (3), the temperature of the insulation condition is 70-90°C.

5. The preparation method according to claim 4, characterized in that: In step (2), the partial sucrose is 50% of the total sucrose weight; the temperature of the Chinese medicine extract is 80°C; In step (3), the temperature of the insulation condition is 75-85°C.

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