Traditional Chinese medicine suppository for treating low incomplete cancerous intestinal obstruction

Abstract

The invention discloses a traditional Chinese medicine suppository for treating low-level incomplete cancerous intestinal obstruction. The traditional Chinese medicine suppository comprises the following raw materials in parts by weight: 10-30 parts of seaweed, 10-20 parts of radix aucklandiae, 5-15 parts of rheum officinale, 10-20 parts of fried semen brassicae, 10-30 parts of fried semen raphani, 10-20 parts of fried semen pharbitidis, 1-5 parts of vinegar-processed euphorbia pekinensis, 1-5 parts of vinegar-processed euphorbia kansui, 1-15 parts of snow lotus herb, 5-15 parts of rhodiola rosea, 1-3 parts of meconopsis horridula and 0.5-1.5 parts of alkali. The traditional Chinese medicine composition is scientific and reasonable in formula compatibility, can effectively improve intestinal microcirculation, relieve intestinal spasm, promote intestinal peristalsis and recover the intestinal conduction function so as to relieve intestinal obstruction symptoms, can be effectively used for treating low-level incomplete cancerous intestinal obstruction, and is convenient to use, free of trauma, small in side effect, stable and reliable in curative effect, good in effect and free of toxic and side effects. The traditional Chinese medicine composition is a great innovation of medicines for treating low-level incomplete cancerous intestinal obstruction, and has huge social and economic benefits.

Description

Technical Field

[0001] The invention relates to the field of medicine, in particular to a traditional Chinese medicine suppository for treating low-position incomplete cancerous intestinal obstruction. Background Art

[0002] Cancerous intestinal obstruction is intestinal obstruction caused by primary or metastatic malignant tumors. It is a common complication of malignant tumors. The incidence rate in cancer patients is about 3%~6%, and the average survival period is less than 4 months. Among them, the total mortality rate of incomplete intestinal obstruction is 8%~13%, and there is currently no method to prevent its formation. Incomplete intestinal obstruction is the initial stage of intestinal obstruction. The obstruction may originate from the small intestine or large intestine or exist simultaneously. The intestinal contents caused by primary or secondary abdominal or pelvic tumors cannot run or are blocked when passing through the intestine. Clinical manifestations include progressive abdominal distension, abdominal pain, anal gas and defecation function obstruction, and even complete intestinal obstruction, causing intestinal ischemia and necrosis, seriously endangering the patient's life. Although this disease can be treated surgically, surgical treatment of incomplete intestinal obstruction may bring new surgical trauma, such as causing new complications such as abdominal adhesions or intestinal stenosis, which increases the patient's treatment cycle and increases the economic burden, so most people choose conservative treatment. Western medicine conservative treatment includes fasting, gastrointestinal decompression, correction of electrolyte imbalance and acid-base balance and other symptomatic treatments. Although it can improve the patient's clinical symptoms to a certain extent, it is slow to take effect and the efficacy is uncertain. Long-term use may further increase the patient's gastrointestinal burden and aggravate the condition. Traditional Chinese medicine has its unique advantages in treating incomplete intestinal obstruction. It can effectively promote the recovery of gastrointestinal function, stimulate intestinal peristalsis, relieve abdominal distension, and has few side effects, but there has been no relevant public reports so far. Summary of the invention

[0003] In view of the above situation, in order to overcome the defects of the prior art, the purpose of the present invention is to provide a Chinese medicine suppository for treating low incomplete cancerous intestinal obstruction, which can effectively solve the medication problem of low incomplete cancerous intestinal obstruction.

[0004] To achieve the above object, the technical solution provided by the present invention is a Chinese medicine suppository for treating low incomplete cancerous intestinal obstruction, comprising the following raw materials in parts by weight: 10-30 parts of seaweed, 10-20 parts of costusroot, 5-15 parts of rhubarb, 10-20 parts of stir-fried white mustard seeds, 10-30 parts of stir-fried radish seeds, 10-20 parts of stir-fried morning glory seeds, 1-5 parts of vinegar euphorbia, 1-5 parts of vinegar kansui, 1-15 parts of snow lotus, 5-15 parts of rhodiola rosea, 1-3 parts of meconopsis spinosa and 0.5-1.5 parts of alkali flower; the preparation method comprises the following steps: (1)Water extraction and ethanol precipitation: Seaweed, rhubarb, rhodiola, and stir-fried pharbitis seeds were subjected to water extraction and ethanol precipitation. First, 8 times the volume of water based on the total weight of the drugs was added, and it was decocted 3 times, each time for 1 h. The filtrates of the three times were combined and concentrated to a relative density of 1.15 (60 °C). Then, 95% ethanol was added until the ethanol content reached 70%, and it was allowed to stand for 24 h. The supernatant was taken, and ethanol was recovered by distillation to obtain an extract. (2)Volatile oil extraction: Aucklandia lappa, stir-fried brassica alba, and stir-fried raphanus sativus were used to extract volatile oil by steam distillation for 6 h. The distillate was included with β-cyclodextrin, and the weight-volume ratio of the distillate to β-cyclodextrin was 1:6 to obtain a volatile oil inclusion complex. (3)Preparation of solid lipid nanoparticles: Euphorbia pekinensis and Euphorbia kansui were ultrasonically extracted with 70% ethanol 2 times, each time for 30 min (power 300 W). The extract was filtered through a 0.22 μm filter membrane to sterilize and obtain an extract. Glycerol monostearate was heated in a water bath at 65 - 70 °C until completely melted, and the extract was heated to 65 - 70 °C. Then, according to the ratio of extract:glycerol monostearate = 1:2, under stirring at 300 - 500 rpm, the extract was added to the melted glycerol monostearate. After the addition was completed, stirring was continued for 30 min. Subsequently, it was filtered through a 0.22 μm filter membrane and quickly transferred to an ice bath at 0 - 4 °C, and stirred and cooled for 10 - 15 min until the lipid was completely solidified to obtain solid lipid nanoparticles. (4)Preparation of extracts: Saussurea involucrata and Meconopsis horridula were dried at low temperature at 60 °C and then ultra-finely pulverized and passed through a 150-mesh sieve. A mixed solvent was prepared according to the volume ratio of ethanol:water of 7:3 and pre-cooled to -20 °C in a low-temperature environment. Saussurea involucrata and Meconopsis horridula were added to the -20 °C mixed solvent at a weight-volume ratio of 1:8 - 1:15 respectively, stirred and mixed evenly. Then, the mixed solution was treated at -20 °C under an electric field strength of 20 kV / cm and a pulse frequency of 10 Hz for 1 - 5 min. The treated mixed solution was continuously stirred at 200 - 300 r / min at -20 °C for 30 - 60 min, and then centrifuged at 4 °C and 8000 - 10000 r / min for 10 - 15 min. The supernatant was collected and freeze-dried to obtain Saussurea involucrata extract and Meconopsis horridula extract. 5% mannitol was added to the Saussurea involucrata extract and freeze-dried at -50 °C for 24 h to obtain Saussurea involucrata freeze-dried powder. (5)Preparation of natron / Eudragit S100 complex: Natron was dry-heat sterilized at 150 °C for 1 h, ground fine and passed through a 200-mesh sieve to obtain natron powder. The natron powder was dispersed in an ethanol solution of Eudragit S100 and ultrasonically dispersed for 30 min to obtain a suspension. The suspension was volatilized at room temperature to remove the solvent, dried and pulverized and sieved to obtain the natron / Eudragit S100 complex. (6) Preparation of suppositories: Heat the matrix Witepsol E85 in a water bath to 45°C until it melts. Sequentially add sodium alginate-chitosan microspheres, PEG 400, N-acetylcysteine, and the alkali flower / Eudragit S100 complex. Among them, the weight-to-volume ratio of Witepsol E85:sodium alginate-chitosan microspheres:PEG 400:N-acetylcysteine:alkali flower / Eudragit S100 complex is 60:20:15:3:2. Stir at 200 rpm for 10 min. Then add the extract, volatile oil inclusion complex, solid lipid nanoparticles, Saussurea involucrata freeze-dried powder, and Meconopsis horridula extract. Homogenize and emulsify at 8000 rpm for 3 min. Then degas under vacuum at -0.08 MPa for 5 min to remove air bubbles, obtaining a mixed medicinal liquid. Pre-cool a stainless-steel mold to -5°C, spray liquid paraffin on the inner wall for lubrication. Keep the medicinal liquid at a constant temperature of 40°C and pour it into the mold at a rate of 0.5 mL / second. Immediately transfer it to a 0°C cooling tunnel after pouring and cool for 10 min. Then gradually raise the temperature to 25°C for demolding, and cut off the overflow. The weight of each suppository is 1.9 - 2.1 g. Package it with an aluminum foil blister and seal it with nitrogen filling to obtain the traditional Chinese medicine suppository for treating low-level incomplete carcinomatous intestinal obstruction; the weight-to-volume is calculated with solids in g and liquids in mL.

[0005] The formula compatibility of the present invention is scientific and reasonable, which can effectively improve intestinal microcirculation, relieve intestinal spasm, promote intestinal peristalsis, and restore intestinal conduction function, thereby relieving the symptoms of intestinal obstruction. It can be effectively used to treat low-level incomplete carcinomatous intestinal obstruction. It is convenient to use, non-invasive, has few side effects, and has stable and reliable curative effects and good results. It is a major innovation in the drugs for treating low-level incomplete carcinomatous intestinal obstruction and has great social and economic benefits. Detailed implementation mode

[0006] The following will describe in detail the specific implementation mode of the present invention in combination with examples and specific situations.

[0007] When the present invention is specifically implemented, it is given by the following examples. Example 1

[0008] A traditional Chinese medicine suppository for treating low-level incomplete carcinomatous intestinal obstruction, comprising the following raw materials in parts by weight: 20 parts of seaweed, 15 parts of Aucklandia lappa, 10 parts of Rheum palmatum, 15 parts of stir-fried white mustard seeds, 20 parts of stir-fried radish seeds, 15 parts of stir-fried Pharbitis nil seeds, 3 parts of Euphorbia pekinensis processed with vinegar, 3 parts of Kansui processed with vinegar, 7 parts of Saussurea involucrata, 7 parts of Rhodiola rosea, 2 parts of Meconopsis horridula, and 1 part of alkali flower; the preparation method comprises the following steps: (1)Water extraction and ethanol precipitation: Seaweed, rhubarb, rhodiola, and stir-fried pharbitis seeds were subjected to water extraction and ethanol precipitation. First, 8 times the volume of water based on the total weight of the drugs was added, and decocted 3 times, each time for 1 h. The filtrates of the three times were combined and concentrated to a relative density of 1.15 (60 °C). Then, 95% ethanol was added until the ethanol content reached 70%, and left standing for 24 h. The supernatant was taken, and ethanol was recovered by distillation to obtain an extract. (2)Volatile oil extraction: Aucklandia lappa, stir-fried white mustard seeds, and stir-fried radish seeds were used to extract volatile oil by steam distillation for 6 h. The distillate was included with β-cyclodextrin, and the weight-volume ratio of the distillate to β-cyclodextrin was 1:6 to obtain a volatile oil inclusion complex. (3)Preparation of solid lipid nanoparticles: Euphorbia pekinensis and Euphorbia kansui were ultrasonically extracted with 70% ethanol 2 times, each time for 30 min (power 300 W). The extract was filtered through a 0.22 μm filter membrane to sterilize and obtain an extract. Glycerol monostearate was taken and heated in a water bath at 65 - 70 °C until completely melted. The extract was heated to 65 - 70 °C, and then according to the ratio of extract:glycerol monostearate = 1:2, under stirring at 300 - 500 rpm, the extract was added to the melted glycerol monostearate. After dropping, stirring was continued for 30 min, and then it was filtered through a 0.22 μm filter membrane and quickly transferred to an ice bath at 0 - 4 °C, and stirred and cooled for 10 - 15 min until the lipid was completely solidified to obtain solid lipid nanoparticles. (4)Preparation of extracts: Saussurea involucrata and Meconopsis horridula were dried at low temperature at 60 °C and then ultra-finely pulverized and passed through a 150-mesh sieve. A mixed solvent was prepared according to the volume ratio of ethanol:water of 7:3, and pre-cooled to -20 °C in a low-temperature environment. Saussurea involucrata and Meconopsis horridula were respectively added to the -20 °C mixed solvent according to the weight-volume ratio of 1:8 - 1:15, stirred and mixed evenly. Then, the mixed solution was treated at -20 °C under an electric field strength of 20 kV / cm and a pulse frequency of 10 Hz for 1 - 5 min. The treated mixed solution was continued to be stirred at -20 °C at 200 - 300 r / min for 30 - 60 min, and then centrifuged at 4 °C at 8000 - 10000 r / min for 10 - 15 min. The supernatant was collected and freeze-dried to obtain Saussurea involucrata extract and Meconopsis horridula extract. 5% mannitol was added to the Saussurea involucrata extract and freeze-dried at -50 °C for 24 h to obtain Saussurea involucrata freeze-dried powder. (5)Preparation of alkali flower / Eudragit S100 complex: The alkali flower was dry-heat sterilized at 150 °C for 1 h, ground fine and passed through a 200-mesh sieve to obtain alkali flower powder. The alkali flower powder was dispersed in an ethanol solution of Eudragit S100 and ultrasonically dispersed for 30 min to obtain a suspension. The solvent of the suspension was volatilized at room temperature, dried and pulverized and sieved to obtain an alkali flower / Eudragit S100 complex. (6) Preparation of suppositories: The matrix Witepsol E85 was heated in a water bath to 45 °C until melted, and sodium alginate-chitosan microspheres, PEG 400, N-acetylcysteine, and alkali flower / Eudragit S100 complex were added in sequence. Among them, the weight-to-volume ratio of Witepsol E85:sodium alginate-chitosan microspheres:PEG 400:N-acetylcysteine:alkali flower / Eudragit S100 complex was 60:20:15:3:2. Stir at 200 rpm for 10 min, then add the extract, volatile oil inclusion complex, solid lipid nanoparticles, freeze-dried Saussurea involucrata, and Meconopsis horridula extract. Homogenize and emulsify at 8000 rpm for 3 min, and then degas under vacuum at -0.08 MPa for 5 min to remove air bubbles, obtaining a mixed liquid medicine. The stainless-steel mold was pre-cooled to -5 °C, and the inner wall was sprayed with liquid paraffin for lubrication. The liquid medicine was kept at a constant temperature of 40 °C and poured into the mold at a rate of 0.5 mL / second. After pouring, it was immediately transferred to a 0 °C cooling tunnel for cooling for 10 min, and then gradually heated to 25 °C for demolding. The overflow material was cut off. The weight of each suppository was 1.9 - 2.1 g, and it was packaged in an aluminum foil blister and sealed with nitrogen to obtain the traditional Chinese medicine suppository for treating low-level incomplete carcinomatous intestinal obstruction. Example 2

[0009] A traditional Chinese medicine suppository for treating low-level incomplete carcinomatous intestinal obstruction, comprising the following raw materials by weight: 30 parts of Sargassum, 20 parts of Aucklandia lappa, 15 parts of Rheum palmatum, 20 parts of stir-fried Semen Sinapis Albae, 30 parts of stir-fried Semen Raphani, 20 parts of stir-fried Pharbitis nil, 5 parts of Euphorbia pekinensis in vinegar, 5 parts of Kansui in vinegar, 15 parts of Saussurea involucrata, 15 parts of Rhodiola rosea, 3 parts of Meconopsis horridula, and 1.5 parts of alkali flower. The preparation steps are the same as those in Example 1. Example 3

[0010] A traditional Chinese medicine suppository for treating low-level incomplete carcinomatous intestinal obstruction, comprising the following raw materials by weight: 10 parts of Sargassum, 10 parts of Aucklandia lappa, 5 parts of Rheum palmatum, 10 parts of stir-fried Semen Sinapis Albae, 10 parts of stir-fried Semen Raphani, 10 parts of stir-fried Pharbitis nil, 1 part of Euphorbia pekinensis in vinegar, 1 part of Kansui in vinegar, 1 part of Saussurea involucrata, 5 parts of Rhodiola rosea, 1 part of Meconopsis horridula, and 0.5 part of alkali flower. The preparation steps are the same as those in Example 1. Example 4

[0011] A traditional Chinese medicine suppository for treating low-level incomplete carcinomatous intestinal obstruction, comprising the following raw materials by weight: 15 parts of Sargassum, 18 parts of Aucklandia lappa, 8 parts of Rheum palmatum, 17 parts of stir-fried Semen Sinapis Albae, 14 parts of stir-fried Semen Raphani, 18 parts of stir-fried Pharbitis nil, 2 parts of Euphorbia pekinensis in vinegar, 4 parts of Kansui in vinegar, 3 parts of Saussurea involucrata, 7 parts of Rhodiola rosea, 2 parts of Meconopsis horridula, and 0.9 part of alkali flower. The preparation steps are the same as those in Example 1. Example 5

[0012] A traditional Chinese medicine suppository for treating low - level incomplete cancerous intestinal obstruction, comprising raw materials in the following parts by weight: 27 parts of seaweed, 14 parts of Aucklandia lappa, 13 parts of Rheum palmatum, 12 parts of stir - fried Semen Sinapis Albae, 28 parts of stir - fried Semen Raphani, 14 parts of stir - fried Pharbitis nil, 4 parts of Euphorbia pekinensis processed with vinegar, 2 parts of Kansui processed with vinegar, 13 parts of Saussurea involucrata, 7 parts of Rhodiola rosea, 3 parts of Meconopsis horridula and 1.3 parts of alkali flower. The preparation steps are the same as those in Example 1.

[0013] Among the above - mentioned drugs, Seaweed: Bitter, salty, cold in nature, attributing to the liver, stomach and kidney meridians. It has the effects of softening hard masses, dissipating phlegm and promoting diuresis.

[0014] Aucklandia lappa: Pungent, bitter, warm in nature. Attributing to the spleen, stomach, large intestine, triple energizer and gallbladder meridians. Aucklandia lappa is pungent, fragrant, warm and dredging, bitter and drying with a descending property, and can rise and fall. When used raw, it is specialized in promoting circulation and relieving qi stagnation, being able to regulate qi in the middle - jiao and relieve pain, promoting digestion, appetizing and strengthening the spleen. When used after baking, it has a function of stopping while promoting qi circulation, being able to strengthen the intestine and stop diarrhea. It dredges the triple energizer, especially good at promoting qi stagnation in the gastrointestinal tract, and also strengthening the spleen and promoting digestion. It is an important drug for regulating qi in the middle - jiao and relieving pain, and is most suitable for those with qi stagnation in the gastrointestinal tract with cold or accompanied by food accumulation and damp - stagnation.

[0015] Rheum palmatum: Bitter, cold in nature. Attributing to the spleen, stomach and large intestine meridians. Rheum palmatum is bitter, cold and descending, clearing and purging, entering the spleen, stomach, large intestine meridians, as well as the heart, liver meridians and blood aspect. Orally, it is good at purging the accumulation of solid food and heat in the gastrointestinal tract, purging heat and relieving constipation, guiding the pathogenic damp - heat from the feces and promoting bile secretion to reduce jaundice. Topically, it is good at clearing fire, reducing swelling, relieving pain and detoxifying, and treating sores and scalds.

[0016] Stir - fried Semen Sinapis Albae: Pungent, warm in nature, attributing to the lung meridian, having the effects of warming the lung to resolve phlegm, promoting qi circulation to disperse nodules, dredging collaterals and relieving pain, etc. It is mainly used for treating cold - phlegm cough, phlegm nodes and yin abscesses, joint swelling and pain and other diseases. After processing, its medicinal property becomes milder, which can reduce the stimulation to the gastrointestinal tract.

[0017] Stir - fried Semen Raphani: Semen Raphani is pungent, sweet, neutral in nature, attributing to the lung, spleen and stomach meridians. It can both disperse and astringe, both regulate upward and dredge downward. When acting on the spleen and stomach, it is good at eliminating food accumulation and abdominal distension; when acting on the lungs, it can resolve phlegm and improve cough and asthma. The stir - fried ripe Semen Raphani is more good at promoting digestion and relieving flatulence.

[0018] Stir - fried Pharbitis nil: Cold in nature, bitter in taste, attributing to the lung, kidney and large intestine meridians, having the effects of purging water and relieving constipation, eliminating phlegm and removing fluid retention, expelling parasites, etc. It is mainly used for treating edema and fullness, unobstructed urination and defecation, phlegm - fluid accumulation, abdominal pain due to worm accumulation and other symptoms.

[0019] Euphorbia pekinensis processed with vinegar: Euphorbia pekinensis is bitter, cold in nature, toxic, attributing to the lung, spleen and kidney meridians, having the effects of purging water and expelling fluid retention, reducing swelling and dissipating nodules. Processing with vinegar can reduce toxicity and moderate the medicinal property.

[0020] Kansui processed with vinegar: Bitter, cold in nature; toxic. Attributing to the lung, kidney and large intestine meridians. It has the effects and functions of purging edema, eliminating phlegm and relieving cough, detoxifying and reducing swelling, relieving pain, etc.

[0021] Snow lotus flower: sweet, slightly bitter, warm in nature. It belongs to the liver and kidney meridians. It has the effects of dispelling wind-dampness, strengthening tendons and bones, tonifying the kidney yang, and regulating thoroughfare and conception vessels. It is mainly used to treat wind-dampness arthralgia, amenorrhea and dysmenorrhea, metrorrhagia and leukorrhagia, impotence, etc.

[0022] Rhodiola rosea: sweet, bitter, flat in nature. It belongs to the lung and heart meridians. It has both nourishing effects and can regulate the body. It functions by supplementing qi, relieving asthma and promoting blood circulation. It is suitable for treating physical weakness and fatigue, chronic cough and asthma, and various symptoms caused by poor qi and blood circulation, especially suitable for people with a dry-heat constitution.

[0023] Meconopsis horridula: bitter in taste, cold in nature, belonging to the heart and liver meridians, having the effects of clearing heat and detoxifying, reducing swelling and alleviating pain, relieving cough and asthma, etc.

[0024] Alkaline flower: sweet, salty, flat in nature. It is used for indigestion, hyperacidity, stomach cold, gastric distension, retention of the placenta, amenorrhea, ulceration of sores and wounds, and worm diseases.

[0025] In the present invention, seaweed and stir-fried radish seeds are used as the monarch drugs. Seaweed resolves phlegm and dissipates nodules, promotes diuresis and reduces swelling; stir-fried radish seeds lower qi and resolve phlegm, promote digestion and relieve distension, assisting seaweed to resolve phlegm and stagnation, and together they are the monarch drugs. Stir-fried white mustard seeds and stir-fried morning glory seeds are used as the minister drugs. Stir-fried white mustard seeds warm the lung and resolve phlegm, disperse nodules and dredge collaterals, assisting seaweed to disperse phlegm nodules; stir-fried morning glory seeds induce defecation and promote diuresis, expel phlegm and eliminate fluid retention, strengthening the power of promoting diuresis and resolving phlegm. The herbs of Aucklandia lappa, Rheum palmatum, snow lotus flower, Rhodiola rosea, and Meconopsis horridula are used as adjuvant drugs. Aucklandia lappa promotes qi flow and relieves pain, preventing the attacking and purging drugs from damaging the stomach, and also regulating qi movement; Rheum palmatum purges heat and induces defecation, moderating the drastic nature of various drugs and guiding pathogenic factors downward; snow lotus flower and Rhodiola rosea supplement qi and blood, preventing excessive attacking and purging, and taking into account the healthy qi; Meconopsis horridula clears heat and promotes blood circulation, assisting in removing stasis, and also moderating the dryness of warm drugs. Alkaline flower, vinegar-processed Euphorbia pekinensis, and vinegar-processed Kansui are used as envoy drugs. Alkaline flower eliminates phlegm and breaks up accumulation; vinegar-processed Euphorbia pekinensis and vinegar-processed Kansui drastically reduce water retention. The three drugs are used together to guide various drugs directly to the affected area.

[0026] As can be seen from the above, the traditional Chinese medicine suppository for treating low-level incomplete carcinomatous intestinal obstruction of the present invention has the advantages of high curative effect and no toxic and side effects. The curative effect is very good through clinical experiments. Taking Example 1 as an example, the clinical data are as follows: I. Case selection: 1.1 Diagnostic criteria Adopt the relevant diagnostic criteria in the "Expert Consensus on the Treatment of Intestinal Obstruction Complicated with Advanced Cancer Patients" promulgated by the Chinese Anti-Cancer Association: ① Malignant tumor with pathological diagnosis; ② It may be accompanied by related symptoms: intermittent nausea, vomiting, abdominal pain, abdominal distension, or reduced exhaust, reduced defecation, etc.; ③ Relevant pathological signs can be seen in the abdomen: abdominal distension, intestinal shape showing, abnormal bowel sounds, etc.; ④ Multiple fluid-air levels or dilated intestinal lumen can be seen in the abdomen under imaging.

[0027] 1.2 Selected cases: A total of 320 cases of cancerous incomplete intestinal obstruction were admitted to the Third Affiliated Hospital of Henan University of Chinese Medicine from February 2020 to February 2025.

[0028] II. Treatment plan: Usage method: The patient takes the left lateral position, bends the legs, exposes the anus, pads a disposable towel under the buttocks to prevent soiling the bedsheet, wears gloves, applies an appropriate amount of lubricant to the front end of the suppository to reduce discomfort during insertion, gently separates the buttocks with one hand to expose the anus, and slowly inserts the suppository with the other hand with the tip facing the anus. The insertion depth is 2 - 4 cm (for adults) or 1 - 2 cm (for children). After insertion, gently press the anus with toilet paper for a few seconds to prevent the suppository from slipping out, maintain the lying position for 5 - 10 minutes, and avoid getting up immediately to prevent the suppository from slipping out. Once a day, 3 days is a course of treatment, with a 2-day interval between courses, and the curative effect is statistically analyzed after 2 courses.

[0029] III. Curative effect judgment criteria: The curative effect judgment criteria for cancerous incomplete intestinal obstruction are formulated according to "Practical Tumor Treatment of Integrated Traditional Chinese and Western Medicine" and "Expert Consensus on the Diagnosis and Treatment of Cancerous Intestinal Obstruction".

[0030] Complete remission (CR): The patient can eat, has flatulence, mild abdominal pain and distension, normal bowel sounds, and normal abdominal X-ray; Improvement (PR): The patient can eat, has flatulence, and the abdominal pain, distension, bowel sounds, and abdominal X-ray are improved compared with before; No effect (NP): There is no remission after treatment or it gets worse compared with before and even requires surgery.

[0031] Total effective rate = (complete remission + improvement) / total number of cases × 100%.

[0032] IV. Treatment effect: According to the curative effect evaluation criteria, after statistical processing, the results are as follows: 34 cases (10.6%) had complete remission, 208 cases (65.0%) had improvement, 78 cases (24.4%) had no effect, and the total effective rate was 75.6%.

[0033] V. Typical cases 1. Wang XX, female, 87 years old, from Fuyang, Anhui She was diagnosed with ovarian cancer for 2 years and had incomplete intestinal obstruction for more than 1 month, with abdominal distension and occasional nausea and vomiting. Treated with the drug of the present invention therapeutically, the symptoms were relieved after 1 day, and the symptoms were basically relieved after continuous application for 1 course of treatment.

[0034] 2. Zhang XX, female, 33 years old, from Jining, Shandong She had ovarian cancer for more than 5 years and incomplete intestinal obstruction for more than half a year, with abdominal distension and occasional nausea and vomiting. Treated with the drug of the present invention therapeutically, the symptoms were relieved after 2 courses of treatment.

[0035] 3. Yan Moumou, male, 42 years old, from Zhengzhou, Henan He has had gastric cancer for more than 5 years and incomplete intestinal obstruction for 3 days. After eating, he feels nausea, vomits, has abdominal distension and pain. The symptoms disappeared after one course of treatment with the drug of the present invention used therapeutically.

[0036] VI. Conclusion In summary, the formula of the present invention is scientifically and rationally combined. By using the rectal administration method, the drug is directly absorbed through the rectal mucosa and quickly reaches the lesion site, avoiding the influence of oral traditional Chinese medicine by the gastrointestinal environment and the first-pass effect of the liver, improving the bioavailability of the drug, and quickly exerting the drug effect. The traditional Chinese medicine components in the formula act synergistically, can effectively improve intestinal microcirculation, relieve intestinal spasm, promote intestinal peristalsis, and restore intestinal conduction function, thus relieving intestinal obstruction symptoms such as abdominal pain, abdominal distension, and difficulty in defecation and flatulence. The present invention is convenient to use, non-invasive, has few side effects, can reduce the secondary harm to the patient's body, provides a safe and effective treatment option for patients with low-level incomplete carcinomatous intestinal obstruction. Through clinical trials, the effective rate is as high as 75.6%, which is a major innovation in the drugs for treating low-level incomplete carcinomatous intestinal obstruction and has huge social and economic benefits.

[0037] It should be noted that the technical features and key of the present invention are the compatibility of the traditional Chinese medicine composition. The dosage forms given above are only partial embodiments. Any technical solutions that are essentially the same as the present invention made by using equivalent replacement means or various dosage forms suitable for taking prepared by using the traditional Chinese medicine composition of the present invention by conventional preparation methods belong to the protection scope of the present invention.

Claims

1. A Chinese medicine suppository for treating low incomplete cancerous intestinal obstruction, characterized in that: The invention comprises the following raw materials in parts by weight: 10-30 parts of seaweed, 10-20 parts of costusroot, 5-15 parts of rhubarb, 10-20 parts of fried white mustard seeds, 10-30 parts of fried radish seeds, 10-20 parts of fried morning glory seeds, 1-5 parts of vinegared euphorbia, 1-5 parts of vinegared kansui, 1-15 parts of snow lotus, 5-15 parts of rhodiola rosea, 1-3 parts of meconopsis thornii and 0.5-1.5 parts of alkali flower; The preparation method comprises the following steps: (1) Water extraction and alcohol precipitation: extract seaweed, rhubarb, rhodiola rosea and stir-fried morning glory seeds with water and alcohol precipitation. First, add 8 times the total weight of the drug in water and boil for 3 times, each time for 1 h. Combine the three filtrates and concentrate to a relative density of 1.15 (60°C). Then add 95% ethanol to an alcohol content of 70%. Let it stand for 24 h, take the supernatant, and recover the ethanol by distillation to obtain an extract. (2) Extraction of volatile oil: Volatile oil was extracted from costusroot, stir-fried white mustard seeds and stir-fried radish seeds by steam distillation for 6 h. The distillate was then included with β-cyclodextrin in a weight-to-volume ratio of 1:6 to obtain a volatile oil inclusion complex. (3) Preparation of solid lipid nanoparticles: Extract Euphorbia acetosellariae and Gleditsia acetosellariae with 70% ethanol by ultrasonic extraction twice, each time for 30 min (power 300 W, the extract was sterilized by filtering through a 0.22 μm filter membrane, and the extract was heated to 65-70°C in a water bath until completely melted. The extract was heated to 65-70°C, and then the extract was added to the molten glyceryl monostearate at a ratio of 1:2 under stirring at 300-500 rpm. After the addition was complete, the extract was stirred for 30 min, and then filtered through a 0.22 μm filter membrane and quickly transferred to an ice bath at 0-4°C, stirred and cooled for 10-15 min until the lipid was completely solidified, to obtain solid lipid nanoparticles. (4) Preparation of extracts: After low-temperature drying of snow lotus and Meconopsis spinulosa at 60°C, ultrafinely grind and pass through a 150-mesh sieve, prepare a mixed solvent with a volume ratio of ethanol to water of 7:3, place in a low-temperature environment and pre-cool to -20°C, add snow lotus and Meconopsis spinulosa to the mixed solvent at a weight volume ratio of 1:8 to 1:15, stir and mix, and then treat the mixture at a field strength of 20 kV / cm and a pulse frequency of 10 Hz at -20°C for 1 to 5 min. The treated mixture is further stirred at 200 to 300 r / min for 30 to 60 min at -20°C, and then centrifuged at 4°C and 8000 to 10000 r / min for 10 to 15 min, collect the supernatant, and freeze-dry to obtain snow lotus extract and Meconopsis spinulosa extract. Add 5% mannitol to the snow lotus extract and freeze-dry at -50°C for 24 h to obtain snow lotus freeze-dried powder; (5) Preparation of alkali flower / Eudragit S100 complex: dry-heat sterilize alkali flower at 150°C for 1 h, grind and sieve through a 200-mesh sieve to obtain alkali flower pollen, disperse the alkali flower powder in an ethanol solution of Eudragit S100, and ultrasonically disperse for 30 min to obtain a suspension. The solvent of the suspension is evaporated at room temperature, dried, and then crushed and sieved to obtain an alkali flower / Eudragit S100 complex. (6) Preparation of suppositories: Heat the matrix Witepsol E85 in a water bath to 45°C to melt, and add sodium alginate-chitosan microspheres, PEG 400, N-acetylcysteine ​​and alkali flower / Eudragit S100 complex in sequence, wherein the weight volume ratio of Witepsol E85: sodium alginate-chitosan microspheres: PEG 400: N-acetylcysteine: alkali flower / Eudragit S100 complex is 60:20:15:3:

2. Stir at 200 rpm for 10 min, then add the extract, volatile oil inclusion complex, solid lipid nanoparticles, snow lotus freeze-dried powder and Meconopsis polysaccharides extract, and homogenize and emulsify at 8000 rpm for 3 min. Then, degas under vacuum at -0.08 MPa for 5 min. min, remove bubbles to obtain a mixed drug solution, precool the stainless steel mold to -5°C, spray liquid paraffin on the inner wall for lubrication, maintain a constant temperature of 40°C for the drug solution, pour it into the mold at 0.5mL / second, and immediately transfer it to a 0°C cooling tunnel for cooling for 10 min after pouring, then gradually heat it to 25°C for demoulding, cut off the overflow, each suppository weighs 1.9-2.1g, and is packaged in aluminum foil blisters and sealed with nitrogen to obtain a traditional Chinese medicine suppository for treating low incomplete cancerous intestinal obstruction; the weight and volume are measured in g for solids and in ml for liquids.

2. The Chinese medicine suppository for treating low incomplete cancerous intestinal obstruction according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 20 parts of seaweed, 15 parts of costusroot, 10 parts of rhubarb, 15 parts of fried white mustard seeds, 20 parts of fried radish seeds, 15 parts of fried morning glory seeds, 3 parts of vinegar euphorbia, 3 parts of vinegar kansui, 7 parts of snow lotus, 7 parts of rhodiola rosea, 2 parts of meconopsis thornii and 1 part of alkali flower.

3. The Chinese medicine suppository for treating low incomplete cancerous intestinal obstruction according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 30 parts of seaweed, 20 parts of costusroot, 15 parts of rhubarb, 20 parts of fried white mustard seeds, 30 parts of fried radish seeds, 20 parts of fried morning glory seeds, 5 parts of vinegar euphorbia, 5 parts of vinegar kansui, 15 parts of snow lotus, 15 parts of rhodiola rosea, 3 parts of meconopsis thornii and 1.5 parts of alkali flower.

4. The Chinese medicine suppository for treating low incomplete cancerous intestinal obstruction according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 10 parts of seaweed, 10 parts of costusroot, 5 parts of rhubarb, 10 parts of fried white mustard seeds, 10 parts of fried radish seeds, 10 parts of fried morning glory seeds, 1 part of vinegar euphorbia, 1 part of vinegar kansui, 1 part of snow lotus, 5 parts of rhodiola rosea, 1 part of meconopsis pilosa and 0.5 part of alkali flower.

5. The Chinese medicine suppository for treating low incomplete cancerous intestinal obstruction according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 15 parts of seaweed, 18 parts of costusroot, 8 parts of rhubarb, 17 parts of fried white mustard seeds, 14 parts of fried radish seeds, 18 parts of fried morning glory seeds, 2 parts of vinegar euphorbia, 4 parts of vinegar kansui, 3 parts of snow lotus, 7 parts of rhodiola rosea, 2 parts of meconopsis thornii and 0.9 part of alkali flower.

6. The Chinese medicine suppository for treating low incomplete cancerous intestinal obstruction according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 27 parts of seaweed, 14 parts of costusroot, 13 parts of rhubarb, 12 parts of fried white mustard seeds, 28 parts of fried radish seeds, 14 parts of fried morning glory seeds, 4 parts of vinegar euphorbia, 2 parts of vinegar kansui, 13 parts of snow lotus, 7 parts of rhodiola rosea, 3 parts of meconopsis thornii and 1.3 parts of alkali flower.