Traditional Chinese medicine composition for promoting postoperative gastrointestinal function recovery and application thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for promoting postoperative gastrointestinal function recovery and application thereof.The composition comprises rheum officinale and mangnolia officinalis which serve as active ingredients, and the weight ratio of the rheum officinale to the mangnolia officinalis is (1.5-3): 1. Wherein the rhubarb is used as the monarch material and has the functions of purging, removing food retention and cleaning intestines and viscera; the mangnolia officinalis is used as a ministerial drug for promoting qi circulation and relieving distension and restricting the cold property of rheum officinale; the medicine is applied to specific acupuncture points such as Tianshu and Zusanli, so that the dual effects of directly reaching the effect of the medicine to an affected area and regulating meridians and collaterals are realized. Compared with oral administration, the traditional Chinese medicine composition can remarkably promote postoperative borborygmus recovery, shorten the first-time exhaust and defecation time, effectively relieve abdominal distension, avoid direct stimulation of the medicine to postoperative weak gastrointestinal tracts and provide a safe and effective traditional Chinese medicine external treatment new scheme for rapid postoperative rehabilitation.

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 promoting postoperative recovery of gastrointestinal function and application thereof. BACKGROUND

[0002] Gynecological laparoscopic surgery as a minimally invasive technique has been widely used in clinical practice, but postoperative recovery of gastrointestinal function is still delayed. This is mainly due to multiple factors such as surgical trauma, anesthetic drug inhibition and pneumoperitoneum pressure, which often leads to abdominal distension, abdominal pain, difficulty in passing gas and other symptoms of intestinal paralysis. Such symptoms not only aggravate the postoperative discomfort of patients, but also may prolong hospitalization time and increase the risk of complications such as intestinal adhesion and poor wound healing, which becomes a key factor restricting the rapid recovery of patients.

[0003] Currently, there are various clinical interventions for postoperative gastrointestinal dysfunction. In the field of Western medicine, early ambulation, chewing gum, drug stimulation and other means are often used, which have certain effects, but have limitations such as poor compliance or drug side effects. In the field of traditional Chinese medicine, rhubarb and magnolia officinalis, as a classic drug pair, have clear pharmacological effects of purgation, accumulation, qi movement and stagnation, and have been widely used in oral preparations to promote gastrointestinal motility. However, the oral administration route may cause gastrointestinal irritation in postoperative patients, and the harsh nature of the drug may harm the healthy qi in patients with weak spleen and stomach.

[0004] At the same time, according to the meridian theory of traditional Chinese medicine, acupoint stimulation can effectively regulate the qi movement of zang-fu organs and has unique advantages for the recovery of gastrointestinal function. The efficacy of specific acupoints such as Tianshu and Zusanli in regulating the spleen and stomach and regulating the intestines and bowels has been clinically verified. However, there is no systematic research or literature report on the use of rhubarb and magnolia officinalis, which have clear efficacy, in a specific proportion to form an external preparation for direct application to related acupoints to form a synergistic effect, and to be used exclusively for postoperative recovery after gynecological laparoscopic surgery at home and abroad. The existing rehabilitation means cannot integrate and accurately apply the pharmacological effects of traditional Chinese medicine and the meridian regulation effect of acupoints. SUMMARY

[0005] The present application aims to provide a traditional Chinese medicine composition for promoting postoperative recovery of gastrointestinal function and application thereof, which is composed of rhubarb and magnolia officinalis, and has the effects of purgation and qi movement by acupoint application, which can effectively restore intestinal peristalsis and avoid the disadvantages of oral administration.

[0006] To achieve the above technical purposes and effects, the present application is realized by the following technical scheme:

[0007] A traditional Chinese medicine composition for promoting postoperative recovery of gastrointestinal function, which comprises rhubarb and magnolia officinalis as active ingredients, wherein the weight ratio of rhubarb to magnolia officinalis is (1.5-3):1.

[0008] Furthermore, the weight ratio of rhubarb to magnolia bark is 2:1, and the composition is configured as a dosage form for transdermal administration via acupoints.

[0009] Furthermore, the dosage form includes a patch, poultice, or gel patch; the composition also includes pharmaceutically acceptable excipients, including adhesives and transdermal penetration enhancers.

[0010] Furthermore, the adhesive is any one or more of honey, glycerin, gelatin, sodium carboxymethyl cellulose, and polyvinylpyrrolidone carbomer gel; the transdermal penetration enhancer is any one or more of vinegar, borneol, amino ketone, menthol, and ethanol.

[0011] On the other hand, the present invention proposes a medical acupoint patch for promoting postoperative gastrointestinal function recovery, comprising a base and a drug unit supported thereon, wherein the drug unit comprises the above-mentioned traditional Chinese medicine composition.

[0012] The drug unit is a circular or near-circular structure with a diameter of 0.5-2 cm; and / or, in a unit dose of the drug unit, the total content of the active ingredient is 0.1-5 grams.

[0013] On the other hand, the present invention proposes the application of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for promoting the recovery of postoperative gastrointestinal function.

[0014] On the other hand, the present invention proposes a method for preparing the above-mentioned medical acupoint patch, comprising the following steps:

[0015] S1: Rhubarb and magnolia bark are provided, dried, pulverized, and passed through an 80-200 mesh sieve to obtain a mixed powder;

[0016] S2: Mix the powder with the binder and transdermal penetration enhancer, and stir to form a uniform paste;

[0017] S3: The paste is quantitatively coated or filled onto the substrate, and the product is obtained after molding.

[0018] in:

[0019] Rhubarb: Properties: Bitter, cold; enters the stomach, large intestine, and liver meridians. Indications: Clears heat and toxins, breaks up stagnation, and promotes blood circulation. Treats constipation due to excess heat, delirium, abdominal distension due to food stagnation, early-stage dysentery, tenesmus, amenorrhea due to blood stasis, abdominal masses, epidemic febrile diseases, sudden onset of red and painful eyes, hematemesis, epistaxis, jaundice, edema, urinary tract infections, carbuncles, boils, and burns.

[0020] Magnolia officinalis: Properties: Bitter, pungent, warm; Meridians: Spleen, Stomach, Lung, Large Intestine. Indications: Dries dampness and resolves phlegm, regulates qi and relieves fullness. Used for dampness stagnation injuring the middle jiao, epigastric fullness and vomiting, diarrhea, food stagnation and qi stagnation, abdominal distension and constipation, phlegm retention and cough.

[0021] The beneficial effects of this invention are:

[0022] In this invention, rhubarb is the principal ingredient, utilizing its bitter, cold, and descending properties to primarily enter the blood level, effectively purging and eliminating tangible accumulations in the intestines and stomach. Magnolia bark is the assistant ingredient, relying on its bitter, pungent, and warm properties to primarily enter the qi level, excelling at promoting qi circulation and relieving bloating, focusing on dispersing intangible qi stagnation. The combination of these two ingredients creates a harmonious balance of qi and blood, and a coordinated descending and purging effect. The warming properties of magnolia bark effectively counteract the coldness of rhubarb, preventing the stagnation of qi due to cold. This method of combining warming and cold properties deeply addresses the complex pathogenesis of postoperative weakness and excess. Transdermal drug delivery through acupoints, acting on specific key points such as Tianshu, Zhongwan, and Zusanli, achieves an organic unity of therapeutic effects and meridian regulation. The medicinal power, leveraging the meridian's connection to the internal organs and external limbs, directly reaches the affected area, exerting both the purge effect of the drug itself and stimulating meridian qi through acupoint stimulation, thus regulating the qi mechanism of the middle jiao. This dual mechanism of action complements each other, ensuring significant promotion of intestinal peristalsis and elimination of abdominal distension while effectively avoiding direct damage to the weakened spleen and stomach caused by oral purgatives after surgery.

[0023] Of course, any product implementing this invention does not necessarily need to achieve all of the advantages described above at the same time. Detailed Implementation

[0024] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0025] Example 1

[0026] This embodiment describes a traditional Chinese medicine composition for promoting postoperative gastrointestinal function recovery. The composition includes rhubarb and magnolia bark as active ingredients, wherein the weight ratio of rhubarb to magnolia bark is 2:1.

[0027] Example 2

[0028] This embodiment describes a traditional Chinese medicine composition for promoting postoperative gastrointestinal function recovery. The composition includes rhubarb and magnolia bark as active ingredients, wherein the weight ratio of rhubarb to magnolia bark is 3:1.

[0029] Example 3

[0030] Animal experiments, toxicity testing methods

[0031] 1. Experimental materials

[0032] Experimental animals: 100 healthy, unmated female SD rats (Experimental Animal Center of Hebei Medical University), 5 weeks old, approximately 25 grams each, were selected. Experimental drugs: Rhubarb and Magnolia officinalis: provided by Shijiazhuang Maternity Hospital. Recommended daily dose: 22 g / 60 kg. -1 The maximum concentration of the drug that can be administered via gavage using distilled water is 7.26 g·mL. -1 For use in acute toxicity testing; prepared at a concentration of 1.1 g·mL. -1 2.2 g·mL -1 and 4.4 g·mL -1 Xiangshu pills 11g·kg were used in the long-term toxicity test respectively -1 22 g·kg -1 44 g·kg -1 The three doses were 30, 60, and 120 times the clinically recommended dose, respectively.

[0033] 2. Experimental Methods

[0034] Acute toxicity test: Twenty mice were randomly divided into two groups: an experimental group and a control group, with 10 mice in each group. The experimental group was administered the maximum concentration that could be passed through a 16-gauge gavage injection: 7.04 mL·g. -1 The mice were administered the drug twice, 12 hours apart. The control group received an equal volume of distilled water. Toxicity and mortality were observed immediately after administration. The mice were observed for 14 days, recording toxicity, mortality, body weight, and food intake. At the end of the observation period, blood biochemistry tests were performed, and the lesions of major organs were visually examined. The organ coefficient [organ coefficient = organ weight (g) / body weight (g) × 100%] and the maximum dose were calculated. If the size, color, or texture of the organs in the administered group differed from normal organs, further histopathological examination was performed.

[0035] Long-term toxicity experiment: Eighty female SD rats were randomly divided into a control group and an experimental group (rhubarb and magnolia bark) 11 g·kg -1 Group, 22 g·kg -1 Group and 44 g·kg -1 Groups (equivalent to 30, 60, and 120 times the clinical dose, respectively), with 20 animals in each group. Administered via gavage for 13 consecutive weeks, once daily, at a volume of 0.01 mL / g. -1 The control group was given an equal volume of distilled water. Rats were observed daily for general behavior, and their body weight and food intake were measured weekly. After 13 weeks of drug administration, 10 rats were randomly selected from each group for hematological and blood biochemical tests, observation of organ morphology, weighing, and calculation of organ coefficients. The results were observed and recorded for both the control and experimental groups at 44 g / kg. -1Pathological changes in the organs and tissues of the group were observed. The remaining rats were fed normally for 4 weeks after drug withdrawal, and the detection indicators were the same as those mentioned above after the recovery period.

[0036] 3. Biochemical indicator testing items:

[0037] Acute toxicity observation indicators:

[0038] 1. Blood biochemical indicators (ALT, AST, ALP, ALB, TP, Glu, Crea, Urea, TG, T-CHO, CK, pH value). Arabic numerals. Organ coefficients (brain, heart, liver, spleen, lung, kidney, adrenal gland, thymus, uterus, ovary). 2. Macroscopic observation of the location, shape, size, color, and texture of major organs (brain, heart, liver, spleen, lung, kidney, adrenal gland, thymus, uterus, ovary, breast, stomach, small intestine, large intestine, etc.). 3. Long-term toxicity monitoring indicators: Hematological indicators (RBC, HGB, PLT, HCT, MCH, MCV, MCHC, WBC). Blood biochemical indicators (ALT, AST, ALP, ALB, TP, Glu, TG, T-CHO, CK, K). + Na + Cl - pH value). Location, shape, size, color, and texture of the examined organs and tissues (brain, heart, liver, spleen, lungs, kidneys, adrenal glands, thymus, uterus, ovaries, breasts, stomach, small intestine, large intestine). Organ coefficients (brain, heart, liver, spleen, lungs, kidneys, adrenal glands, thymus, uterus, ovaries). Pathological changes in organ tissues (brain, heart, liver, spleen, lungs, kidneys, adrenal glands, thymus, uterus, ovaries, breasts).

[0039] Pharmacodynamics Methods Experiment

[0040] 1. Experimental materials

[0041] Experimental animals: Sixty healthy, unmated female Kunming mice, 5 weeks old and weighing about 25 grams, were selected.

[0042] Preparation of ink: Accurately weigh 100g of gum arabic, add 800mL of water, and boil until the solution is clear. Weigh 50g of activated carbon (powder) and add it to the above solution, then boil it three times. After the solution cools, add water to make up to 1000mL. Store in a refrigerator at 4℃ and shake well before use.

[0043] Experimental drugs: The compositions described in Examples 1 and 2, rhubarb and magnolia bark, and rhubarb and magnolia bark plaster were all provided by Shijiazhuang Maternity Hospital.

[0044] 2. Experimental Methods

[0045] Twenty mice were randomly selected and divided into two groups of ten each: an experimental group and a control group. Mice in the experimental group received a rhubarb and magnolia bark patch applied to their abdomen, while mice in the control group received a blank patch applied to the same area of ​​their abdomen. The patches were changed every 24 hours in both groups, and the quantity and quality of feces were monitored. Seventy-two hours after the initial application, both groups of mice were administered 0.1 mL / kg of ink via gavage. -1 25 minutes after gavage, mice were euthanized by cervical dislocation. The intestinal segment from the upper end of the pylorus to the lower end of the ileocecal junction was cut off. The length of the intestinal segment was measured as the "total length of the small intestine", and the length from the pylorus to the ink front edge was measured as the "ink propulsion length". The ink propulsion rate was calculated according to formula (2).

[0046] Twenty mice were randomly selected and divided into two groups of 10 each: an experimental group and a control group. The experimental group was given rhubarb and magnolia bark by gavage, while the control group was given an equal volume of distilled water. After administration, the time of first defecation, the number of defecation particles within 5 hours after administration, and the fecal mass of the mice in both groups were measured.

[0047] Twenty mice were randomly selected and divided into two groups of 10 each: an experimental group and a control group. The experimental group was administered rhubarb and magnolia bark by gavage at the maximum concentration that could pass through a 16-gauge gavage injection, 7.04 mL·g. -1 The mice were administered the drug twice, 12 hours apart, at 8:00 AM and 8:00 PM. The control group received an equal volume of distilled water. Both groups of mice were given 0.1 mL / kg of ink by gavage 30 minutes after administration. The mice were euthanized by cervical dislocation 25 minutes after gavage. The mesentery was separated by opening the abdominal cavity. The intestinal segment from the pylorus to the ileocecal junction was cut off and placed on a tray. The small intestine was gently pulled into a straight line and the length of the segment was measured as the "total length of the small intestine". The length from the pylorus to the ink tip was measured as the "ink propulsion length". The ink propulsion rate was calculated according to formula (2).

[0048] Example 4

[0049] clinical trials

[0050] Study participants: Patients with benign or malignant gynecological diseases who visited the participating institutions between May 2025 and October 2025 and were scheduled to undergo laparoscopic surgery. Inclusion criteria: 1. Age ≥ 18 years; 2. Benign or malignant gynecological diseases, scheduled for laparoscopic surgery; 3. ASA score I-II; 4. Patients or their families understood the study protocol and were willing to participate in the study, providing written informed consent. Exclusion criteria: 1. Gastrointestinal dysfunction; 2. Possibility of intraoperative gastrointestinal surgery; 3. Contraindications to laparoscopic surgery; 4. Refusal to sign informed consent.

[0051] Postoperatively, the experimental group received rhubarb and magnolia bark mixed with honey and vinegar in a 2:1 ratio to form a paste, which was then applied to a 1 cm diameter patch. Four hours postoperatively, the patch was applied to four acupoints: Tianshu, Zusanli, Zhongwan, and Xiawan, and remained in place for 4-6 hours. The control group received no treatment.

[0052] Study Design and Methods: Participants were assessed by their respective surgeons at the participating institutions, and enrollment was determined based on the patients' own wishes. Preoperatively, patients uniformly avoided dairy products and starchy solid foods for 6 hours (fried, fatty, and meat foods were avoided for at least 8 hours), and fasted for clear liquids for 2 hours. A suitable amount of clear beverage was consumed 2 hours before surgery. Patients were able to ambulate within 24 hours postoperatively. Baseline characteristics, disease data, and gastrointestinal function recovery time were collected for each group, and statistical differences were compared between different postoperative treatment methods.

[0053] Data Collection: 1. Basic Information: Age, Body Mass Index; 2. Admission Information: History of abdominal surgery, underlying diseases, blood electrolyte levels; 3. Surgical Information: Surgical procedure, surgical time, intraoperative blood loss, intraoperative fluid replacement; 4. Postoperative Information: ① Time of first flatus and defecation, i.e., the time from the patient's return to the ward after surgery to the first flatus and defecation; ② Time for bowel sound recovery: i.e., the time for bowel sounds to return to 3-4 times / min, auscultated every 2 hours; ③ Abdominal distension: after application, record abdominal distension every 6 hours, i.e., the patient's abdomen is distended, complains of mild distension and pain, auscultation reveals weakened or absent bowel sounds, and no flatus; ④ Appetite: feeling hungry, no abdominal distension after eating, no nausea or vomiting is good; no feeling hungry, feeling full after eating, nausea or vomiting is poor. Record abdominal distension and appetite until bowel sounds return to normal; ⑤ Skin reaction: observe skin itching, redness, swelling, papules, vesicles, and necrosis at 24, 48, and 72 hours. Data on various observation indicators were collected from two groups of patients after the initial treatment, and the overall efficacy was judged according to the following criteria: Significant effect: Passing gas 6 hours after treatment, bowel sounds >3 times / min, and disappearance of abdominal distension and pain symptoms, with a feeling of hunger. Effective: Passing gas 6–12 hours after treatment, bowel sounds <3 times / min, gradual improvement and disappearance of abdominal distension and pain symptoms, with a feeling of hunger. Ineffective: No passing gas 12 hours after treatment, bowel sounds <1 time / min.

[0054] Statistical analysis was performed using SPSS 21.0 with a two-tailed test. A p-value < 0.05 was considered statistically significant.

[0055] The preferred embodiments of the present invention disclosed above are merely illustrative of the invention. These preferred embodiments do not exhaustively describe all details, nor do they limit the invention to the specific implementations described. Clearly, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to better understand and utilize the invention. The invention is limited only by the claims and their full scope and equivalents.

Claims

1. A traditional Chinese medicine composition for promoting recovery of gastrointestinal function after surgery, characterized in that, The composition comprises rhubarb and magnolia bark, wherein the weight ratio of rhubarb to magnolia bark is (1.5-3):

1. 2.The traditional Chinese medicine composition for promoting recovery of gastrointestinal function after surgery of claim 1, characterized in that: The weight ratio of rhubarb to magnolia bark is 2:1, and the composition is configured as a transdermal administration dosage form via acupoints. 3.The traditional Chinese medicine composition for promoting recovery of gastrointestinal function after surgery of claim 2, characterized in that: The dosage form comprises a patch, cataplasm or gel ointment; the composition further comprises a pharmaceutically acceptable excipient, which comprises a binder and a transdermal enhancer. 4.The traditional Chinese medicine composition for promoting recovery of gastrointestinal function after surgery of claim 3, characterized in that: The binder is any one or more of honey, glycerol, gelatin, sodium carboxymethyl cellulose and polyvinyl pyrrolidone; the transdermal enhancer is any one or more of vinegar, borneol, aminoketone, menthol and ethanol.

5. A medical acupoint patch for promoting recovery of gastrointestinal function after surgery, comprising a base support and a drug unit carried thereon, characterized in that: The pharmaceutical unit comprises the traditional Chinese medicine composition according to any one of claims 1-4. 6.The traditional Chinese medicine composition for promoting recovery of gastrointestinal function after surgery according to claim 5, characterized in that: The pharmaceutical unit is in a circular or quasi-circular structure with a diameter of 0.5-2 cm; and / or, in a unit dose of the pharmaceutical unit, the total content of the active ingredients is 0.1-5 g.

7. Use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a medicament for promoting recovery of gastrointestinal function after surgery.