Traditional Chinese medicine composition for intestinal preparation and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for intestinal tract preparation and a preparation method thereof, and the traditional Chinese medicine composition is prepared from the following raw materials: raw astragalus membranaceus roasted with honey, freeze-dried sun-dried ginseng, radix scrophulariae steamed with wine, radix ophiopogonis and steamed radix rehmanniae; the components of the traditional Chinese medicine are adaptive to pathogenesis, and a targeted conditioning effect is realized: after the raw astragalus membranaceus roasted with honey is specifically processed, the effects of tonifying qi, strengthening superficies, tonifying spleen and reinforcing stomach are enhanced, the physical weakness of unauthorized spleen qi transportation and transformation of old people can be improved, qi consumption and body fluid impairment caused by inadequate diarrhea during intestinal preparation are avoided, and a foundation is laid for intestinal function regulation; the freeze-dried sun-dried ginseng adopts a low-temperature freeze-drying process to retain core active components of the sun-dried ginseng capable of reinforcing vital energy, promoting salivation and restoring pulse, can directly supplement vital energy deficiency of elderly patients, and relieves weakness, dizziness and other discomforts caused by body fluid loss in the intestinal tract preparation process; after the wine steamed radix scrophulariae is compounded and processed by the yellow wine and the radix ophiopogonis juice, the effects of nourishing yin, promoting salivation, clearing heat and moistening dryness are remarkably improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for intestinal preparation and a preparation method thereof. BACKGROUND

[0002] Colonoscopy is the "gold standard" for screening and diagnosis of colorectal cancer and precancerous lesions, and its diagnosis and treatment effect directly depends on sufficient intestinal preparation. The residual feces in the intestinal tract will cause the endoscopic field to be blocked, increase the risk of missed diagnosis of lesions, prolong the operation time, and significantly increase the medical cost. The elderly population (age ≥ 60 years old) has a high incidence of insufficient intestinal preparation due to the degenerative changes in physiological functions. On the one hand, their digestive and absorptive functions are decreased, gastrointestinal motility is weakened, and colon bands are relaxed, resulting in slow transmission of intestinal contents and easy accumulation of feces. On the other hand, the elderly population often has the physical characteristics of declining yang qi, insufficient dirty qi, and deficiency of essence and blood, and their tolerance to intestinal preparation drugs is much lower than that of the general population, further increasing the difficulty of intestinal preparation.

[0003] The current clinical mainstream intestinal cleaning schemes all have the technical bottleneck of being difficult to balance "low volume, high cleaning degree, and high safety": first, compound polyethylene glycol electrolyte powder solution is the first choice for intestinal cleaning in clinical practice, but it needs to be taken within 2 hours. 2-3 liters not only have a bitter taste, but also a large amount of liquid intake in a short time will bring additional burden to the cardiovascular and urinary systems of the elderly. About 15% of elderly patients cannot complete the preparation due to intolerance, and the incidence of adverse reactions such as abdominal distension, nausea, and vomiting is high. Second, although the oral dose of sodium phosphate solution is only 1.5L, it solves the problem of excessive liquid intake, but as a hypertonic intestinal cleaning drug, its mechanism of action easily leads to rapid loss of water in the intestinal tract, causing water and electrolyte imbalance, especially in elderly people with decreased renal reserve capacity. Domestic and foreign clinical guidelines clearly do not recommend routine use of sodium phosphate solution in elderly patients, limiting its application in the elderly population.

[0004] To optimize the intestinal preparation effect of the elderly population, existing research mainly focuses on the improvement of the administration method of compound polyethylene glycol (such as taking it in several doses), but it still does not solve the core problem of poor gastrointestinal motility and low tolerance of elderly patients, and does not individualize the conditioning of their special constitution. Although traditional Chinese medicine has shown potential in the field of intestinal preparation, existing technologies have disclosed single herbs such as rhubarb and senna leaves or simple compounds with purgative effects, but they mainly focus on single laxation, lack of targeted regulation of the pathogenesis of excessive diarrhea, consumption of qi and body fluid in the elderly population, and are difficult to achieve the concept of "overall balance" in traditional Chinese medicine treatment. In addition, there are problems such as unstable intestinal cleaning effect and lack of systematic verification in clinical application.

[0005] At present, there is no mature integrated traditional Chinese and western medicine optimization scheme for preventing and controlling adverse reactions of sodium phosphate for intestinal preparation in elderly patients, and there is an urgent need in the clinic for an intestinal preparation auxiliary drug that can adapt to the physical characteristics of the elderly, does not affect the intestinal cleaning efficiency, and can reduce adverse reactions and improve tolerance, to fill the gap in the existing technology and meet the clinical needs of the elderly for colonoscopy. SUMMARY

[0006] The purpose of the present application is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine composition for intestinal preparation and a preparation method thereof.

[0007] The specific technical solution is as follows: a traditional Chinese medicine composition for intestinal preparation, which is composed of the following processed raw materials by weight: honey-roasted raw astragalus 25-35 parts, freeze-dried raw sun-dried ginseng 5-7 parts, wine-steamed radix scrophulariae 25-35 parts, radix ophiopogonis 20-28 parts, and steamed raw rehmannia 20-28 parts.

[0008] As a further technical solution, the processing technology of the honey-roasted raw astragalus is as follows: slice the raw astragalus to a thickness of 2-3 mm, mix with a 12-14% mass fraction of honey water, soak for 35 min, and fry at 115-120℃ for 18 min until the surface is brownish brown, and then cool to room temperature to obtain.

[0009] As a further technical solution, the preparation process of the freeze-dried raw sun-dried ginseng is as follows: after washing the raw sun-dried ginseng, remove the root hairs, freeze at -35 to -30℃ for 2.5h, then freeze-dry at a vacuum degree of 15Pa and a temperature of 35℃ for 9h, and pulverize to 80 mesh.

[0010] As a further technical solution, the processing technology of the wine-steamed radix scrophulariae is as follows: remove impurities and woody core from fresh radix scrophulariae, slice to a thickness of 3-4 mm, soak in a mixture of yellow rice wine and radix ophiopogonis juice for 60-70 min; after soaking, take out, pre-ripen at 95℃ for 20 min, then transfer to a sealed steaming pot, steam at 100-105℃ and 0.02-0.03MPa pressure for 50 min, stir every 15 min during the steaming process at a stirring rate of 50r / min, and after steaming, dry in a vacuum dryer to a moisture content of ≤6%, then bake in a far infrared oven for 10 min at a wavelength of 2-6μm and a temperature of 70℃.

[0011] As a further technical solution, the yellow rice wine-radix ophiopogonis juice mixture is prepared by mixing yellow rice wine and radix ophiopogonis juice at a volume ratio of 3:1.

[0012] As a further technical solution, the preparation method of the radix ophiopogonis juice is as follows: add water to radix ophiopogonis at a mass ratio of 1:10, decoct for 30 min, then beat the pulp at a speed of 3500r / min for 20 min, then filter and remove the filter residue to obtain the radix ophiopogonis juice.

[0013] As a further technical solution, the vacuum drying temperature is 60 DEG C, and the vacuum degree is -0.05 MPa.

[0014] A preparation method of a traditional Chinese medicine composition for intestinal preparation, comprising the following steps: (1) The prepared raw materials are weighed by weight parts, crushed to 110-120 meshes, mixed uniformly, and mixed medicine powder is obtained; (2) 10 times the amount of purified water is added to the mixed medicine powder, and soaked for 45 min; (3) Gradient boiling: first boiling at 92-95 DEG C for 40 min, then heating to 102-105 DEG C for 50 min, filtering, and collecting the first decoction; 8 times the amount of purified water is added to the dregs, and boiled at 98-100 DEG C for 40 min, filtered, and the second decoction is collected; (4) The two decoctions are combined, 0.15% of the weight of the decoction is added to the β-cyclodextrin, and stirred at 50-55 DEG C at a speed of 120 r / min for 30 min until completely dissolved, and then placed for 20 min, and filtered to remove impurities; (5) The filtrate is concentrated under reduced pressure at a pressure of -0.075 to -0.08 MPa and a temperature of 58-60 DEG C to a traditional Chinese medicine composition extract with a relative density of 1.18-1.20.

[0015] As a further technical solution, the prepared traditional Chinese medicine composition extract is used by mixing with water at a mass ratio of 1:8-10 when used, and the water temperature is 50-60 DEG C; the traditional Chinese medicine composition is suitable for people aged ≥60 years old.

[0016] As a further technical solution, the taking time of the traditional Chinese medicine composition is 3 days before intestinal preparation, 100 mL each time, 2 times a day, 45ml of sodium phosphate solution is taken at 16:00 the day before colonoscopy, diluted with 750ml of warm water, shaken well, and drunk within 1 hour, and 45ml of sodium phosphate solution is taken at 5:00 the day of colonoscopy, diluted with 750ml of warm water, shaken well, and drunk within 1 hour.

[0017] Compared with the prior art, the present application has the following beneficial effects: The components of the present application adapt to pathogenesis and realize targeted conditioning effect: after honey-roasting raw Huangqi, the ability of tonifying Qi and consolidating exterior and invigorating spleen and stomach is enhanced, which can improve the physical short board of spleen Qi transportation deficiency in the elderly population, avoid excessive diarrhea during bowel preparation, and lay a foundation for intestinal function regulation; the core active ingredients of tonifying primordial Qi and replenishing fluid are retained in the freeze-dried raw sun-dried ginseng, which can directly supplement the primordial Qi deficiency of elderly patients and relieve fatigue, dizziness and other discomforts caused by fluid loss during bowel preparation; after wine-steaming Scrophulariaceae, the effect of nourishing Yin, generating fluid and clearing heat and moistening dryness is significantly improved, and the effects of nourishing Yin and moistening dryness and supplementing intestinal fluid are synergistically enhanced by Ophiopogon and steamed raw Rehmannia, which together improve the problem of insufficient water in the intestinal tract and reduce the stimulation of hypertonic laxatives on intestinal mucosa. Each component is guided by the theory of tonifying Qi and Yin and increasing fluid and generating fluid, and aims at the core pathogenesis of diarrhea and Qi consumption and Yin deficiency and injury during bowel preparation in the elderly, and realizes positive regulation of intestinal function from the perspective of physical conditioning.

[0018] The processing technology and preparation method in the present application synergistically enable the improvement of efficacy and safety: honey-roasting raw Huangqi by precisely controlling the thickness of the slice, the concentration of honey and the frying parameters makes the active ingredients such as astragaloside more easily dissolved, while reducing its warm-dry nature to avoid the occurrence of symptoms of hyperactivity in elderly patients after taking; freeze-dried raw sun-dried ginseng is treated by low-temperature freezing and vacuum freeze-drying, which maximally retains heat-sensitive active ingredients such as ginsenosides, and after being pulverized to 80 mesh, the dissolution efficiency in the subsequent decoction process can be improved; wine-steaming Scrophulariaceae adopts a composite process of yellow rice wine-Ophiopogon juice soaking, stepwise steaming, vacuum drying and far-infrared baking, which not only enhances the Yin-nourishing effect of Scrophulariaceae by the drug-inducing effect of yellow rice wine, but also improves the utilization rate of active ingredients by pre-maturation and high-pressure steaming to destroy the fiber structure of its xylem, and far-infrared baking further reduces the moisture content of the medicinal material to ensure storage stability. Gradient decoction process is adopted in the preparation process to control temperature and time in stages, realizing the full dissolution of active ingredients of different polarities, the addition of β-cyclodextrin effectively improves the taste and improves the compliance of elderly patients, and the low-temperature concentration process avoids the high-temperature degradation of active ingredients, and finally the obtained extract type is not only convenient for dose control, but also can quickly take effect.

[0019] The present application scheme is synergistic as a whole, and comprehensively solves the core problem of elderly intestinal preparation: the traditional Chinese medicine composition in the present application is used in combination with sodium phosphate, and through the use mode of regulating 3 days in advance in combination with sodium phosphate, a complete closed loop of constitution regulation, intestinal cleaning and adverse reaction prevention and control is formed. The components synergize, on the one hand, through qi and yin double supplementation to improve the constitution of elderly patients, enhance the tolerance of the body to hypertonic purgative, and reduce the incidence of gastrointestinal adverse reactions such as abdominal distension, abdominal pain and nausea; on the other hand, through the effect of increasing fluid and generating saliva, a suitable moist environment is formed in the intestinal tract, which assists sodium phosphate to play a role in cleaning the intestine, and avoids incomplete cleaning or excessive stimulation due to dry intestinal tract. Compared with the use of sodium phosphate alone, the combination scheme not only retains the advantages of low volume intake of sodium phosphate, but also compensates for the short board of water and electrolyte disorder through the overall regulation of traditional Chinese medicine, significantly improves the intestinal preparation satisfaction and completion rate of elderly patients, and at the same time does not affect the intestinal cleanliness and polyp detection effect, realizes the dual goals of not reducing the cleaning efficiency and improving the safety tolerance, and effectively solves the clinical problems of insufficient intestinal preparation, many adverse reactions and poor compliance of the elderly population before colonoscopy. DETAILED DESCRIPTION

[0020] The technical solutions in the embodiments of the present application will be clearly and completely described below. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of the present application.

[0021] (I) Raw material processing technology: Honey-roasted raw astragalus preparation: raw astragalus is cut into slices with a thickness of 2-3 mm, mixed with 12-14% honey water solution, soaked for 35 min, and then fried at 115-120℃ for 18 min until the surface is brown, and then cooled to room temperature to obtain honey-roasted raw astragalus. Preferably, the mass fraction of honey water solution is 13%, and the frying temperature is controlled at 118℃ to ensure that the astragalus retains effective components and has a mild medicinal property after processing.

[0022] Freeze-dried raw sun-dried ginseng preparation: raw sun-dried ginseng is washed and the rootlets are removed, frozen at -35 to -30℃ for 2.5h, and then freeze-dried at a vacuum degree of 15Pa and a temperature of 35℃ for 9h. After freeze-drying, it is ground to 80 mesh to obtain freeze-dried raw sun-dried ginseng. This process can maximize the retention of effective components of raw sun-dried ginseng and avoid the loss of effective components due to high temperature.

[0023] Wine-steamed radix scrophulariae processing: Ophiopogon juice preparation: according to the mass ratio of ophiopogon to water 1:10, purified water is added to ophiopogon, decocted for 30 min, and then beaten for 20 min at a speed of 3500r / min. The filtrate is collected after removing the filter residue to obtain ophiopogon juice.

[0024] Mixed liquid preparation: mix the rice wine and the prepared ophiopogon japonicus juice in a volume ratio of 3:1 to obtain a rice wine-ophiopogon japonicus juice mixed liquid.

[0025] Soaking treatment: take fresh radix scrophulariae, remove impurities and xylem core, cut into slices with a thickness of 3-4 mm, and soak in the rice wine-ophiopogon japonicus juice mixed liquid for 60-70 min.

[0026] Pre-maturation and steaming: after soaking, take out the radix scrophulariae slices, pre-mature at 95°C for 20 min, then transfer to a sealed steaming pot, steam at 100-105°C and a pressure of 0.02-0.03 MPa for 50 min, stir every 15 min during the steaming process at a stirring rate of 50 r / min.

[0027] Drying and baking: after steaming, place the radix scrophulariae slices in an environment of 60°C and a vacuum degree of-0.05 MPa for vacuum drying until the moisture content is ≤6%, then use far infrared baking at a wavelength of 2-6 μm and a temperature of 70°C for 10 min to obtain wine-steamed radix scrophulariae. Preferably, the soaking time is 65 min, the steaming temperature is 103°C, and the pressure is 0.025 MPa, to ensure that the effective components of radix scrophulariae are fully dissolved and the medicinal properties are mild.

[0028] Ophiopogon japonicus and steamed radix rehmanniae: ophiopogon japonicus is directly selected as a medicinal material meeting the standard of the pharmacopoeia, without additional processing; steamed radix rehmanniae is selected as a processed radix rehmanniae to ensure its stable yin-nourishing and heat-clearing effects.

[0029] (II) Preparation method of traditional Chinese medicine composition The preparation process of the traditional Chinese medicine composition is described in detail below through three examples, and the weight parts of the raw materials are different in each example, and the other process parameters are the same. Example 1

[0030] Raw material weighing: weigh the processed raw materials according to the weight parts, wherein 25 parts of honey-fried radix astragali, 5 parts of freeze-dried radix ginseng, 25 parts of wine-steamed radix scrophulariae, 20 parts of ophiopogon japonicus, and 20 parts of steamed radix rehmanniae.

[0031] Mixing and crushing: crush the above-weighed raw materials to 110 mesh, mix them evenly in a mixer to obtain mixed medicinal powder.

[0032] Soaking treatment: add 10 times the amount of purified water to the mixed medicinal powder, soak for 45 min, so that the medicinal powder is fully wetted, which is beneficial to the dissolution of effective components.

[0033] Gradient decoction: first, decoct the mixture of the soaked medicinal powder and purified water at 92°C for 40 min, then increase the temperature to 102°C and decoct for 50 min. After decoction, filter to collect the first decoction; add 8 times the amount of purified water to the filtered residue, decoct at 98°C for 40 min, filter to collect the second decoction.

[0034] Decoction treatment: combine the first and second decoctions, add 0.15% of the weight of the decoction to the combined decoction β-cyclodextrin, stir at 120 r / min for 30 min at 50°C until the β-cyclodextrin is completely dissolved, and filter out the impurities after standing for 20 min.

[0035] Reduced pressure concentration: place the filtered filtrate in a reduced pressure concentration device, and concentrate under reduced pressure at a pressure of -0.075 MPa and a temperature of 58°C until the relative density of the filtrate is 1.18 to obtain the traditional Chinese medicine composition extract.

[0036] Method of use: the prepared traditional Chinese medicine composition extract is diluted into 50°C warm water at a mass ratio of 1:8, stirred uniformly, and taken orally; the taking time is 3 days before bowel preparation, 2 times a day, 100 mL each time; 16:00 the day before the colonoscopy, 45 ml of sodium phosphate solution is taken orally, diluted with 750 ml of warm water, and shaken well, and consumed within 1 hour; 5:00 on the day of the colonoscopy, 45 ml of sodium phosphate solution is taken orally, diluted with 750 ml of warm water, and shaken well, and consumed within 1 hour; after each time of taking sodium phosphate solution, 300 ml of warm water is consumed, until the excretion liquid is like clear water. Example 2:

[0037] Raw material weighing: the processed raw materials are weighed according to the weight parts, including 30 parts of honey-roasted radix astragali, 6 parts of freeze-dried radix ginseng, 30 parts of wine-steamed radix scrophulariae, 24 parts of radix ophiopogonis, and 24 parts of steamed radix rehmanniae.

[0038] Mixing and crushing: the above weighed raw materials are crushed to 115 mesh, mixed uniformly in a mixer, and a mixed medicinal powder is obtained.

[0039] Soaking treatment: 10 times the amount of purified water is added to the mixed medicinal powder, and soaked for 45 min to make the medicinal powder fully wetted, which is beneficial to the dissolution of effective components.

[0040] Gradient decoction: the soaked medicinal powder and purified water mixture is first decocted at 93°C for 40 min, and then heated to 103°C for 50 min, and after the decoction is completed, the first decoction is collected by filtration; 8 times the amount of purified water is added to the filtered residue, and decocted at 99°C for 40 min, and the second decoction is collected by filtration.

[0041] Decoction treatment: combine the first and second decoctions, add 0.15% of the weight of the decoction to the combined decoction β-cyclodextrin, stir at 120 r / min for 30 min at 52°C until the β-cyclodextrin is completely dissolved, and filter out the impurities after standing for 20 min.

[0042] Vacuum concentration: The filtered liquid is placed in a vacuum concentration device and concentrated under reduced pressure of -0.078 MPa and 59°C until the relative density of the liquid is 1.19, thus obtaining the extract of traditional Chinese medicine composition.

[0043] Instructions for use: Mix the prepared herbal extract with 55°C warm water at a mass ratio of 1:9, stir well, and then take orally. Take 100mL twice daily for 3 days prior to bowel preparation. The day before colonoscopy, at 16:00, take 45mL of sodium phosphate solution orally, diluted with 750mL of warm water and shaken well, and drink within 1 hour. On the day of colonoscopy, at 5:00, take 45mL of sodium phosphate solution orally, diluted with 750mL of warm water and shaken well, and drink within 1 hour. After each dose of sodium phosphate solution, drink 400mL of warm water until the excrement is clear. Example 3:

[0044] Raw material weighing: Weigh the processed raw materials according to the weight parts, including 35 parts honey-processed raw astragalus, 7 parts freeze-dried raw ginseng, 35 parts wine-steamed scrophularia, 28 parts ophiopogon japonicus, and 28 parts steamed rehmannia glutinosa.

[0045] Mixing and pulverizing: Pulverize the above-weighed raw materials to 120 mesh, place them in a mixer and mix evenly to obtain mixed powder.

[0046] Soaking treatment: Add 10 times the amount of purified water to the mixed powder and soak for 45 minutes to fully wet the powder and facilitate the dissolution of the active ingredients.

[0047] Gradient decoction: First, decoct the mixture of soaked medicinal powder and purified water at 95℃ for 40 minutes, then raise the temperature to 105℃ and decoct for 50 minutes. After decoction, filter and collect the first decoction. Add 8 times the amount of purified water to the filtered residue and decoct at 100℃ for 40 minutes. Filter and collect the second decoction.

[0048] Decoction treatment: Combine the first decoction and the second decoction, add 0.15% of the weight of β-cyclodextrin to the combined decoction, stir at 55℃ and 120 r / min for 30 min until the β-cyclodextrin is completely dissolved, let stand for 20 min and then filter to remove impurities.

[0049] Vacuum concentration: The filtered liquid is placed in a vacuum concentration device and concentrated under reduced pressure of -0.08 MPa and 60°C until the relative density of the liquid is 1.20, thus obtaining the extract of traditional Chinese medicine composition.

[0050] Use method: the prepared traditional Chinese medicine composition extract is diluted into 60℃ warm water at a mass ratio of 1:10, stirred uniformly and taken; the taking time is 3 days before intestinal preparation, 2 times a day, 100ml each time; 45ml of sodium phosphate solution is taken at 16:00 the day before colonoscopy, diluted with 750ml warm water, shaken uniformly and drunk within 1 hour; 45ml of sodium phosphate solution is taken at 5:00 the day of colonoscopy, diluted with 750ml warm water, shaken uniformly and drunk within 1 hour; 500ml of warm boiled water is drunk after taking sodium phosphate solution each time until the excretion liquid is like clear water.

[0051] Test verification: Treatment scheme: The treatment group is given "traditional Chinese medicine composition diluted water" combined with sodium phosphate solution. The treatment group dilutes the prepared traditional Chinese medicine composition extract into 60℃ warm water at a mass ratio of 1:10 3 days before sodium phosphate intestinal preparation, stirs uniformly and takes; the taking time is 3 days before intestinal preparation, 2 times a day, 100ml each time; 45ml of sodium phosphate solution is taken at 16:00 the day before colonoscopy, diluted with 750ml warm water, shaken uniformly and drunk within 1 hour; 45ml of sodium phosphate solution is taken at 5:00 the day of colonoscopy, diluted with 750ml warm water, shaken uniformly and drunk within 1 hour; 500ml of warm boiled water is drunk after taking sodium phosphate solution each time until the excretion liquid is like clear water.

[0052] The control group is given placebo combined with sodium phosphate solution. The control group takes placebo 100ml, 2 times a day 3 days before sodium phosphate intestinal preparation (the placebo is concentrated from similar flavored traditional Chinese medicine, has no therapeutic effect and has no influence). 45ml of sodium phosphate solution is taken at 16:00 the day before colonoscopy (diluted with 750ml warm water, shaken uniformly and drunk within 1 hour), and 45ml of sodium phosphate solution is taken at 5:00 the day of colonoscopy (diluted with 750ml warm water, shaken uniformly and drunk within 1 hour).

[0053] Each group drinks 300-500ml of warm boiled water after taking sodium phosphate solution each time until the excretion liquid is like clear water.

[0054] Randomized grouping: stratified randomly according to center (the first medical center of the general hospital of the People's Liberation Army, the second medical center of the general hospital of the People's Liberation Army), and age (60-75 years old, 75-85 years old, ≥85 years old), and randomly divided into 2 groups (the treatment group and the control group) at a ratio of 1:1. Random numbers are generated by SAS statistical software programming. Parameters for generating random numbers are set, and subjects are allocated to the test group or the control group according to the ratio. Random number table is generated, and the random grouping results generated by the program are printed out to develop the code.

[0055] Test object: Old people preparing for colonoscopy.

[0056] (1) Inclusion criteria: ① Age over 60 years old, male or female, who are ready for colonoscopy; ② Patients who are in good health, no other serious illness found by comprehensive physical examination; ③ Patients with clear consciousness, who can actively cooperate and complete the bowel preparation according to the doctor's advice; ④ Voluntary enrollment and signing of informed consent, the informed consent process complies with the relevant provisions of GCP.

[0057] (2) Exclusion criteria: ① Not in line with the above inclusion criteria; ② Patients with renal insufficiency; ③ Known allergy to the test drug or any related components; ④ Participated in other clinical trials within 1 month; ⑤ Patients suspected of having inflammatory bowel disease, digestive tract bleeding, digestive tract obstruction, digestive tract stenosis, patients with abdominal surgery history; ⑥ Combined with a large amount of ascites, cardiovascular, cerebral, liver, kidney, hematopoietic system and other serious primary diseases, tumors and mental illness.

[0058] Observation index and follow-up plan; (1) Main observation index; Boston bowel preparation score. It is an evaluation scale for bowel preparation. The colon and rectum are divided into 3 segments: left colon (sigmoid colon, rectum), middle colon (transverse colon, descending colon), and right colon (ileocecal junction, ascending colon). Each segment is scored 3 points, for a total of 9 points. 3 points: clear vision, no impact on scope and observation; 2 points: clear vision, no impact on observation after suction; 1 point: blurred vision, affecting scope and observation, poor bowel preparation; 0 point: intestinal cavity filled with paste or fecal water, poor bowel preparation, severely affecting scope and observation.

[0059] (2) Secondary observation index; ① Use a 0-5 point satisfaction score scale to evaluate patients' satisfaction with bowel preparation methods.

[0060] (3) Evaluation index of patient tolerance and safety; ① Patient tolerance: after the completion of bowel preparation, patients fill out the bowel preparation discomfort questionnaire, and ask patients whether they are willing to undergo colonoscopy again with the same method.

[0061] ② Safety: record the adverse reactions during bowel preparation, including: abdominal distension, abdominal pain, nausea, cold sweat, dizziness, palpitations and hunger, etc. Complete liver and kidney function biochemical examination, measure once before and on the day of colonoscopy in the elderly, a total of 2 times.

[0062] (4) Follow-up plan; ①Baseline: the first day of medication (oral traditional Chinese medicine composition mixed with water).

[0063] ②Endpoint: the main observation index follow-up point, the day before the colonoscopy was completed before 19:00.

[0064] Record and fill in the Boston bowel preparation score, patient satisfaction with the way of bowel preparation, endoscopy time, and intestinal discomfort questionnaire.

[0065] ③Secondary observation index follow-up point: the day of oral sodium phosphate solution in the elderly.

[0066] Record the amount of sodium phosphate solution taken by the elderly at 16:00 the day before colonoscopy and 5:00 the day of colonoscopy.

[0067] ④Safety line follow-up: baseline-endpoint 19:00 daily.

[0068] Baseline-endpoint 19:00 daily, collect adverse reactions. Complete liver and kidney function biochemical tests at 7:00 the day before colonoscopy and 19:00 the day of colonoscopy.

[0069] All adverse events occurring during colonoscopy and bowel preparation should be tracked until they are properly resolved or stable. All subjects with abnormal liver and kidney function should be followed up until all abnormal values return to normal or to baseline, and the results should be recorded in the research medical record, electronic case report form, and database.

[0070] ⑤Dropout of study subjects: Exit decided by the experimenter: during the experiment, the selected subjects in the experiment appeared conditions that were not suitable for continuing the experiment, and the experimenter decided to exit the experiment: poor compliance, affecting effectiveness and safety evaluation; serious adverse events, complications, and special physiological changes, not suitable for continuing the experiment; self-exit during the experiment; combined use of drugs, especially drugs that have a greater impact on the test drug, affecting effectiveness and safety evaluation; cases that did not complete the treatment and were lost to follow-up or died due to other reasons; incomplete data, affecting effectiveness and safety evaluation.

[0071] Self-exit of test subjects: according to relevant regulations such as GCP, test subjects have the right to exit the experiment midway, or test subjects no longer receive medication and testing and are lost to follow-up without explicitly withdrawing from the experiment, which is also considered "withdrawal" (or "dropout").

[0072] For whatever reason, the case of withdrawal from the trial, should keep its case record table, and with its last test results as the final results, the efficacy or adverse reactions of the full data set analysis.

[0073] The determination of sample size; This trial plan to include 228 patients.

[0074] According to the results of the pilot study, the elderly use of traditional Chinese medicine "traditional Chinese medicine composition mixed with water" combined with sodium phosphate solution of intestinal preparation sufficient rate of 92%, the control group sodium phosphate solution group reached 75%, alpha = 0.05, Power = 0.9, the drop-out rate of 20%, 1:1 enrollment. According to the calculation method of independent sample rate comparison, it is calculated that each group needs 114 cases, a total of 228 cases.

[0075] Statistical analysis method; (1) statistical analysis software; Statistical analysis will be calculated by SPSS22.0 software.

[0076] (2) statistical method description; All statistical tests are two-sided tests, the comparison between the two groups is in line with the normal distribution using t test, not in line with the normal distribution using rank sum test, P<0.05 as the difference between the test is statistically significant standard (except for special explanation). For continuous variables, list the number, mean, standard deviation, median, minimum, maximum. For categorical variables, list the frequency and percentage. The baseline is defined as the last observation before the first medication.

[0077] (3) effectiveness analysis; Boston intestinal preparation score, satisfaction score, enter / exit time score difference: describe the difference between the Boston intestinal preparation score, satisfaction score, enter / exit time score and the control group general statistical description, list the number, mean, standard deviation, median, minimum, maximum, using independent sample t test for comparison.

[0078] Whether every intake of full dose of intestinal preparation solution, patient tolerance score difference: describe the change of frequency and constituent ratio of whether every intake of full dose of intestinal preparation solution, patient tolerance score change score compared with the control group, using signed rank test for independent sample comparison.

[0079] (4) safety analysis; Adverse events: All adverse events, adverse events related to the test drug, serious adverse events, adverse events leading to withdrawal were summarized according to the system organ classification (number of cases, number of times and incidence rate were calculated). All adverse events and related adverse events in each system were summarized according to the severity (mild, moderate and severe), and the list of all adverse events and related adverse events was listed.

[0080] Laboratory examination: All completed examination items were listed in the form of cross table before and after treatment (judged according to clinical significance), and the abnormal examination items after treatment were listed according to the index as the main line and the subject as the main line.

[0081] Results of the study; A total of 207 patients were included in this study, including 103 patients in the test group and 104 patients in the control group. There was no statistical difference in demographic data and baseline characteristics between the two groups (P>0.05), which was comparable (Table 1).

[0082] (1) Demographic data and baseline situation; Table 1 shows that there was no significant difference in age, gender, BMI, defecation frequency, colonoscopy history and polypectomy history between the test group and the control group (P>0.05), indicating that the two groups were balanced at the baseline level, which was beneficial to the comparison of efficacy and safety.

[0083] Table 1 Demographic data and baseline situation ± SD)

[0084] (2) Comparison of intestinal cleansing degree Table 2 shows that there was no statistical difference in Boston score total score and each segment score, Bubble score total score and complete intestinal cleansing rate between the two groups (P>0.05). It is shown that the use of the combination of traditional Chinese medicine composition and water on the basis of sodium phosphate does not significantly affect or even reduce the degree of intestinal cleansing after administration of sodium phosphate.

[0085] Table 2 Comparison of intestinal cleansing degree after treatment ± SD)

[0086] (3) Comparison of intestinal polyp detection situation; Tables 3 and 4 show that there was no significant difference in total detection rate of colon polyps, size distribution of polyps (≤5mm, >5mm), detection rate of adenomas and size distribution of adenomas between the two groups (P>0.05). In addition, there was no difference in the distribution of polyps in the left colon, transverse colon and right colon between the two groups. It is indicated that the combined use of drugs does not have negative effect on the detection rate and distribution of polyps.

[0087] Table 3 Comparison of intestinal polyps after the test

[0088] Table 4 Comparison of intestinal polyps after the test

[0089] (Four) Comparison of patient satisfaction and adverse reactions; Table 5 shows that there are significant differences in the total score of VA score, intestinal preparation acceptance, abdominal pain, abdominal distension, nausea and other adverse reactions between the two groups (P<0.05). The incidence of adverse events in the test group was 0.97% (1 / 103), and that in the control group was 3.85% (4 / 104), which was lower in the test group.

[0090]

[0091] Conclusion: In this study, the application effect of the Chinese medicine composition combined with sodium phosphate for intestinal preparation in the elderly before colonoscopy was explored by randomized controlled trial. The results show that: in terms of intestinal cleaning effect, there is no significant difference in Boston score, Bubble score and complete cleaning rate between the combination group and the pure sodium phosphate group, which shows that the product will not have a negative impact on sodium phosphate intestinal preparation.

[0092] In terms of patient tolerance and safety, there are significant differences in satisfaction scores, incidence of various gastrointestinal symptoms and adverse events between the two groups, which shows that the Chinese medicine composition can significantly improve the subjective tolerance of patients and reduce the incidence of adverse reactions.

[0093] In summary, this study shows that the use of Chinese medicine composition combined with sodium phosphate intestinal preparation scheme can significantly improve the intestinal cleaning tolerance of elderly patients.

[0094] The preferred embodiments of the application disclosed above are only used to help explain the application. The preferred embodiments do not describe all the details and do not limit the application to the specific embodiments described. Obviously, many modifications and changes can be made according to the content of the specification.

Claims

1. A traditional Chinese medicine composition for bowel preparation, characterized in that, It is composed of the following processed raw materials in parts by weight: 25-35 parts honey-processed raw astragalus, 5-7 parts freeze-dried raw ginseng, 25-35 parts wine-steamed scrophularia, 20-28 parts ophiopogon japonicus, and 20-28 parts steamed rehmannia glutinosa.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The processing method of honey-processed raw astragalus is as follows: slice raw astragalus into pieces with a thickness of 2-3 mm, mix with a honey aqueous solution with a mass fraction of 12-14%, let it soak for 35 minutes, stir-fry at 115-120℃ for 18 minutes until the surface turns brown, and cool to room temperature to obtain the product.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The preparation process of freeze-dried ginseng is as follows: after washing the ginseng and removing the fibrous roots, freeze it at -35 to -30℃ for 2.5 hours, then freeze-dry it at a vacuum of 15 Pa and a temperature of 35℃ for 9 hours, and then pulverize it to 80 mesh.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The processing method of wine-steamed Scrophularia is as follows: Take fresh Scrophularia, remove impurities and the xylem core, slice it into pieces with a thickness of 3-4 mm, and soak it in a mixture of rice wine and Ophiopogon japonicus juice for 60-70 minutes; after soaking, take it out and pre-cook it by micro-steaming at 95℃ for 20 minutes, then transfer it to a sealed steaming tank and steam it at 100-105℃ and 0.02-0.03MPa pressure for 50 minutes. Stir it once every 15 minutes during the steaming process, with a stirring rate of 50 r / min. After steaming, vacuum dry it until the moisture content is ≤6%, and then bake it with far-infrared radiation for 10 minutes at a wavelength of 2-6 μm and a temperature of 70℃.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, The rice wine-Ophiopogon japonicus juice mixture is made by mixing rice wine and Ophiopogon japonicus juice in a volume ratio of 3:

1.

6. The traditional Chinese medicine composition according to claim 5, characterized in that, The method for preparing Ophiopogon japonicus juice is as follows: Ophiopogon japonicus is decocted with water at a mass ratio of 1:10 for 30 minutes, then pulped at a speed of 3500 r / min for 20 minutes, then filtered to remove the residue, and Ophiopogon japonicus juice is obtained.

7. The traditional Chinese medicine composition according to claim 4, characterized in that, The vacuum drying temperature is 60℃ and the vacuum degree is -0.05MPa.

8. A method for preparing a traditional Chinese medicine composition for bowel preparation according to any one of claims 1-7, characterized in that, Includes the following steps: (1) Weigh each processed raw material according to the weight, pulverize to 110-120 mesh, mix evenly to obtain mixed powder; (2) Add 10 times the amount of purified water to the mixed powder and soak for 45 minutes; (3) Gradient decoction: First decoct at 92-95℃ for 40 min, then raise the temperature to 102-105℃ and decoct for 50 min, filter and collect the first decoction; add 8 times the amount of purified water to the residue, decoct at 98-100℃ for 40 min, filter and collect the second decoction. (4) Combine the two decoctions, add 0.15% of the weight of β-cyclodextrin, stir at 120 r / min at 50-55℃ for 30 min until completely dissolved, let stand for 20 min, and filter to remove impurities; (5) The filtrate is concentrated under reduced pressure at a pressure of -0.075 to -0.08 MPa and a temperature of 58-60℃ to obtain a Chinese herbal composition extract with a relative density of 1.18-1.

20.

9. The method according to claim 8, characterized in that, The prepared herbal extract should be diluted with water at a mass ratio of 1:8-10 and used at a water temperature of 50-60℃. The herbal extract is suitable for people aged ≥60 years.

10. The method according to claim 8, characterized in that, The Chinese herbal composition is to be taken 3 days before bowel preparation, twice a day, 100mL each time. The day before the colonoscopy, at 16:00, take 45ml of sodium phosphate solution orally, dilute with 750ml of warm water and shake well, and drink it within 1 hour. On the day of the colonoscopy, at 5:00, take 45ml of sodium phosphate solution orally, dilute with 750ml of warm water and shake well, and drink it within 1 hour.

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