A composite traditional Chinese medicine and application thereof to preparation of a medicine for preventing and treating postoperative gastrointestinal dysfunction

Abstract

The application belongs to the technical field of traditional Chinese medicines, and provides a compound traditional Chinese medicine and application thereof in preparation of a medicine for preventing and treating postoperative gastrointestinal dysfunction. The compound traditional Chinese medicine is composed of radix codonopsis extract, radix bupleuri extract, fructus aurantii extract, radix astragali extract and radix angelicae extract with a mass ratio of 1:3-4:1-2:3-5:2-3. Animal experiments show that the compound traditional Chinese medicine can significantly reverse the decrease of postoperative gastrointestinal motility function, reverse the changes of gastrointestinal hormones VIP and MTL, and help and promote the recovery of postoperative gastrointestinal motility function. The compound traditional Chinese medicine has reasonable formula, is convenient to use, and has a wide application range, and has curative effects on the recovery of postoperative gastrointestinal function caused by various conditions.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and relates to a compound traditional Chinese medicine and its application in the preparation of drugs for preventing and treating postoperative gastrointestinal dysfunction. Background Technology

[0002] Postoperative gastrointestinal dysfunction is a common complication after gastrointestinal surgery, also described as postoperative paralytic ileus, gastroparesis, delayed gastric emptying, postoperative intestinal obstruction, and gastric motility disorders. It often manifests as a variety of clinical symptoms such as nausea, vomiting, abdominal distension, and delayed flatus and defecation. The incidence of postoperative gastrointestinal dysfunction after abdominal surgery ranges from 4% to 32%, with a higher incidence after gastrointestinal surgery. This may be related to factors such as surgical technique, intraoperative anesthesia, instrument traction, postoperative medication use, and inflammatory responses, which can lead to damage to the gastrointestinal mucosa and disruption of its barrier function.

[0003] Currently, Western medicine treatment for postoperative gastrointestinal dysfunction mainly involves nutritional support, electrolyte balance, gastrointestinal decompression, and the use of prokinetic drugs.

[0004] Postoperative gastrointestinal dysfunction is undoubtedly an additional source of suffering for patients. Early detection, diagnosis, prevention, and treatment are of great significance, and Traditional Chinese Medicine (TCM) has a unique advantage in this regard. From the perspective of TCM, surgery can be considered a kind of artificially imposed external pathogen. Surgery depletes the body's vital energy, affects the opening and closing of the pores, and allows external pathogens to directly invade the internal organs, causing disordered Qi flow in the Triple Burner. The inability to eat normally after surgery further weakens the spleen and stomach, affecting the distribution of nutrients and the excretion of turbid Qi. The large intestine becomes unable to conduct properly, further aggravating the symptoms of postoperative gastrointestinal dysfunction, such as nausea, abdominal distension, and difficulty passing gas and stool.

[0005] There is a need to provide a compound traditional Chinese medicine that is highly safe, has few side effects, and promotes the recovery of gastrointestinal function in surgical patients after surgery, for clinical use. Summary of the Invention

[0006] In view of this, the present invention provides a compound traditional Chinese medicine and its application in the preparation of drugs for preventing and treating postoperative gastrointestinal dysfunction.

[0007] The present invention also provides a method for preparing the above-mentioned compound traditional Chinese medicine.

[0008] This invention also provides the application of the above-mentioned compound traditional Chinese medicine in the preparation of drugs for treating postoperative gastrointestinal dysfunction.

[0009] The technical solution adopted by the present invention to achieve the above objectives is as follows: In a first aspect, the present invention provides a compound traditional Chinese medicine comprising the following components: Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract, and Angelica sinensis extract.

[0010] As some preferred technical solutions of the present invention, the compound Chinese medicine is composed of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:3-4:1-2:3-5:2-3. The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata and Citrus aurantium were taken separately, and water was added for extraction. The mass-to-volume ratio of g:mL was 1:8-10. The extraction was carried out by heating and reflux extraction for 0.5-1.0h, and the extraction was repeated 2-3 times. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract and Citrus aurantium extract respectively.

[0011] The preparation method of the Astragalus extract and Angelica extract is as follows: Take dried and pulverized Astragalus membranaceus and Angelica sinensis separately, add 60-80% ethanol aqueous solution as extraction solvent, with a mass-to-volume ratio of g:mL of 1:8-10, and extract by heating and reflux extraction for 0.5h, 2-3 times, combine the extracts, concentrate and dry under reduced pressure to obtain Astragalus membranaceus extract and Angelica sinensis extract respectively.

[0012] The above extracts are mixed in the specified proportions to obtain the compound Chinese medicine.

[0013] As a preferred technical solution of the present invention, the compound Chinese medicine is composed of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:3:1:4:2. The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata and Citrus aurantium were taken separately, and water was added for extraction. The mass-to-volume ratio was 1:10 g:mL. The extraction was carried out by heating and reflux extraction for 1.0 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract and Citrus aurantium extract, respectively.

[0014] The preparation method of the Astragalus extract and Angelica extract is as follows: Dry and pulverized Astragalus membranaceus and Angelica sinensis were taken separately, and 75% ethanol aqueous solution was added as the extraction solvent. The mass-volume ratio of g:mL was 1:10. The extraction was carried out by heating and reflux extraction for 0.5 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Astragalus membranaceus extract and Angelica sinensis extract, respectively.

[0015] As a preferred technical solution of the present invention, the compound Chinese medicine is composed of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:4:2:5:3. The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata, and Citrus aurantium were taken separately, and water was added for extraction. The mass-to-volume ratio was 1:8 (g:mL). The extraction was carried out by heating and reflux extraction for 0.5 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract, respectively.

[0016] The preparation method of the Astragalus extract and Angelica extract is as follows: Dry and pulverized Astragalus membranaceus and Angelica sinensis were taken separately, and 65% ethanol aqueous solution was added as the extraction solvent. The mass-volume ratio of g:mL was 1:8. The extraction was carried out by heating and reflux extraction for 0.5 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Astragalus membranaceus extract and Angelica sinensis extract, respectively.

[0017] As a preferred technical solution of the present invention, the compound Chinese medicine is composed of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:3:2:3:2. The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata and Citrus aurantium were taken separately, and water was added for extraction. The mass-to-volume ratio was 1:10 g:mL. The extraction was carried out by heating and reflux extraction for 1.0 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract and Citrus aurantium extract, respectively.

[0018] The preparation method of the Astragalus extract and Angelica extract is as follows: Dry and pulverized Astragalus membranaceus and Angelica sinensis were taken separately, and 75% ethanol aqueous solution was added as the extraction solvent. The mass-volume ratio of g:mL was 1:10. The extraction was carried out by heating and reflux extraction for 0.5 h, and the extraction was repeated 3 times. The extracts were combined, concentrated and dried under reduced pressure to obtain Astragalus membranaceus extract and Angelica sinensis extract, respectively.

[0019] In a second aspect, the present invention provides a pharmaceutical preparation for treating postoperative gastrointestinal dysfunction, characterized in that the pharmaceutical preparation comprises the effective components of the above-mentioned compound traditional Chinese medicine.

[0020] As a preferred embodiment of the present invention, the pharmaceutical preparation further includes excipients.

[0021] As a preferred embodiment of the present invention, the dosage form of the pharmaceutical preparation is granules, tablets, or capsules.

[0022] As a preferred embodiment of the present invention, the dosage form of the pharmaceutical preparation is granules.

[0023] A third aspect of the present invention provides the use of the compound traditional Chinese medicine in the preparation of a medicine for the prevention or treatment of postoperative gastrointestinal dysfunction.

[0024] As a preferred technical solution of the present invention, the postoperative gastrointestinal dysfunction is gastrointestinal dysfunction after gastric perforation repair surgery.

[0025] The present invention also provides the use of the compound traditional Chinese medicine in the preparation of drugs for the prevention or treatment of postoperative intestinal obstruction.

[0026] The beneficial effects of the compound traditional Chinese medicine of this invention in treating postoperative gastrointestinal dysfunction are as follows: Pharmacodynamic experiments show that the compound Chinese medicine of this invention significantly reverses the decline in postoperative gastrointestinal motility, reverses the changes in gastrointestinal hormones VIP and MTL, and helps and promotes the recovery of postoperative gastrointestinal motility.

[0027] In modern gastrointestinal motility, electromyography (EMG) is considered a reliable indicator of gastrointestinal motility, with interdigestive compound electromyography (IMC) and its phase III strong contraction phase being important indicators. When gastrointestinal motility is low, gastric peristalsis slows, gastric emptying is delayed, and in EMG, IMC shows prolonged cycles, a low incidence of phase III, and a shortened phase III duration. The results of this study suggest that after treatment with the compound traditional Chinese medicine of this invention, the IMC cycles were shorter than those in the model group, while the phase III duration was prolonged, the frequency increased, and the amplitude increased, confirming that the compound traditional Chinese medicine of this invention has a significant effect on promoting gastrointestinal motility.

[0028] The compound Chinese medicine formula of this invention is reasonable, easy to use, and has a wide range of applications. It is effective for the recovery of postoperative gastrointestinal function in various situations and has good clinical application value. Attached Figure Description

[0029] Figure 1 Comparison of IMC cycles in rats of different groups, compared with the model group. P <0.05, P <0.01.

[0030] Figure 2 Comparison of phase III time course in each group of rats with the model group. P <0.05, P <0.01.

[0031] Figure 3 Comparison of the frequency of phase III in each group of rats with that in the model group. P <0.05, P <0.01.

[0032] Figure 4 Comparison of phase III amplitude in each group of rats with that in the model group. P <0.05, P <0.01. Detailed Implementation

[0033] To better understand the above technical solutions, a detailed description of the specific implementation methods will be provided below. Obviously, the described embodiments are merely some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0034] It should also be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that an article or device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such an article or device. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the article or device that includes said element.

[0035] Unless otherwise specified, all raw materials and excipients of the compound Chinese medicine of this invention can be obtained commercially. Any compound Chinese medicine of any range described in this invention, including any value between the endpoints and any subranges formed by the endpoints or any values ​​between the endpoints, can achieve the effects described in this invention.

[0036] The daily dosage of the compound traditional Chinese medicine described in this invention can be adjusted according to the patient's condition.

[0037] Example 1 This embodiment provides a compound traditional Chinese medicine, which is composed of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:3:1:4:2.

[0038] The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata and Citrus aurantium were taken separately, and water was added for extraction. The mass-to-volume ratio was 1:10 g:mL. The extraction was carried out by heating and reflux extraction for 1.0 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract and Citrus aurantium extract, respectively.

[0039] The preparation method of the Astragalus extract and Angelica extract is as follows: Dry and pulverized Astragalus membranaceus and Angelica sinensis were taken separately, and 75% ethanol aqueous solution was added as the extraction solvent. The mass-volume ratio of g:mL was 1:10. The extraction was carried out by heating and reflux extraction for 0.5 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Astragalus membranaceus extract and Angelica sinensis extract, respectively.

[0040] The above extracts are mixed in the specified proportions to obtain the compound Chinese medicine.

[0041] Example 2 This embodiment provides a compound traditional Chinese medicine, which is composed of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:4:2:5:3.

[0042] The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata, and Citrus aurantium were taken separately, and water was added for extraction. The mass-to-volume ratio was 1:8 (g:mL). The extraction was carried out by heating and reflux extraction for 0.5 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract, respectively.

[0043] The preparation method of the Astragalus extract and Angelica extract is as follows: Dry and pulverized Astragalus membranaceus and Angelica sinensis were taken separately, and 65% ethanol aqueous solution was added as the extraction solvent. The mass-volume ratio of g:mL was 1:8. The extraction was carried out by heating and reflux extraction for 0.5 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Astragalus membranaceus extract and Angelica sinensis extract, respectively.

[0044] The above extracts are mixed in the specified proportions to obtain the compound Chinese medicine.

[0045] Example 3 This embodiment provides a compound traditional Chinese medicine, which is composed of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:3:2:3:2.

[0046] The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata and Citrus aurantium were taken separately, and water was added for extraction. The mass-to-volume ratio was 1:10 g:mL. The extraction was carried out by heating and reflux extraction for 1.0 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract and Citrus aurantium extract, respectively.

[0047] The preparation method of the Astragalus extract and Angelica extract is as follows: Dry and pulverized Astragalus membranaceus and Angelica sinensis were taken separately, and 75% ethanol aqueous solution was added as the extraction solvent. The mass-volume ratio of g:mL was 1:10. The extraction was carried out by heating and reflux extraction for 0.5 h, and the extraction was repeated 3 times. The extracts were combined, concentrated and dried under reduced pressure to obtain Astragalus membranaceus extract and Angelica sinensis extract, respectively.

[0048] The above extracts are mixed in the specified proportions to obtain the compound Chinese medicine.

[0049] Example 4 This embodiment provides a compound traditional Chinese medicine, which is composed of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:4:1:4:2.

[0050] The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata, and Citrus aurantium were taken separately, and water was added for extraction. The mass-to-volume ratio was 1:10 g:mL. The extraction was carried out by heating and reflux extraction for 0.5 h, and the extraction was repeated 3 times. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract, respectively.

[0051] The preparation method of the Astragalus extract and Angelica extract is as follows: Dry and pulverized Astragalus membranaceus and Angelica sinensis were taken separately, and 80% ethanol aqueous solution was added as the extraction solvent. The mass-volume ratio of g:mL was 1:8. The extraction was carried out by heating and reflux extraction for 0.5 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Astragalus membranaceus extract and Angelica sinensis extract, respectively.

[0052] The above extracts are mixed in the specified proportions to obtain the compound Chinese medicine.

[0053] Example 5 This embodiment provides a compound traditional Chinese medicine, which is composed of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:3:2:3:3.

[0054] The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata, and Citrus aurantium were taken separately, and water was added for extraction. The mass-to-volume ratio was 1:8 (g:mL). The extraction was carried out by heating and reflux extraction for 0.5 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract, respectively.

[0055] The preparation method of the Astragalus extract and Angelica extract is as follows: Dry and pulverized Astragalus membranaceus and Angelica sinensis were taken separately, and 75% ethanol aqueous solution was added as the extraction solvent. The mass-volume ratio of g:mL was 1:10. The extraction was carried out by heating and reflux extraction for 0.5 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Astragalus membranaceus extract and Angelica sinensis extract, respectively.

[0056] The above extracts are mixed in the specified proportions to obtain the compound Chinese medicine.

[0057] Example 6 This embodiment provides a compound traditional Chinese medicine, which is composed of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:4:1:4:3.

[0058] The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata and Citrus aurantium were taken separately, and water was added for extraction. The mass-to-volume ratio was 1:10 g:mL. The extraction was carried out by heating and reflux extraction for 1.0 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract and Citrus aurantium extract, respectively.

[0059] The preparation method of the Astragalus extract and Angelica extract is as follows: Dry and pulverized Astragalus membranaceus and Angelica sinensis were taken separately, and 80% ethanol aqueous solution was added as the extraction solvent. The mass-volume ratio of g:mL was 1:8. The extraction was carried out by heating and reflux extraction for 0.5h, and the extraction was repeated 3 times. The extracts were combined, concentrated and dried under reduced pressure to obtain Astragalus membranaceus extract and Angelica sinensis extract, respectively.

[0060] The above extracts are mixed in the specified proportions to obtain the compound Chinese medicine.

[0061] Example 7 This embodiment provides a compound traditional Chinese medicine, which is composed of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:3:2:5:2.

[0062] The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata and Citrus aurantium were taken separately, and water was added for extraction. The mass-to-volume ratio was 1:10 g:mL. The extraction was carried out by heating and reflux extraction for 1.0 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract and Citrus aurantium extract, respectively.

[0063] The preparation method of the Astragalus extract and Angelica extract is as follows: Dry and pulverized Astragalus membranaceus and Angelica sinensis were taken separately, and 75% ethanol aqueous solution was added as the extraction solvent. The mass-volume ratio of g:mL was 1:10. The extraction was carried out by heating and reflux extraction for 0.5 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Astragalus membranaceus extract and Angelica sinensis extract, respectively.

[0064] The above extracts are mixed in the specified proportions to obtain the compound Chinese medicine.

[0065] Comparative Example 1 A compound traditional Chinese medicine is composed of extracts of Codonopsis pilosula, Pinellia ternata, Citrus aurantium, Astragalus membranaceus, and Angelica sinensis in a mass ratio of 1:3:1:4:2.

[0066] The only difference between this comparative example and Example 1 is that the preparation methods of Astragalus membranaceus extract and Angelica sinensis extract are different.

[0067] The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract, and Angelica sinensis extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata, Citrus aurantium, Astragalus membranaceus, and Angelica sinensis were taken separately, and water was added for extraction. The mass-to-volume ratio was 1:10 g:mL. The extraction was carried out by heating and reflux extraction for 1.0 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract, and Angelica sinensis extract, respectively.

[0068] The above extracts are mixed in the specified proportions to obtain the compound Chinese medicine.

[0069] Comparative Example 2 A compound traditional Chinese medicine is composed of extracts of Codonopsis pilosula, Pinellia ternata, Citrus aurantium, Astragalus membranaceus, and Angelica sinensis in a mass ratio of 1:3:1:4:2.

[0070] The only difference between this comparative example and Example 1 is that the preparation methods of Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract are different.

[0071] The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract, and Angelica sinensis extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata, Citrus aurantium, Astragalus membranaceus, and Angelica sinensis were taken separately and 75% ethanol aqueous solution was added as extraction solvent. The mass-volume ratio of g:mL was 1:10. The extraction was carried out by heating and reflux extraction for 0.5h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract, and Angelica sinensis extract, respectively.

[0072] The above extracts are mixed in the specified proportions to obtain the compound Chinese medicine.

[0073] Comparative Example 3 A compound traditional Chinese medicine is composed of extracts of Codonopsis pilosula, Pinellia ternata, Citrus aurantium, Astragalus membranaceus, and Angelica sinensis in a mass ratio of 1:3:1:4:2.

[0074] The only difference between this comparative example and Example 1 is the preparation method of the Codonopsis pilosula extract.

[0075] The preparation method of the Codonopsis pilosula extract is as follows: Take dried and pulverized Codonopsis pilosula, add 75% ethanol aqueous solution as extraction solvent, with a mass-to-volume ratio of g:mL of 1:10, and extract by heating and reflux extraction for 0.5h, extract twice, combine the extracts, concentrate and dry under reduced pressure to obtain Codonopsis pilosula extract.

[0076] The preparation methods for the remaining extracts remain unchanged.

[0077] Comparative Example 4 A compound traditional Chinese medicine is composed of extracts of Codonopsis pilosula, Pinellia ternata, Citrus aurantium, Astragalus membranaceus, and Angelica sinensis in a mass ratio of 1:3:1:4:2.

[0078] The only difference between this comparative example and Example 1 is the preparation method of the Pinellia ternata extract.

[0079] The preparation method of the Pinellia ternata extract is as follows: Take dried and pulverized Pinellia ternata, add 75% ethanol aqueous solution as extraction solvent, with a mass-to-volume ratio of g:mL of 1:10, and extract by heating and reflux extraction for 0.5h, extract twice, combine the extracts, concentrate and dry under reduced pressure to obtain Pinellia ternata extract.

[0080] The preparation methods for the remaining extracts remain unchanged.

[0081] Comparative Example 5 A compound traditional Chinese medicine is composed of extracts of Codonopsis pilosula, Pinellia ternata, Citrus aurantium, Astragalus membranaceus, and Angelica sinensis in a mass ratio of 1:3:1:4:2.

[0082] The only difference between this comparative example and Example 1 is the preparation method of the Citrus aurantium extract.

[0083] The method for preparing the Citrus aurantium extract is as follows: Take dried and pulverized bitter orange peel, add 75% ethanol aqueous solution as extraction solvent, with a mass-to-volume ratio of g:mL of 1:10, and extract by heating and reflux extraction for 0.5h, extract twice, combine the extracts, concentrate and dry under reduced pressure to obtain bitter orange peel extract.

[0084] The preparation methods for the remaining extracts remain unchanged.

[0085] Comparative Example 6 A compound traditional Chinese medicine is composed of extracts of Codonopsis pilosula, Pinellia ternata, Citrus aurantium, Astragalus membranaceus, and Angelica sinensis in a mass ratio of 1:3:1:4:2.

[0086] The only difference between this comparative example and Example 1 is the preparation method of the Astragalus extract.

[0087] The preparation method of the Astragalus extract is as follows: Take dried and pulverized Astragalus membranaceus, add water for extraction, with a mass-to-volume ratio of g:mL of 1:10, and extract by heating and reflux for 1.0 h, extract twice, combine the extracts, concentrate and dry under reduced pressure to obtain Astragalus membranaceus extract.

[0088] The preparation methods for the remaining extracts remain unchanged.

[0089] Comparative Example 7 A compound traditional Chinese medicine is composed of Codonopsis pilosula extract, Pinellia ternata extract, Raphanus sativus seed extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:3:1:4:2.

[0090] The only difference between this comparative example and Example 1 is that radish seed extract is used instead of bitter orange peel extract.

[0091] The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, and Raphanus sativus seed extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata and Raphanus sativus seeds were taken separately, and water was added for extraction. The mass-to-volume ratio was 1:10 g:mL. The extraction was carried out by heating and reflux extraction for 1.0 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract and Raphanus sativus seed extract, respectively.

[0092] The preparation method of the Astragalus extract and Angelica extract is as follows: Dry and pulverized Astragalus membranaceus and Angelica sinensis were taken separately, and 75% ethanol aqueous solution was added as the extraction solvent. The mass-volume ratio of g:mL was 1:10. The extraction was carried out by heating and reflux extraction for 0.5 h, and the extraction was repeated twice. The extracts were combined, concentrated and dried under reduced pressure to obtain Astragalus membranaceus extract and Angelica sinensis extract, respectively.

[0093] The above extracts are mixed in the specified proportions to obtain the compound Chinese medicine.

[0094] Comparative Example 8 A compound traditional Chinese medicine is composed of extracts of Codonopsis pilosula, Pinellia ternata, Citrus aurantium, Astragalus membranaceus, and Angelica sinensis in a mass ratio of 3:1:0.5:4:0.5.

[0095] The only difference between this comparative example and Example 1 is the ratio of the amounts of each component.

[0096] Experimental study of the effects of compound traditional Chinese medicine on gastrointestinal function in mice with postoperative intestinal obstruction. 1. Experimental Methods Sixty-six 8-week-old SPF-grade C57BL / 6 mice, weighing 18-22g, were used. The mice were given free access to food and water and were acclimatized for 7 days. They were then randomly divided into a sham-operated group and a model group using a random number table.

[0097] In the model group, a postoperative intestinal obstruction model was replicated using classic small bowel interference surgery. The method was as follows: Mice were anesthetized by intraperitoneal injection of sodium pentobarbital solution and placed supine on the operating table. Hair was removed and the area was disinfected. The abdominal cavity was opened along the linea alba, and a sterile gauze drape was placed over the mouse's abdomen. Two sterile cotton swabs moistened with physiological saline were used to gently remove a segment of the small intestine from the abdominal cavity and place it on the gauze. The small intestine was then rolled back and forth three times from the Treitz ligament near the proximal jejunum to the terminal ileum, with gentle compression, for a total of 15 minutes. After stimulation, the small intestine was returned to the abdominal cavity, and the abdominal cavity was closed with double-layer continuous sutures. In the sham surgery group, no intestinal intervention was performed after abdominal opening; the remaining procedures were the same as described above.

[0098] After successful modeling, the mice were randomly divided into model group, drug administration group 1, drug administration group 2, drug administration group 3, drug administration group 4, drug administration group 5, drug administration group 6, drug administration group 7, drug administration group 8, and drug administration group 9, with 6 mice in each group.

[0099] Group 1 was administered the compound Chinese medicine of Example 1 by gavage at a dose of 90 mg / kg; Group 2 was administered the compound Chinese medicine of Comparative Example 1 by gavage at a dose of 90 mg / kg; Group 3 was administered the compound Chinese medicine of Comparative Example 2 by gavage at a dose of 90 mg / kg; Group 4 was administered the compound Chinese medicine of Comparative Example 3 by gavage at a dose of 90 mg / kg; Group 5 was administered the compound Chinese medicine of Comparative Example 4 by gavage at a dose of 90 mg / kg; Group 6 was administered the compound Chinese medicine of Comparative Example 5 by gavage at a dose of 90 mg / kg; Group 7 was administered the compound Chinese medicine of Comparative Example 6 by gavage at a dose of 90 mg / kg; Group 8 was administered the compound Chinese medicine of Comparative Example 7 by gavage at a dose of 90 mg / kg; and Group 9 was administered the compound Chinese medicine of Comparative Example 8 by gavage at a dose of 90 mg / kg.

[0100] Mice in the sham-operated group and the model group were administered an equal volume of distilled water by gavage. Each group of mice was given the water twice, with an interval of 6 hours, and each gavage session lasted approximately 5 seconds.

[0101] 2. Indicator Testing Gastrointestinal motility Mice were administered a charcoal complex (10% gum arabic + 10% edible activated charcoal powder, 10 mL / kg) by gavage. After 20 minutes, they were anesthetized by intraperitoneal injection of sodium pentobarbital solution. Blood was collected from the orbital cavity, and the mice were euthanized by cervical dislocation. The entire small intestine was removed, and the total length of the small intestine and the distance the charcoal powder was propelled were measured.

[0102] Gastrointestinal push rate (%) = Distance of charcoal powder propelled in the small intestine / Total length of the small intestine × 100%.

[0103] Centrifuge the blood, collect the supernatant, and freeze it immediately for later use.

[0104] Gastrointestinal hormone levels Serum vasoactive intestinal peptide (VIP) and motilin (MTL) levels were measured using an ELISA kit according to the instructions.

[0105] 3. Statistical Methods Statistical analysis was performed using GraphPad Prism 8 software. All data are expressed as mean ± standard deviation. Statistical significance was determined by t-test and one-way ANOVA. P < 0.05 was considered statistically significant.

[0106] 4. Experimental Results Comparison of gastrointestinal motility function among different groups of mice Compared with the sham-operated group, the gastrointestinal push rate of mice in the model group was significantly reduced.

[0107] Compared with the model group, the gastrointestinal expulsion rate of mice in the treatment group 1 was significantly increased. Compared with the treatment groups 2-9, the gastrointestinal expulsion rate of mice in the treatment group 1 was significantly increased. The results are shown in Table 1.

[0108] Table 1 Comparison of gastrointestinal expulsion rates in mice of different groups Note: Compared with the sham surgery group. & P <0.05, && P <0.01; compared with the model group, P <0.05, P <0.01; compared with group 1, # P <0.05, ## P <0.01.

[0109] Comparison of gastrointestinal hormone levels in mice of different groups Table 2 Comparison of VIP and MTL levels in mice of different groups Note: Compared with the sham surgery group. & P <0.05, && P <0.01; compared with the model group, P <0.05, P <0.01; compared with group 1, # P <0.05, ## P <0.01.

[0110] Compared with the sham-operated group, the model group mice showed significantly increased VIP levels and significantly decreased MTL levels.

[0111] Compared with the model group, the VIP level in treatment group 1 was significantly decreased, and the MTL level was significantly increased. Compared with treatment groups 2-9, the VIP level in treatment group 1 was significantly decreased, and the MTL level was significantly increased. The results are shown in Table 2. The results indicate that the compound traditional Chinese medicine of this invention has a certain ameliorative effect on gastrointestinal function in mice with postoperative intestinal obstruction.

[0112] The compound Chinese medicine of this invention significantly reverses the decline in postoperative gastrointestinal motility, reverses the changes in gastrointestinal hormones VIP and MTL, and helps and promotes the recovery of postoperative gastrointestinal motility.

[0113] The efficacy results of the compound traditional Chinese medicine in Example 1 and Comparative Examples 1-8 show that, compared with Comparative Examples 1-8, Example 1 exhibits a more significant effect in promoting gastrointestinal motility.

[0114] The extraction process of traditional Chinese medicine can affect the dissolution efficiency and types of active ingredients, thereby affecting the efficacy. Comparative Examples 1, 2, 3, 4, 5, and 6, by changing the preparation method of the extracts, showed a significant decrease in the effect of improving postoperative gastrointestinal dysfunction, suggesting that the preparation method of the extracts in this invention plays an important role in the efficacy of the medicine.

[0115] In Comparative Example 7, replacing the extract of Citrus aurantium with radish seed extract significantly reduced the effect of improving postoperative gastrointestinal dysfunction, suggesting that the selection of Chinese herbal raw materials in this invention plays an important role in the efficacy of the medicine.

[0116] The dosage ratio of each extract component in Comparative Example 8 is different from that in Example 1 of the present invention. The effect of Comparative Example 8 in improving postoperative gastrointestinal dysfunction is not as good as that of Example 1, suggesting that the compound Chinese medicine of the present invention has a better therapeutic effect in treating postoperative gastrointestinal dysfunction.

[0117] Experimental study on the effect of compound traditional Chinese medicine on the recovery of gastrointestinal function in rats after gastric perforation repair surgery. 1. Experimental Methods Twenty-four SPF-grade SD rats, 8 weeks old and weighing 180-220g, were used. The rats had free access to food and water and were acclimatized for 7 days. A gastric perforation model was established in all rats. The rats were fasted for 24 hours but allowed free access to water before surgery. They were anesthetized by intraperitoneal injection of sodium pentobarbital solution. A longitudinal incision of approximately 2cm was made 0.5cm below the xiphoid process to locate the stomach. 0.05mL of glacial acetic acid was injected into the subserosa near the muscle layer of the anterior gastric antrum. Four days later, a simple gastric perforation repair was performed. Under general anesthesia, interrupted full-thickness silk sutures were used to suture the perforation site. The site was then covered and fixed with the greater omentum. The peritoneal cavity was repeatedly irrigated to treat peritoneal effusion. An electrode was then implanted 5mm above the pylorus on the anterior wall of the gastric antrum. A lead was passed through the abdominal muscles, subcutaneously, and brought out at the neck of both scapulae. The lead was fixed, and the abdominal wall was sutured layer by layer. Postoperative penicillin antibiotics were administered for 3 days.

[0118] After successful modeling, rats were randomly divided into four groups using a random number table: model group, treatment group 1, treatment group 2, and treatment group 3, with six rats in each group. Treatment group 1 was administered the compound Chinese medicine of Example 1 by gavage at a dose of 60 mg / kg, treatment group 2 was administered the compound Chinese medicine of Example 2 by gavage at a dose of 60 mg / kg, and treatment group 3 was administered the compound Chinese medicine of Example 3 by gavage at a dose of 60 mg / kg.

[0119] The model group rats were administered an equal volume of distilled water by gavage. Each group of rats was given the drug once daily for 7 consecutive days.

[0120] 2. Indicator Testing General conditions such as defecation, food intake, water intake, activity, and body weight were monitored. Gastric electromyography (GEG) was recorded on day 11 after grouping. All rats were fasted for 18 hours prior to recording, but water was allowed. During GEG recording, the rats were immobilized, and the posterior neck leads were connected to the BL2420F biofunctional experimental system. For slow wave recording, the parameters were set as follows: time constant 5 s, high-frequency filter 100 Hz, and X-axis velocity 2.56 s / div. Recording was performed continuously for 2 hours per rat. The duration and period of interdigestive myocardial electromyography (IMc), phase III duration, frequency, and amplitude were measured and calculated. After GEG recording, 6-8 mL of blood was collected from the femoral vein per rat to prepare plasma, which was stored at -20°C.

[0121] 3. Statistical Methods Statistical analysis was performed using GraphPad Prism 8 software. All data are expressed as mean ± standard deviation. Statistical significance was determined by t-test and one-way ANOVA. P < 0.05 was considered statistically significant.

[0122] 4. Experimental Results Comparison of gastrointestinal electrical activity in rats of different groups Compared with the model group, rats in drug administration groups 1, 2, and 3 showed shortened IMC cycles, prolonged phase III duration, increased phase III frequency, and increased phase III amplitude, all with significant differences. Results are shown below. Figure 1 , Figure 2 , Figure 3 , Figure 4 .

[0123] In modern gastrointestinal motility, electromyography (EMG) is considered a reliable indicator of gastrointestinal motility, with interdigestive compound electromyography (IMC) and its phase III strong contraction phase being important indicators. When gastrointestinal motility is low, gastric peristalsis slows, gastric emptying is delayed, and in EMG, IMC shows prolonged cycles, a low incidence of phase III, and a shortened phase III duration. The results of this study suggest that after treatment with the compound traditional Chinese medicine of this invention, the IMC cycles were shorter than those in the model group, while the phase III duration was prolonged, the frequency increased, and the amplitude increased, confirming that the compound traditional Chinese medicine of this invention has a significant effect on promoting gastrointestinal motility.

[0124] The preferred embodiments of the present invention have been described in detail above, but the present invention is not limited to the embodiments described. Those skilled in the art can make various equivalent modifications or substitutions without departing from the spirit of the present invention, and these equivalent modifications or substitutions are all included within the scope defined by the claims of this application.

Claims

1. A compound traditional Chinese medicine, characterized in that, The compound Chinese medicine is composed of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:3-4:1-2:3-5:2-3. The preparation methods for the Codonopsis pilosula extract, Pinellia ternata extract, and Citrus aurantium extract are as follows: Dry and pulverized Codonopsis pilosula, Pinellia ternata and Citrus aurantium were taken separately, and water was added for extraction. The mass-to-volume ratio of g:mL was 1:8-10. The extraction was carried out by heating and reflux extraction for 0.5-1.0h, and the extraction was repeated 2-3 times. The extracts were combined, concentrated and dried under reduced pressure to obtain Codonopsis pilosula extract, Pinellia ternata extract and Citrus aurantium extract, respectively. The preparation method of the Astragalus extract and Angelica extract is as follows: Take dried and pulverized Astragalus membranaceus and Angelica sinensis separately, add 60-80% ethanol aqueous solution as extraction solvent, with a mass-to-volume ratio of g:mL of 1:8-10, and extract by heating and reflux extraction for 0.5h, 2-3 times, combine the extracts, concentrate and dry under reduced pressure to obtain Astragalus membranaceus extract and Angelica sinensis extract respectively. The above extracts are mixed in the specified proportions to obtain the compound Chinese medicine.

2. The compound traditional Chinese medicine according to claim 1, characterized in that, The compound Chinese medicine consists of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:3:1:4:

2.

3. The compound traditional Chinese medicine according to claim 1, characterized in that, The compound Chinese medicine consists of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:4:2:5:

3.

4. The compound traditional Chinese medicine according to claim 1, characterized in that, The compound Chinese medicine consists of Codonopsis pilosula extract, Pinellia ternata extract, Citrus aurantium extract, Astragalus membranaceus extract and Angelica sinensis extract in a mass ratio of 1:3:2:3:

2.

5. A pharmaceutical preparation for treating postoperative gastrointestinal dysfunction, characterized in that, The pharmaceutical preparation comprises the compound traditional Chinese medicine as described in any one of claims 1-4.

6. The pharmaceutical preparation according to claim 5, characterized in that, The pharmaceutical preparation also includes excipients.

7. The pharmaceutical preparation according to claim 5 or 6, characterized in that, The dosage form of the pharmaceutical preparation is granules, tablets, or capsules.

8. The pharmaceutical preparation according to claim 7, characterized in that, The dosage form of the pharmaceutical preparation is granules.

9. The use of the compound traditional Chinese medicine according to any one of claims 1-4 in the preparation of drugs for the prevention or treatment of postoperative gastrointestinal dysfunction.

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