Compound berberine tablet and preparation method thereof

Abstract

The compound berberine tablet is prepared from the following traditional Chinese medicine decoction piece extracts in parts by weight and berberine compatibility: 10-20 parts of cassia twig, 8-12 parts of radix angelicae pubescentis, 15-25 parts of baked ginger, 12-18 parts of radix angelicae, 8-12 parts of wrinkled gianthyssop herb, 10-20 parts of ginseng, 15-25 parts of rhizoma atractylodis macrocephalae, 10-20 parts of poria cocos and the like, and is prepared by the following steps: extracting with water by a steam distillation method, adding berberine, adding starch, granulating, finishing the granules, adding magnesium stearate, and preparing the compound berberine tablet. The tablets can be used for treating the cold-dampness type dysentery.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine preparations, and in particular to a compound berberine tablet and a preparation method thereof. Background Art

[0002] Compound berberine tablets contain 30g berberine hydrochloride, 116g costusroot, 40g evodia rutaecarpa, and 162g white peony root. Berberine hydrochloride is the main drug in the prescription, which is an effective medicine for treating dysentery. It is supplemented with costusroot and white peony root to promote qi and relieve pain, relieve umbilical pain and tenesmus in dysentery; it is supplemented with evodia rutaecarpa to warm the middle and dispel cold, and it is used to control the bitterness and coldness of coptis root. The combination of these medicines has the functions of clearing intestinal heat, promoting qi and relieving urgency, relieving pain and stopping diarrhea. Compound berberine tablets are heat-clearing agents, which have the functions of clearing heat and drying dampness, promoting qi and relieving pain, stopping dysentery and stopping diarrhea. It is mainly used to treat damp-heat in the large intestine, red and white dysentery, tenesmus or violent diarrhea, and burning anus; enteritis and dysentery with the above symptoms. It can be seen that compound berberine tablets are mainly used for damp-heat type dysentery.

[0003] Dysentery is characterized by red and white pus and blood in the stool, abdominal pain, and tenesmus. The main causes are exogenous pathogenic pathogens and toxins, and internal injuries caused by unclean diet. The disease is located in the intestines and is closely related to the spleen and stomach. The pathogenesis is that damp heat, toxins, and cold dampness are accumulated in the intestines, qi and blood are stagnant, the lipid membrane and blood vessels are damaged, and pus and blood are transformed, and the large intestine conduction is dysfunctional, resulting in dysentery. Sudden dysentery is mostly a positive syndrome, while chronic dysentery is mostly a deficiency syndrome. Dysentery is located in the large intestine, which is related to the spleen and stomach and may involve the kidneys. The pathological factors are mainly damp heat and toxins, and the pathological properties are divided into cold, heat, deficiency, and excess. The basic pathogenesis is that the evil accumulates in the intestines, qi and blood are stagnant, conduction is dysfunctional, and lipid vessels are damaged to form dysentery. Pathological properties: In the early stage, it is mostly a positive syndrome, caused by damp heat or cold dampness. As diarrhea lasts for a long time, it can turn from excess to deficiency or a mixture of deficiency and excess. Pathological evolution: damp heat and toxins invade the inside, the toxins are strong inside, the intestines are fumigated, and qi and blood are damaged, which is dysentery caused by toxins. If dysentery is not treated properly, it will linger for a long time, or it will be cured too early, which will lead to the entrapment of pathogens and the development of intermittent dysentery. Due to the change of lifestyle, modern people like to eat cold drinks, and more and more patients suffer from cold-damp dysentery, but compound berberine tablets cannot play a good role.

[0004] CN115969906A provides a Chinese medicine composition for treating diarrhea, enteritis and dysentery, which is prepared from Herba Agrimoniae and Herba Phyllanthae in a ratio of 1:1. The preparation method of the Chinese medicine composition comprises the following steps: mixing Herba Agrimoniae and Herba Phyllanthae in a ratio of 1:1, grinding into powder, and obtaining a mixed powder; passing the mixed powder through a 60-mesh sieve to obtain the Chinese medicine composition. The present invention can solve the problems of the complicated Chinese medicine formula for treating intestinal inflammation and the slow effect in the prior art. However, no Chinese medicine syndrome differentiation and typing of dysentery is performed.

[0005] CN113499386A discloses a Chinese medicine granule for treating bacillary dysentery and a preparation method thereof, wherein the mixture is prepared from the following raw materials in parts by weight: 13 parts of Pulsatillae Radix, 6 parts of White Peony Root, 5 parts of Raw Licorice, 5 parts of Coptis Root, 12 parts of Poria, 8 parts of Fragrant Cortex, 6 parts of Scutellariae Radix, 12 parts of Portulaca Oleracea, 6 parts of Cortex Moutan, 12 parts of Honeysuckle, 6 parts of Aucklandiae Radix, 5 parts of Citrus Reticulatae, 9 parts of Citrus Reticulatae, 2 parts of Jujube, 6 parts of Citrus Aurantii Immaturus, 6 parts of Radish Seed, 9 parts of Phellodendron Amurense, 16 parts of Patriniae Herba, and 10 parts of Forsythiae Fructus. The medicine of the present invention is based on the principle of traditional Chinese medicine for treating bacillary dysentery, and the Chinese medicine granule of the present invention has a good therapeutic effect on fever, abdominal pain, diarrhea, tenesmus, and mucus, pus, and blood in stool caused by bacillary dysentery, is safe, has no toxic side effects, is easy to take, has a short course of treatment, and is effective quickly. The invention has no clinical data, only individual cases, and cannot solve the problem of treating cold-damp type dysentery. Summary of the invention

[0006] In view of the problems raised by the background technology, the purpose of the present invention is to provide a compound berberine tablet, which has the effects of warming and removing cold and dampness, promoting qi and blood circulation, and has obvious effects on cold and dampness type dysentery.

[0007] The second purpose of the present invention is to propose a method for preparing a compound berberine tablet, which is used to prepare the above-mentioned compound berberine tablet. The preparation process of the compound berberine tablet of the present invention is simple, the production time is short, and it can effectively improve production efficiency and achieve energy saving and consumption reduction.

[0008] To achieve this object, the present invention adopts the following technical solutions:

[0009] A compound berberine tablet is prepared by extracting the following Chinese medicinal pieces in parts by weight and mixing with berberine: 10-20 parts of cassia twig, 8-12 parts of angelica dahurica, 15-25 parts of roasted ginger, 12-18 parts of angelica dahurica, 8-12 parts of patchouli, 10-20 parts of ginseng, 15-25 parts of atractylodes macrocephala, 10-20 parts of tuckahoe, 8-12 parts of white peony root, 8-12 parts of cyperus rotundus, 10-20 parts of oriental water plantain, 15-25 parts of coix seed, 10-20 parts of umbelliferae, 8-12 parts of cornus officinalis, 10-20 parts of rehmannia root, 10-20 parts of fructus aurantii, 8-12 parts of costusroot, 15-25 parts of dried tangerine peel, 10-20 parts of angelica sinensis, 12-18 parts of ligusticum chuanxiong and 30 parts of berberine.

[0010] Furthermore, the compound berberine tablets are prepared by extracting the following Chinese herbal medicine pieces in parts by weight and combining them with berberine: 15 parts of cinnamon twig, 10 parts of angelica dahurica, 20 parts of dried ginger, 15 parts of angelica dahurica, 10 parts of patchouli, 15 parts of ginseng, 20 parts of atractylodes macrocephala, 15 parts of poria, 10 parts of white peony root, 10 parts of cyperus rotundus, 15 parts of oriental water plantain, 20 parts of coix seed, 15 parts of umbellate, 10 parts of cornus officinalis, 15 parts of rehmannia root, 15 parts of fructus aurantii, 10 parts of costus root, 20 parts of tangerine peel, 15 parts of angelica sinensis, 15 parts of ligusticum chuanxiong, and 30 parts of berberine.

[0011] Furthermore, the preparation method of the compound berberine tablets comprises the following steps:

[0012] (1) Extract volatile oil from roasted ginger, Patchouli, Cyperus rotundus, Fructus Aurantii Immaturus, Aucklandia lappa, Pericarpium Citri Reticulatae, Angelica Sinensis, and Rhizoma Chuanxiong by steam distillation, and include the mixture with cyclodextrin to obtain a volatile oil inclusion compound;

[0013] (2) mixing the residue after preparing volatile oil in step (1) with other Chinese medicinal pieces, adding aromatic water extracted by steam distillation, adding water to 10 times the weight of all the Chinese medicinal pieces, decocting for 2 hours, filtering, decocting the residue again with water, adding water in an amount of 10 times the weight of all the Chinese medicinal pieces, decocting for 1 hour, filtering, combining the two decoctions, concentrating to a relative density of 1.2-1.3 at 25° C., and obtaining an extract;

[0014] (3) The volatile oil inclusion compound obtained in step (1) and the extract obtained in step (2) are mixed, berberine is added, and starch is added to granulate the granules. Magnesium stearate is added and tablets are pressed. Each tablet weighs 0.5 g and contains 30 mg berberine.

[0015] Furthermore, the relative density of the compound berberine tablets when concentrated to 25° C. in step (2) of the preparation method is 1.25.

[0016] The third purpose of the present invention is to propose the use of the compound berberine tablets in the preparation of medicines for cold-dampness type dysentery.

[0017] Symptoms of cold-damp dysentery: abdominal pain and cramps, red, white, sticky and frozen stool, more white and less red, or pure white and frozen stool, tenesmus, tasteless mouth, fullness in the middle abdomen without thirst, heaviness in the head and fatigue, clear urine, pale tongue, greasy white fur, and slow pulse. It may also be accompanied by external symptoms such as aversion to cold, body pain, fever, no sweating, and floating pulse.

[0018] The main pathogenesis of cold-damp dysentery is that qi and blood stagnate, body fluid in the intestines stagnates, transportation and transformation are abnormal, and conduction is dysfunctional. "Compendium of Materia Medica" records that cinnamon twig: "It treats all wind-cold and rheumatism, joint spasms and pains, relaxes muscles and opens pores, suppresses liver qi, supports spleen and earth, and irons yin numbness." Therefore, cinnamon twig, angelica dahurica, and roasted ginger are used to warm and transform cold and dampness. "Discussion on the Spleen and Stomach: The Principle of the Life and Death of Yin and Yang in Heaven and Earth in the Theory of Rising and Falling" says: "Food enters the stomach, and the essence is first transported to the spleen and lungs, and then goes up in spring and summer to nourish the whole body. It is the clear air that is the sky." If the spleen cannot ascend, the essence of water and grain cannot be transported to the heart and lungs to nourish the internal organs and tissues. This is often seen with spleen deficiency and is one of the mechanisms of spleen deficiency and dysfunction. In severe cases, the Qi is trapped downwards. In addition to the general symptoms of spleen deficiency, dampness blocks the spleen yang, and the Qi cannot rise. Spleen deficiency produces dampness, and deficiency causes stagnation, which affects the spleen's transportation and transformation. Angelica dahurica and Patchouli are also needed to raise the clear Qi. Cinnamon twig, Duhuo, Paojiang, Angelica dahurica, and Patchouli are used as the main drugs.

[0019] Cold and dampness block the spleen and stomach, Yang Qi is suppressed, and transportation and transformation are abnormal, so the mouth is tasteless and dull, and the middle abdomen is stuffy. The head is heavy and the body is tired. The urine is clear and white, the tongue is white and greasy, and the pulse is soft and slow, which are all signs of excessive cold and dampness. Ginseng, Atractylodes macrocephala, and Poria cocos are used to move the spleen and dry dampness, and white peony root and Cyperus rotundus are used to suppress the liver and support the spleen. Ginseng, Atractylodes macrocephala, Poria cocos, white peony root, and Cyperus rotundus are all ministerial drugs;

[0020] Cold condenses body fluids, and dampness damages the qi, so there is white frost in diarrhea, or more white and less red. Alisma, coix seed, and Polyporus are also needed to promote diuresis and eliminate dampness. "Medical Essential Reading: Dysentery" says: "The spleen is the foundation of the acquired constitution, and the kidney is the foundation of the innate constitution." Long-term dysentery that does not heal will inevitably damage the spleen and stomach, and then the kidney. Dysentery caused by cold and dampness can easily undermine the middle yang, and eventually cause the decline of the fire of the life gate; dysentery caused by dampness and heat can easily consume body fluids, resulting in kidney yin deficiency. In addition, people who usually work too much or have insufficient endowment and weak spleen and kidney are also affected by cold and dampness, or take too much cold and cool laxatives because of dysentery, which often weakens the yang qi and causes cold dysentery. Zhang Jingyue's saying "People with weak spleen and kidney are very likely to suffer from dysentery if they are exposed to raw and cold food" refers to this. Therefore, Cornus officinalis and Rehmannia glutinosa are used to nourish the kidney, and Alisma, coix seed, Polyporus glutinosa, Cornus officinalis, and Rehmannia glutinosa are used as adjuvants;

[0021] Coldness is the main cause of contraction, qi stagnation and blood stagnation, so it causes abdominal pain and urgency. Qi stagnation and dampness obstruction, diarrhea is not smooth, so it causes heaviness in the lower back. Use Citrus aurantium, costus root, dried orange peel, to promote qi, angelica, Chuanxiong to harmonize blood, Citrus aurantium, costus root, dried orange peel, angelica, Chuanxiong as the guiding drugs.

[0022] In addition, berberine is added, which is a quaternary ammonium alkaloid isolated from the traditional Chinese medicine Coptis chinensis and is the main active ingredient of Coptis chinensis for antibacterial effect. Berberine has antibacterial effects on hemolytic streptococci, Staphylococcus aureus, gonococci, and Shigella dysenteriae, and enhances the phagocytic effect of leukocytes. It also has varying degrees of inhibitory effects on tuberculosis and plague bacteria, and also has inhibitory effects on ameba in rats. Berberine has an anti-curare effect in animals and has peripheral antihypertensive and antipyretic effects. Berberine hydrochloride (commonly known as berberine hydrochloride) has been widely used to treat gastroenteritis, bacillary dysentery, etc., and also has certain effects on tuberculosis, scarlet fever, acute tonsillitis and respiratory tract infections.

[0023] The invention contains cassia twig, angelica dahurica, roasted ginger, angelica dahurica, patchouli, ginseng, atractylodes macrocephala, tuckahoe, white peony root, cyperus rotundus, oriental water plantain, coix seed, umbellate, cornus officinalis, rehmannia glutinosa, fructus aurantii, costusroot, tangerine peel, angelica sinensis, ligusticum chuanxiong and berberine, and achieves the purpose of treating cold-damp type dysentery by warming and transforming cold-dampness, raising clear qi, moving the spleen and drying dampness, suppressing the liver and supporting the spleen, promoting diuresis and eliminating dampness, tonifying the kidney, promoting qi and harmonizing blood.

[0024] The present invention combines its own understanding of the core pathogenesis of cold-damp dysentery to provide a Chinese medicine compound preparation with the functions of warming and transforming cold and dampness, ascending clear qi, moving the spleen and drying dampness, etc. It has been confirmed through clinical application and pharmacological research that it can be used to improve the clinical symptoms of patients, shorten the disappearance time of abdominal pain, diarrhea and tenesmus, and improve the quality of life of patients. It has definite therapeutic effect and significant effect.

[0025] The raw materials used in the Chinese medicine composition of the present invention are cheap, the preparation is simple, the use is convenient, the side effects are small, and it can be taken for a long time. After many years of clinical application and observation and analysis, the composition has good clinical efficacy in treating cold-damp type dysentery. The Chinese medicine composition and compound preparation provided by the present invention have good application prospects. DETAILED DESCRIPTION

[0026] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content of the present invention, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms fall within the scope limited by the appended claims of the application equally.

[0027] Example 1: Take 15g of cinnamon twig, 10g of angelica dahurica, 20g of roasted ginger, 15g of angelica dahurica, 10g of patchouli, 15g of ginseng, 20g of atractylodes macrocephala, 15g of tuckahoe, 10g of white peony root, 10g of cyperus rotundus, 15g of oriental water plantain, 20g of coix seed, 15g of umbellate, 10g of cornus officinalis, 15g of prepared rehmannia, 15g of fructus aurantii, 10g of costusroot, 20g of dried tangerine peel, 15g of angelica sinensis, 15g of ligusticum chuanxiong, and 30g of berberine, and the preparation method comprises the following steps:

[0028] (1) Extract volatile oil from roasted ginger, Patchouli, Cyperus rotundus, Fructus Aurantii Immaturus, Aucklandia lappa, Pericarpium Citri Reticulatae, Angelica Sinensis, and Rhizoma Chuanxiong by steam distillation, and include the mixture with cyclodextrin to obtain a volatile oil inclusion compound;

[0029] (2) mixing the residue after preparing volatile oil in step (1) with other Chinese medicinal pieces, adding aromatic water extracted by steam distillation, adding water to 10 times the weight of all the Chinese medicinal pieces, decocting for 2 hours, filtering, decocting the residue again with water, adding water in an amount of 10 times the weight of all the Chinese medicinal pieces, decocting for 1 hour, filtering, combining the two decoctions, concentrating to a relative density of 1.25 at 25° C., and obtaining an extract;

[0030] (3) The volatile oil inclusion compound obtained in step (1) and the extract obtained in step (2) are mixed, berberine is added, and starch is added to granulate the granules. Magnesium stearate is added and tabletted to prepare 1000 compound berberine tablets, each weighing 0.5 g and containing 30 mg berberine.

[0031] Example 2: Take 10g of cinnamon twig, 12g of angelica dahurica, 15g of roasted ginger, 18g of angelica dahurica, 8g of patchouli, 20g of ginseng, 15g of atractylodes macrocephala, 20g of Poria, 8g of white peony root, 12g of cyperus rotundus, 10g of oriental water plantain, 25g of coix seed, 10g of umbellate, 12g of cornus officinalis, 10g of prepared rehmannia, 20g of fructus aurantii, 8g of costusroot, 25g of dried orange peel, 10g of angelica sinensis, 18g of ligusticum chuanxiong, and 30g of berberine, and the preparation method comprises the following steps:

[0032] (1) Extract volatile oil from roasted ginger, Patchouli, Cyperus rotundus, Fructus Aurantii Immaturus, Aucklandia lappa, Pericarpium Citri Reticulatae, Angelica Sinensis, and Rhizoma Chuanxiong by steam distillation, and include the mixture with cyclodextrin to obtain a volatile oil inclusion compound;

[0033] (2) mixing the residue after preparing the volatile oil in step (1) with other Chinese medicinal pieces, adding aromatic water extracted by steam distillation, adding water to 10 times the weight of all the Chinese medicinal pieces, decocting for 2 hours, filtering, decocting the residue again with water, adding water in an amount of 10 times the weight of all the Chinese medicinal pieces, decocting for 1 hour, filtering, combining the two decoctions, concentrating to a relative density of 1.20 at 25° C., and obtaining an extract;

[0034] (3) The volatile oil inclusion compound obtained in step (1) and the extract obtained in step (2) are mixed, berberine is added, and starch is added to granulate the granules. Magnesium stearate is added and tabletted to prepare 1000 compound berberine tablets, each weighing 0.5 g and containing 30 mg berberine.

[0035] Example 3: Take 20g of cinnamon twig, 8g of angelica pubescens, 25g of roasted ginger, 12g of angelica dahurica, 12g of patchouli, 10g of ginseng, 25g of atractylodes macrocephala, 10g of Poria, 12g of white peony root, 8g of cyperus rotundus, 20g of oriental water plantain, 15g of coix seed, 20g of umbelliferae, 8g of cornus officinalis, 20g of prepared rehmannia, 10g of fructus aurantii, 12g of costusroot, 15g of dried orange peel, 20g of angelica sinensis, 12g of ligusticum chuanxiong, and 30g of berberine, and the preparation method comprises the following steps:

[0036] (1) Extract volatile oil from roasted ginger, Patchouli, Cyperus rotundus, Fructus Aurantii Immaturus, Aucklandia lappa, Pericarpium Citri Reticulatae, Angelica Sinensis, and Rhizoma Chuanxiong by steam distillation, and include the mixture with cyclodextrin to obtain a volatile oil inclusion compound;

[0037] (2) mixing the residue after preparing the volatile oil in step (1) with other Chinese medicinal pieces, adding aromatic water extracted by steam distillation, adding water to 10 times the weight of all the Chinese medicinal pieces, decocting for 2 hours, filtering, decocting the residue again with water, adding water in an amount of 10 times the weight of all the Chinese medicinal pieces, decocting for 1 hour, filtering, combining the two decoctions, concentrating to a relative density of 1.30 at 25° C., and obtaining an extract;

[0038] (3) The volatile oil inclusion compound obtained in step (1) and the extract obtained in step (2) are mixed, berberine is added, and starch is added to granulate the granules. Magnesium stearate is added and tabletted to prepare 1000 compound berberine tablets, each weighing 0.5 g and containing 30 mg berberine.

[0039] Comparative Example 1: Take 30g of berberine hydrochloride, 116g of costus root, 40g of Evodia rutaecarpa, and 162g of white peony root. The above four flavors, 80g of costus root and Evodia rutaecarpa are crushed into fine powder, sieved, and the coarse powder that does not pass through the sieve is mixed with white peony root and the remaining costus root. According to the percolation method under the fluid extract and extract, percolation is performed with 70% ethanol as a solvent, the percolation liquid is collected, the ethanol is recovered from the percolation liquid and concentrated into a thick paste, the above fine powder is added, mixed, dried, crushed, berberine hydrochloride is added, mixed, made into granules, dried, pressed into 1000 tablets, and coated with sugar to obtain, each tablet containing 30mg of berberine hydrochloride.

[0040] Example 4: Clinical study

[0041] Case selection: 60 patients with bacillary dysentery admitted from December 2022 to December 2023 were selected as the research subjects. Among them, there were 28 male patients and 32 female patients, aged 18 to 27 years old. All patients were diagnosed by routine stool tests, bacterial culture, and routine blood tests.

[0042] Western medicine inclusion criteria: meet the relevant diagnostic criteria in "Infectious Diseases"; stool culture of Shigella is positive, typical symptoms: fever, diarrhea, abdominal pain, tenesmus, mucus, pus and blood in the stool, and bowel movement frequency more than 3 times / d.

[0043] TCM diagnostic criteria: abdominal pain and cramps, red, white, sticky and frozen dysentery, more white and less red, or pure white and frozen, tenesmus, tasteless mouth, fullness in the middle of the abdomen without thirst, heaviness in the head and fatigue, clear urine, pale tongue, greasy white fur, and soft pulse. It may also be accompanied by external symptoms such as aversion to cold, body pain, fever, no sweating, and floating pulse, which are consistent with the symptoms of cold-damp type dysentery.

[0044] Treatment method: According to the random number table, the patients were divided into a control group and a treatment group, with 30 cases in each group. Both groups of patients received basic treatment and dietary guidance, wherein the basic treatment included fluid replacement, correction of electrolyte disorders, etc., and the dietary guidance included eating light and easily digestible food. The control group took the compound berberine tablets prepared in comparative example 1 orally on the basis of basic treatment, 5 tablets / time, 3 times / d. The treatment group took the compound berberine tablets prepared in example 1 of the present invention orally on the basis of basic treatment, 5 tablets / time, 3 times / d. Both groups of patients were treated continuously for 1 week.

[0045] Efficacy criteria: Cured: After treatment, the patient's clinical symptoms disappeared completely, the number of bowel movements was ≤2 times / day, the stool characteristics were normal, there was no pus, blood or water, and the pathogenic bacteria test showed negative; markedly effective: The patient's clinical symptoms basically disappeared, the number of bowel movements was ≤2 times / day, the stool characteristics improved, and the pathogenic bacteria test showed a significant reduction; effective: The patient's clinical symptoms improved, the number of bowel movements decreased, the stool characteristics improved, and the pathogenic bacteria test showed more positive results; ineffective: The patient's clinical symptoms did not improve at all, the number of bowel movements was still high, the stool characteristics did not improve significantly, and the pathogenic bacteria test showed positive results. Effective rate = (cured + markedly effective + effective) / total number of cases.

[0046] Results: The time of disappearance of clinical symptoms in the two groups is shown in Table 1, and the comparison of clinical effects is shown in Table 2.

[0047] Table 1 Comparison of clinical efficacy of two groups of drugs in the treatment of cold-damp dysentery

[0048] Grouping Time for abdominal pain and diarrhea to disappear (h) Time for tenesmus to disappear (h) Control group 38.45±14.63 46.84±19.28 Treatment Group <![CDATA[26.79±11.47 * ]]> <![CDATA[24.97±17.53 * ]]>

[0049] Compared with the model group ** <0.01, * P<0.05

[0050] As shown in Table 1, after treatment, the disappearance time of abdominal pain, diarrhea and tenesmus in the treatment group was significantly shorter than that in the control group, and the difference between the two groups was statistically significant (P < 0.01), indicating that the improved compound berberine tablets are superior to the original compound berberine tablets in the treatment of cold-damp dysentery.

[0051] Table 2 Comparison of clinical efficacy of two groups of drugs in the treatment of cold-damp dysentery

[0052] Grouping cure Significant effect efficient invalid Effectiveness (%) Control group 11 6 5 8 73.3 Treatment Group 19 5 4 2 <![CDATA[93.3 * ]]>

[0053] Compared with the model group * P<0.05

[0054] As can be seen from Table 2, after treatment, 11 cases in the control group were cured, 6 cases were significantly effective, 5 cases were effective, 8 cases were ineffective, and the total effective rate was 73.3%; 19 cases in the treatment group were cured, 5 cases were significantly effective, 4 cases were effective, 2 cases were ineffective, and the total effective rate was 93.3%. The difference in clinical efficacy between the two groups was statistically significant (P < 0.05), indicating that the improved compound berberine tablets are superior to the original compound berberine tablets in the treatment of cold-damp type dysentery.

[0055] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A compound berberine tablet, characterized in that: The invention is prepared by extracting the following Chinese medicinal pieces in parts by weight and combining them with berberine: 10-20 parts of cassia twig, 8-12 parts of angelica dahurica, 15-25 parts of roasted ginger, 12-18 parts of angelica dahurica, 8-12 parts of patchouli, 10-20 parts of ginseng, 15-25 parts of atractylodes macrocephala, 10-20 parts of tuckahoe, 8-12 parts of white peony root, 8-12 parts of cyperus rotundus, 10-20 parts of oriental water plantain, 15-25 parts of coix seed, 10-20 parts of umbellate, 8-12 parts of cornus officinalis, 10-20 parts of rehmannia prepared, 10-20 parts of fructus aurantii, 8-12 parts of costusroot, 15-25 parts of dried tangerine peel, 10-20 parts of angelica sinensis, 12-18 parts of ligusticum chuanxiong and 30 parts of berberine.

2. The compound berberine tablet according to claim 1, characterized in that: The medicine is prepared by extracting the following Chinese herbal medicine pieces in parts by weight and combining them with berberine: 15 parts of cinnamon twig, 10 parts of angelica dahurica, 20 parts of roasted ginger, 15 parts of angelica dahurica, 10 parts of patchouli, 15 parts of ginseng, 20 parts of atractylodes macrocephala, 15 parts of tuckahoe, 10 parts of white peony root, 10 parts of cyperus rotundus, 15 parts of orientalis, 20 parts of coix seed, 15 parts of umbellate, 10 parts of cornus officinalis, 15 parts of rehmannia prepared, 15 parts of fructus aurantii, 10 parts of costus root, 20 parts of tangerine peel, 15 parts of angelica sinensis, 15 parts of ligusticum chuanxiong and 30 parts of berberine.

3. The compound berberine tablet according to claim 1, characterized in that: The preparation method comprises the following steps: (1) Extract volatile oil from roasted ginger, Patchouli, Cyperus rotundus, Fructus Aurantii Immaturus, Aucklandia lappa, Pericarpium Citri Reticulatae, Angelica Sinensis, and Rhizoma Chuanxiong by steam distillation, and include the mixture with cyclodextrin to obtain a volatile oil inclusion compound; (2) mixing the residue after preparing volatile oil in step (1) with other Chinese medicinal pieces, adding aromatic water extracted by steam distillation, adding water to 10 times the weight of all the Chinese medicinal pieces, decocting for 2 hours, filtering, decocting the residue again with water, adding water in an amount of 10 times the weight of all the Chinese medicinal pieces, decocting for 1 hour, filtering, combining the two decoctions, concentrating to a relative density of 1.2-1.3 at 25° C., and obtaining an extract; (3) The volatile oil inclusion compound obtained in step (1) and the extract obtained in step (2) are mixed, berberine is added, and starch is added to granulate the granules. Magnesium stearate is added and tablets are pressed. Each tablet weighs 0.5 g and contains 30 mg berberine.

4. The compound berberine tablet according to claim 3, characterized in that: The relative density when concentrated to 25° C. in step (2) of the preparation method is 1.

25.

5. Use of the compound berberine tablets as claimed in claim 1 in the preparation of medicines for cold-damp type dysentery.