Composition for intestinal preparation as well as preparation method and application thereof

Abstract

The invention discloses a composition for intestinal preparation and a preparation method and application thereof. The composition for intestinal preparation comprises a first oral preparation and a second oral preparation; the first oral preparation is a preparation taking polyethylene glycol as an active ingredient; the second oral preparation is prepared from the following medicinal raw materials: fructus cannabis, fried semen armeniacae amarae, radix et rhizoma rhei, radix aucklandiae, pericarpium citri reticulatae and radix paeoniae alba. The fructus cannabis intestine moistening pills and the polyethylene glycol are combined for use, a synergistic effect is generated, on one hand, the intestinal tract is emptied through a physical effect, on the other hand, the intestinal tract is protected through the conditioning effect of the traditional Chinese medicine, and the intestinal tract preparation efficiency and quality are jointly improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of combined medication, and particularly relates to a composition for intestinal preparation, a preparation method and an application thereof. Background Art

[0002] Colonoscopy is the most commonly used diagnostic and treatment method for early detection of intestinal lesions such as colon polyps and colon cancer. High-quality intestinal preparation helps to clearly display the mucosal surface and detect early colon lesions.

[0003] Compound polyethylene glycol electrolyte powder is currently the most widely used and effective bowel preparation and cleansing agent. Using compound polyethylene glycol electrolyte powder alone for bowel cleansing 4-6 hours before surgery is the most common approach. Compound polyethylene glycol electrolyte powder is a purely osmotic cathartic containing polyethylene glycol, sodium bicarbonate, sodium chloride, and potassium chloride. Its advantages include a mild onset of action, no risk of causing fluid and electrolyte imbalances or liver or kidney damage, and is suitable for patients of all ages.

[0004] However, the bowel preparation effect, adverse reaction incidence, and bowel preparation time of compound polyethylene glycol electrolyte powder alone still need to be improved. Some patients experience symptoms such as nausea and vomiting, abdominal distension, abdominal pain, dizziness, fatigue, and palpitations, and cannot tolerate it. Summary of the Invention

[0005] In view of this, the object of the present invention is to provide a composition for intestinal preparation, a preparation method and application thereof, so as to improve the intestinal preparation effect and reduce the incidence of adverse reactions.

[0006] In order to achieve the above object, the present invention provides the following technical solutions:

[0007] In a first aspect, the present invention provides a composition for intestinal preparation, comprising a first oral preparation and a second oral preparation; the first oral preparation is a preparation with polyethylene glycol as an active ingredient; the second oral preparation is composed of the following medicinal raw materials: hemp seed, fried bitter almonds, rhubarb, costus root, tangerine peel and white peony root.

[0008] As a preferred technical solution, the dosage form of the first oral preparation is any one of a solution, a granule or an effervescent.

[0009] As a preferred technical solution, the components of the first oral preparation include polyethylene glycol, sodium chloride, potassium chloride and sodium bicarbonate. Preferably, the molecular weight of the polyethylene glycol in the first oral preparation is 3000-5000, preferably polyethylene glycol with a molecular weight of 4000.

[0010] As a preferred technical solution, the second oral preparation is made of the following medicinal raw materials in the following parts by mass: 10-13 parts of hemp seed, 4-7 parts of fried bitter almonds, 10-13 parts of rhubarb, 4-7 parts of costus root, 10-13 parts of tangerine peel, and 4-7 parts of white peony root.

[0011] As a more preferred technical solution, the second oral preparation is made of the following medicinal raw materials in parts by mass: 12 parts of hemp seeds, 6 parts of fried bitter almonds, 12 parts of rhubarb, 6 parts of costus root, 12 parts of tangerine peel, and 6 parts of white peony root.

[0012] In a second aspect, the present invention further provides a method for preparing the second oral preparation. Specifically, the method adopts preparation method B.

[0013] Preparation, the preparation method B comprises the following steps:

[0014] B1: extracting hemp seed with petroleum ether by refluxing, filtering to obtain a filtrate and hemp seed residue; concentrating the filtrate under reduced pressure to recover the petroleum ether to obtain hemp seed oil, and drying the hemp seed residue and then grinding it into hemp seed fine powder;

[0015] B2: Grind bitter almonds, rhubarb, costus root, dried tangerine peel, and white peony root to obtain a mixed powder of other medicinal materials; mix the hemp seed powder with the mixed powder of other medicinal materials to obtain a total mixed powder;

[0016] B3: Mix the total mixed drug powder and hemp seed oil to form a medicine ball, and use the medicine ball to make pills, which is the second oral preparation.

[0017] As a preferred technical solution, refined honey is also added in step B3.

[0018] Furthermore, as an alternative technical solution, the second oral preparation is prepared using Preparation Method C, which comprises the following steps:

[0019] C1: Extracting hemp seed with petroleum ether by reflux, filtering to obtain a filtrate and hemp seed residue; concentrating the filtrate under reduced pressure to recover the petroleum ether to obtain hemp seed oil, and drying the hemp seed residue and then grinding it into hemp seed fine powder;

[0020] C2: Rhubarb, costus root, dried tangerine peel and white peony root are mixed and ground, extracted by alcohol extraction, and the obtained alcohol extract is concentrated to obtain an alcohol extract mixed with other medicinal materials;

[0021] C3: grinding the bitter almonds, extracting them with n-hexane as an extraction solvent, and recovering the n-hexane after extraction to obtain bitter almond oil and bitter almond residue;

[0022] C4: Mix hemp seed powder, bitter almond residue and other medicinal material residues to obtain a total mixed powder, and use the total mixed powder, hemp seed oil, bitter almond oil and alcohol extract as raw materials to prepare pills, which are the second oral preparation.

[0023] As an alternative technical solution, refined honey is further added in step C4.

[0024] In a third aspect, the present invention further provides a use of the aforementioned composition for intestinal preparation in the preparation of a drug for colonoscopy preparation.

[0025] As a preferred technical solution, the application is specifically:

[0026] Start taking the second oral preparation 2 to 4 times within 12 to 36 hours before the colonoscopy, and take the first oral preparation 2 to 8 hours before the colonoscopy.

[0027] The beneficial effects of the present invention are:

[0028] This invention creatively combines Ma Ren Run Chang Wan with polyethylene glycol, creating a significant synergistic effect. During bowel preparation, polyethylene glycol effectively empties the intestines through its physical properties, while Ma Ren Run Chang Wan leverages the power of traditional Chinese medicine to enhance the efficiency and quality of bowel preparation. Specifically, Ma Ren Run Chang Wan plays the following key roles in bowel preparation:

[0029] Intestinal moisturizing and laxative: Ma Ren Run Chang Wan is rich in core ingredients such as hemp seed, stir-fried bitter almonds, and rhubarb. Hemp seed moistens and lubricates the intestines, stir-fried bitter almonds calm the qi and moisten the intestines, and rhubarb has a laxative effect. These ingredients work together to effectively soften stool, significantly promote intestinal peristalsis, and facilitate efficient excretion of stool from the colon, laying a solid foundation for intestinal cleansing.

[0030] Protecting the intestinal mucosa: The various Chinese medicinal herbs in Ma Ren Run Chang Wan have excellent protective properties for the intestinal mucosa. They can reduce the sensitivity of the intestinal mucosa to various stimuli and strengthen the intestinal mucosal barrier function. When using polyethylene glycol powder for bowel preparation, it can effectively reduce potential irritation and damage to the intestinal mucosa, thereby reducing the occurrence of intestinal discomfort symptoms.

[0031] Reduced adverse reactions: Ma Ren Run Chang Wan has a mild effect and, when used in combination with polyethylene glycol powder, can significantly alleviate common adverse reactions of polyethylene glycol powder. For example, it can effectively reduce uncomfortable symptoms such as abdominal distension and diarrhea, significantly improving patients' tolerance and comfort during bowel preparation and enhancing their compliance with the bowel preparation regimen.

[0032] Adjusting intestinal function: Ma Ren Run Chang Wan has the benefits of invigorating Qi and nourishing Yin, comprehensively regulating intestinal function. It optimizes the intestinal environment, regulates the balance of intestinal flora, and enhances the intestine's self-repair and regulatory capabilities, creating more ideal intestinal conditions for subsequent colonoscopy examinations and improving the accuracy and reliability of examination results. DETAILED DESCRIPTION

[0033] The present invention will be further described below with reference to specific examples so that those skilled in the art can better understand the present invention and implement it, but the examples are not intended to limit the present invention.

[0034] The following examples are only used to more clearly illustrate the technical scheme of the present invention and are therefore only used as examples, and cannot be used to limit the scope of the present invention. For those skilled in the art, any equivalent modifications and substitutions to the embodiments described below are also within the scope of the present invention. Therefore, the equalization conversions and modifications made without departing from the spirit and scope of the present invention should all be encompassed within the scope of the present invention. In the examples, if specific conditions are not indicated, they are carried out according to normal conditions or the conditions recommended by the manufacturer. All reagents or instruments that do not indicate the manufacturer are conventional products that can be purchased commercially.

[0035] In order to better illustrate the present invention, numerous specific details are provided in the specific embodiments below. It should be understood by those skilled in the art that without certain specific details, the present invention can be implemented equally. In other embodiments, methods, means, equipment and steps well known to those skilled in the art are not described in detail to highlight the gist of the present invention. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art. Unless otherwise specified, the units used in this specification are international standard units, and the numerical values and numerical ranges appearing in the present invention are all understood to include inevitable errors in industrial production.

[0036] It should be noted that in the following embodiments:

[0037] The first oral preparation is a commercially available compound polyethylene glycol electrolyte powder with the trade name Shutaiqing. It is a compound preparation consisting of two doses, A and B. Dose A contains 13.125 g of polyethylene glycol 4000; dose B contains 0.1785 g of sodium bicarbonate, 0.3507 g of sodium chloride, and 0.0466 g of potassium chloride.

[0038] Honey is refined from a uniform batch and the specific preparation method is as follows:

[0039] When refining honey, place the honey in a honey refining pot and heat it to 116-118℃ (medium honey). Light red shiny foam will appear, and it will be sticky but not sticky when you rub it with your hands. Wait until the refined honey cools to 60-80℃ and it is ready.

[0040] Example 1

[0041] This embodiment provides a second oral preparation and its preparation method, which is prepared using Preparation Method B, as follows:

[0042] Step B1:

[0043] Medicinal material drying and hemp seed processing: 12 parts of hemp seed, 6 parts of fried bitter almonds, 12 parts of rhubarb, 6 parts of costus root, 12 parts of dried tangerine peel, and 6 parts of white peony root were dried in a drying oven at 60° C. until the moisture content was less than 8.0%.

[0044] Extract hemp seeds with petroleum ether under reflux for 3 hours, and concentrate the filtrate under reduced pressure to recover the petroleum ether to obtain hemp seed oil;

[0045] The hemp seed residue is released, dried and crushed into 80-mesh fine powder to obtain hemp seed fine powder.

[0046] Step B2:

[0047] Processing of other medicinal materials: Take the fried bitter almonds, rhubarb, costus root, tangerine peel, and white peony root, mix them separately into 80-mesh fine powder, sieve them and mix them according to the mass parts, and add them together with the above-mentioned hemp seed fine powder into a three-dimensional motion mixer and mix for 20 minutes to obtain the total mixed medicinal powder.

[0048] Step B3:

[0049] Preparation of pills: according to the total mixed powder, refined honey and purified water (powder: refined honey: water = 70:23:85) and all the hemp seed oil, add them into a trough mixer and mix for 15 minutes to make a soft and hard, uniform and plastic medicine ball, add the medicine ball into the pill making machine in batches, squeeze the medicine ball through the spiral propeller, squeeze out the medicine strip from the preset small hole, connect the strip medicine to the traction disk, and continuously cut it into pills by a cutter, then place the pills in a hot air circulation box, dry at 75 ° C, dry 8 hours, add pills: purified water in a ratio of 10:1 into the coating pot, rotate the pot to moisten the surface of the pellets, and constantly collide until the surface is bright and round, without exposed surface and mottling, turn on the hot air blower (80°C) for 30 minutes, and blow hot air on the constantly moving pills until the pills become dry, compact and bright, turn off the coating machine, take out the pills and place them on a baking tray, push them into the oven, set the drying temperature to 75°C, and dry them for 2 hours until the moisture of the pills is ≤10.0%, thereby obtaining Ma Ren Run Chang Wan sample 1.

[0050] Example 2

[0051] This embodiment provides a second oral preparation and its preparation method, which is prepared using Preparation Method B, as follows:

[0052] Step B1: Same as Example 1.

[0053] Step B2: Same as Example 1.

[0054] Step B3:

[0055] Preparation of pills: According to the total mixed powder, purified water (powder: water = 70:108) and all the hemp seed oil, add them into a trough mixer and mix for 15 minutes to make a soft and hard, uniform, and plastic pill. Then, the pill is prepared as Ma Ren Run Chang Wan sample 2 with reference to the method of Example 1.

[0056] Example 3

[0057] This embodiment provides a second oral preparation and its preparation method, which is prepared using Preparation Method C, as follows:

[0058] Step C1:

[0059] The drying of medicinal materials and the processing of hemp seeds are the same as those in Example 1.

[0060] Step C2:

[0061] Processing of other medicinal materials: Take rhubarb, costus root, tangerine peel and white peony root and grind them into 80 mesh fine powder through 30B grinder respectively, then mix them according to the mass ratio, and then use alcohol extraction method to extract their active ingredients, specifically: according to the material-liquid ratio of 1:

[0062] (8-10) The extraction was performed twice, each time for 3-5 h, and the obtained alcohol extract was concentrated to obtain an alcohol extract mixed with other medicinal materials.

[0063] Bitter almond oil and bitter almond residue: grinding bitter almonds, extracting with n-hexane as an extraction solvent, and recovering the n-hexane after extraction to obtain bitter almond oil and bitter almond residue;

[0064] Total mixed medicinal powder: add hemp seed powder, bitter almond residue and other medicinal material residues into a three-dimensional motion mixer and mix for 20 minutes to obtain the total mixed medicinal powder.

[0065] Step C3:

[0066] Preparation of pills: The total mixed powder, hemp seed oil, bitter almond oil and alcohol extract are added to a trough mixer and mixed for 15 minutes to form a medicine ball with moderate hardness, uniformity and certain plasticity. The medicine ball is then prepared into Ma Ren Run Chang Wan sample 3 according to the method of Example 1.

[0067] Example 4

[0068] This embodiment provides a second oral preparation and its preparation method, which is prepared using Preparation Method C, as follows:

[0069] Step C1:

[0070] The drying of medicinal materials and the processing of hemp seeds are the same as those in Example 3.

[0071] Step C2:

[0072] Other medicinal material processing: the same as Example 3.

[0073] Step C3:

[0074] Preparation of pills: The total mixed powder, hemp seed oil, bitter almond oil, alcohol extract and refined honey (the amount of refined honey added is the same as in Example 1) are added to a trough mixer and mixed for 15 minutes to form a medicine ball with moderate hardness, uniformity and certain plasticity. The medicine ball is then prepared as Ma Ren Run Chang Wan sample 4 according to the method of Example 1.

[0075] Comparative Example 1

[0076] The present invention provides a second oral preparation and a preparation method thereof, which is prepared using preparation method A, as follows:

[0077] Prescription: 120g hemp seed, 60g fried bitter almond, 120g rhubarb, 60g costus root, 120g tangerine peel, 60g white peony root;

[0078] The preparation method is as follows:

[0079] Dry 12 parts of hemp seed, 6 parts of roasted bitter almonds, 12 parts of rhubarb, 6 parts of costus root, 12 parts of dried tangerine peel, and 6 parts of white peony root in a drying oven at 60°C until the moisture content is less than 8.0%. Grind the above six ingredients into fine powder (pass through an 80-mesh sieve), sieve the fine powder, and mix thoroughly.

[0080] Slowly add 150g refined honey to the powder at a ratio of 100g of powder and stir until it forms a plastic pellet. Separate the pellets into uniform pellets to obtain the large honeyed Ma Ren Run Chang Wan pills, which are recorded as Ma Ren Run Chang Wan Reference Substance 1.

[0081] Comparative Example 2

[0082] The present invention provides a second oral preparation and a preparation method thereof, which is prepared using preparation method D, as follows:

[0083] Prescription: 120g hemp seed, 60g fried bitter almond, 120g rhubarb, 60g costus root, 120g tangerine peel, 60g white peony root;

[0084] The preparation method is as follows:

[0085] Dry 12 parts of hemp seed, 6 parts of roasted bitter almonds, 12 parts of rhubarb, 6 parts of costus root, 12 parts of dried tangerine peel, and 6 parts of white peony root in a drying oven at 60°C until the moisture content is less than 8.0%. Grind the above six ingredients into fine powder (pass through an 80-mesh sieve), combine the powders and mix thoroughly.

[0086] Take starch and add appropriate amount of water to boil to make starch water, cool to 50-60℃, slowly add to the medicinal powder, stirring while adding to make a soft material with appropriate hardness, use a pill-making machine or manually to make pill strips, cut into uniform pills, roll into water pills, and dry them. Record them as Ma Ren Run Chang Wan water pills and record them as Ma Ren Run Chang Wan reference substance 2.

[0087] Comparative Example 3

[0088] Based on the aforementioned Example 3, this comparative example is intended to provide a comparative example with respect to Example 3, which is a prescription of a second oral preparation and a preparation method thereof, and is prepared by the following method:

[0089] Step E1:

[0090] The drying of medicinal materials and the processing of hemp seeds are the same as those in Example 1.

[0091] Step E2:

[0092] Processing of other medicinal materials: Rhubarb, costus root, tangerine peel, white peony root and fried bitter almonds were respectively crushed into 80-mesh fine powder by 30B grinder, and then mixed according to the mass ratio. The active ingredients were extracted by alcohol extraction method, specifically: the extraction was performed twice according to the material-liquid ratio of 1: (8-10), and the extraction time for each time was 3-5 hours. The obtained alcohol extract was concentrated to obtain the alcohol extract and the mixed residue with other medicinal materials.

[0093] Total mixed medicinal powder: add hemp seed powder and other medicinal materials mixed residue into a three-dimensional motion mixer and mix for 20 minutes to obtain the total mixed medicinal powder.

[0094] Step E3:

[0095] Preparation of pills: The total mixed powder, hemp seed oil, refined honey (mass ratio of the total mixed powder to refined honey = 70:23), and the alcohol extract are added to a trough mixer and mixed for 15 minutes to form a medicine ball with moderate hardness, uniformity, and a certain plasticity. The medicine ball is then prepared as Ma Ren Run Chang Wan reference substance 3 according to the method of Example 1.

[0096] Comparative Example 4

[0097] Based on the aforementioned Example 3, this comparative example is intended to provide a comparative example with respect to Example 3, which is a prescription of a second oral preparation and a preparation method thereof, and is prepared by the following method:

[0098] Step F1:

[0099] The drying of medicinal materials and the processing of hemp seeds are the same as those in Example 1.

[0100] Step F2:

[0101] Processing of other medicinal materials: Rhubarb, costus root, tangerine peel, white peony root and fried bitter almonds were respectively crushed into 80-mesh fine powder by 30B grinder, and then mixed according to the mass ratio. The active ingredients were extracted by alcohol extraction method, specifically: the extraction was performed twice according to the material-liquid ratio of 1: (8-10), and the extraction time for each time was 3-5 hours. The obtained alcohol extract was concentrated to obtain the alcohol extract and the mixed residue with other medicinal materials.

[0102] Total mixed medicinal powder: add hemp seed powder and other medicinal materials mixed residue into a three-dimensional motion mixer and mix for 20 minutes to obtain the total mixed medicinal powder.

[0103] Step F3:

[0104] Preparation of pills: The total mixed powder, hemp seed oil and alcohol extract are added to a trough mixer and mixed for 15 minutes to form a medicine ball with moderate hardness, uniformity and certain plasticity. The medicine ball is then prepared as Ma Ren Run Chang Wan reference substance 4 according to the method of Example 1.

[0105] Experimental Example 1 Mouse Experiment

[0106] 1.1 Experimental methods

[0107] 100 Kunming male mice (KM mice), 18-22 g, were divided into 10 groups, with 10 mice in each group, as blank control group, model control group, experimental groups 1-3, and control groups 1-4, respectively. The mice were adaptively raised for 1 week in an environment maintained at a temperature of 22±2°C, a relative humidity of 50%-60%, a 12-h light / 12-h dark cycle, and free access to food and water.

[0108] After the experiment began, except for the normal control group, the mice in the other groups were gavaged with compound diphenoxylate (5 mg / kg) for 3 consecutive days to induce constipation. Starting from the 4th day after model establishment, each group was gavaged with the corresponding drug (0.6 g / kg) once a day for 7 consecutive days. Specifically, the dosing regimen of each group is shown in Table 1:

[0109] Table 1 Dosage regimen for mice

[0110]

[0111] The dosage is 0.6 g / kg, which is calculated based on the crude drug amount (the crude drug amount contained in each 6 g of the finished product Ma Ren Run Chang Wan is calculated to be 2.5 g).

[0112] 1.2 Observation indicators

[0113] (1) Time of first black stool discharge (reflects intestinal motility)

[0114] After the last administration, the mice were fasted but not watered for 12 h. The mice in each group were gavaged with 5% activated carbon solution (dissolved in saline) (0.2 ml / 10 g body weight). The time from gavage with activated carbon solution to discharge of the first black stool was recorded.

[0115] (2) Number and weight of stool particles within 6 hours (reflecting laxative effect)

[0116] The number and weight of feces discharged by mice within 6 hours after gavage with activated carbon solution were recorded.

[0117] (3) Water content of stool (reflecting the intestinal moistening effect of Ma Ren Run Chang Wan)

[0118] Fecal moisture content: Collect feces excreted by mice within 6 hours, weigh the wet weight, and then place the feces in a 60°C oven to a constant weight. Weigh the dry weight and calculate the fecal moisture content according to the formula:

[0119] Fecal moisture content (%) = (wet weight - dry weight) / wet weight × 100%.

[0120] 1.3 Experimental Results

[0121] The experimental results are shown in Table 2:

[0122] Table 2 Mouse experimental results

[0123]

[0124]

[0125] * indicates a significant difference compared with the model control group (p<0.05), ** indicates p<0.01; # indicates better effect than the comparative example 1 group (p<0.05); ▲ indicates a significant difference compared with the comparative example 3 group (p<0.05); there was no significant difference between the example 4 group and the example 3 group.

[0126] The above experiments show that Comparative Example 1 adopts the traditional method to prepare the hemp seed intestinal moistening preparation, and its process is relatively rough, and the effect of moistening the intestines and relieving constipation is poor, while the extraction of hemp seed oil significantly improves the water content of feces (Example 1 vs. Comparative Example 1), which proves the lubricating and water-retaining effect of grease; and refined honey prolongs the drug residence time by sustained release and improves the water absorption efficiency (Example 1 vs. Example 2); In the process of Example 3, hemp seed oil and bitter almond oil are extracted at the same time, and they synergize with the alcohol extract to achieve the optimal water-retaining effect. Example 4 adopts a similar process to Example 3, and although refined honey is added in Example 4 (honey itself has the medicinal effects of nourishing the middle and moisturizing dryness, relieving acute pain, and synergizing with the core effect of "moistening the intestines and relieving constipation" in the hemp seed intestinal moistening pills (such as hemp seed moistening and rhubarb purging heat), it can enhance the overall therapeutic effect, and the "moist" property of refined honey can also alleviate the strong purgative effect of drugs such as rhubarb, making the medicinal effect more mild and lasting, and reducing intestinal irritation), its technical effect is no significantly different from that of Example 3. At the same time, in the improved preparation process of hemp seed runchang pills, hemp seed oil and bitter almond oil are indispensable, otherwise the effect of moisturizing the intestines and promoting bowel movements will be reduced.

[0127] This shows that the medicinal effects of Examples 3 and 4 are close and optimal, and Example 3 with a simpler process (no need to add refined honey) can be preferred in the future. At the same time, the following technical problems are also solved:

[0128] Traditional refined honey contains a large amount of sugar (glucose, fructose, etc.), which may increase blood sugar and is not suitable for diabetics or those who need to control their sugar intake. Hemp seed oil and bitter almond oil are lipid components and do not contain sugar, which can significantly reduce the impact of the preparations on blood sugar and expand the population of patients who can use them. At the same time, diabetics often have abnormal lipid metabolism, but the unsaturated fatty acids in hemp seed oil (such as linoleic acid and linolenic acid) and the active ingredients in bitter almond oil (such as amygdalin) may indirectly improve metabolic disorders by regulating intestinal function, rather than directly increasing the sugar load.

[0129] These experimental results suggest that dual-oil combinations may enhance efficacy through multi-target synergy, surpassing the effects of either single oils or refined honey alone. Replacing refined honey with hemp seed oil and bitter almond oil not only addresses medication contraindications for patients with diabetes, but also enhances efficacy and stability through ingredient synergy and process optimization, aligning with the development direction of modern Chinese medicine preparations: "safe, effective, and precise."

[0130] Experimental Example 2 Evaluation of the effectiveness, tolerability and safety of bowel preparation before colonoscopy

[0131] Bowel preparation is essential before a colonoscopy or surgery. It encompasses both basic and specialized nursing care, and is closely linked to nosocomial infection control, clinical healthcare quality, and the occurrence of complications. High-quality bowel preparation plays a crucial role in ensuring a smooth colonoscopy or surgery, improving examination quality, alleviating patient suffering, and preventing complications.

[0132] 2.1 Experimental Grouping and Experimental Methods

[0133] 500 volunteers were recruited, and the inclusion and exclusion criteria were as follows:

[0134] Inclusion criteria: patients aged 18-70 years who needed to undergo colonoscopy; without severe abnormalities of heart, liver, or kidney function; and signed informed consent.

[0135] Exclusion criteria: pregnant or lactating women; allergic to the test drug ingredients; recent (within 1 week) use of laxatives or drugs that affect intestinal motility.

[0136] The above volunteers were randomly divided into 5 groups, with 100 people in each group. The experimental groups and experimental plan are shown in Table 3:

[0137] Table 3 Bowel preparation dosing regimen

[0138]

[0139] (1) The medication regimen for the single-drug group of Shutai is as follows: on the day of colonoscopy, start taking Shutaiqing (compound polyethylene glycol electrolyte powder solution) orally 6 hours before the examination, and implement the 2L PEG regimen, that is, use 16 bags of each of the two doses A and B of the compound polyethylene glycol electrolyte powder preparation, dissolve them in 2000ml of warm water, take 250ml every 10 to 15 minutes, and finish taking it within 2 hours.

[0140] (2) The medication regimen for the other groups is as follows:

[0141] The day before the colonoscopy, take one Ma Ren Run Chang Wan pill (prepared according to the corresponding method) orally (each pill contains 2.5g of the raw medicinal material) after meals, for a total of two doses before the procedure. On the day of the colonoscopy, take Shutaiqing orally according to the aforementioned Shutai single-drug regimen.

[0142] Alternatively, two days before the colonoscopy, take two Shouhui Tongbian Capsules (0.35g each, equivalent to 0.79g of the medicinal piece) three times a day after meals, for a total of six doses before the procedure. On the day of the colonoscopy, take Shutaiqing orally according to the aforementioned Shutai monotherapy regimen.

[0143] 2.2 Evaluation indicators

[0144] The bowel preparation quality of each group of volunteers was scored. The scoring items included adverse reactions of bowel preparation, Boston Bowel Preparation Score, and Intestinal Bubble Score, as follows:

[0145] The Boston Bowel Preparation Score (BPS) has a total score range of 0-9 and is based on the following three areas of bowel performance:

[0146] cecum and ascending colon;

[0147] Transverse colon (including the hepatic flexure, splenic flexure and other curved parts);

[0148] Left colon (including the descending colon, sigmoid colon and rectum).

[0149] The specific scoring criteria for each area can be found in Table 4.

[0150] Table 4 Boston bowel preparation scoring criteria

[0151]

[0152] (2) Intestinal bubble score (0-3 points), the standard is shown in Table 5:

[0153] Table 5 Intestinal bubble scoring criteria

[0154]

[0155] (3) Adverse reactions to bowel preparation include nausea, vomiting, abdominal distension, abdominal pain, dizziness, collapse, palpitations, and others. Record the number of cases and severity (mild / moderate / severe). Specifically:

[0156] Total number of adverse reactions: including all recorded adverse reactions such as nausea, vomiting, abdominal distension, abdominal pain, dizziness, collapse, palpitations, etc. (multiple symptoms in the same subject were counted only once);

[0157] Severity ratings include:

[0158] Mild: symptoms are mild and do not affect examination or daily activities;

[0159] Moderate: symptoms are obvious but tolerable, requiring a short rest;

[0160] Severe: symptoms are severe and require medical intervention;

[0161] 2.3 Experimental Results and Analysis

[0162] (1) Primary endpoints: including the total Boston Scale score (mean ± standard deviation) and the intestinal bubble score (mean ± standard deviation); the experimental results are shown in Table 6 (synergy index = combination group score / single drug group score, >1 indicates synergy).

[0163] Secondary endpoints: including the incidence of adverse reactions (%), the experimental results are shown in Table 7.

[0164] (2) Statistical methods:

[0165] One-way analysis of variance (ANOVA) or nonparametric test (Kruskal-Wallis) was used for comparison among the groups; the incidence of adverse reactions was analyzed using the chi-square test; the significance level was: p < 0.05.

[0166] Table 6 Boston score and bubble score

[0167]

[0168] *: Significant difference compared to the Shutai monotherapy group (p<0.05). #: Better effect than control group 1 (p<0.05). ▲: Significant difference compared to the positive control group (p<0.05). No significant difference between Example 3 and Example 4 groups (p>0.05).

[0169] Table 7 Incidence of adverse reactions (%)

[0170]

[0171] Table 8 Total number of adverse reactions and their severity

[0172]

[0173]

[0174] The above experimental results show that there is no significant difference in the Boston score between Examples 3 and 4, and it is obvious that the traditional method is used to prepare the Ma Ren Run Chang Wan, which suggests that the improved process of the present invention may reduce intestinal bubble interference and have a positive impact on the effect of combined medication. In terms of safety, the incidence of adverse reactions (abdominal distension, nausea) of the Ma Ren Run Chang Wan is significantly lower than that of the Shu Tai Qing and positive control groups, and is more suitable for sensitive populations. The improved Ma Ren Run Chang Wan process provided in Example 3 is expected to play a better role in clinical practice, and it provides a safer choice for patients who need to control blood sugar.

[0175] The above experiments prove that the combined use of Ma Ren Run Chang Wan and polyethylene glycol produces a synergistic effect. On the one hand, it empties the intestine through physical action, and on the other hand, it protects the intestine through the conditioning effect of traditional Chinese medicine, thereby jointly improving the efficiency and quality of intestinal preparation. In particular, the combined use of Ma Ren Run Chang Wan and polyethylene glycol is better than the combined use of Shou Hui Tongbian Capsules and polyethylene glycol.

[0176] The above embodiments are only preferred embodiments for fully illustrating the present invention, and the protection scope of the present invention is not limited thereto. Any equivalent substitution or modification made by those skilled in the art based on the present invention is within the protection scope of the present invention.

Claims

1. A composition for intestinal preparation, characterized in that: The invention comprises a first oral preparation and a second oral preparation; the first oral preparation is a preparation with polyethylene glycol as an active ingredient; the second oral preparation is composed of the following medicinal raw materials: hemp seed, fried bitter almond, rhubarb, costus root, tangerine peel and white peony root.

2. A composition for intestinal preparation according to claim 1, characterized in that: The dosage form of the first oral preparation is any one of a solution, a granule or an effervescent.

3. A composition for intestinal preparation according to claim 2, characterized in that: The components of the first oral preparation include polyethylene glycol, sodium chloride, potassium chloride and sodium bicarbonate, and the molecular weight of the polyethylene glycol in the first oral preparation is 3000-5000.

4. The composition for intestinal preparation according to claim 1, characterized in that The second oral preparation is prepared from the following medicinal raw materials in parts by weight: 10-13 parts of hemp seeds, 4-7 parts of fried bitter almonds, 10-13 parts of rhubarb, 4-7 parts of costus root, 10-13 parts of tangerine peel and 4-7 parts of white peony root.

5. A composition for intestinal preparation according to claim 4, characterized in that The second oral preparation is prepared from the following medicinal raw materials in parts by mass: 12 parts of hemp seeds, 6 parts of fried bitter almonds, 12 parts of rhubarb, 6 parts of costus root, 12 parts of dried tangerine peel and 6 parts of white peony root.

6. The composition for intestinal preparation according to claim 4, characterized in that: The second oral preparation is prepared using preparation method B, which comprises the following steps: B1: extracting hemp seed with petroleum ether by refluxing, filtering to obtain a filtrate and hemp seed residue; concentrating the filtrate under reduced pressure to recover the petroleum ether to obtain hemp seed oil, and drying the hemp seed residue and then grinding it into hemp seed fine powder; B2: Grind bitter almonds, rhubarb, costus root, dried tangerine peel, and white peony root to obtain a mixed powder of other medicinal materials; mix the hemp seed powder with the mixed powder of other medicinal materials to obtain a total mixed powder; B3: Mix the total mixed drug powder and hemp seed oil to form a medicine ball, and use the medicine ball to make pills, which is the second oral preparation.

7. The composition for intestinal preparation according to claim 6, characterized in that: Refined honey is also added in step B3.

8. The composition for intestinal preparation according to claim 4, characterized in that: The second oral preparation is prepared using Preparation Method C, which comprises the following steps: C1: Extracting hemp seed with petroleum ether by reflux, filtering to obtain a filtrate and hemp seed residue; concentrating the filtrate under reduced pressure to recover the petroleum ether to obtain hemp seed oil, and drying the hemp seed residue and then grinding it into hemp seed fine powder; C2: Rhubarb, costus root, dried tangerine peel and white peony root are mixed and ground, extracted by alcohol extraction, and the obtained alcohol extract is concentrated to obtain an alcohol extract mixed with other medicinal materials; C3: grinding the bitter almonds, extracting them with n-hexane as an extraction solvent, and recovering the n-hexane after extraction to obtain bitter almond oil and bitter almond residue; C4: Mix hemp seed powder, bitter almond residue and other medicinal material residues to obtain a total mixed powder, and use the total mixed powder, hemp seed oil, bitter almond oil and alcohol extract as raw materials to prepare pills, which are the second oral preparation.

9. The composition for intestinal preparation according to claim 8, characterized in that: Refined honey is also added in step C4.

10. Use of the composition for intestinal preparation according to any one of claims 1 to 9 in preparing a drug for colonoscopy preparation, characterized in that: Start taking the second oral preparation 2 to 4 times within 12 to 36 hours before the colonoscopy, and take the first oral preparation 2 to 8 hours before the colonoscopy.

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