A Cynanchum bungei Decne. extract and its application

Abstract

The present invention belongs to the field of plant extracts, and particularly relates to the application of an extract of Cynanchum auriculatum Royle ex Wight (Asclepiadaceae) in regulating intestinal motility. The preparation method of the Cynanchum auriculatum Royle ex Wight extract comprises the following steps: pulverizing the stems and leaves of Cynanchum auriculatum Royle ex Wight, soaking, decocting, and filtering with 6-15 times the amount of water; decocting and filtering the residue with 4-10 times the amount of water; decocting and filtering the residue again with 4-8 times the amount of water, and then filtering; combining the filtrates of the three times, and concentrating under reduced pressure to obtain the Cynanchum auriculatum Royle ex Wight extract. By analyzing the active ingredients of the stems and leaves of Cynanchum auriculatum Royle ex Wight and simultaneously analyzing its effective parts, the present invention finds that it has very good effects on regulating intestinal motility and treating hemorrhoids, and its effects are far better than those of the extract of the tuberous roots of Cynanchum auriculatum Royle ex Wight.

Description

Technical Field

[0001] The present invention belongs to the field of plant extracts, and particularly relates to a Cynanchum bungei Decne. extract and its application in regulating intestinal motility and treating hemorrhoids. Background Art

[0002] Constipation is a common disease that endangers human health. Chronic functional constipation is mostly caused by qi and blood depletion, and dryness of body fluid due to old age, weakness, and after childbirth or surgery, resulting in difficult passage of stools. Constipation is often manifested as: less desire to defecate and fewer bowel movements; difficult and strenuous defecation; unsmooth defecation; dry and hard stools, and a feeling of incomplete defecation; constipation accompanied by abdominal pain or discomfort, and some patients are also accompanied by mental and psychological disorders such as insomnia, irritability, dreaminess, depression, and anxiety. Since constipation is a relatively common symptom with varying degrees of severity, most people often do not pay special attention and think that constipation is not a disease and does not require treatment. However, in fact, constipation is very harmful. The "warning" signs of constipation include bloody stools, anemia, weight loss, fever, black stools, abdominal pain, etc.

[0003] Hemorrhoids are chronic diseases in which varices occur in the venous plexus at the bottom of the anorectum, forming venous masses, including internal hemorrhoids, external hemorrhoids, and mixed hemorrhoids, and are the most common anorectal diseases in clinical practice. Hemorrhoids are directly related to the gastrointestinal tract. Because when patients have gastrointestinal heat, it is easy to induce dry and hard stools or constipation in patients. At this time, normal defecation will be affected, resulting in an extended defecation time, which is likely to induce pathological hypertrophy and downward displacement of the anal cushions, and then induce hemorrhoids. If the gastrointestinal function is poor and diarrhea or indigestion occurs, it is also easy to damage the anal and rectal mucosa at this time, and then induce anal fissure or external hemorrhoids.

[0004] At present, the treatment of intestinal diseases still mainly relies on drugs. However, the use of these drugs often leads to changes in the intestinal nerve stress response. In the long run, it will lead to dependence on drugs and even cause the intestine to lose normal digestive and defecation functions. In addition to Western medicines, currently, traditional Chinese medicine physiotherapy and biofeedback therapy are also relatively common. However, the disadvantages that have gradually emerged are also relatively obvious, such as body electrolyte imbalance, inflammatory response, microecological imbalance, etc.

[0005] The source of Cynanchum bungei Decne. (Cynanchum auriculatum Royle ex Wight) is the tuberous roots of various plants of the genus Cynanchum in the family Asclepiadaceae, and the sources are different in different regions. Cynanchum bungei Decne. has now been included in the "Jiangsu Province Traditional Chinese Medicine Decoction Pieces Processing Specification" (2020 edition). The local standard of Hunan Province has included this product many times, namely the "Hunan Traditional Chinese Medicine Decoction Pieces Processing Specification" in 1977 edition, 1983 edition, 2009 edition, and the "Hunan Province Chinese Medicinal Materials Standard" in 2010 edition. The "Hunan Traditional Chinese Medicine Decoction Pieces Processing Specification" currently under revision also includes this product. By sorting out the local standards across the country, the inclusion situation is as follows:

[0006]

[0007]

[0008] In Hunan Province, Cynanchum auriculatum Royle ex Wight of the Asclepiadaceae family is mainly cultivated in Jiangyong area and has a history of application.

[0009] The tuberous roots of Cynanchum bungei Decne. are commonly used medicinal materials in traditional Chinese medicine and have the function of regulating the body's immune function. For some friends with hair loss problems, Cynanchum bungei Decne. can relieve hair loss, is beneficial to the liver and kidneys, nourishes essence and blood, and has anti-aging effects. Cynanchum bungei Decne. also has the effects of reducing blood lipid and antioxidant.

[0010] Currently, the prior art only studies the effects of the tuberous roots of Cynanchum bungei Decne., but there is no literature on the stems and leaves of Cynanchum bungei Decne. Summary of the Invention

[0011] The purpose of the present invention is to provide an extract of Cynanchum bungei Decne. (Cynanchum auriculatum Royle ex Wight of the Asclepiadaceae family) and its application in regulating intestinal motility and treating hemorrhoids.

[0012] In order to solve the above technical problems, the technical solution of the present invention is as follows:

[0013] An extract of Cynanchum bungei Decne., the preparation method thereof comprises the following steps: pulverize the stems and leaves of Cynanchum bungei Decne., soak, decoct and filter with 6-15 times the amount of water; decoct and filter the filter residue with 4-10 times the amount of water; decoct the filter residue with 4-8 times the amount of water again, and then filter; combine the filtrates of the three times, and concentrate under reduced pressure to obtain the extract of Cynanchum bungei Decne.

[0014] The greater the amount of water added for decocting, the more components are extracted. However, considering that the concentration time will be prolonged, the manufacturing cost will increase. If the amount of water added is too small, the extraction will be insufficient.

[0015] The reason for decocting three times in the present invention is that for the stems and leaves of Cynanchum bungei Decne., it is necessary to decoct in multiple parts to extract all the effective components. Otherwise, the extracted components will be incomplete, resulting in waste of medicinal material resources.

[0016] Preferably, the Cynanchum bungei Decne. is of the genus Cynanchum of the Asclepiadaceae family. Preferably, the Cynanchum bungei Decne. is produced in Jiangyong, Yongzhou, Dao County, Shuangpai, and Lingling of Hunan Province.

[0017] Preferably, the process of concentration under reduced pressure is: control the pressure at -0.06M to -0.08MPa and the temperature at 60-65°C.

[0018] 1. Concentration is to reduce the dosage; 2. Adopting low-temperature concentration under reduced pressure can improve the concentration efficiency and reduce the loss of effective components.

[0019] Preferably, it is concentrated under reduced pressure to 1 g of crude drug per ml of the medicinal liquid to obtain the Cynanchum bungei extract.

[0020] The present invention also claims the use of the Cynanchum bungei extract in the preparation of a drug or food for regulating intestinal motility and treating hemorrhoids.

[0021] The present invention also claims a drug for regulating intestinal motility and treating hemorrhoids, which uses the above Cynanchum bungei extract as an active ingredient.

[0022] The beneficial effects of the present invention are as follows:

[0023] 1. The present invention discovers for the first time that the active ingredients of the stems and leaves of Cynanchum bungei and the tuberous roots of Cynanchum bungei are completely different, and their effects are also completely different.

[0024] 2. By analyzing the active ingredients of the stems and leaves of Cynanchum bungei and at the same time analyzing its effective site, the present invention finds that it has very good effects on regulating intestinal motility and treating hemorrhoids, and its effects are far better than those of the extract of the tuberous roots of Cynanchum bungei. Description of the Drawings

[0025] Figure 1 is the chromatogram of Cynanchum bungei roots and Cynanchum bungei stems and leaves at 230 nm;

[0026] Figure 2 is the chromatogram of Cynanchum bungei roots and Cynanchum bungei stems and leaves at 265 nm;

[0027] Figure 3 is the chromatogram of Cynanchum bungei roots and Cynanchum bungei stems and leaves at 280 nm;

[0028] Figure 4 is the chromatogram of Cynanchum bungei roots and Cynanchum bungei stems and leaves at 290 nm;

[0029] Figure 5 is the peak spectrogram (200 - 400 nm) of Cynanchum bungei roots at 7.749 - 8.029 min;

[0030] Figure 6 is the peak spectrogram (200 - 400 nm) of Cynanchum bungei stems and leaves at 7.120 - 7.440 min

[0031] Figure 7 is the peak spectrogram (200 - 400 nm) of Cynanchum bungei roots at 40.996 - 41.649 min;

[0032] Figure 8 is the peak spectrogram (200 - 400 nm) of Cynanchum bungei stems and leaves at 41.626 - 42.140 min; Detailed Embodiments

[0033] To facilitate the understanding of the present invention, the present invention will be described more comprehensively below. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided to make the understanding of the disclosure of the present invention more thorough and comprehensive.

[0034] Example 1

[0035] Comparison between the extract of Cynanchum auriculatum Royle ex Wight. roots and the extract of Cynanchum auriculatum Royle ex Wight. stems and leaves

[0036] 1. Experimental method

[0037] 1.1 Instruments and reagents

[0038] Agilent 1260 liquid chromatograph, OpenLab CDS 2.6 chromatographic workstation, DAD detector, Venusil MPC18 chromatographic column (250mm×4.6mm, 5μm), ultrasonic cleaner (KM7200DE, Kunshan Meimei Ultrasonic Instrument Co., Ltd.), methanol (chromatographic grade, TEDIA), acetonitrile (chromatographic grade, TEDIA), phosphoric acid (analytical grade, Sinopharm Chemical Reagent Co., Ltd.), ultrapure water was prepared by a pure water machine (Direct-Q○ R 5UV-R, Millipore, USA), the roots of Cynanchum auriculatum Royle ex Wight. and the stems and leaves of Cynanchum auriculatum Royle ex Wight. were provided by Hunan Jiangyong Yaoyongwang Food Co., Ltd., and were the roots and stems and leaves collected from the same plant respectively (batch number: 20210901), and were identified as the dried roots and stems and leaves of Cynanchum auriculatum Royle ex Wight. by Professor Liu Tas of Hunan University of Chinese Medicine. See the identification report for details.

[0039] The specific characteristics of its stems and leaves are as follows:

[0040]

Appearance

[0041] The stem is slightly pubescent, slender ellipsoidal or cylindrical, with a surface color ranging from brownish-yellow to bluish-green, having longitudinal ridges, and sometimes twisted to one side, with obvious nodes, light in weight, brittle in texture, and easy to break, with a hollow cross-section. The leaves are opposite, often wrinkled or broken, and the intact ones are broadly ovate to ovate-oblong, with a deeply cordate base, and the two sides are auriculate and curved inward, covered with minute hairs; the petiole is relatively thin, 3-9 cm long, and oblate. It has a faint odor and a light taste.

[0042]

Microscopy

[0043] (1) Transverse section:

[0044] Cross section of stem: Epidermal cells are composed of a row of square cells, cortex is 7-10 rows wide, the pericarp fibers are intermittently arranged in a ring, the vascular bundle is double-tough, the inner and outer phloem cells are small, the cambium is in a ring, the secondary xylem has large vessels arranged on both sides, the primary xylem vessels are small and have wood fibers. The pith is well developed with large fissures, the thin-walled cells contain clusters of calcium oxalate crystals, and there are scattered latex ducts.

[0045] Leaf cross section: Both upper and lower epidermal cells are composed of a row of cells, and multicellular non-glandular hairs can be seen in the epidermal cells.

[0046] The mesophyll tissue is composed of palisade tissue and spongy tissue. There is thick horn tissue distributed in the inner side of the epidermal cells of the main vein, the vascular bundle is double-tough, the inner and outer phloem cells are small, the xylem is located in the middle, the vessels are polygonal, single-row longitudinally, and the cambium is obvious. The thin-walled cells contain clusters of calcium oxalate crystals, and there are scattered latex ducts.

[0047] (2) Powder characteristics

[0048] Powder characteristics: Fibers are arranged in multiple rows or bundles, with extremely thick walls, linear cell cavities, and a diameter of 25-50um. Calcium oxalate clusters are common, with short and blunt edges and a diameter of 17-40um, and sometimes crystal-containing cells are arranged in rows. The lower epidermal cells are polygonal, with slightly straight anticlimax walls, and many stomata, which are indefinite or flat axis; multicellular non-glandular hairs are curved or straight; stone cells are square, rectangular or polygonal, scattered or several aggregates, with obvious pores and grooves, and a diameter of 17-60um; there are bordered pit ducts, reticular ducts and spiral ducts.

[0049] [Inspection] The moisture content shall be determined according to the moisture determination method (Method 2, Part 4, 0832 of the 2020 edition of the Chinese Pharmacopoeia) and shall not exceed 9.0%.

[0050] 1.2 Preparation of test solution

[0051] Preparation of the test solution of Radix Cynanchum multiflorum: Take 300g of Radix Cynanchum multiflorum (batch number: 20210901), crush it into coarse powder, add 8 times the amount of water to soak for 30 minutes, heat and boil for 2 hours, and filter the medicinal solution; add 6 times the amount of water to the residue and heat and boil for 1.5 hours, and filter the medicinal solution; add 6 times the amount of water to the residue and heat and boil for 1 hour, and filter the medicinal solution; combine the three filtrates, concentrate under reduced pressure (-0.06M~-0.08MPa, 60-65℃) to 300ml (each ml of medicinal solution contains 1g of crude drug); take 1ml of the above 1g / ml medicinal solution, place it in a 50ml volumetric flask, dilute to the scale with water, shake well, filter through a 0.45μm filter membrane, and take the subsequent filtrate as the test solution of Radix Cynanchum multiflorum.

[0052] Preparation of the test solution of Cynanchum bungei Decne. stem and leaf: Take 300 g of Cynanchum bungei Decne. stem and leaf (batch number: 20210901), crush it into coarse powder, soak it with 8 times the amount of water for 30 minutes, decoct it by heating for 2 hours, and filter the medicinal liquid; add 6 times the amount of water to the medicinal residues, decoct it by heating for 1.5 hours, and filter the medicinal liquid; add 6 times the amount of water to the medicinal residues, decoct it by heating for 1 hour, and filter the medicinal liquid; combine the filtrates of the three times, concentrate it under reduced pressure (-0.06 M to -0.08 MPa, 60 - 65 °C) to 300 ml (each ml of the medicinal liquid contains 1 g of crude drug); take 1 ml of the above 1 g / ml medicinal liquid, place it in a 50 ml volumetric flask, dilute it to the scale with water, shake it well, filter it through a 0.45 μm filter membrane, and take the subsequent filtrate as the test solution of Cynanchum bungei Decne. stem and leaf.

[0053] 1.3 Chromatographic conditions

[0054] Use acetonitrile as mobile phase A and 0.1% phosphoric acid solution as mobile phase B, and perform gradient elution according to the regulations in the following table; the column temperature is 30 °C; the detection wavelength is 200 - 400 nm, and chromatograms at 230 nm, 265 nm, 280 nm, and 290 nm are extracted. [1][2] 。

[0055] Table 1 Elution conditions

[0056]

[0057] 1.4 Determination method

[0058] Precisely pipette 5 μl of the blank solution (water), the test solution of Cynanchum bungei Decne. root, and the test solution of Cynanchum bungei Decne. stem and leaf respectively, inject them into the liquid chromatograph, and perform the determination to obtain the results.

[0059] 2. Experimental results

[0060] 2.1 Precision test

[0061] Take the test solutions (the test solution of Cynanchum bungei Decne. root and the test solution of Cynanchum bungei Decne. stem and leaf) under item "1.2", and inject them continuously for determination 6 times respectively according to the chromatographic conditions under item "1.3", and calculate the RSD (%) of the retention time and peak area of each common peak. The results show that the RSD of the retention time of each common peak of Cynanchum bungei Decne. root is 0.86% - 2.17%, and the RSD of the peak area of each common peak is 0.76 - 2.29% (n = 6); the RSD of the retention time of each common peak of Cynanchum bungei Decne. stem and leaf is 0.91% - 2.45%, and the RSD of the peak area of each common peak is 0.84 - 2.55% (n = 6), indicating that the method has good precision.

[0062] 2.2 Repeatability test

[0063] Take the crude powder of Cynanchum bungei Decne. roots and the crude powder of Cynanchum bungei Decne. stems and leaves, and prepare 6 portions of the test solution of Cynanchum bungei Decne. roots and 6 portions of the test solution of Cynanchum bungei Decne. stems and leaves respectively according to the preparation method of the test solution under item "1.2". Then, inject the samples for determination respectively according to the chromatographic conditions under item "1.3", and calculate the RSD (%) of the retention time and peak area of each common peak. The results show that the RSD of the retention time of each common peak in Cynanchum bungei Decne. roots is 0.97% - 2.82%, and the RSD of the peak area of each common peak is 1.02 - 2.46% (n = 6); the RSD of the retention time of each common peak in Cynanchum bungei Decne. stems and leaves is 0.95% - 2.68%, and the RSD of the peak area of each common peak is 0.96 - 2.83% (n = 6), indicating that the method has good repeatability.

[0064] 2.3 Stability test

[0065] Take the test solutions (the test solution of Cynanchum bungei Decne. roots and the test solution of Cynanchum bungei Decne. stems and leaves) under item "1.2", and inject the samples for determination respectively according to the chromatographic conditions under item "1.3" at 0, 4, 8, 12, 24, and 48 h after standing at room temperature, and calculate the RSD (%) of the retention time and peak area of each common peak. The results show that the RSD of the retention time of each common peak in Cynanchum bungei Decne. roots is 0.64% - 2.31%, and the RSD of the peak area of each common peak is 1.21 - 2.58% (n = 6); the RSD of the retention time of each common peak in Cynanchum bungei Decne. stems and leaves is 0.81% - 2.71%, and the RSD of the peak area of each common peak is 1.08 - 2.92% (n = 6), indicating that the test solution has good stability after standing at room temperature for 48 h.

[0066] Extract the chromatograms and data of Cynanchum bungei Decne. roots and Cynanchum bungei Decne. stems and leaves at wavelengths of 230 nm, 265 nm, 280 nm, and 290 nm, and list the retention time and peak area of each peak. The specific data are shown in Tables 1 - 4. Figures 1 - 8 。

[0067] Table 2 Chromatographic peaks and peak areas of Cynanchum bungei Decne. roots and Cynanchum bungei Decne. stems and leaves at 230 nm wavelength

[0068]

[0069]

[0070] Table 3 Chromatographic peaks and peak areas of Cynanchum bungei Decne. roots and Cynanchum bungei Decne. stems and leaves at 265 nm wavelength

[0071]

[0072] Table 4 Chromatographic peaks and peak areas of Cynanchum bungei Decne. roots and Cynanchum bungei Decne. stems and leaves at 280 nm wavelength

[0073]

[0074]

[0075] Table 5 Chromatographic Peaks and Peak Areas of the Roots and Stem-Leaves of Cynanchum bungei Decne. at a Wavelength of 290 nm

[0076]

[0077] The results showed that by comparison, the retention times of 2 pairs of chromatographic peaks in the chromatograms of the roots and stem-leaves of Cynanchum bungei Decne. were close. For example, at a wavelength of 265 nm, they were Peak 1 of the roots of Cynanchum bungei Decne. and Peak 1 of the stem-leaves of Cynanchum bungei Decne., Peak 4 of the roots of Cynanchum bungei Decne. and Peak 6 of the stem-leaves of Cynanchum bungei Decne. The ultraviolet absorption spectra (200 - 400 nm) of the above 2 pairs of chromatographic peaks with close retention times were extracted. By analyzing the spectrograms, it was found that Peak 1 of the roots of Cynanchum bungei Decne. and Peak 1 of the stem-leaves of Cynanchum bungei Decne., Peak 4 of the roots of Cynanchum bungei Decne. and Peak 6 of the stem-leaves of Cynanchum bungei Decne. were not the same components, and the other chromatographic peaks were also different components.

[0078] The test results showed that: under these chromatographic conditions, among the substances presented in the chromatograms of the roots and stem-leaves of Cynanchum bungei Decne., there were no common components, and the differences were significant.

[0079]

References

[0080] [1] Yan Jian, Lin Ling, Liu Yuanyuan, et al. Study on the Chemical Constituents of Cynanchum wilfordii (Maxim.) Hemsl. by HPLC [J]. Northern Pharmacy, 2015, 12(09): 14.

[0081] [2] Xu Xia, Jia Xiaodong, Yao Xinmei, et al. Study on the Fingerprint of Cynanchum auriculatum Royle ex Wight [J]. Chinese Wild Plant Resources, 2009, 28(03): 45 - 48.

[0082] Example 2

[0083] Effects of a Series of Extracts from Cynanchum bungei Decne. on the Intestinal Motility of Normal Mice

[0084] 1 Experimental Materials

[0085] 1.1 Drugs

[0086] 1.1.1 Test articles: A series of extracts from Cynanchum bungei Decne. (Cynanchum auriculatum Royle ex Wight), the extraction method was the same as that in Example 1, batch number: 20201113; specification: 100 mL; dosage form: fluid extract; content: 1 g of crude drug / mL; property: brown liquid; expiration date: 2021.06.13; produced by Hunan Zhongjia Biopharmaceutical Co., Ltd.

[0087] 1.1.2 Positive control drug: Domperidone, batch number: 190701; specification: 10 mg / tablet; expiration date: 2021.06; clinical dosage: 30 mg / day, produced by Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.

[0088] Simo Decoction, batch number: 2008304283; specification: 10 mL / ampoule; expiration date: July 2022; clinical dosage: 60 mL / day, produced by Hunan Hansen Pharmaceutical Co., Ltd.

[0089] 1.2 Experimental animals: 90 SPF-grade ICR mice, half male and half female, weighing 18 - 22 g, with quality certificate for experimental animals: No. 430726211100025264, purchased from Hunan Slack Jingda Experimental Animal Co., Ltd., production license number for experimental animals: SCXK(Xiang)2019 - 0004, raised in a barrier environment, and the license number for using experimental animals: SYXK(Xiang)2020 - 0015.

[0090] 1.3 Main reagents: Sodium carboxymethylcellulose (CMC-Na) (batch number: 20200604), product of Shanghai Shanpu Chemical Co., Ltd.; Gum arabic powder (batch number: 20201012), product of Tianjin Fuchen Chemical Reagent Factory; Activated carbon (batch number: 20190928), product of Beijing Jingdong Aobo Technology Development Co., Ltd.; Semi-solid black paste, prepared by dissolving 2 g of CMC-Na and 1 g of gum arabic in water, adding 1 g of activated carbon powder and stirring evenly, and finally adding water for injection to 100 mL. 1.4 Main instruments: AUY type analytical balance (center number: 085 / 153, produced by Shimadzu Corporation, Japan).

[0091] 2 Test methods [1-4]

[0092] 2.1 Test grouping

[0093] Select 90 ICR mice with qualified quarantine, and randomly divide them into a blank control group, domperidone group, Simo Decoction group, low- and high-dose groups of polygoni multiflori radix extract, low- and high-dose groups of polygoni multiflori folium extract, and low- and high-dose groups of polygoni multiflori radix + folium extract according to body weight and gender, with 10 mice in each group. Before daily administration, the series of polygoni multiflori extracts, Simo Decoction and domperidone are prepared into corresponding concentration solutions with pure water. Each group of mice is given the corresponding dose of the test substance by gavage at 20 mL / kg once a day for 3 consecutive days. The blank control group is given an equal volume of pure water by gavage. 12 h before the last administration, food is withheld but water is not restricted. After the last administration, the intestinal propulsion rate is measured. 30 min after administration, each group of mice is given the blue paste by gavage at 20 mL / kg. 30 min later, the mice in each group are sacrificed by cervical dislocation, and the small intestine from the pylorus to the ileocecal junction of the mice is taken out, and its total length and the distance from the front of the blue paste to the pylorus are measured, and the percentage of it to the total length is calculated, that is, the propulsion percentage.

[0094] 2.2 Dose design

[0095] The clinically proposed dosage of the Cynanchum bungei Decne. series extract is 20 g (raw drug amount) per day. Converted to the equivalent dosage for mice by the body surface area method, it is 20 g / day × 0.0026 / 0.02 kg = 2.6 g raw drug / kg. In this experiment, the low and high dosage groups were set at 1 times and 4 times the clinically equivalent dosage of the Cynanchum bungei Decne. series extract for rats, that is, 2.6 g raw drug / kg and 10.4 g raw drug / kg; the clinically used dosage of domperidone is 30 mg per day. Converted to the equivalent dosage for mice by the body surface area method, it is 30 mg / day × 0.0026 / 0.02 kg = 3.9 mg / kg. In this experiment, 1 times the equivalent dosage of domperidone for mice was used as the administration dosage for the domperidone group, that is, 3.9 mg / kg; the clinically used dosage of Simo Decoction is 60 mL per day. Converted to the equivalent dosage for mice by the body surface area method, it is 60 mL / day × 0.0026 / 0.02 kg = 7.8 mL / kg. In this experiment, 1 times the equivalent dosage of Simo Decoction for mice was used as the administration dosage for the Simo Decoction group, that is, 7.8 mL / kg. For the specific dosage design, see Table 6.

[0096] Table 6 Effects of Cynanchum bungei Decne. series extract on intestinal motility in normal mice

[0097]

[0098] 2.3 Detection index: Take out the small intestine from the pylorus to the ileocecal part, lay it flat on the glass plate without traction, measure its total length and the distance from the carbon powder front edge to the pylorus, and calculate the percentage of it to the total length, that is, the propulsion percentage.

[0099] 2.4 Statistical method

[0100] SPSS 16.0 was used for statistical analysis, and the significance level was set at P ≤ 0.05. Measurement data were expressed as mean ± standard deviation The Leven’s test method was used to test normality and homogeneity of variance. If it met normality and homogeneity of variance, one-way ANOVA and post Hoc LSD were used for statistical analysis; if it did not meet normality and heterogeneity of variance, the Kruskal-Wallis test was used. If the Kruskal-Wallis test was statistically significant (P ≤ 0.05), Dunnett’s Test (non-parametric method) was used for comparative analysis. Statistical differences and biological significance were considered during evaluation.

[0101] 3 Experimental results

[0102] As shown in Table 7, compared with the blank control group, there were no significant differences in the small intestine propulsion percentage of mice in the medium and high dosage groups of the Cynanchum bungei Decne. series extract, the domperidone group, and the Simo Decoction oral liquid group.

[0103] Effect of Cynanchum auriculatum Royle ex Wight series extracts on intestinal propulsion and gastric emptying in normal mice

[0104] Group Dose (crude drug / kg) Intestinal propulsion rate (%) Blank control group -- 62.0±15.5 Domperidone group 3.9 mg / kg 70.2±13.2 Simo Decoction group 7.8 mL / kg 64.8±11.7 Low-dose Cynanchum bungei Decne. root group 2.6 55.4±17.2 High-dose Cynanchum bungei Decne. root group 10.4 58.8±10.0 Low-dose Cynanchum bungei Decne. leaf group 2.6 63.5±12.5 High-dose Cynanchum bungei Decne. leaf group 10.4 67.2±13.2 Low-dose Cynanchum bungei Decne. root + leaf group 2.6 74.5±9.3 High-dose Cynanchum bungei Decne. root + leaf group 10.4 65.4±9.2

[0105] 4 Experimental summary

[0106] The above results indicate that Cynanchum auriculatum Royle ex Wight series extracts have no obvious effect on the intestinal motility of normal mice.

[0107] Example 3

[0108] Effect of Cynanchum auriculatum Royle ex Wight series extracts on intestinal inhibition induced by atropine in mice

[0109] 1 Experimental materials

[0110] 1.1 Drugs

[0111] 1.1.1 Tested product: Cynanchum auriculatum Royle ex Wight (Cynanchum auriculatum Royle ex Wight) series extracts, the extraction method is the same as that in Example 1, batch number: 20201113; specification: 100 ml; dosage form: fluid extract; content: 1 g of crude drug / mL; property: brownish liquid; expiration date: 2021.06.13; produced by Hunan Zhongjia Biopharmaceutical Co., Ltd.

[0112] 1.1.2 Positive control drug: Domperidone, batch number: 190701; specification: 10 mg / tablet; expiration date: 2021.06; clinical dosage: 30 mg / day, produced by Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.

[0113] Simo Decoction, batch number: 2008304 283; specification: 10 mL / branch; expiration date: 2022.07; clinical dosage: 60 mL / day, produced by Hunan Hansen Pharmaceutical Co., Ltd.

[0114] 1.2 Experimental animals: 100 SPF-grade ICR mice, half male and half female, weighing 18 - 22 g, half male and half female. The quality certificate of experimental animals: No.430726211100028184, purchased from Hunan Slack Jingda Experimental Animal Co., Ltd. The production license number of experimental animals: SCXK(Xiang)2019 - 0004, raised in a barrier environment. The license number for the use of experimental animals: SYXK(Xiang)2020 - 0015.

[0115] 1.3 Main reagents: Atropine Sulfate Injection (batch number: 191152), product of Tianjin Pharmaceutical Group Xinzheng Co., Ltd.; Sodium Carboxymethylcellulose (CMC-Na) (batch number: 20200604), product of Shanghai Shanpu Chemical Co., Ltd.; Gum Arabic Powder (batch number: 20201012), product of Tianjin Fuchen Chemical Reagent Factory; Activated Carbon (batch number: 20190928), product of Beijing Jingdong Aobo Technology Development Co., Ltd.; Semi-solid black paste, prepared by dissolving 2 g of CMC-Na and 1 g of Gum Arabic in water, adding 1 g of activated carbon powder and stirring evenly, and finally adding water for injection to 100 mL.

[0116] 1.4 Main instruments: AUY type analytical balance (center number: 085, produced by Shimadzu Corporation, Japan).

[0117] 2 Test methods [1-4]

[0118] 2.1 Experimental grouping

[0119] Select 100 ICR mice with qualified quarantine, and randomly divide them into normal control group, model control group, domperidone group, Simo Decoction group, low and high dose groups of Cynanchum bungei root extract, low and high dose groups of Cynanchum bungei leaf extract, low and high dose groups of Cynanchum bungei root + leaf extract, with 10 mice in each group. Before drug administration every day, the Cynanchum bungei series extracts, Simo Decoction and domperidone are prepared into corresponding concentration solutions with pure water. Each group of mice is given the corresponding dose of the test substance by gavage at 20 mL / kg once a day for 3 consecutive days. The normal control group and the model control group are given the same volume of pure water by gavage. Immediately after the last drug administration, 0.1 mg / kg of atropine is injected intraperitoneally. 30 minutes after drug administration, each group of mice is given the blue paste by gavage at 20 mL / kg. 30 minutes later, the mice in each group are sacrificed by cervical dislocation, and the small intestine from the pylorus to the ileocecal part of the mice is taken out, and its total length and the distance from the front edge of the blue paste to the pylorus are measured, and the percentage of it to the total length is calculated, that is, the propulsion percentage.

[0120] 2.2 Dose design

[0121] The clinically proposed dosage of the Cynanchum bungei Decne. series extract is 20 g (raw drug amount) per day. Calculated by the body surface area method, the equivalent dosage for mice is 20 g / day × 0.0026 / 0.02 kg = 2.6 g raw drug / kg. In this experiment, the low and high dose groups were set at 1 times and 4 times the clinically equivalent dosage of the Cynanchum bungei Decne. series extract for rats, namely 2.6 g / kg and 10.4 g raw drug / kg; the clinically used dosage of domperidone is 30 mg per day. Calculated by the body surface area method, the equivalent dosage for mice is 30 mg / day × 0.0026 / 0.02 kg = 3.9 mg / kg. In this experiment, 1 times the equivalent dosage of domperidone for mice was used as the administration dosage for the domperidone group, namely 3.9 mg / kg; the clinically used dosage of Simo Decoction is 60 mL per day. Calculated by the body surface area method, the equivalent dosage for mice is 60 mL / day × 0.0026 / 0.02 kg = 7.8 mL / kg. In this experiment, 1 times the equivalent dosage of Simo Decoction for mice was used as the administration dosage for the Simo Decoction group, namely 7.8 mL / kg. The specific dosage design is the same as Table 6.

[0122] 2.3 Detection index: Take out the small intestine from the pylorus to the ileocecal part, lay it flat on the glass plate without traction, measure its total length and the distance from the carbon powder front edge to the pylorus, and calculate the percentage of it to the total length, that is, the propulsion percentage.

[0123] 2.4 Statistical methods

[0124] SPSS 16.0 was used for statistical analysis. The level of statistical significance was set at P ≤ 0.05. Measurement data were expressed as mean ± standard deviation (x ± s). The Leven’s test method was used to test normality and homogeneity of variance. If it met normality and homogeneity of variance, one-way analysis of variance (One-way ANOVA) and post Hoc LSD were used for statistical analysis; if it did not meet normality and heterogeneity of variance, the Kruskal-Wallis test was used. If the Kruskal-Wallis test was statistically significant (P ≤ 0.05), Dunnett’s Test (non-parametric method) was used for comparative analysis. Statistical differences and biological significance were considered during evaluation.

[0125] 3 Experimental results

[0126] As shown in Table 8, compared with the normal control group, the intestinal propulsion rate of the model control group mice decreased significantly (P ≤ 0.01); compared with the model control group, the intestinal propulsion rates of the low and high dose groups of Cynanchum bungei Decne. root, leaf and root + leaf in mice increased significantly (P ≤ 0.01), suggesting that the extracts of Cynanchum bungei Decne. root and stem and leaf can significantly improve intestinal inhibition, promote intestinal motility and relieve defecation difficulties. Compared with the high dose group of Cynanchum bungei Decne. root, the intestinal propulsion rate of the high dose group of Cynanchum bungei Decne. leaf in mice increased significantly (P ≤ 0.05), suggesting that the regulatory effect of Cynanchum bungei Decne. leaf extract on intestinal inhibition is better than that of Cynanchum bungei Decne. root extract.

[0127] Table 8 Effects of Cynanchum bungei Decne. series extracts on atropine-induced intestinal inhibition in mice( n = 10)

[0128]

[0129]

[0130] Note: Compared with the normal control group ++ P ≤ 0.01, compared with the model control group, *P ≤ 0.05, **P ≤ 0.01; compared with the high-dose group of Cynanchum bungei Decne. root, ΔP ≤ 0.05.

[0131] 4 Summary of the experiment

[0132] The above experimental results show that Cynanchum bungei Decne. series extracts (root, leaf, root + leaf) have obvious improvement effects on atropine-induced intestinal inhibition in mice, and the adjustment effect of Cynanchum bungei Decne. leaf extract on intestinal inhibition is better than that of Cynanchum bungei Decne. root extract.

[0133] Example 4

[0134] Effects of Cynanchum bungei Decne. series extracts on neostigmine-induced intestinal hyperactivity in mice

[0135] 1 Experimental materials

[0136] 1.1 Drugs

[0137] 1.1.1 Test articles: Cynanchum bungei Decne. (Cynanchum auriculatum Royle ex Wight) series extracts, the extraction method is the same as that in Example 1, batch number: 20201113; specification: 100 ml; dosage form: fluid extract; content: 1 g of crude drug / mL; character: brown liquid; expiration date: 2021.06.13; produced by Hunan Zhongjia Biopharmaceutical Co., Ltd.

[0138] 1.1.2 Positive control drugs: Domperidone, batch number: 190701; specification: 10 mg / tablet; expiration date: 2021.06; clinical dosage: 30 mg / day, produced by Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.

[0139] Simo Decoction, batch number: 2008304 283; specification: 10 mL / branch; expiration date: 2022.07; clinical dosage: 60 mL / day, produced by Hunan Hansen Pharmaceutical Co., Ltd.

[0140] 1.2 Experimental animals: 100 SPF-grade ICR mice, 50 males and 50 females, weighing 18 - 22 g. Quality certificate for experimental animals: No.430726211100028184, purchased from Hunan Slack Jingda Experimental Animal Co., Ltd. Production license number for experimental animals: SCXK(Xiang)2019 - 0004, raised in a barrier environment. License number for the use of experimental animals: SYXK(Xiang)2020 - 0015.

[0141] 1.3 Main reagents: Neostigmine methylsulfate injection (batch number: 190903), product of Shanghai Xinyi Pharmaceutical Co., Ltd.; Carboxymethyl cellulose sodium (CMC-Na) (batch number: 20200604), product of Shanghai Shanpu Chemical Co., Ltd.; Gum arabic powder (batch number: 20201012), product of Tianjin Fuchen Chemical Reagent Factory; Activated carbon (batch number: 20190928), product of Beijing Jingdong Aobo Technology Development Co., Ltd. Semi-solid black paste was prepared by dissolving 2 g of CMC-Na and 1 g of gum arabic in water, adding 1 g of activated carbon powder and stirring evenly, and finally adding water for injection to 100 mL.

[0142] 1.4 Main instruments: AUY type analytical balance (center number: 085, produced by Shimadzu Corporation, Japan).

[0143] 2 Test methods [1-4]

[0144] 2.1 Experimental grouping

[0145] Select 100 ICR mice with qualified quarantine, and randomly divide them into normal control group, model control group, domperidone group, Simo Decoction group, low- and high-dose groups of Cynanchum bungei root extract, low- and high-dose groups of Cynanchum bungei leaf extract, low- and high-dose groups of Cynanchum bungei root + leaf extract, with 10 mice in each group. Before daily administration, the Cynanchum bungei series extracts, Simo Decoction and domperidone were prepared into corresponding concentration solutions with pure water. Each group of mice was given the corresponding dose of the test substance by gavage at 20 mL / kg, once a day for 3 consecutive days. The normal control group and the model control group were given an equal volume of pure water by gavage. 12 h before the last administration, food was withheld but water was not restricted. 0.15 mg / kg of neostigmine methylsulfate was injected intramuscularly after the last administration. 30 min after administration, each group of mice was given the blue paste by gavage at 20 mL / kg. 30 min later, the mice in each group were sacrificed by cervical dislocation, and the small intestine from the pylorus to the ileocecal part of the mice was taken out, and its total length and the distance from the front edge of the blue paste to the pylorus were measured, and the percentage of it to the total length was calculated, that is, the propulsion percentage.

[0146] 2.2 Dose design

[0147] The clinically proposed dosage of the Cynanchum bungei Decne. series extracts is 20 g (raw drug amount) per day. Converted to the equivalent dosage for mice by the body surface area method, it is 20 g / day × 0.0026 / 0.02 kg = 2.6 g raw drug / kg. In this experiment, the low and high dosage groups were set at 1 time and 4 times the clinically equivalent dosage of the Cynanchum bungei Decne. series extracts for rats, namely 2.6 g raw drug / kg and 10.4 g raw drug / kg; the clinically used dosage of domperidone is 30 mg per day. Converted to the equivalent dosage for mice by the body surface area method, it is 30 mg / day × 0.0026 / 0.02 kg = 3.9 mg / kg. In this experiment, 1 time the equivalent dosage of domperidone for mice was used as the dosage for the domperidone group, namely 3.9 mg / kg; the clinically used dosage of Simo Decoction is 60 mL per day. Converted to the equivalent dosage for mice by the body surface area method, it is 60 mL / day × 0.0026 / 0.02 kg = 7.8 mL / kg. In this experiment, 1 time the equivalent dosage of Simo Decoction for mice was used as the dosage for the Simo Decoction group, namely 7.8 mL / kg. For the specific dosage design, see Table 6.

[0148] 2.3 Detection index: Take out the small intestine from the pylorus to the ileocecal part, lay it flat on the glass plate without traction, measure its total length and the distance from the carbon powder front to the pylorus, and calculate the percentage of it to the total length, that is, the propulsion percentage.

[0149] 2.4 Statistical methods

[0150] SPSS 16.0 was used for statistical analysis, and the level of statistical significance was set at P ≤ 0.05. Measurement data were expressed as mean ± standard deviation The Leven’s test method was used to test the normality and homogeneity of variance. If it meets the normality and homogeneity of variance, one-way analysis of variance (One-way ANOVA) and post Hoc LSD were used for statistical analysis; if it does not meet the normality and the variance is inhomogeneous, the Kruskal-Wallis test was used. If the Kruskal-Wallis test has statistical significance (P ≤ 0.05), the Dunnett’s Test (non-parametric method) was used for comparative analysis. Statistical differences and biological significance were considered during the evaluation.

[0151] 3 Experimental results

[0152] As shown in Table 9, compared with the normal control group, the intestinal propulsion rate of the mice in the model control group was significantly increased (P≤0.01); compared with the model control group, the intestinal propulsion rates of the low- and high-dose groups of Cynanchum auriculatum Royle ex Wight leaves were significantly decreased (P≤0.05), and the intestinal propulsion rates of the low- and high-dose groups of Cynanchum auriculatum Royle ex Wight roots and the low- and high-dose groups of roots + leaves were significantly decreased (P≤0.05 or P≤0.01), suggesting that the leaf, root, and root + leaf extracts of Cynanchum auriculatum Royle ex Wight could significantly reduce intestinal motility and relieve intestinal hyperactivity caused by diarrhea. Compared with the high-dose group of Cynanchum auriculatum Royle ex Wight roots, the intestinal propulsion rate of the high-dose group of Cynanchum auriculatum Royle ex Wight stems and leaves was significantly decreased (P≤0.05), suggesting that the extract of Cynanchum auriculatum Royle ex Wight stems and leaves had a better effect on adjusting intestinal hyperactivity than the extract of Cynanchum auriculatum Royle ex Wight roots.

[0153] Table 9 Effects of a series of Cynanchum auriculatum Royle ex Wight extracts on neostigmine-induced intestinal hyperactivity in mice ( n = 10)

[0154] Group Dose (crude drug / kg) Intestinal propulsion rate (%) Normal control group -- 68.7±11.4 Model control group -- <![CDATA[88.6±6.8 ++ > Domperidone group 3.9 mg / kg 81.8±9.9 Simo Decoction group 7.8 mL / kg 76.7±17.1* Low-dose root group 2.6 75.0±18.0* High-dose root group 10.4 70.2±14.0** Low-dose leaf group 2.6 68.1±8.2* High-dose leaf group 10.4 <![CDATA[60.9±6.1** Δ > Low-dose root + leaf group 2.6 78.8±13.9* High-dose root + leaf group 10.4 68.2±9.5**

[0155] Note: Compared with the normal control group ++ P≤0.01, *P≤0.05, **P≤0.01 compared with the model control group; ΔP≤0.05 compared with the high-dose group of Cynanchum auriculatum Royle ex Wight roots.

[0156] 4 Experimental summary

[0157] The above experimental results showed that a series of Cynanchum auriculatum Royle ex Wight extracts had an obvious improvement effect on neostigmine-induced intestinal hyperactivity in mice, and the extract of Cynanchum auriculatum Royle ex Wight leaves had a better effect on adjusting intestinal hyperactivity than the extract of Cynanchum auriculatum Royle ex Wight roots.

[0158] Example 5

[0159] Effects of a series of Cynanchum auriculatum Royle ex Wight extracts on croton oil-induced hemorrhoid model in rats

[0160] 1 Experimental materials

[0161] 1.1 Drugs

[0162] 1.1.1 Test articles: A series of extracts of Cynanchum auriculatum Royle ex Wight (Cynanchum auriculatum Royle ex Wight), the extraction method was the same as in Example 1, batch number: 20201113; specification: 100 ml; dosage form: fluid extract; property: brown liquid; expiration date: 2021.06.13; produced by Hunan Zhongjia Biomedical Co., Ltd.

[0163] 1.1.2 Positive control drug: Hemorrhoid capsules, batch number: 200701; specification: 0.3 g / capsule; expiration date: 2021.06; produced by Jilin Baiqi Pharmaceutical Co., Ltd.

[0164] 1.2 Experimental animals: 100 SPF-grade SD rats, 50 males and 50 females, weighing 180 - 220 g. Quality certificate of experimental animals: No.430727211100204434, purchased from Hunan Slack Jingda Experimental Animal Co., Ltd. Production license number of experimental animals: SCXK(Xiang)2019 - 0004, raised in a barrier environment. License number for the use of experimental animals: SYXK(Xiang)2020 - 0015.

[0165] 1.3 Main reagents: Croton oil (batch number: 191152), product of sigma company.

[0166] 1.4 Main instruments: AUY type analytical balance (center number: 085, produced by Shimadzu Corporation, Japan).

[0167] 2 Test methods

[0168] 2.1 Experimental grouping

[0169] Select 100 SD rats with qualified quarantine, randomly divided into normal control group, model control group, domperidone group, Simo Decoction group, low and high dose groups of Cynanchum bungei root extract, low and high dose groups of Cynanchum bungei leaf extract, low and high dose groups of Cynanchum bungei root + leaf extract, with 10 rats in each group. Before daily administration, the Cynanchum bungei series extracts and Hemorrhoids Capsules are prepared into corresponding concentration liquid medicines with pure water. Each group of rats is given the corresponding dose of the test substance by gavage at 20 mL / kg, once a day, for 3 consecutive days. The normal control group and the model control group are given an equal volume of pure water by gavage. Before the last administration, model establishment is carried out (using a cotton ball soaked with 0.16 mL of croton oil mixture to wet the animal's anus for 10 s), and immediately after model establishment, the medicine is administered once. After 6 h, the animals are sacrificed, the rectum (13 - 15 mm from the edge of the anal fur) and anus are cut, and the wet weight is weighed.

[0170] 2.2 Dose design

[0171] The clinically proposed dose of the Cynanchum bungei series extracts is 20 g (raw drug amount) per day. Calculated according to the body surface area method, the equivalent dose for rats is 20 g / day × 0.018 / 0.2 kg = 1.8 g raw drug / kg. In this experiment, 1 times and 4 times of the equivalent dose are set as the low and high dose groups of Cynanchum bungei root, leaf, and root + leaf extracts, that is, 1.8 g raw drug / kg and 7.2 g raw drug / kg; the clinical usage amount of Hemorrhoids Capsules is 0.3 capsules * 3 times * 5 grains / time = 4.5 g / day. Calculated according to the body surface area method, the equivalent dose for rats is 4.5 g / day × 0.018 / 0.2 kg = 0.4 g / kg. In this experiment, 1 times of the clinical equivalent dose of Hemorrhoids Capsules is used as the administration dose of the Hemorrhoids Capsules group, that is, 0.4 g / kg. The specific dose design is shown in Table 10.

[0172] Table 10 Experimental grouping and dose design

[0173]

[0174]

[0175] 2.3 Statistical methods

[0176] Statistical analysis was performed using SPSS 16.0, and the level of statistical significance was set at P ≤ 0.05. Measurement data were expressed as mean ± standard deviation Leven’s test was used to test normality and homogeneity of variance. If normality and homogeneity of variance were met, one-way ANOVA and post Hoc LSD were used for statistical analysis; if normality was not met and variance was not homogeneous, the Kruskal-Wallis test was used. If the Kruskal-Wallis test was statistically significant (P ≤ 0.05), Dunnett’s Test (non-parametric method) was used for comparative analysis. Statistical differences and biological significance were considered during evaluation

[0177] 3 Experimental results

[0178] As shown in Table 11, compared with the normal control group, the anal wet weight of rats in the model control group was significantly increased (P ≤ 0.01); compared with the model control group, the anal wet weights of rats in the low-dose, high-dose groups of Cynanchum bungei Decne. leaves and roots and the low-dose, high-dose groups of roots + leaves were significantly decreased (P ≤ 0.05 or P ≤ 0.01), suggesting that the leaf and root extracts of Cynanchum bungei Decne. could significantly reduce the anal wet weight of rats with anal swelling and relieve acute inflammatory reactions such as anal edema caused by hemorrhoids. Moreover, compared with the high-dose group of Cynanchum bungei Decne. roots, the anal wet weight of rats in the high-dose group of Cynanchum bungei Decne. leaves was significantly decreased (P ≤ 0.05), suggesting that the inhibitory effect of Cynanchum bungei Decne. leaf extract on perianal swelling was better than that of Cynanchum bungei Decne. root extract

[0179] Table 11 Effects of Cynanchum bungei Decne. on rat anal swelling model( n = 10)

[0180]

[0181]

[0182] Note: Compared with the normal control group ++ P ≤ 0.01; compared with the model control group * P ≤ 0.05, ** P ≤ 0.01; compared with the high-dose group of Cynanchum bungei Decne. roots Δ P ≤ 0.05..

[0183] 4 Experimental summary

[0184] The above experimental results indicate that the series of Cynanchum bungei Decne. extracts can relieve the perianal swelling caused by croton oil, suggesting its improvement effect on hemorrhoids, and the inhibitory effect of Cynanchum bungei Decne. leaf extract on perianal swelling is better than that of Cynanchum bungei Decne. root extract.

[0185] Conclusion:

[0186] This study observed the effects of the series of Cynanchum bungei Decne. extracts (root, leaf, root + leaf) on gastrointestinal motility in normal, intestinal inhibition, and intestinal hyperactivity mice. At the same time, croton oil was used to induce perianal swelling in rats to simulate the perianal swelling state during hemorrhoid attacks to evaluate the therapeutic effect of the series of Cynanchum bungei Decne. extracts on hemorrhoids. The results showed that: (1) The series of Cynanchum bungei Decne. extracts (root, leaf, root + leaf) had no obvious effect on the intestinal propulsion rate of normal mice. (2) Low and high doses of Cynanchum bungei Decne. root, leaf, and root + leaf extracts could significantly increase the intestinal propulsion rate of intestinal inhibition mice, and the efficacy of Cynanchum bungei Decne. leaf extract was significantly better. (3) Low and high doses of Cynanchum bungei Decne. leaf, root, and root + leaf extracts could significantly reduce the intestinal propulsion rate of intestinal hyperactivity mice, and the effect of Cynanchum bungei Decne. leaf extract in reducing the intestinal propulsion rate of intestinal hyperactivity mice was more obvious. (4) Low and high doses of Cynanchum bungei Decne. leaf, root, and root + leaf extracts could significantly reduce the wet weight of the rat anus and inhibit the perianal swelling caused by croton oil, and the efficacy of Cynanchum bungei Decne. leaf extract was significantly better.

[0187] In summary, (1) The series of Cynanchum bungei Decne. extracts have no obvious effect on the intestinal motility of the normal small intestine, but can adjust the intestinal motility of the intestine with inhibition and hyperactivity, suggesting that the series of Cynanchum bungei Decne. extracts have a dual regulatory effect on intestinal motility, and the adjustment effect of Cynanchum bungei Decne. leaf extract on intestinal inhibition and hyperactivity is better; (2) The series of Cynanchum bungei Decne. extracts can significantly inhibit the perianal swelling caused by croton oil, suggesting that it may have a certain therapeutic effect on hemorrhoids, and the inhibitory effect of Cynanchum bungei Decne. leaf extract on perianal swelling is better than that of Cynanchum bungei Decne. root extract.

Claims

1. Use of a Cynanchum bungei Decne. extract in the preparation of a drug for regulating intestinal motility, Characterized in that, The preparation method of the Cynanchum bungei Decne. extract comprises the following steps: pulverize the stems and leaves of Cynanchum bungei Decne., soak with 6 - 15 times the amount of water, decoct, and filter; decoct the filter residue with 4 - 10 times the amount of water and filter; decoct the filter residue with 4 - 8 times the amount of water again, filter after decocting; combine the filtrates of the three times, concentrate under reduced pressure to obtain the Cynanchum bungei Decne. extract; the Cynanchum bungei Decne. is a plant of the genus Cynanchum of the family Asclepiadaceae; The Cynanchum bungei Decne. is produced in Jiangyong, Yongzhou, Dao County, Shuangpai, and Lingling of Hunan Province; The process of concentration under reduced pressure is: control the pressure at -0.06 M~-0.08 MPa and the temperature at 60 - 65 °C.

2. The use according to claim 1, Characterized in that, Concentrate under reduced pressure to obtain 1 g of crude drug per ml of the medicinal liquid to obtain the Cynanchum bungei Decne. extract.

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