Traditional Chinese medicine composition hydrogel for improving infantile constipation and preparation method thereof
By combining the traditional Chinese medicine composition with hydrogel, a traditional Chinese medicine composition hydrogel that improves constipation in children was prepared, which solved the oral difficulties and skin allergies in the treatment of constipation in children, and achieved efficient and long-lasting therapeutic effects.
Patent Information
- Application Number
- CN202510175340.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-02-18
- Publication Date
- 2025-05-02
AI Technical Summary
The treatment of constipation in children has the problem of difficulty in taking oral Chinese medicine and the problem of traditional external plasters that can easily lead to skin allergies, and the efficacy is not long-lasting.
Combining the traditional Chinese medicine composition with hydrogel, a traditional Chinese medicine composition hydrogel is prepared to improve constipation in children. Through the extraction of volatile oils and the preparation of drug-carrying hydrogel, a special gel dosage form is formed, which is easy to use and pollution-free.
The hydrogel has excellent water absorption performance, high drug loading and stable chemical properties. It has rapid onset of effect, long medicinal duration, and is effective in avoiding skin allergies and has a high clinical cure rate.
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Abstract
Description
Technical Field
[0001] The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition hydrogel for improving constipation in children and a preparation method thereof. Background Art
[0002] Pediatric constipation is a common disease, which is manifested by a series of symptoms such as dry stool, difficulty in defecation, long interval between defecation, or inability to defecate despite the urge to defecate. At present, Western medicine in China mainly uses enema, probiotics, lactulose, polyethylene glycol and other drugs in combination or alone to treat pediatric constipation. Although it can achieve good results in the short term, the children have poor compliance and are prone to dependence. In addition, it is mainly symptomatic treatment, and the effect is not long-lasting.
[0003] Traditional Chinese medicine has a long history of understanding constipation and contains a lot of content, but Chinese medicine prescriptions are usually difficult to take, and it is even more difficult to treat children's symptoms. Therefore, it is more suitable for external treatment of traditional Chinese medicine, which can not only improve symptoms, but also achieve better long-term effects. However, children's skin is delicate, and traditional plasters are prone to tape skin allergies. Summary of the invention
[0004] In order to solve the above technical problems, the present invention provides a Chinese medicine composition hydrogel for improving pediatric constipation and a preparation method thereof. The Chinese medicine composition for treating pediatric constipation is combined with the hydrogel to prepare a special gel dosage form, which is convenient, clean, pollution-free, and highly practical. It can maximize the efficacy of the Chinese medicine composition, is easy for patients to absorb, and has a good therapeutic effect on various pediatric constipation.
[0005] In one aspect, the present invention provides a method for preparing a hydrogel of a Chinese medicine composition for improving constipation in children, comprising: an extraction process of volatile oil of the Chinese medicine composition, a preparation process of a drug-loaded hydrogel, and a preparation process of a hydrogel of the Chinese medicine composition; wherein, The extraction process of volatile oil of the traditional Chinese medicine composition comprises the following steps: taking 10-20 parts of rheum officinale, 10-20 parts of sapodilla, 15-30 parts of raw radix polygoni multiflori, 10-20 parts of scutellaria baicalensis and 5-15 parts of stinking ginseng by weight, crushing, mixing and sieving the above medicinal materials to obtain the traditional Chinese medicine composition; mixing the traditional Chinese medicine composition with water in a ratio of 1:2-1:8, soaking for 0.5-3 hours, extracting volatile oil by steam distillation for 1-8 hours, and separating the volatile oil; The preparation process of the traditional Chinese medicine composition hydrogel includes mixing the volatile oil and the drug-carrying hydrogel in a ratio of 1:1-1:9, heating and stirring until the mixed solution is in a gel state, and freezing and solidifying the mixed solution in an environment of -20°C-0°C.
[0006] Furthermore, the preparation process of the drug-loaded hydrogel includes taking 4-8 parts of acrylamide, 2-5 parts of chitosan, 1-3 parts of silk protein, 0.01-0.1 parts of a cross-linking agent, 10-20 parts of tetramethylethylenediamine and 10-30 parts of water by weight, preparing the above materials by free radical polymerization, and then crushing them into particles.
[0007] Furthermore, the cross-linking agent is a persulfate, such as common potassium persulfate and ammonium persulfate.
[0008] As a preferred embodiment, the Chinese medicine composition comprises: 10 parts of rhubarb, 15 parts of sapodilla, 20 parts of raw Polygonum multiflorum, 15 parts of water chestnut and 10 parts of stinking ginseng, by weight.
[0009] The extraction process of the volatile oil of the Chinese medicine composition also includes dissolving the separated volatile oil in anhydrous ethanol for standby use. Preferably, the weight ratio of the Chinese medicine composition to anhydrous ethanol is 1:20-1:80.
[0010] As a preferred embodiment, the drug-loaded hydrogel comprises: 6 parts of acrylamide, 2.5 parts of chitosan, 1.5 parts of silk protein, 0.08 parts of a cross-linking agent, 15 parts of tetramethylethylenediamine and 20 parts of water by weight.
[0011] Furthermore, during the preparation of the Chinese medicine composition hydrogel, the heating and stirring conditions are 60-300 r / min and the reaction time is 0.5-4 hours.
[0012] On the other hand, the present invention provides a hydrogel produced by the method for producing a hydrogel of a traditional Chinese medicine composition according to any of the above technical solutions.
[0013] The present invention also provides an application of a hydrogel of a traditional Chinese medicine composition for improving constipation in children, which is prepared by the preparation method described in any of the above technical solutions.
[0014] The Chinese medicine composition hydrogel for improving constipation in children provided by the present invention exhibits excellent water absorption performance, high drug loading and stable chemical properties. When the hydrogel is used to improve the symptoms of constipation, its characteristics are fully utilized, specifically manifested in rapid onset, long duration of medicinal use, and can effectively avoid causing adverse reactions such as skin allergies, redness, swelling and discomfort. The medicinal materials used in the present invention have a wide range of sources, relatively low cost, and the preparation method is simple and easy, and it is very easy to achieve large-scale industrial production. DETAILED DESCRIPTION
[0015] In order to enable those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application are clearly and completely described. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in the field without creative work should fall within the scope of protection of the present application.
[0016] It should be noted that the terms "include" and "have" and any variations thereof are intended to cover non-exclusive inclusions. For example, a process, method, system, product or apparatus comprising a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to these processes, methods, products or apparatus.
[0017] This embodiment combines a Chinese medicine composition with hydrogel technology and applies it to the treatment of pediatric constipation, thereby solving the problem that children have difficulty taking Chinese medicine orally and that traditional external plasters easily cause skin allergies.
[0018] Prescription basis of the present invention: The prescription of the present invention is guided by the overall concept and dialectical treatment of traditional Chinese medicine. The gel is to use gel as a carrier to apply the drug directly to the abdomen, and exert its effect of regulating qi and moistening the intestines and relieving constipation. Thereby promoting the recovery of body functions and achieving the purpose of treatment. The raw Polygonum multiflorum selected in the prescription of the present invention can moisten the intestines and relieve constipation, detoxify and eliminate carbuncle, and is the main medicine. Rhubarb can relieve qi, purge fire and relieve constipation, remove blood stasis and detoxify, and is the minister. With the help of water chestnut fragrance, it can warm the middle and dispel cold, relieve pain and regulate qi, and prevent cold and coolness from hurting the stomach and intestines. With the help of saponin, it can promote qi and open the orifices, disperse stagnation and reduce swelling, moisten the intestines and discharge pus, so that the warm qi of the internal organs can be promoted, and the orifices can be opened and the stool can be unblocked. Stinky ginseng can replenish qi and produce blood, dredge the meridians, and aid digestion. The whole prescription uses both cold and warm, and attacks and supplements at the same time, and plays the role of regulating qi and moistening the intestines and relieving constipation. It is clinically applicable to the treatment of acute and chronic constipation in children, and can be used for clinical symptoms such as constipation, abdominal distension, abdominal pain, dry mouth, night sweats, hot flashes, red tongue with little and dry coating, etc. Its efficacy and related pharmacological research are summarized as follows: (1) Rheum officinale: good at clearing away heat and purging fire, purging and attacking accumulation, cooling blood and detoxifying, removing blood stasis and promoting menstruation. Indications: abdominal pain due to stagnation, constipation, and damp-heat jaundice. The rheum officinale glycosides contained in Rheum officinale are rich in pharmacological activities, and rheum officinale glycosides have a wide range of pharmacological effects, including anti-inflammatory, antioxidant, anti-thrombotic, anti-allergic, hypoglycemic, and anti-tuberculosis Mycobacterium. It can bind to human serum albumin and be transported to the target site to exert its efficacy; it can also be absorbed by the gastrointestinal tract and generate a metabolite, rheum officinale, through the action of human intestinal microbial flora, and then more biological activities are exerted through rheum officinale. The study used hamster lung fibroblasts V79-4 as the research object. After treating V79-4 cells with H2O2, it was found that rheum officinale glycosides had a good scavenging ability against intracellular peroxides, DPPH free radicals and H2O2, and its mechanism of action was related to the activation of H2O2 enzymes. Related studies have found that rhubarb glycosides (100 mg / kg) can significantly reduce the disease activity index of mice with acute gastroenteritis model induced by sodium dextran sulfate, while protecting intestinal mucosal cells and colon tissues, inhibiting myeloperoxidase (MPO) activity, and significantly reducing the levels of multiple inflammatory factors: tumor necrosis factor α (TNF-α), interleukin 1β (IL1β), IL-8, IL-10], and inhibiting the mRNA expression of inflammatory factors IL-1β and transforming growth factor β (TGF-β); rhubarb glycosides can significantly inhibit the activity of NLRP3 inflammasomes and the expression of Caspase-1 and cyclooxygenase 2; in addition, rhubarb glycosides can also exert anti-colitis effects by inhibiting intestinal epithelial cell apoptosis and regulating intestinal tight junction proteins.
[0019] (2) Gleditsia sinensis (thorns): Good at moistening the intestines and draining pus, removing phlegm and opening the orifices, dispersing nodules and reducing swelling. Indications: constipation, carbuncle, phlegm and qi reversal, orifice blockage and coma. Gleditsia sinensis has multiple pharmacological activities in drug research, such as anti-inflammatory, bactericidal, hemolytic, and immune regulation. The study found that 39 cases of buttocks carbuncle were treated by taking Xianfang Huomingyin (gleditsia sinensis thorns, angelica root, licorice, honeysuckle, red peony root, frankincense, myrrh, radix trichosanthis, tangerine peel, saposhnikovia divaricata, fritillaria, and angelica dahurica) and applying Xiaodusan externally. 35 cases were cured, accounting for 90%; 4 cases improved, accounting for 10%; the total effective rate was 100%. The antibacterial effect of the gasification and explosion extraction solution from Gleditsia sinensis thorns was determined by the in vitro antibacterial test method, and compared with its water decoction and alcohol extract. The ethyl acetate extract of the gasification and explosion extraction solution of Gleditsia sinensis thorns had a significant inhibitory effect on Escherichia coli, Bacillus subtilis, and Staphylococcus aureus. The ethanol extract of Gleditsia sinensis was used on Avian broilers to study its effect on the immune system function of broilers. The results showed that a low dose of ethanol extract of Gleditsia sinensis can significantly increase the conversion rate of B and T lymphocytes in broilers, effectively promote the immune system, and also promote growth and development.
[0020] (3) Raw Polygonum multiflorum: good at detoxifying and eliminating carbuncle, moistening the intestines and relieving constipation. It is mainly used to treat Yin deficiency syndrome, carbuncle, dry intestines and constipation. "Treatise on the Causes and Symptoms of Various Diseases" records that "people with asthenia have exhausted essence and weak blood and qi". Polygonum multiflorum nourishes the kidney and marrow, nourishes blood and liver, moistens the intestines and relieves constipation, and has a good nourishing effect. The main active ingredients of Polygonum multiflorum are diphenylethylene glycoside compounds and anthraquinone compounds. It also contains lecithin and a variety of trace elements. Modern research has found that Polygonum multiflorum has many effects such as lowering blood lipids, enhancing immunity, and anti-aging. After treatment with Danggui Shouwu Decoction for 40 patients with intractable constipation, 31 cases were significantly effective, accounting for 77.5%; 8 cases were effective, accounting for 20.0%; 1 case was ineffective, accounting for 2.5%, and the effective rate was 97.5%. Shouwu Zengye Decoction Sanjiu Decoction Granules were used to treat 60 patients with PD constipation. By comparing the Wexner constipation scoring scale, it was concluded that Shouwu Zengye Decoction Sanjiu Decoction Granules are effective in treating Parkinson's disease (PD) constipation, and the effect is more obvious in patients whose constipation occurs after motor symptoms.
[0021] (4) Ma Ti Xiang: Good at warming the middle and dispelling cold, relieving pain and regulating qi. Indications: sandstone stranguria, urinary incontinence, stomachache, and chronic pain. Modern research shows that Ma Ti Xiang has a good effect of regulating qi and eliminating accumulation. Its roots and rhizomes have anti-tumor, antibacterial, and antiviral drug activities. The study conducted a preliminary antimicrobial activity test on the compounds separated by ethyl acetate extraction of Ma Ti Xiang extract to detect the antibacterial activity of the compounds. The results showed that most compounds had different degrees of inhibitory effect on microbial growth. Among them, Ma Ti Xiang alkaloids had good antibacterial activity against Gram-positive bacteria; aristolochic acid and aristolochic acid also had certain antibacterial activity. Through the analysis of the compound structure, it was preliminarily judged that the group that produces biological activity was the amide group. By measuring and comparing the amino acid content in the traditional Chinese medicine Ma Ti Xiang and 5 drugs for treating gastrointestinal diseases, it was concluded that Ma Ti Xiang powder contained rich amino acids, and its glutamic acid and arginine contents were relatively high. The content of these amino acids may be related to the effectiveness of Ma Ti Xiang in treating viral enteritis, that is, promoting the repair of damaged intestinal mucosa.
[0022] (5) Stinky ginseng: It is good at replenishing qi and generating blood, unblocking meridians, and aiding digestion. It is mainly used to treat constipation due to physical weakness, injuries from falls, and rheumatism and numbness. The pharmacological effects of stinky ginseng are concentrated on gastrointestinal function, immune function, and the blood system. Some pharmacodynamic and acute toxicity experiments were conducted on stinky ginseng (Codonopsis bulleyana Forest ex Dilets). The results showed that stinky ginseng xCd has a significant excitatory effect on intestinal propulsion and has the function of strengthening gastrointestinal motility; it can promote the recovery of Hb, RBC, WBC, and IgG in mice with cyclophosphamide immunosuppression and hemorrhagic anemia, improve the phagocytic function of mouse peritoneal macrophages and the transformation rate of lymphocytes, have certain immunomodulatory and anti-anemia effects, and can improve the ability to tolerate hypoxia and fatigue. Acute toxicity test LD50 It cannot be measured, and the maximum tolerable dose is 409 / kg (including 24009 of fresh raw medicinal materials). It is 960 times the adult dosage (259 / kg). Research on the determination of the nutritional components of stinking ginseng shows that in addition to the basic nutrients, its roots are also rich in vitamin B and trace elements, especially vitamin B, which is 3 to 84 times higher than other edible and medicinal roots and tubers (comparison standard: Chinese Academy of Preventive Medicine. Nutrition and Food Hygiene Institute, Food Composition Table. People's Medical Publishing House, 1998). It is suggested that stinking ginseng is a tonic medicine with good health care effects that can prevent and treat vitamin B deficiency, promote food digestion, eliminate flatulence, promote appetite, prevent anemia, inhibit cholesterol deposition, prevent atherosclerosis, and prevent fetal malformations. Example
[0023] A method for preparing a hydrogel of a traditional Chinese medicine composition for improving constipation in children comprises the following steps: S1. Extraction process of volatile oil from Chinese medicine composition; S2, the preparation process of drug-loaded hydrogel; S3. The preparation process of Chinese medicine composition hydrogel.
[0024] Specifically, the extraction process of volatile oil from the traditional Chinese medicine composition includes: taking 10-20 parts of rheum officinale, 10-20 parts of saponins, 15-30 parts of raw Polygonum multiflorum, 10-20 parts of water chestnuts and 5-15 parts of stinking ginseng by weight, crushing, mixing and sieving the above medicinal materials to obtain the traditional Chinese medicine composition; mixing the above traditional Chinese medicine composition with water in a ratio of 1:2-1:8, soaking for 0.5-3 hours, extracting volatile oil by steam distillation for 1-8 hours, extracting volatile oil and separating effective components therein.
[0025] As a preferred embodiment, the medicinal materials constituting the traditional Chinese medicine composition are 10 parts of rhubarb, 15 parts of sapodilla, 20 parts of raw Polygonum multiflorum, 15 parts of Cyperus rotundus and 10 parts of Glehnia littoralis by weight.
[0026] Usually, the separated volatile oil needs to be dissolved in anhydrous ethanol for later use, so as to preserve the active ingredients of the medicine and better combine with the hydrogel later. Preferably, the weight ratio of the traditional Chinese medicine composition to anhydrous ethanol is 1:20-1:80.
[0027] The preparation process of the drug-loaded hydrogel includes: taking 4-8 parts of acrylamide, 2-5 parts of chitosan, 1-3 parts of silk protein, 0.01-0.1 parts of a cross-linking agent, 10-20 parts of tetramethylethylenediamine and 10-30 parts of water by weight, preparing the above materials by free radical polymerization, and then crushing them into fine powder particles. The cross-linking agent is preferably a persulfate, and common ones include potassium persulfate, ammonium persulfate and the like.
[0028] As a preferred embodiment, 6 parts of acrylamide, 2.5 parts of chitosan, 1.5 parts of silk protein, 0.08 parts of a cross-linking agent, 15 parts of tetramethylethylenediamine and 20 parts of water are taken by weight.
[0029] The preparation process of the Chinese medicine composition hydrogel includes: mixing the volatile oil and the drug-carrying hydrogel in a ratio of 1:1-1:9, heating and stirring until the mixed solution is in a gel state, and freezing and solidifying in an environment of -20℃-0℃.
[0030] Preferably, the heating and stirring reaction conditions are 60-300 r / min, and the reaction is 0.5-4 hours. The heated and stirred gel solution is poured into a mold, allowed to stand to remove bubbles, and then frozen and solidified in an environment of -20°C-0°C to obtain a hydrogel of a Chinese medicine composition for improving constipation in children.
[0031] It should be noted that the extraction process of the volatile oil of the traditional Chinese medicine composition and the preparation process of the drug-loaded hydrogel are not in order. This embodiment is only for the convenience of explanation. The above steps are used as an example, and the order of the two processes is not actually limited.
[0032] This embodiment also provides a hydrogel produced according to the method for producing a hydrogel of a traditional Chinese medicine composition described in any of the above technical solutions. Example
[0033] The present invention provides an application of a hydrogel of a traditional Chinese medicine composition for improving constipation in children, which is prepared according to the preparation method described in Example 1.
[0034] The clinical trial results are as follows: The present invention is an external medicine, and has been used to treat 2,000 children with constipation, with a cure rate of 98% and a markedly effective rate of 93%.
[0035] The following are 4 clinical cases: 1. Child, female, 3 years and 4 months old, the child had dry stool for more than 2 years. Current symptoms: dry stool is difficult to resolve, enema is needed to resolve stool, no abdominal pain and bloating, sleep is good, urination is normal, and bowel movements are once every 3-4 days. Physical examination: The child's mental state is good, the tongue is red, and the fur is thin and yellow. Chinese medicine diagnosis: constipation. Syndrome differentiation: heat evil damages body fluid syndrome. After using the children's constipation gel of the present invention, the parents reported that the child's constipation was slightly relieved after taking the medicine, and the child could defecate on his own without enema, and the tongue fur was slightly greasy. Continue to use the present invention for external treatment for half a month, and return to visit two weeks later. The child no longer has difficulty in defecation and has a bowel movement once a day.
[0036] 2. A child, male, 8 years old, complained of dry stools, once every two days, and poor appetite on his behalf. Physical examination: pale red tongue and lips, thin white fur, slightly congested pharynx (+), no enlargement of both tonsils, no secretions, no abnormalities in the heart and lungs. After half a month of treatment with the pediatric constipation gel of the present invention, the stool became soft and the appetite increased. After continuing to use the present invention for 1 week, the stool was soft and once a day, and there was no recurrence of constipation.
[0037] 3. Child, female, 4 years old, with a history of constipation for 4 years. The child has white skin and thin body, and constipation recurs and does not heal. He seeks medical treatment everywhere, and all treatments by Chinese and Western medicine are ineffective. The diagnosis is: the stool is hard and hard, the head is like sheep dung, and there is one row every few days, and even anal fissures and blood in the stool. It is often necessary to have artificial defecation such as enema, and occasionally there is poor appetite, thin yellow hair, short and red urine, good appetite, sleep well at night, hot hands and feet; pale lips, red tongue, less moss, and thin pulse. Chinese medicine diagnosis: constipation (dry intestines and dry body fluid). Therapeutic method: replenishing qi and nourishing blood, clearing away heat and promoting body fluid, moistening the intestines and relieving constipation. After treatment with the present invention, the follow-up visit: constipation was significantly relieved after 5 days of self-reported treatment, and there was no difficulty in defecation after 7 days. Current symptoms: no difficulty in defecation, less dry and coarse than before, no lumps like sheep dung, defecation once every 1-2 days, no anal fissure and blood in the stool, normal urination, normal appetite, good sleep at night, less heat in the palms and soles; red tongue, less coating, fine pulse. If the effect is not changed, continue to use this gel for 7 days. Follow-up for several months, the patient recovered after taking the medicine, and constipation did not recur.
[0038] 4. Patient, male, 1 year and 2 months old, parents complained of constipation since childhood, easy abdominal distension, less gas, breastfeeding, less appetite, easy sweating, dry stool like balls, once every 2-3 days. Physical examination: red throat, double flat and undeveloped, no abnormality in heart and lungs, soft abdomen, red lips, red tip of tongue, yellow fur, light purple fingerprints. Diagnosed as constipation. Treatment is to nourish yin and blood, regulate qi and clear bowels, moisten dryness and relieve constipation. Parents complained that the child was difficult to take medicine, so this gel was used for external treatment. Follow-up one week later, the stool was in strips once every 1-2 days, and the previous external application was continued. The stool was soft during follow-up and constipation did not recur.
[0039] Animal model experiments on constipation 1. Experimental animals: 60 male Kunming mice, 5 weeks old, weighing 18-20 g.
[0040] 2. Experimental materials: hydrogel preparation of the present invention.
[0041] 3. Experimental groups: 60 rats were randomly divided into 5 experimental groups, namely blank group (n=12), model group (n=12), low-dose hydrogel group (n=12), medium-dose hydrogel group (n=12), and high-dose hydrogel group (n=12).
[0042] 4. Defecation experiment: Prepare the ink before defecation, accurately weigh 10g of gum arabic, add 80mL of sterile water, put it in a water bath and boil until transparent, then add 5g of activated carbon, stir and mix, sterilize and store in a 4℃ refrigerator for later use. The defecation test method is mainly based on the reference reports with slight adjustments. Specifically, the mice were fasted before the defecation test, and different groups of mice were gavaged normally after 12h. After 30 minutes, the prepared ink was gavaged at a dose of 0.1 mL / 10 g body weight. Each mouse was placed in a cage alone, free to drink water, and the feces were collected immediately and stored in a sterilized EP tube. The time of each feces was recorded, and the time of the first black stool and the number and weight of feces discharged by the mouse within 6h were counted. After the observation, the collected feces samples were dried to constant weight, and the water content of the feces of each group of mice was calculated.
[0043] 5. The experimental results are shown in Table 1.
[0044] Table 1 The results show that the Chinese medicine compositions provided by the present invention all have the effect of treating constipation and the high-dose group has the best effect.
[0045] Clinical trial effectiveness test Take 10 parts of rhubarb, 15 parts of sapodilla, 20 parts of raw Polygonum multiflorum, 15 parts of water chestnut, and 10 parts of stinking ginseng, and make a hydrogel preparation according to the preparation method described in Example 1, which is used in clinical trials to preliminarily test the safety and effectiveness of the drug.
[0046] The 20 cases were aged 5-14 years old, with an average age of 9 years old, and 20 children had constipation. The control group was 22 (retrospective cases), aged 5-14 years old, with an average age of 8 years old, and 22 children had constipation.
[0047] 1. Treatment methods: Control group: external use of constipation patch, once a day, 7 consecutive days as a course of treatment.
[0048] Treatment group: Apply hydrogel externally once a day for 7 consecutive days as a course of treatment.
[0049] 2. Efficacy judgment criteria: Both groups of subjects filled out a questionnaire on defecation status after one course of treatment. Cured: All six items in the diagnostic criteria for pediatric constipation are negative and the clinical symptoms disappear.
[0050] Markedly effective: Only one of the diagnostic criteria for pediatric constipation is positive and the clinical symptoms disappear.
[0051] Effective: Only 2 items in the diagnostic criteria for pediatric constipation were positive, and clinical symptoms were significantly improved.
[0052] Ineffective: 3 items in the diagnostic criteria for pediatric constipation are positive, and there is no improvement in clinical symptoms.
[0053] The comparison of the overall efficacy between the two groups is shown in Table 2.
[0054] Table 2 The results showed that the treatment group had better efficacy than the control group.
[0055] 3. Comparison of relapse rates between the two groups: After 3 months, the cured cases in the treatment group and the control group were selected for relapse rate investigation. There were 3 relapses in the control group, with a relapse rate of 3 / 8; there was 1 relapse in the treatment group, with a relapse rate of 1 / 15. The relapse rate in the treatment group was lower than that in the control group.
[0056] The above description is only the preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.
Claims
1. A method for preparing a hydrogel of a traditional Chinese medicine composition for improving constipation in children, characterized in that: include: The process of extracting volatile oil from a Chinese medicine composition, the process of preparing a drug-loaded hydrogel, and the process of preparing a hydrogel from a Chinese medicine composition; wherein, The extraction process of volatile oil of the traditional Chinese medicine composition comprises the following steps: taking 10-20 parts of rheum officinale, 10-20 parts of sapodilla, 15-30 parts of raw radix polygoni multiflori, 10-20 parts of scutellaria baicalensis and 5-15 parts of stinking ginseng by weight, crushing, mixing and sieving the above medicinal materials to obtain the traditional Chinese medicine composition; mixing the traditional Chinese medicine composition with water in a ratio of 1:2-1:8, soaking for 0.5-3 hours, extracting volatile oil by steam distillation for 1-8 hours, and separating the volatile oil; The preparation process of the traditional Chinese medicine composition hydrogel includes mixing the volatile oil and the drug-carrying hydrogel in a ratio of 1:1-1:9, heating and stirring until the mixed solution is in a gel state, and freezing and solidifying the mixed solution in an environment of -20°C-0°C.
2. The method for preparing the hydrogel of the Chinese medicine composition for improving constipation in children according to claim 1, characterized in that: The preparation process of the drug-loaded hydrogel includes taking 4-8 parts of acrylamide, 2-5 parts of chitosan, 1-3 parts of silk protein, 0.01-0.1 parts of a crosslinking agent, 10-20 parts of tetramethylethylenediamine and 10-30 parts of water by weight, preparing the above materials through free radical polymerization, and then crushing them into particles.
3. The method for preparing the hydrogel of the Chinese medicine composition for improving constipation in children according to claim 2, characterized in that: The cross-linking agent is persulfate.
4. The method for preparing the hydrogel of the Chinese medicine composition for improving constipation in children according to claim 1, characterized in that: Take 10 parts of rhubarb, 15 parts of sapodilla, 20 parts of raw Polygonum multiflorum, 15 parts of water chestnut and 10 parts of stinking ginseng by weight.
5. The method for preparing the hydrogel of the Chinese medicine composition for improving constipation in children according to claim 1, characterized in that: The extraction process of the volatile oil of the traditional Chinese medicine composition also includes dissolving the separated volatile oil in anhydrous ethanol for later use.
6. The method for preparing the hydrogel of the Chinese medicine composition for improving constipation in children according to claim 5, characterized in that: The weight ratio of the traditional Chinese medicine composition to anhydrous ethanol is 1:20-1:
80.
7. The method for preparing the hydrogel of the Chinese medicine composition for improving constipation in children according to claim 2, characterized in that: The preparation process of the drug-loaded hydrogel comprises taking, by weight, 6 parts of acrylamide, 2.5 parts of chitosan, 1.5 parts of silk protein, 0.08 parts of a cross-linking agent, 15 parts of tetramethylethylenediamine and 20 parts of water.
8. The method for preparing the hydrogel of the Chinese medicine composition for improving constipation in children according to claim 1, characterized in that: The heating and stirring conditions are 60-300 r / min, and the reaction time is 0.5-4 hours.
9. A hydrogel produced according to the method for producing a Chinese medicine composition hydrogel according to any one of claims 1 to 8.
10. Use of a hydrogel of a traditional Chinese medicine composition for improving constipation in children prepared by the preparation method according to any one of claims 1 to 8.