A traditional Chinese medicine antiemetic mixture for preventing and treating postoperative nausea and vomiting, and its preparation method and application

Abstract

The invention discloses a Chinese medicine antiemetic mixture for preventing and treating postoperative nausea and vomiting, and a preparation method and application thereof. The Chinese medicine antiemetic mixture comprises the following Chinese medicine ingredients: codonopsis pilosula, pinellia tuber, atractylodes lancea, magnolia officinalis, tangerine peel, clove, roasted liquorice, black dates and dried ginger. The Chinese medicine antiemetic mixture is a pure Chinese medicine preparation, which embodies the characteristics of multi-target and comprehensive synergistic treatment of Chinese medicine, has the effects of strengthening the spleen and stomach, reducing adverse reactions and stopping hiccups, removing dampness and resolving phlegm, and is mainly used to treat spleen deficiency and vomiting. The Chinese medicine antiemetic mixture has a wide range of application, can be widely used to prevent nausea and vomiting, can be promoted and applied to the prevention and treatment of various surgical PONV, vomiting caused by radiotherapy and chemotherapy, alcohol detoxification and vomiting, and motion sickness and seasickness of passengers. It has a significant effect on the treatment of postoperative nausea and vomiting, especially postoperative nausea and vomiting after total knee replacement, has no obvious adverse reactions, can reduce or avoid the frequency of use of other Western medicines, and is worthy of development and clinical promotion.

Description

Technical Field

[0001] The invention relates to the technical field of antiemetic drugs using traditional Chinese medicine, and in particular to a traditional Chinese medicine antiemetic mixture for preventing and treating postoperative nausea and vomiting, and a preparation method and application thereof. Background Art

[0002] Postoperative nausea and vomiting (PONV) is one of the common complications after surgical operations such as total knee arthroplasty (TKA), with an incidence of 20%-30%, and even 70%-80% in high-risk groups. PONV usually occurs within 6h or 24h after surgery, and in a few patients it can last for 3-5d. It can lead to increased suture tension and non-healing of the wound, delay the start of functional exercise for patients, induce esophageal rupture, dehydration, electrolyte imbalance, aspiration pneumonia, etc., which will significantly hinder the postoperative recovery process, prolong hospitalization time, and increase patients' pain and medical expenses. Studies have pointed out that among the 10 common and unbearable adverse reactions after surgery, vomiting and nausea ranked first and fourth respectively, and pain ranked third. Therefore, the management of perioperative PONV urgently needs to be further resolved and improved to promote the rapid recovery of patients and adapt to the current demand for comfortable medical services.

[0003] At present, the management of perioperative PONV is mainly based on drug therapy. Commonly used drugs include 5-HT3 receptor antagonists (such as ondansetron, tropisetron, palonosetron, etc.), neurokinin-1 receptor antagonists (such as aprepitant), glucocorticoids (low-dose dexamethasone, etc.), benzamides (metoclopramide), phenothiazines (chlorpromazine, promethazine, etc.), butyrophenones (droperidol, haloperidol, etc.), anticholinergics (scopolamine transdermal patch, etc.), antihistamines (dimenhydrinate), etc., but in the harvest period, the use of drugs is still limited. While achieving better clinical outcomes, the existing adverse reactions of the above drugs should not be ignored: QT prolongation and arrhythmia caused by droperidol and ondansetron; lethargy, irritability, fatigue and weakness caused by metoclopramide, and fatal events related to overdose; postoperative blood sugar changes and increased risk of wound infection related to corticosteroids; visual impairment, dry mouth, and dizziness caused by scopolamine; dimenhydrinate-induced dizziness and extrapyramidal symptoms; neurokinin-1 receptor antagonist-induced headache, constipation, fatigue, and hiccups. In fact, the effect of using a single drug is not good, and PONV is often treated with combined drugs in clinical practice, which invisibly increases the risk of related adverse events and the patient's medical expenses. Therefore, it is of great significance to find a fulcrum to better balance clinical efficacy and patient expenses. Summary of the invention

[0004] In order to overcome the shortcomings of the prior art, one of the purposes of the present invention is to provide a traditional Chinese medicine antiemetic mixture for preventing and treating postoperative nausea and vomiting, which has the functions of strengthening the spleen and stomach, relieving adverse reactions and stopping vomiting, removing dampness and resolving phlegm, so that the spleen and stomach can be restored to rise and fall, blocked qi can be unblocked, and phlegm and dampness can be transformed; the second purpose of the present invention is to provide a preparation method of a traditional Chinese medicine antiemetic mixture for preventing and treating postoperative nausea and vomiting, which has simple steps and is suitable for large-scale use; the third purpose of the present invention is to provide an application of a traditional Chinese medicine antiemetic mixture for preventing and treating postoperative nausea and vomiting, which can effectively relieve and treat vomiting, and also has a definite therapeutic effect on PONV, can alleviate clinical symptoms, improve traditional Chinese medicine syndromes, improve quality of life, improve patient prognosis, has no obvious adverse reactions, can reduce or avoid the frequency of use of other Western medicines, and is worthy of development and clinical promotion.

[0005] One of the purposes of the present invention is achieved by the following technical solution:

[0006] A Chinese herbal antiemetic mixture for preventing and treating postoperative nausea and vomiting, comprising the following Chinese herbal ingredients:

[0007] Codonopsis pilosula slices, Pinellia ternata, Atractylodes macrocephala, Magnolia officinalis bark, Tangerine peel, Cloves, Roasted Licorice root, Black dates and Dried ginger.

[0008] Furthermore, the Chinese medicine antiemetic mixture comprises the following Chinese medicine ingredients by weight:

[0009] 160-250 parts of Codonopsis pilosula, 160-250 parts of Pinellia ternata, 120-170 parts of Atractylodes lancea, 40-90 parts of Magnolia officinalis bark, 40-90 parts of Tangerine peel, 24-50 parts of Cloves, 40-90 parts of Roasted Licorice root, 48-90 parts of Black dates and 40-90 parts of Dry ginger.

[0010] Preferably, the Chinese medicine antiemetic mixture comprises the following Chinese medicine ingredients by weight: 240 parts of Codonopsis pilosula, 240 parts of Pinellia ternata, 160 parts of Atractylodes macrocephala, 80 parts of Magnolia officinalis bark, 80 parts of Tangerine peel, 40 parts of Cloves, 80 parts of Radix Glycyrrhizae Preparata, 80 parts of Black Dates and 80 parts of Dry Ginger.

[0011] The second object of the present invention is achieved by adopting the following technical solution:

[0012] The preparation method of the above-mentioned Chinese herbal antiemetic mixture for preventing and treating postoperative nausea and vomiting comprises the following steps: adding the Chinese herbal ingredients into a solvent for extraction to obtain a Chinese herbal extract, which is the Chinese herbal antiemetic mixture for preventing and treating postoperative nausea and vomiting.

[0013] Furthermore, the Chinese medicinal ingredients are first decocted with water, filtered to obtain a filtrate, concentrated, boiled, and added with water to obtain a Chinese medicinal antiemetic mixture for preventing and treating postoperative nausea and vomiting.

[0014] Further, the Chinese herbal ingredients are decocted with water for 1 to 3 times, with 5 to 10 times the amount of water added each time, decocted for 0.5 to 2 hours, filtered, the filtrate is combined, concentrated under reduced pressure to 900 to 950 mL, refrigerated for 24 to 48 hours, filtered to obtain the filtrate, boiled and kept warm for 20 to 40 minutes, filtered and then added with water to 1000 to 2000 mL, stirred evenly, and packaged to obtain the Chinese herbal antiemetic mixture.

[0015] Furthermore, after filtering to obtain a filtrate, sodium benzoate is added, preferably in an amount of 1 to 5 parts.

[0016] The third object of the present invention is achieved by adopting the following technical solution:

[0017] The application of the above-mentioned Chinese herbal antiemetic mixture for preventing and treating postoperative nausea and vomiting, the Chinese herbal antiemetic mixture is used to prepare a product for preventing, treating and relieving the symptoms of nausea and vomiting after total knee replacement, vomiting symptoms caused by radiotherapy and chemotherapy, and nausea and vomiting symptoms caused by drunkenness, motion sickness and seasickness.

[0018] Furthermore, the dosage form of the product is a solid preparation and / or a liquid preparation.

[0019] Furthermore, the solid preparation is one or a combination of two or more of tablets, pills, capsules, effervescent powders, and Chinese medicine powders; the liquid preparation is an oral solution and / or an injection solution.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] (1) A Chinese herbal antiemetic mixture for preventing and treating postoperative nausea and vomiting, comprising the following Chinese herbal ingredients: codonopsis pilosula, pinellia tuber, atractylodes lancea, magnolia officinalis, dried orange peel, clove, roasted liquorice, black dates and dried ginger. This Chinese herbal antiemetic mixture is a pure Chinese herbal preparation, reflecting the characteristics of multi-target and comprehensive synergistic treatment of Chinese medicine, and has the effects of strengthening the spleen and stomach, reducing adverse reactions and stopping hiccups, removing dampness and resolving phlegm, and is mainly used to treat vomiting due to spleen deficiency.

[0022] This prescription follows the principle of "monarch, minister, assistant and envoy" in traditional Chinese medicine. In the prescription, Codonopsis pilosula and black dates are sweet and warm in nature, and are the monarch medicines for invigorating the spleen and replenishing qi; Atractylodes lancea is pungent and warm in nature, and can generate yang qi in the stomach, stop vomiting and diarrhea, and expel phlegm and water; Magnolia officinalis is pungent, warm, bitter and descending, and can remove dampness and fullness, and its bitterness and descending can relieve fullness; Pinellia is pungent and warm in nature, and can release the exterior and relieve depression, and move the adverse qi downward; it is warm and can remove dampness and resolve phlegm, and promote urination, so they are all minister medicines; dried ginger is warm in nature and can warm the stomach and stop vomiting, cloves warm the middle and reduce adverse qi as the assistant, and roasted licorice harmonizes the medicines as the guiding medicine; all the medicines are used together to complement each other and have the effects of invigorating the spleen and stomach, reducing adverse qi and stopping vomiting, removing dampness and resolving phlegm.

[0023] (2) The Chinese medicine antiemetic mixture for preventing and treating postoperative nausea and vomiting provided by the present invention has a wide range of applications and can be widely used to prevent nausea and vomiting. It can be promoted to various surgical PONV, vomiting caused by radiotherapy and chemotherapy, alcohol nausea and vomiting, and the prevention and treatment of passengers' motion sickness and seasickness. It has a significant effect on the treatment of postoperative nausea and vomiting, especially postoperative nausea and vomiting after total knee replacement. It can relieve clinical symptoms, improve TCM syndromes, improve the quality of life, and improve the prognosis of patients without obvious adverse reactions. It can reduce or avoid the frequency of use of other Western medicines, and is worthy of development and clinical promotion.

[0024] (3) The Chinese medicine antiemetic mixture of the present invention has few side effects. Currently commonly used drugs all have certain adverse reactions. For example, mosapride may cause diarrhea, abdominal pain, dry mouth, rash, fatigue and dizziness; 5-HT3 receptor antagonists often cause headaches, constipation, elevated transaminase, abdominal distension and pain, and in severe cases, may cause QT interval prolongation; metoclopramide may cause drowsiness, irritability, fatigue, orthostatic hypotension and other adverse reactions. Long-term use of large doses may lead to extrapyramidal reactions, such as muscle tremor, dysphonia, ataxia, etc. Compared with the above drugs, the antiemetic mixture of the present invention has no obvious adverse reactions and can reduce or avoid the frequency of use of other antiemetic drugs. DETAILED DESCRIPTION

[0025] The present invention is further described below in conjunction with specific implementation methods. It should be noted that, under the premise of no conflict, the various embodiments or technical features described below can be arbitrarily combined to form a new embodiment.

[0026] A Chinese herbal antiemetic mixture for preventing and treating postoperative nausea and vomiting, comprising the following Chinese herbal ingredients:

[0027] Codonopsis pilosula slices, Pinellia ternata, Atractylodes macrocephala, Magnolia officinalis bark, Tangerine peel, Cloves, Roasted Licorice root, Black dates and Dried ginger.

[0028] The above-mentioned Chinese medicinal ingredients have the following effects and pharmacological actions:

[0029] (1) Codonopsis: It is the dried root of Codonopsis pilosula, Codonopsis pilosula or Codonopsis pilosula of the Campanulaceae family. It is sweet and neutral in nature and enters the spleen and lung meridians. It has the effects of tonifying the spleen and lungs, nourishing blood and promoting the production of body fluids. It can treat spleen and lung qi deficiency, poor appetite and fatigue, cough and asthma; qi and blood deficiency, sallow complexion, dizziness and fatigue, palpitations and shortness of breath; qi and body fluid damage, shortness of breath and thirst, internal heat and thirst, etc. Modern pharmacology shows that Codonopsis pilosula mainly contains chemical components such as alkaloids, polyacetylenes, lignans, flavonoid compounds and polysaccharides, which can protect nerves, fight tumors, resist oxidation, fight inflammation, resist stress, protect the liver, etc. ("Chinese Materia Medica" edited by Zhong Gansheng, China Traditional Chinese Medicine Press, 4th edition, new century, page 636).

[0030] (2) French Pinellia: It is the dried tuber of the plant Pinellia of the Araceae family. It is pungent, warm and poisonous. It enters the spleen, stomach and lung meridians. It has the effects of drying dampness and resolving phlegm, relieving adverse reactions and stopping vomiting, and eliminating lumps and dispersing lumps. It can treat damp phlegm and cold phlegm, cough and asthma with excessive phlegm, phlegm and dizziness, wind phlegm and dizziness, phlegm and headache; stomach qi reflux, vomiting and nausea, chest and abdominal distension, plum pit qi; carbuncle swelling and poison, scrofula phlegm nodules, snake bites, etc. Modern pharmacology shows that Pinellia mainly contains chemical components such as alkaloids, volatile oils, organic acids, sterols, amino acids, inorganic elements, etc., which can relieve cough and expectorant, relieve vomiting, prevent early pregnancy, prevent ulcers, prevent tumors, lower blood lipids, and lower blood pressure. ("Chinese Materia Medica" edited by Zhong Gansheng, China Traditional Chinese Medicine Press, New Century Fourth Edition, page 532).

[0031] (3) Atractylodes: It is the dried rhizome of Atractylodes macrocephala or Atractylodes macrocephala, a perennial herb of the Asteraceae family. It is pungent, bitter and warm in nature. It enters the spleen, stomach and liver meridians. It has the effects of drying dampness and strengthening the spleen, dispelling wind and cold, and improving eyesight. It can treat dampness blocking the middle jiao, abdominal distension, diarrhea, edema; rheumatic arthralgia, beriberi, paralysis; cold; night blindness, etc. Modern pharmacology shows that Atractylodes mainly contains volatile oil, atractylodesone, vitamin A-like substances, vitamin B and inulin. ("Chinese Materia Medica" edited by Zhong Gansheng, China Traditional Chinese Medicine Press, New Century Fourth Edition, page 337).

[0032] (4) Magnolia officinalis: It is the dried bark, root bark and branch bark of Magnolia officinalis or Magnolia officinalis of the Magnoliaceae family. It is pungent, bitter and warm in nature. It enters the spleen, stomach, lung and large intestine meridians. It has the effects of drying dampness, promoting qi, eliminating accumulation, eliminating phlegm and relieving asthma. It can treat dampness stagnation, abdominal distension and vomiting and diarrhea; food stagnation and qi stagnation, abdominal distension and constipation; phlegm and cough; plum pit qi syndrome, etc. Modern pharmacology shows that Magnolia officinalis mainly contains chemical components such as phenolic compounds, alkaloids and volatile oils, which can resist diarrhea, improve gastrointestinal motility disorders, resist epilepsy, anti-depression, anti-dementia, lower blood pressure, improve cardiopulmonary function, lower blood sugar, anti-inflammatory, analgesic, antibacterial, anti-tumor, and antioxidant. ("Chinese Materia Medica" edited by Zhong Gansheng, China Traditional Chinese Medicine Press, New Century Fourth Edition, page 339).

[0033] (5) Tangerine peel: It is the dried mature peel of the citrus plant and its cultivated varieties of the Rutaceae family. It is pungent, bitter and warm in nature. It enters the spleen and lung meridians. It has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It can treat stagnation of qi in the spleen and stomach, abdominal distension, loss of appetite, vomiting and diarrhea, vomiting, hiccups, damp phlegm, cold phlegm, cough with excessive phlegm, chest pain, etc. Modern pharmacology shows that tangerine peel mainly contains chemical components such as vitamin B, vitamin C, tangerine peel, flavonoids, volatile oils, etc., which can have anti-tumor, antitussive and antiasthmatic, expectorant, anti-shock, anti-aging, and promote digestive juice secretion. ("Chinese Materia Medica" edited by Zhong Gansheng, China Traditional Chinese Medicine Press, New Century Fourth Edition, page 402).

[0034] (6) Clove: It is the dried flower bud of the Myrtaceae plant clove. It is pungent and warm in nature. It enters the spleen, stomach and kidney meridians. It has the effects of warming the middle and lowering adverse effects, dispelling cold and relieving pain, warming the kidney and supporting yang. It can treat spleen and stomach deficiency and cold, hiccups and vomiting, loss of appetite and vomiting and diarrhea; cold pain in the heart and abdomen; impotence due to kidney deficiency and cold uterus. Modern pharmacology shows that clove mainly contains chemical components such as clove oil, eugenol, flavonoids, steroids, triterpenes, tannins, etc., which can be antioxidant, anti-inflammatory, antipyretic and analgesic, anti-tumor, and memory enhancer. ("Chinese Materia Medica" edited by Zhong Gansheng, China Traditional Chinese Medicine Press, New Century Fourth Edition, page 392).

[0035] (7) Roasted Licorice: It is the dried root and rhizome of the leguminous plants Glycyrrhiza uralensis, Glycyrrhiza uralensis or Glycyrrhiza glabra. It is sweet and slightly warm in nature. It enters the heart, lung, spleen and stomach meridians. It has the effects of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving pain and harmonizing various medicines. It can treat spleen and stomach weakness, fatigue and weakness; insufficient heart qi, palpitations and shortness of breath, and irregular pulse; carbuncle, sore throat, cough and sputum; abdominal and limb spasm and pain; relieve drug toxicity and potency. Modern pharmacology shows that licorice mainly contains triterpenes, flavonoids, polysaccharides, coumarins, volatile oils and amino acids, which can be anti-tumor, anti-bacterial, anti-viral, anti-inflammatory, immune-regulating, anti-oxidant, anti-aging and anti-fibrosis. Roasted Licorice is made by adding honey to raw licorice, which is better at warming and harmonizing. (Chinese Materia Medica, edited by Zhong Gansheng, China Traditional Chinese Medicine Press, 4th edition, new century, page 645).

[0036] (8) Black dates: It is the mature fruit of the plant jujube of the Rhamnaceae family. It is sweet and warm in nature. It enters the spleen, stomach and heart meridians. It has the effects of replenishing the middle qi, nourishing blood and calming the mind. It can treat spleen deficiency, poor appetite, fatigue and loose stools; women's irritability and insomnia. Modern pharmacology shows that it mainly contains organic acids, triterpenoid glycosides, alkaloids, brasses, sugars, vitamins, amino acids, volatile oils, trace elements, etc. It has the effects of strengthening muscle strength, increasing gastrointestinal mucus, resisting allergic reactions, and calming and hypnotizing. ("Chinese Medicine" edited by Zhong Gansheng, China Traditional Chinese Medicine Press, New Century Fourth Edition, page 648).

[0037] (9) Dried ginger: It is the dried rhizome of ginger, a plant of the ginger family. It is pungent and hot in nature. It enters the spleen, stomach, kidney, heart and lung meridians. It has the effects of warming the middle and dispelling cold, restoring yang and unblocking meridians, and warming the lungs and transforming fluid. It can treat spleen and stomach cold syndrome, abdominal cold pain, vomiting and diarrhea; yang deficiency syndrome, cold limbs and weak pulse; cold fluid and cough. Modern pharmacology shows that it mainly contains gingerol, phellandrene, gingerolone, gingerol, zingerone, borneol, gingerol, etc., which have sedative, analgesic, anti-inflammatory and antiemetic effects. (Chinese Materia Medica, edited by Zhong Gansheng, China Traditional Chinese Medicine Press, 4th edition, 2000, page 384).

[0038] Example 1

[0039] A traditional Chinese medicine antiemetic mixture comprises the following traditional Chinese medicine ingredients by weight: 240 parts of codonopsis pilosula, 240 parts of pinellia tuber, 160 parts of atractylodes, 80 parts of ginger magnolia bark, 80 parts of tangerine peel, 40 parts of cloves, 80 parts of roasted liquorice, 80 parts of black dates and 80 parts of dried ginger.

[0040] The preparation method of the above-mentioned Chinese medicine antiemetic mixture comprises the following steps:

[0041] The above-mentioned Chinese medicinal ingredients were decocted with water for 2 times, each time adding 8 times the weight of the Chinese medicinal ingredients, decocted for 1 hour, filtered to obtain a filtrate, combined the filtrates, concentrated under reduced pressure to 900 mL, refrigerated for 48 hours, filtered to obtain a filtrate, added 3 parts of sodium benzoate to the filtrate, boiled and kept warm for 30 minutes, filtered, added water to the filtrate to 1000 mL, stirred well, and packaged in bottles, 100 mL / bottle.

[0042] Example 2

[0043] A traditional Chinese medicine antiemetic mixture comprises the following traditional Chinese medicine ingredients by weight: 160 parts of codonopsis pilosula, 160 parts of pinellia tuber, 120 parts of atractylodes, 40 parts of ginger magnolia bark, 40 parts of tangerine peel, 24 parts of cloves, 40 parts of roasted liquorice, 48 parts of black dates and 40 parts of dried ginger.

[0044] The preparation method of the above-mentioned Chinese medicine antiemetic mixture comprises the following steps:

[0045] The above-mentioned Chinese medicinal ingredients were decocted with water for 2 times, each time adding 5 times the weight of the Chinese medicinal ingredients, decocted for 0.5 h, filtered to obtain a filtrate, combined the filtrates, concentrated under reduced pressure to 950 mL, refrigerated for 24 h, filtered to obtain a filtrate, added 1 part of sodium benzoate to the filtrate, boiled and kept warm for 20 min, filtered, added water to the filtrate to 1000 mL, stirred well, and packaged in bottles, 100 mL / bottle.

[0046] Example 3

[0047] A traditional Chinese medicine antiemetic mixture comprises the following traditional Chinese medicine ingredients by weight: 250 parts of codonopsis pilosula, 250 parts of pinellia tuber, 170 parts of atractylodes, 90 parts of ginger magnolia bark, 90 parts of tangerine peel, 50 parts of cloves, 90 parts of roasted liquorice, 90 parts of black dates and 90 parts of dried ginger.

[0048] The preparation method of the above-mentioned Chinese medicine antiemetic mixture comprises the following steps:

[0049] The above-mentioned Chinese medicinal ingredients were decocted with water for 2 times, each time adding 5 times the weight of the Chinese medicinal ingredients, decocted for 0.5 h, filtered to obtain a filtrate, combined the filtrates, concentrated under reduced pressure to 920 mL, refrigerated for 36 h, filtered to obtain a filtrate, added 5 parts of sodium benzoate to the filtrate, boiled and kept warm for 20 min, filtered, added water to the filtrate to 1000 mL, stirred well, and packaged in bottles, 100 mL / bottle.

[0050] The specifications of the Chinese medicine antiemetic mixtures of Examples 1 to 3 are all 100 mL / bottle, which are applied one day before surgery and continuously until 48 hours after surgery. Usage: Oral, preferably frequent (small amounts, multiple times), 1 bottle cap each time (about 8-10 mL), and the total daily dose is 50 mL.

[0051] Comparative Example 1

[0052] The difference between Comparative Example 1 and Example 1 is that: Comparative Example 1 does not add Codonopsis pilosula slices.

[0053] The total PONV incidence of patients in Example 1 0-72 hours after surgery and the PONV incidence in the time periods 0-6 hours, 6-24 hours, 24-48 hours, and 48-72 hours after replacement were all lower than those in Comparative Example 1, and the differences were significantly significant (P<0.05), as shown in the following table.

[0054] Table 1 Comparison of PONV incidence between Comparative Example 1 and Example 1 n (%)

[0055]

[0056] Comparative Example 2

[0057] The difference between Comparative Example 2 and Example 1 is that: Comparative Example 2 does not add French Pinellia.

[0058] The total PONV incidence of patients in Example 1 0-72 hours after surgery and the PONV incidence in the time periods 0-6 hours, 6-24 hours, 24-48 hours, and 48-72 hours after replacement were all lower than those in Comparative Example 2, and the differences were significantly significant (P<0.05), as shown in the following table.

[0059] Table 2 Comparison of PONV incidence between Comparative Example 2 and Example 1 n (%)

[0060]

[0061] Comparative Example 3

[0062] The difference between Comparative Example 3 and Example 1 is that: Comparative Example 3 does not add Atractylodes lancea.

[0063] The total PONV incidence rate of patients in Example 1 0-72h after surgery and the PONV incidence rates in the time periods 0-6h and 6-24h after replacement were lower than those in Comparative Example 3, and the differences were significant (P<0.05); there was no significant difference in the PONV incidence rates in the time periods 24-48h and 48-72h after surgery between the two groups (P>0.05), as shown in the following table.

[0064] Table 3 Comparison of PONV incidence between Comparative Example 3 and Example 1 n (%)

[0065]

[0066] Comparative Example 4

[0067] The difference between Comparative Example 4 and Example 1 is that: Comparative Example 4 does not add Magnolia officinalis.

[0068] The total PONV incidence rate of patients in Example 1 0-72h after surgery and the PONV incidence rates in the time periods 0-6h and 6-24h after replacement were lower than those in Comparative Example 4, and the differences were significant (P<0.05); there was no significant difference in the PONV incidence rates in the time periods 24-48h and 48-72h after surgery between the two groups (P>0.05), as shown in the following table.

[0069] Table 4 Comparison of PONV incidence between Comparative Example 4 and Example 1 n (%)

[0070]

[0071] Comparative Example 5

[0072] The difference between Comparative Example 5 and Example 1 is that: Comparative Example 5 does not add tangerine peel.

[0073] The total PONV incidence rate of patients in Example 1 0-72h after surgery and the PONV incidence rates in the time periods 0-6h and 6-24h after replacement were lower than those in Comparative Example 5, and the differences were significantly significant (P<0.05); there was no significant difference in the PONV incidence rates in the time periods 24-48h and 48-72h after surgery between the two groups (P>0.05), as shown in the following table.

[0074] Table 5 Comparison of PONV incidence between Comparative Example 5 and Example 1 n (%)

[0075]

[0076]

[0077] Comparative Example 6

[0078] The difference between Comparative Example 6 and Example 1 is that no cloves are added in Comparative Example 6.

[0079] The total PONV incidence rate of patients in Example 1 0-72h after surgery and the PONV incidence rates in the time periods 0-6h and 6-24h after replacement were lower than those in Comparative Example 6, and the differences were significantly significant (P<0.05); there was no significant difference in the PONV incidence rates in the time periods 24-48h and 48-72h after surgery between the two groups (P>0.05), as shown in the following table.

[0080] Table 6 Comparison of PONV incidence between Comparative Example 6 and Example 1 n (%)

[0081]

[0082] Comparative Example 7

[0083] The difference between Comparative Example 7 and Example 1 is that: Comparative Example 7 does not add licorice root.

[0084] The PONV incidence rate of patients in Example 1 during the 6-24h period after surgery was lower than that in Comparative Example 7, and the difference was statistically significant (P<0.05). There was no statistically significant difference in the total PONV incidence rate during the 0-72h period after surgery and the PONV incidence rates during the 0-6h, 24-48h, and 48-72h periods after replacement between the two groups (P>0.05), as shown in the following table.

[0085] Table 7 Comparison of PONV incidence between Comparative Example 7 and Example 1 n (%)

[0086]

[0087] Comparative Example 8

[0088] The difference between Comparative Example 8 and Example 1 is that black dates are not added in Comparative Example 8.

[0089] The total PONV incidence rate of patients in Example 1 0-72h after surgery and the PONV incidence rate in the 6-24h period after replacement were lower than those in Comparative Example 8, and the difference was significant (P<0.05); there was no significant difference in the PONV incidence rates in the 0-6h, 24-48h, and 48-72h time periods after surgery between the two groups (P>0.05), as shown in the following table.

[0090] Table 8 Comparison of PONV incidence between Comparative Example 8 and Example 1 n (%)

[0091]

[0092] Comparative Example 9

[0093] The difference between Comparative Example 9 and Example 1 is that no dried ginger is added in Comparative Example 9.

[0094] The total PONV incidence rate of patients in Example 1 0-72h after surgery and the PONV incidence rates in the time periods 0-6h, 6-24h, and 24-48h after replacement were lower than those in Comparative Example 9, and the differences were significantly significant (P<0.05); there was no significant difference in the PONV incidence rate in the time period 48-72h after surgery between the two groups (P>0.05), as shown in the following table.

[0095] Table 9 Comparison of PONV incidence between Comparative Example 9 and Example 1 n (%)

[0096]

[0097] Clinical trials

[0098] There were 20 volunteers in each treatment group and control group. The treatment group took the antiemetic mixture of Example 1 orally starting from one day before total knee replacement surgery and continuing until 48 hours after surgery; the control group did not take the antiemetic mixture, and the other groups were treated the same way.

[0099] Volunteer criteria: ① 50-65 years old unilateral KOA patients, undergoing TKA treatment; ② meet the diagnostic criteria; ③ X-ray condition meets the grading standards of the "Osteoarthritis Diagnosis and Treatment Guidelines (2018 Edition)" issued by the Joint Surgery Group of the Orthopedic Branch; ④ No mental abnormalities, can communicate accurately; ⑤ Those who have not used other treatments or taken other drugs in the past half month; ⑥ BMI value is less than 28; ⑦ Use epidural anesthesia, general basic conditions are good, and there is no alcohol and opioid dependence; ⑧ Volunteer trial, have good compliance, and agree to participate in this trial study.

[0100] Observation indicators: ①Observe and record the number of postoperative nausea and vomiting in different time periods of 0-6, 6-24, 24-48, 48-72h after surgery and the total number of postoperative nausea and vomiting in 0-72h after surgery in the two groups of patients, and calculate the incidence rate in each time period. ②Compare and analyze the degree of nausea and vomiting reaction in the two groups at 6h, 24h, and 48h after surgery, using the World Health Organization PONV reaction grading standard. Grade 0: no nausea and vomiting reaction; Grade I: nausea, no vomiting; Grade II: temporary vomiting, vomiting ≤1 time; Grade III: vomiting requiring drug treatment, vomiting ≤2 times; Grade IV: vomiting that is difficult to control with drug treatment, vomiting ≥3 times.

[0101] Test results

[0102] 1. Analysis of general data of the two groups of patients

[0103] There was no significant difference in gender composition, age, BMI index, operation time, etc. between the two groups of patients (P>0.05), and the two groups were comparable, as shown in the following table.

[0104] Table 10 Comparison of general data between the two groups

[0105]

[0106] 2. Comparison of PONV incidence between the two groups

[0107] The total PONV incidence in the treatment group within 0-72 hours after surgery and the PONV incidence in the time periods of 0-6 hours, 6-24 hours, and 24-48 hours after replacement were lower than those in the control group, and the differences were significant (P<0.05). There was no significant difference in the PONV incidence in the time period of 48-72 hours after surgery between the two groups (P>0.05), as shown in the following table.

[0108] Table 11 Comparison of PONV incidence between the two groups of patients n (%)

[0109]

[0110]

[0111] 3. Comparison of PONV severity between the two groups of patients

[0112] At 6h, 24h, and 48h after surgery, the degree of PONV in the treatment group was lighter than that in the control group, and the differences were statistically significant (P < 0.05), as shown in the following table.

[0113] Table 12 Comparison of PONV degree between the two groups of patients 6 hours after surgery

[0114]

[0115] Table 13 Comparison of PONV degree between the two groups of patients 24 hours after surgery

[0116]

[0117] Table 14 Comparison of PONV degree between the two groups of patients 48 hours after surgery

[0118]

[0119]

[0120] It can be seen from Tables 11 to 14 that the PONV incidence of patients taking the antiemetic mixture of Example 1 is significantly lower than that of patients not taking the antiemetic mixture, indicating that the Chinese medicine antiemetic mixture of Example 1 can improve the symptoms of anorexia, bloating, abdominal distension and nausea and vomiting in patients after orthopedic surgery after oral administration, and it has a faster onset of action, a lasting effect, and relatively small side effects.

[0121] Typical Cases

[0122] Liu, female, 72 years old, was diagnosed with right knee osteoarthritis (KOA) for more than 10 years. On March 7, 2022, she visited the outpatient clinic of our hospital due to worsening pain in the right knee and limited activity for 5 days. After physical examination and radiography by the outpatient physician, the weight-bearing X-ray of the right knee showed: severe degeneration of the right knee joint, swelling of the suprapatellar bursa, significant narrowing of the medial and lateral joint spaces, obvious sclerosis of the subchondral bone, a large number of osteophytes formed on the edge of the joint, and varus deformity of the right knee. The outpatient physician diagnosed "right knee osteoarthritis" and admitted the patient to the hospital. After admission, she underwent right total knee replacement (TKA). The patient refused to take antiemetic mixture before the operation. On the day of the operation, she developed nausea and vomiting. According to the WHO classification, she was classified as grade III. She was temporarily given symptomatic treatment with metoclopramide injection, which was relieved. On the first day after surgery, the patient still had nausea, which was WHO grade I, accompanied by loss of appetite, decreased food intake, dry mouth and bitter taste, heaviness, fatigue, abdominal distension, pale red tongue with white greasy coating, and soft pulse. The syndrome was diagnosed as spleen deficiency and dampness obstruction, and the treatment was to strengthen the spleen and remove dampness, and to reduce adverse reactions and stop vomiting. The patient was given anti-emetic mixture and was advised to take it frequently, 1 bottle cap each time (about 8-10mL), and the total daily dose reached 50mL. On the second day after surgery, the patient had no nausea and vomiting symptoms, and could eat well, without dry mouth and bitter taste, heaviness, abdominal distension, etc., and was classified as WHO grade 0.

[0123] The patient had undergone total knee replacement. He was older and had weak vital energy. The surgery further depleted vital energy, which hurt the spleen and stomach, causing imbalance in the ascending and descending of the spleen and stomach. He was unable to transport and transform, so he had nausea and vomiting, loss of appetite, reduced food intake, and fullness in the stomach and abdomen. The spleen is responsible for transporting and transforming water. If the spleen and stomach are abnormal, the body fluid cannot be transported upward, resulting in dry mouth. Water accumulates inside, which easily blocks the qi mechanism, so the body feels heavy and weak. The tongue is pale red with a greasy white coating and a moist pulse, which is a sign of spleen deficiency and dampness obstruction. It is treated with an anti-emetic mixture. In the prescription, Codonopsis pilosula and jujube strengthen the spleen and stomach; Atractylodes macrocephala generates yang energy in the stomach, stops vomiting and removes water; Magnolia officinalis removes dampness and relieves fullness; Pinellia ternata reduces adverse reactions and stops vomiting, removes dampness and resolves phlegm; Dried ginger warms the stomach and stops vomiting; Clove warms the middle and reduces adverse reactions and stops vomiting. The combination of these medicines complements each other and has the effects of strengthening the spleen and stomach, reducing adverse reactions and stopping vomiting, and removing dampness.

[0124] The above-mentioned embodiments are only preferred embodiments of the present invention and cannot be used to limit the scope of protection of the present invention. Any non-substantial changes and substitutions made by technicians in this field on the basis of the present invention shall fall within the scope of protection required by the present invention.

Claims

1. A Chinese herbal antiemetic mixture for preventing and treating postoperative nausea and vomiting, characterized in that: The Chinese medicine antiemetic mixture is composed of the following Chinese medicine ingredients by weight: 160-250 parts of Codonopsis pilosula, 160-250 parts of Pinellia ternata, 120-170 parts of Atractylodes lancea, 40-90 parts of Magnolia officinalis bark, 40-90 parts of Tangerine peel, 24-50 parts of Cloves, 40-90 parts of Roasted Licorice root, 48-90 parts of Black dates and 40-90 parts of Dry ginger.

2. The Chinese herbal antiemetic mixture for preventing and treating postoperative nausea and vomiting according to claim 1, characterized in that: The Chinese medicine antiemetic mixture is composed of the following Chinese medicine ingredients by weight: 240 parts of Codonopsis pilosula, 240 parts of Pinellia ternata, 160 parts of Atractylodes macrocephala, 80 parts of Magnolia officinalis bark, 80 parts of Tangerine peel, 40 parts of Cloves, 80 parts of Roasted Licorice, 80 parts of Black Dates and 80 parts of Dry Ginger.

3. The method for preparing the Chinese herbal antiemetic mixture for preventing and treating postoperative nausea and vomiting according to any one of claims 1 to 2, characterized in that: The following steps are involved: The Chinese medicinal ingredients are added into a solvent for extraction to obtain a Chinese medicinal extract, which is a Chinese medicinal antiemetic mixture for preventing and treating postoperative nausea and vomiting.

4. The method for preparing the Chinese medicine antiemetic mixture for preventing and treating postoperative nausea and vomiting as claimed in claim 3, characterized in that: First, the Chinese medicinal ingredients are decocted with water, filtered to obtain a filtrate, concentrated, boiled, and added with water to obtain a Chinese medicinal antiemetic mixture for preventing and treating postoperative nausea and vomiting.

5. The method for preparing the Chinese medicine antiemetic mixture for preventing and treating postoperative nausea and vomiting as claimed in claim 3, characterized in that: The Chinese herbal ingredients are decocted with water for 1 to 3 times, with 5 to 10 times the amount of water added each time, decocted for 0.5 to 2 hours, filtered, the filtrate is combined, concentrated under reduced pressure to 900 to 950 mL, refrigerated for 24 to 48 hours, filtered to obtain the filtrate, boiled and kept warm for 20 to 40 minutes, filtered and then added with water to 1000 to 2000 mL, stirred evenly, and packaged to obtain the Chinese herbal antiemetic mixture.

6. The method for preparing the Chinese medicine antiemetic mixture for preventing and treating postoperative nausea and vomiting as claimed in claim 4 or 5, characterized in that: After filtering to obtain the filtrate, sodium benzoate is added.

7. Use of the Chinese herbal antiemetic mixture for preventing and treating postoperative nausea and vomiting according to any one of claims 1 to 2, characterized in that: The Chinese herbal antiemetic mixture is used to prepare a product for preventing, treating and relieving the symptoms of nausea and vomiting after total knee replacement surgery, vomiting symptoms caused by radiotherapy and chemotherapy, and nausea and vomiting symptoms caused by drunkenness, motion sickness and seasickness.

8. Use of the Chinese herbal antiemetic mixture for preventing and treating postoperative nausea and vomiting according to claim 7, characterized in that: The dosage form of the product is solid preparation and / or liquid preparation.

9. Use of the Chinese herbal antiemetic mixture for preventing and treating postoperative nausea and vomiting as claimed in claim 8, characterized in that: The solid preparation is one or a combination of two or more of tablets, pills, capsules, and Chinese medicine powders; the liquid preparation is an oral solution and / or an injection solution.

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