A traditional Chinese medicine composition for treating epigastralgia syndrome and its use

Abstract

The present invention discloses a traditional Chinese medicine composition for treating epigastralgia syndrome and its use. By mass parts, it is composed of 13 - 17 parts of rose, 8 - 12 parts of costus root, 13 - 17 parts of cyperus rotundus, 8 - 12 parts of sandalwood, 4 - 6 parts of agarwood, 18 - 22 parts of white peony root, 8 - 12 parts of lindera aggregata, 13 - 17 parts of cuttlefish bone, 10 - 14 parts of curcuma aromatica and 5 - 7 parts of liquorice root; the traditional Chinese medicine raw materials of the present invention can be soaked in cold water, decocted for the first time and the second time, and the medicinal residues are filtered out to obtain the decoction, or it can be prepared into traditional Chinese medicine granules; the present invention uses syndrome differentiation of main symptoms, simplifies the complex, hits the key points of the disease, improves the accuracy of syndrome differentiation, obtains remarkable curative effects, and the total effective rates of syndromes and main symptoms can both reach more than 90%.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating upper abdominal pain syndrome and a use thereof. Background Art

[0002] Epigastric pain syndrome is a subtype of functional dyspepsia and a common clinical disease in gastroenterology. The incidence rate is 7% to 45%, with women being the main sufferers. In recent years, with the increasing complexity of people's living environment, the accelerated pace of life, irregular diet and increased mental and psychological pressure, the incidence rate of epigastric pain syndrome has continued to rise. According to literature records, functional dyspepsia has been publicly involved in 37 TCM syndromes, of which 8 syndromes appear most frequently (Liu Jing, Li Feng, Tang Xudong, et al. Modern clinical literature study on the syndrome differentiation criteria of functional dyspepsia [J]. World Traditional Chinese Medicine, 2015.10(1):56-59).

[0003] Modern medicine believes that functional gastrointestinal diseases may be related to many factors, such as changes in gastric acid secretion, gastrointestinal motility disorders, abnormal visceral sensitivity, changes in gastrointestinal hormones, abnormal brain-gut axis function, psychological disorders, Helicobacter pylori infection, etc. Epigastric pain syndrome is mainly characterized by pain in the middle and upper abdomen or burning discomfort in the middle and upper abdomen. Routine examinations, including gastrointestinal endoscopy, have not found any organic, systemic or metabolic evidence that can explain the above symptoms. Combined with clinical symptoms, it belongs to the category of epigastric pain in traditional Chinese medicine. Some studies (Wu Xiuxia, Li Xian, Professor Liu Gaoren and Li Xian's experience in the diagnosis and treatment of epigastric pain [J]. Journal of Clinical Research in Traditional Chinese Medicine, 2020, 12(14): 57-59) mainly treat epigastric pain from five syndromes: cold evil invading the stomach, liver-stomach disharmony, liver-stomach stagnation and heat, mixed cold and heat, and food stagnation in the stomach and intestines. Indeed, in clinical practice, epigastric pain syndrome is accompanied by a variety of symptoms, such as postprandial bloating, belching, nausea, and vomiting in the middle and upper abdomen. Therefore, there are many syndromes that make people confused, the efficacy is difficult to guarantee, and the accuracy of treatment is low. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicine composition for treating upper abdominal pain syndrome, which identifies the basic pathogenesis of the main symptom based on the principle of main symptom differentiation, and then determines the treatment method based on the basic pathogenesis, and then prescribes and uses medicines to achieve accurate treatment and obtain significant therapeutic effects.

[0005] The technical solution adopted by the present invention provides a traditional Chinese medicine composition for treating upper abdominal pain syndrome. The key is that, calculated by weight, the traditional Chinese medicine composition comprises 13 to 17 parts of rose flowers, 8 to 12 parts of costusroot, 13 to 17 parts of cyperus rotundus, 8 to 12 parts of santalin, 4 to 6 parts of agarwood, 18 to 22 parts of white peony root, 8 to 12 parts of lindera stalk, 13 to 17 parts of cuttlebone, 10 to 14 parts of curcuma and 5 to 7 parts of liquorice.

[0006] Preferably, the above traditional Chinese medicine composition for treating epigastralgia syndrome is composed of 15 parts by mass of rose, 10 parts of costus root, 15 parts of cyperus rotundus, 10 parts of sandalwood, 5 parts of agalwood, 20 parts of white peony root, 10 parts of lindera aggregata, 15 parts of cuttlefish bone, 12 parts of turmeric root-tuber and 6 parts of liquorice root.

[0007] Further, the above traditional Chinese medicine composition is soaked in cold water for 40 min to 80 min, decocted with slow fire for 25 min to 35 min for the first decoction and 20 min to 25 min for the second decoction starting from boiling, the medicinal residues are filtered off to obtain the decoction, and it is taken orally twice a day, in the morning and evening.

[0008] The use of a traditional Chinese medicine composition for treating epigastralgia syndrome lies in that by determining that the basic pathogenesis of epigastralgia syndrome is stagnation of liver qi and spleen stagnation, it is used to treat epigastralgia syndrome.

[0009] Compared with the prior art, the present invention has the following beneficial effects:

[0010] The present invention conducts in-depth analysis of the etiology and pathogenesis of epigastralgia syndrome, and uses syndrome differentiation based on the main symptoms, simplifies the complex, hits the key points of the disease, improves the accuracy of syndrome differentiation, and obtains remarkable curative effects.

[0011] Syndrome differentiation based on the main symptoms is different from other syndrome differentiations. The disease is regarded as a unity of contradictions. No matter how many and how complicated the symptoms are, grasping the main symptoms is equivalent to grasping the key minority and the key link. By grasping the main symptoms and conducting syndrome differentiation and treatment around the characteristics of the occurrence and change of the main symptoms, the accuracy will be greatly improved, and the clinical curative effect will naturally be improved. Through syndrome differentiation based on the main symptoms, it is easiest to find the basic pathogenesis. The main symptoms of epigastralgia syndrome are epigastralgia and epigastric burning sensation, and its characteristics are chronic or recurrent, and usually accompanied by mental and psychological problems, common anxiety and depressive emotions. Periodicity, recurrence and being related to spirit, psychology and emotion are the characteristics of the main symptoms. This is related to the fierce social competition, increased pressure, accelerated life rhythm and disrupted life rhythm in modern life, which are likely to cause emotions such as anger and inequality. Liver qi stagnation, excessive liver fire, hyperactivity of the liver attacking the spleen and stomach horizontally, resulting in abnormal ascending and descending of the spleen and stomach and stagnation of the qi mechanism of the triple energizer.

[0012] At the same time, due to the large amount of social information obtained, it is easy to produce admiration for the high and envy for the low, excessive thinking and being unable to extricate oneself, resulting in anxiety and depression, interfering with the functions of the zang-fu organs. Overthinking causes qi stagnation, stagnation of the spleen qi, failure of the spleen and stomach to ascend and descend properly, and obstruction of the qi movement in the fu organs. Therefore, the characteristics of the main symptoms of epigastralgia syndrome cannot be explained by "pain due to deficiency", and "pain due to deficiency" should be persistent symptoms. The characteristics of the main symptoms conform to "pain due to obstruction". Therefore, when the qi mechanism is unobstructed, the symptoms will disappear, and there may even be no symptoms for several days. The relationship between the emotional ups and downs and the severity of the symptoms is also very clear.

[0013] Based on the recurrent and non-persistent characteristics of epigastric pain syndrome, which is related to emotional changes, the present invention believes that liver depression and spleen stagnation are the basic pathogenesis of epigastric pain syndrome.

[0014] It is recorded in "Classified Treatises of Syndromes" that "the liver is a strong organ responsible for dredging and discharging. When using medicine, it is not easy to be rigid but easy to be gentle, not easy to attack but easy to harmonize". This discussion gives the fundamental guidance on how to select medicine when soothing liver depression; as for invigorating the spleen, it is based on the relevant discussions of the ancients on treating spleen qi stagnation, such as "aromatic substances can relieve spleen depression" in "Compendium of Materia Medica" and "qi being fragrant can wake up the spleen" in "Medical Records of Combining Chinese and Western Medicine", that is, using aromatic drugs to stimulate the spleen qi and relieve spleen qi stagnation. According to "treating diseases must seek the root cause", the basic pathogenesis of functional epigastric pain syndrome is liver depression and spleen stagnation. The present invention treats epigastric pain syndrome by the method of soothing the liver and invigorating the spleen, and the effect is remarkable. The total effective rates of syndromes and main symptoms can both reach more than 90%.

[0015] Explanation of the formula of the present invention: Rose is the main drug for soothing the liver and invigorating the spleen. It is recorded in "The Righteousness of Materia Medica" that "the fragrance of rose is the strongest, clear but not turbid, gentle but not violent, soothing the liver and waking the stomach, promoting qi and activating blood circulation, dredging stasis without any disadvantages of pungent-warm and rigid drugs. Among qi-regulating drugs, it is the most effective and gentle one, and among aromatic substances, it is almost unrivaled". It is recorded in "Seeking Truth from Materia Medica" that "costus root can descend qi and soothe the middle-jiao, and is an important drug for qi in the three energizers. However, among the three energizers, the middle-jiao is the most important... when the middle-jiao is soothed, the upper and lower parts are both unobstructed, so it is called an important agent for dredging stagnation in the three energizers". It is recorded in "Materia Medica for Compatibility" that Cyperus rotundus "combined with Aquilaria sinensis can regulate qi in all directions. Combined with Santalum album, it can regulate qi and invigorate the spleen". Both Cyperus rotundus and costus root are important drugs for promoting qi and relieving pain. Cyperus rotundus, costus root, Aquilaria sinensis, and Santalum album all have the record of invigorating the spleen in the literature, and can assist rose in soothing the liver and invigorating the spleen to relieve pain, and they are all assistant drugs. White peony root soothes the liver and relieves pain and also nourishes yin to prevent excessive consumption of yin due to too many aromatic and dry drugs; Lindera aggregata and Curcuma aromatica promote qi and relieve pain; Endoconcha Sepiae can relieve acid regurgitation and pain, which is most effective for epigastric burning sensation; these four drugs are all adjuvant drugs. Licorice combined with peony root forms the famous Shaoyao Gancao Decoction, which has a good effect of relieving smooth muscle spasm and relieving abdominal pain, and licorice also harmonizes all the drugs and is the guiding drug. The combination of all the drugs implements the method of soothing the liver and invigorating the spleen, can soothe the liver nature, relieve liver depression, promote spleen stagnation, raise and lower the spleen and stomach, dredge the three energizers, make the qi mechanism smooth, and can treat epigastric pain and epigastric burning. According to clinical research, it is found that after applying the present invention, along with the elimination of the main symptoms, accompanying symptoms such as belching, loss of appetite, nausea, etc. often disappear. Detailed implementation mode

[0016] The present invention provides a traditional Chinese medicine composition for treating epigastric pain syndrome and its use. The technical solutions in the embodiments of the present invention are clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0017] Example 1

[0018] A traditional Chinese medicine composition for treating upper abdominal pain syndrome is composed of the following traditional Chinese medicines: 15g of rose, 10g of costusroot, 15g of cyperus, 10g of santalin, 5g of agarwood, 20g of white peony, 10g of lindera, 15g of cuttlebone, 12g of curcuma and 6g of liquorice.

[0019] Soak the above Chinese medicinal materials in cold water for 60 minutes, and then simmer them on low heat from the moment the pot boils, i.e. the first decocting time is 30 minutes; the second decocting time is 20 minutes, and a total of 300 mL of juice is collected, which is called "Ganrouxinpixiang Mixture".

[0020] Take orally twice a day, morning and evening. One course of treatment is four weeks.

[0021] Embodiment 2

[0022] A traditional Chinese medicine composition for treating upper abdominal pain syndrome is composed of the following traditional Chinese medicines: 13g of rose flower, 12g of costusroot, 17g of cyperus rotundus, 8g of santalin, 4g of agarwood, 24g of white peony root, 8g of lindera stigma, 17g of cuttlebone, 14g of curcuma and 7g of liquorice.

[0023] Soak the above Chinese medicinal materials in cold water for 80 minutes, and simmer over low heat for the first 25 minutes from the moment the pot boils; simmer for the second 25 minutes, and take 320 mL of juice in total.

[0024] Take orally twice a day, morning and evening. One course of treatment is four weeks.

[0025] Embodiment 3

[0026] A traditional Chinese medicine composition for treating upper abdominal pain syndrome is composed of the following traditional Chinese medicines: 17g of rose, 8g of costusroot, 13g of cyperus, 12g of santalin, 6g of agarwood, 18g of white peony, 12g of lindera, 13g of cuttlebone, 10g of curcuma and 5g of liquorice.

[0027] Soak the above Chinese medicinal materials in cold water for 40 minutes, and simmer over low heat from the moment the pot boils, i.e., the first decoction is 35 minutes; the second decoction is 23 minutes, and a total of 295 mL of juice is obtained.

[0028] Take orally twice a day, morning and evening. One course of treatment is four weeks.

[0029] Embodiment 4

[0030] A traditional Chinese medicine composition for treating upper abdominal pain syndrome consists of the following traditional Chinese medicines, measured by mass: 15 parts of rose flowers, 10 parts of costusroot, 15 parts of cyperus rotundus, 10 parts of santalin, 5 parts of agarwood, 20 parts of white peony, 10 parts of lindera, 15 parts of cuttlebone, 12 parts of curcuma and 6 parts of liquorice.

[0031] Weigh the traditional Chinese medicine raw materials according to the above ratio, crush them for standby; add 2 times the amount of water, soak for 4 hours, reflux extract 4 times, filter by suction, obtain the concentrated solution, add dextrin and stir evenly, spray dry, and obtain the traditional Chinese medicine granules by dry granulation.

[0032] Next, the effects of the traditional Chinese medicine composition for treating epigastralgia syndrome provided by the present invention will be described.

[0033] 1. General information

[0034] 120 patients with epigastralgia syndrome were randomly divided into groups, with 60 cases in the treatment group and 60 cases in the control group. There were 27 males and 33 females in the treatment group, with an average age of 36.3 years and an average disease course of 31.5 months; there were 26 males and 34 females in the control group, with an average age of 35.1 years and an average disease course of 29.3 months. The clinical data of the two groups of patients were statistically processed and there was no significant difference, so they were judged to be comparable.

[0035] 2. Diagnostic and exclusion criteria

[0036] 2.1 Diagnostic criteria

[0037] According to the diagnostic criteria of functional epigastralgia syndrome in Rome IV functional gastrointestinal diseases, it must include one or both of the following, and at least one day per week:

[0038] (1) Epigastralgia in the middle and upper abdomen, which affects daily activities.

[0039] (2) Burning discomfort in the middle and upper abdomen, which affects daily activities.

[0040] No evidence of organic, systemic or metabolic diseases that can explain the above symptoms was found in routine examinations (including gastroscopy).

[0041] 2.2 Efficacy evaluation and judgment criteria

[0042] According to the judgment criteria for new traditional Chinese medicine in the "Guidelines for Clinical Research of New Traditional Chinese Medicine" for treating the syndrome of disharmony between the liver and stomach, the changes in scores before and after treatment were statistically analyzed. Calculated according to the Nimodipine method, the calculation formula is: [(score before treatment - score after treatment) ÷ score before treatment] × 100%.

[0043] 2.2.1 Syndrome efficacy judgment criteria

[0044] (1) Clinical cure: Symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥ 95%.

[0045] (2) Marked effect: Symptoms and signs are significantly improved, and the syndrome score decreases by ≥ 70%.

[0046] (3) Effective: Symptoms and signs are both improved, and the syndrome score decreases by ≥ 30%.

[0047] (4) Ineffective: There is no obvious improvement or even aggravation in symptoms and signs, and the reduction of syndrome score is less than 30%.

[0048] 2.2.2 Evaluation of the curative effect of main symptoms

[0049] (1) Clinical cure: The main symptoms disappear or basically disappear, and the score reduction is ≥ 95%.

[0050] (2) Marked: The reduction of the main symptom score is ≥ 70%.

[0051] (3) Effective: The reduction of the main symptom score is ≥ 30%.

[0052] (4) Ineffective: The reduction of the main symptom score is less than 30%.

[0053] 2.2.3 Statistical methods

[0054] Statistical analysis was performed using the medical statistical software SPSS 22.0. Among them, t-tests and X 2 tests were used for measurement data and count data respectively. P < 0.05 indicates significant differences, showing statistical significance.

[0055] 3. Treatment methods

[0056] The treatment group was administered the Rougan Xingpi Mixture described in Example 1 of the present invention, 150 mL each time, twice a day, half an hour before breakfast and dinner.

[0057] The control group was administered Trimebutine Maleate Tablets, one tablet (0.1 g / tablet) each time, three times a day, half an hour before meals.

[0058] Both the treatment group and the control group had a treatment course of 4 weeks, and the symptoms were scored before and after treatment.

[0059] 4. Treatment results

[0060] After 4 weeks of treatment, the total effective rates of syndromes and main symptoms were analyzed respectively.

[0061] (1) The total effective rate of syndromes in the treatment group was 90%, and that in the control group was 68%. It can be seen that the treatment group was superior to the control group. Using t-tests and X 2 tests, the results showed *P < 0.05, indicating significant statistical results. The specific results are shown in Table 1.

[0062] Table 1: Comparison of the curative effects of traditional Chinese medicine syndromes after treatment

[0063] Group Number of cases Clinical cure Marked improvement Effective Ineffective Dropout Total effective rate Treatment group 60 cases 33 cases 13 cases 8 cases 6 cases 0 cases 90％ Control group 60 cases 20 cases 11 cases 9 cases 19 cases 1 case 68％

[0064] (2) The total effective rate of the main symptoms in the treatment group was 92%, and the total effective rate of the main symptoms in the control group was 64%. It can be seen that the treatment group was superior to the control group. Using t-tests and X2 The test results showed that *P < 0.05, indicating that the statistical results were significant. For specific results, see Table 2.

[0065] Table 2 Comparison of Efficacy of Main Symptoms after Treatment

[0066] Group Number of cases Clinical control Marked progress Progress Ineffective Dropout Total effective rate Treatment group 60 cases 35 cases 14 cases 6 cases 5 cases 0 cases 92％ Control group 60 cases 19 cases 10 cases 9 cases 21 cases 1 case 64％

[0067] In the clinical trial, all cases in the treatment group completed the clinical trial, and 1 case in the control group dropped out due to ineffective medication after two weeks and stopped taking the medicine on their own. When calculating the total effective rate, the dropped cases were excluded. The total number of cases in the control group was calculated as 59 cases. The total effective rate = [(number of clinically cured / clinically controlled cases + markedly effective / significantly improved cases + effective / improved cases)] ÷ total number of cases × 100%.

[0068] In summary, after 4 weeks of treatment, the total effective rates of syndromes and main symptoms in the treatment group were higher than those in the control group, and both could reach over 90%.

Claims

1. A traditional Chinese medicine composition for treating epigastralgia syndrome, characterized in that, by mass parts, it is composed of 13 - 17 parts of rose, 8 - 12 parts of costus root, 13 - 17 parts of cyperus rotundus, 8 - 12 parts of sandalwood, 4 - 6 parts of agarwood, 18 - 22 parts of white peony root, 8 - 12 parts of lindera aggregata, 13 - 17 parts of cuttlebone, 10 - 14 parts of turmeric and 5 - 7 parts of licorice.

2. The traditional Chinese medicine composition for treating epigastralgia syndrome according to claim 1, characterized in that, by mass parts, it is composed of 15 parts of rose, 10 parts of costus root, 15 parts of cyperus rotundus, 10 parts of sandalwood, 5 parts of agarwood, 20 parts of white peony root, 10 parts of lindera aggregata, 15 parts of cuttlebone, 12 parts of turmeric and 6 parts of licorice.

3. The traditional Chinese medicine composition for treating epigastralgia syndrome according to claim 1, characterized in that, soak the traditional Chinese medicine composition in cold water for 40 min - 80 min, decoct it with slow fire for the first time for 25 min - 35 min and for the second time for 20 min - 25 min starting from boiling, filter out the medicinal residues to obtain the decoction, and take it orally twice a day, in the morning and evening.