Calculus bovis heart-fire-clearing pill and preparation process thereof

Abstract

The invention discloses a calculus bovis heart-clearing pill which is prepared from the following raw material components in parts by weight: 25.7 parts of calculus bovis, 50 parts of felwort, 50 parts of radix curcumae, 45 parts of bulbus fritillariae cirrhosae, 45 parts of arisaema cum bile, 35 parts of pinellia ternate, 45 parts of angelica sinensis, 39 parts of ligusticum wallichii, 150 parts of liquorice, 210 parts of Chinese yam, 45 parts of scutellaria baicalensis and the like. The bulbus fritillariae cirrhosae, the arisaema cum bile and the pinellia ternate are used for reducing phlegm and inducing resuscitation so as to lower adverse qi and achieve a more obvious effect on treating the phlegm-fire disturbing type epilepsy.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine, in particular to an improved Niuhuang Qingxin Pill for treating phlegm-fire disturbing mind type epilepsy and a preparation method thereof. Background Art

[0002] Epilepsy, also known as epilepsy, is a chronic brain disease with clinical manifestations of recurrent epileptic seizures. Epilepsy is mainly caused by excessive discharge of brain neurons, and is characterized by paroxysmal, transient, repetitive and stereotyped nature, and can manifest as sensory, motor, consciousness, mental, behavioral and autonomic dysfunction.

[0003] Traditional Chinese medicine believes that epilepsy is caused by internal injuries due to the seven emotions, irregular diet, and insufficient endowment, which lead to phlegm and qi stagnation, imbalance of internal qi, imbalance of yin and yang, blockage of the heart, and disorder of the spirit. The disease is located in the heart and is closely related to the liver, gallbladder, spleen, and stomach. Epilepsy is characterized by depression, indifferent expression, silence, dementia, incoherent speech, and quietness and joy. The treatment is to regulate qi and relieve depression, and to promote the smooth flow of qi. It is caused by phlegm, fire, blood stasis, and congenital factors, which lead to disorder of qi and blood, obstruction of the clear orifices, and the disease is characterized by sudden fainting, rigid convulsions, spontaneous awakening after a while, and normal after waking up.

[0004] Traditional Chinese medicine believes that epilepsy can be divided into syndromes of internal liver wind movement, syndrome of phlegm and fire disturbing the mind, syndrome of deficiency of both heart and spleen, etc. Different treatment methods are selected according to different syndrome types.

[0005] 1. Syndrome of liver wind movement

[0006] Liver wind is a syndrome of TCM, which refers to liver and kidney yin deficiency and liver yang hyperactivity, which causes patients to experience limb convulsions, dizziness and other symptoms. Patients can follow the doctor's advice to use traditional Chinese medicine such as Tianma Gou Teng Yin and Zhengan Xifeng Decoction for treatment, or they can be treated by acupuncture at Fengchi, Ganshu, Hegu and other acupoints under the operation of professional doctors.

[0007] 2. Phlegm-fire disturbing the mind

[0008] Phlegm-fire disturbing the heart syndrome is a syndrome type in traditional Chinese medicine, which refers to the excessive phlegm-fire, which disturbs the mind and causes patients to experience symptoms such as restlessness, insomnia, and epilepsy. Patients can follow the doctor's advice to use Chinese medicine such as Huanglian Wendan Decoction and Daotan Decoction for treatment, or they can be treated by acupuncture at the Xinshu, Geshu, Neiguan, Shenmen and other acupoints under the operation of professional doctors.

[0009] 3. Deficiency of both heart and spleen

[0010] Heart and spleen deficiency syndrome is a syndrome type in traditional Chinese medicine, which refers to insufficient blood supply to the heart and dysfunction of the spleen, leading to symptoms such as palpitations, forgetfulness and insomnia. Patients can follow the doctor's advice to use traditional Chinese medicine such as Guipi Decoction and Fuzi Lizhong Decoction for treatment, or they can be treated by acupuncture at the spleen point, stomach point, Neiguan point, Shenmen point and other acupoints.

[0011] Among them, phlegm-fire disturbing the mind syndrome is the most common in clinical practice.

[0012] CN118717899A provides a medicine for treating epilepsy, including: cinnabar, cicada shell, silkworm chrysalis, cherry tomato, poria, shallot, Chinese yam, and gastrodia; the present invention also provides a preparation method of the medicine for treating epilepsy, including the following steps: drying and grinding cicada shell, silkworm chrysalis, cherry tomato, poria, shallot, Chinese yam, and gastrodia one by one, and mixing and mixing to prepare. Further, the cicada shell and silkworm chrysalis are dried on tiles with charcoal and then ground into fine powder, the cherry tomato, poria, and Chinese yam are dried and ground into fine powder, and the shallot is dried with a low fire and then ground into fine powder. Compared with traditional drug treatment, the method of taking the present invention is simple; there is no certain risk and effect uncertainty during surgical treatment. In addition to epileptic diseases, the present invention is also applicable to some metabolic diseases; the present invention cooperates with ketogenic diet to control high-carbohydrate food, rely on fat metabolism to produce ketone bodies, and use them as energy sources to achieve the purpose of directly controlling epileptic seizures; the present invention is mainly used for medication in the quiescent period of epilepsy, especially for children under 15 years old with an effective rate of 95-98%. However, the instructions only record the effects of single drugs, do not explain the compatibility between drugs, and do not conduct classification research on epilepsy syndromes.

[0013] The prescription of Niuhuang Qingxin Pills produced by Nanjing Tongrentang Pharmaceutical Co., Ltd. is: Niuhuang 25.7g, Angelica 45g, Chuanxiong 39g, Licorice 150g, Chinese Yam 210g, Scutellaria 45g, Bitter Apricot (fried) 37.5g, Soybean Yellow Roll 57g, Jujube (pitted) 90g, Atractylodes (fried) 75g, Poria 48g, Platycodon 39g, Saposhnikovia 45g, Bupleurum 39g, Donkey-hide Gelatin 51g , dried ginger 25g, white peony root 75g, ginseng 75g, Liushenqu (fried) 75g, cinnamon 54g, ophiopogon 44g, white peony root 22.5g, pollen (fried) 7.5g, musk 6.4g, borneol 16.1g, buffalo horn concentrated powder 28.5g, antelope horn 28.4g, cinnabar 69.7g, realgar 24g, bezoar in this prescription is good at clearing heat and detoxifying, removing phlegm and opening the orifices, and calming the wind and convulsions, so it is the main medicine. Buffalo horn concentrated powder and antelope horn clear the heart and cool the liver, calm the wind and convulsions, scutellaria and realgar clear heat and purge fire, remove phlegm and detoxify, cinnabar clears heat and calms the nerves, so it is the assistant medicine. Musk and borneol can open the mind and wake up the brain; white mulberry, platycodon grandiflorum, bitter almond can clear the lungs and resolve phlegm, relieve depression and dissipate stagnation; cinnamon can treat heat with heat and guide fire back to its origin; Chuanxiong and pollen can promote blood circulation and stop bleeding; Bupleurum and saposhnikovia can eliminate wind evil and dissipate heat; soybean yellow roll can disperse dampness and clear blood vessels; ginseng, Poria, Atractylodes macrocephala, dried ginger, jujube, Chinese yam, angelica, white peony, Ophiopogon japonicus, and donkey-hide gelatin can nourish qi and blood, and Shenqu can help digestion and relieve stagnation, and ginger and jujube can strengthen the spleen and stimulate appetite, so that the tonic is not stagnant, and the nourishing is not greasy, which are all adjuvants. Licorice can not only replenish qi with ginseng, Poria, and Atractylodes, but also detoxify and harmonize the various medicines, so it is the guiding medicine. The whole prescription has the effects of clearing the heart and opening the mind, resolving phlegm and calming the nerves, calming the wind and unblocking the meridians, and strengthening the body and calming the mind. Clinical studies have found that the effect of the pills on epilepsy caused by phlegm-fire disturbing the mind is not ideal. Therefore, the company organized technical personnel to conduct research and proposed an improved Niuhuang Qingxin Pill for treating epilepsy caused by phlegm-fire disturbing the mind and its preparation method. Summary of the invention

[0014] In view of the above-mentioned defects in the prior art, the present invention also provides the above-mentioned improved Niuhuang Qingxin Pills, and the use of the improved Niuhuang Qingxin Pills in the preparation of drugs for treating epilepsy, especially in the preparation of drugs for treating epilepsy of phlegm-fire disturbing the mind type.

[0015] In order to achieve the above object, the first aspect of the present invention is to provide a Niuhuang Qingxin Pill, which is prepared from the following raw material components in parts by weight: 25.7 parts of bezoar, 50 parts of gentian, 50 parts of curcuma, 45 parts of fritillaria, 45 parts of biliary arisaema, 35 parts of pinellia, 45 parts of angelica, 39 parts of chuanxiong, 150 parts of liquorice, 210 parts of yam, 45 parts of scutellaria, 37.5 parts of fried bitter almonds, 57 parts of soybean yellow rolls, 90 parts of pitted jujubes. , 75 parts of stir-fried Atractylodes macrocephala, 48 parts of Poria cocos, 39 parts of Platycodon grandiflorum, 45 parts of Saposhnikovia divaricata, 39 parts of Bupleurum chinense, 51 parts of donkey-hide gelatin, 25 parts of dried ginger, 75 parts of white peony root, 75 parts of ginseng, 75 parts of stir-fried Liushenqu, 54 parts of cinnamon bark, 44 parts of Ophiopogon japonicus, 22.5 parts of Bletilla striata, 7.5 parts of stir-fried Pollen Typhae, 6.4 parts of Musk, 16.1 parts of Borneolum, 28.5 parts of buffalo horn concentrated powder, 28.4 parts of antelope horn, 69.7 parts of cinnabar, and 24 parts of realgar.

[0016] The second aspect of the present invention is to provide a method for preparing Niuhuang Qingxin Pills:

[0017] (1) For the above thirty-four ingredients, except bezoar, musk, borneol, and buffalo horn concentrated powder, cinnabar and realgar are separately ground into very fine powders; antelope horn is filed into fine powder; the remaining twenty-seven ingredients including yam are crushed into fine powders; bezoar, musk, borneol, and buffalo horn concentrated powder are ground into fine powders, mixed with the above powders, sieved, and mixed evenly;

[0018] (2) Add 90-110 g of refined honey to every 100 g of powder to make large honey pills.

[0019] The third aspect of the present invention is to provide the use of the Niuhuang Qingxin Pill in the preparation of a drug for treating epilepsy.

[0020] The fourth aspect of the present invention is to provide the use of Niuhuang Qingxin Pills in the preparation of a drug for treating epilepsy of the phlegm-fire disturbing mind type.

[0021] The above-mentioned traditional Chinese medicines all comply with the Chinese Pharmacopoeia and relevant ministerial and provincial standards.

[0022] Soybean yellow roll is a processed product made from mature seeds of soybean (L.) Merr., a plant of the leguminous family. Soak clean soybeans in water until they swell, drain the water, cover with a wet cloth, and water twice a day. When the sprouts grow to 0.5-1 cm, take them out and dry them.

[0023] Beneficial effects:

[0024] Traditional Chinese medicine believes that epilepsy is caused by wind, fire, phlegm, and blood stasis, which lead to imbalance of heart, liver, spleen, kidney, and internal organs. Liver and kidney yin deficiency, yin deficiency leads to hyperactivity of yang, hyperactivity of yang leads to internal liver wind movement, hyperactivity leads to excessive heat, excessive heat turns into fire, extreme fire generates wind, and wind and fire help each other. In addition, spleen deficiency and dysfunction, clear qi does not rise, and turbid qi descends, which leads to phlegm accumulation, phlegm confuses the mind, and blood stasis in the heart leads to blood stasis. Stasis leads to blocked meridians, phlegm blocks blood stasis and disturbs the clear mind, eventually causing epileptic seizures. According to the pathogenesis, treatment methods are often used to calm epilepsy and extinguish wind, soothe the liver and purge fire, remove phlegm and open the mind, and activate blood circulation and remove blood stasis. Among them, epilepsy with phlegm and fire disturbing the mind is caused by stagnation of liver qi, liver failure, and phlegm; or stagnation of heart and spleen qi, stagnation and phlegm, and phlegm and qi are mutually bound, which leads to obstruction of the mind.

[0025] Zhang Zihe of the Jin Dynasty pointed out in "Rumen Shiqin": "Generally, when epilepsy occurs, the neck is stiff and the patient is unconscious. This is because there is heat in the liver meridian." In this prescription, bezoar and gentian grass are used together. Bezoar is good at clearing heat and detoxifying, dispelling phlegm and opening the orifices, and calming the wind and calming the nerves. Gentian grass clears heat and dries dampness, and relieves liver and gallbladder fire. Curcuma relieves qi and relieves depression, and gentian grass is bitter and dry and hurts yin. They are all monarch drugs. Zhu Danxi's "Danxi Xinfa·Epilepsy" pointed out: "There are five epilepsy symptoms... nothing but saliva obstruction and obstruction of the orifices." Therefore, Chuanbei, Nanxing, and Pinellia are used to dispel phlegm and open the orifices to descend the adverse qi. Phlegm and fire are intertwined, like a raging fire in a strong wind, disturbing the mind, causing restlessness and irritability, and the symptoms of visceral agitation arise from this. Water buffalo horn concentrated powder and antelope horn are used to clear the heart and cool the liver, calm the wind and calm the nerves. Scutellaria and realgar clear heat and purge fire, dispel phlegm and detoxify, and cinnabar clears heat and calms the nerves, which are all minister drugs. The Treatise on the Causes and Symptoms of Various Diseases believes that wind, shock, and food can all lead to epilepsy. The Puji Prescription states that "blood stagnation in the heart, evil qi in the heart, and accumulated shock leads to epilepsy." Musk and borneol are used to open the heart and wake up the brain; white peony, platycodon, and bitter almonds clear the lungs and resolve phlegm, relieve depression and resolve knots; cinnamon uses heat to treat heat and guide fire back to its origin; Chuanxiong and pollen to promote blood circulation and stop bleeding; Bupleurum and saposhnikovia remove wind evil and dissipate heat; soybean yellow rolls disperse dampness and clear blood vessels; ginseng, Poria, Atractylodes, dried ginger, jujube, yam, angelica, white peony, ophiopogon, and donkey-hide gelatin replenish qi and nourish blood, and add Shenqu, which can help digestion and remove stagnation, and ginger and jujube, which can strengthen the spleen and stimulate appetite, so that it can replenish without stagnation and nourish without being greasy, and they are all adjuvants. Licorice can not only replenish qi with ginseng, Poria, and Atractylodes, but also detoxify and harmonize the various medicines, so it is a guiding medicine. The whole formula has the effects of clearing the liver and purging fire, clearing the heart and opening the orifices, resolving phlegm and calming the nerves, calming wind and unblocking the meridians, and strengthening the body and tranquilizing the mind.

[0026] In short, the improved Niuhuang Qingxin Pills can treat epilepsy of the phlegm-fire disturbing the mind type through the following aspects: 1. Treat from the liver: Epilepsy is characterized by twitching, and the movement belongs to wind, which is blamed on the liver, so it is necessary to relieve the liver's real fire, and use gentian and turmeric; 2. Treat from the spleen. Often, patients overeat alcohol, fat and sweet foods, which damage the spleen and stomach and cause phlegm heat, which blocks the heart and causes epilepsy. Use ginseng, Poria, Atractylodes, dried ginger, jujube, yam, angelica, white peony, Ophiopogon, donkey-hide gelatin, Shenqu, and combine with ginger and jujube that strengthen the spleen and appetite; 3. Treat from the phlegm. The so-called "no phlegm, no epilepsy", at the beginning of phlegm heat 1. It blocks the heart and in the later stage, phlegm and dampness disturb the mind, so bezoar, Fritillaria cirrhosa, Arisaema consanguineum, Pinellia ternata, Scutellaria baicalensis, Realgar, Bletilla striata, Platycodon grandiflorum, and Apricot kernel are used to dissipate phlegm and open the mind; 2. Treat from the perspective of blood stasis. Epilepsy often recurs. Long-term illness enters the collaterals, leading to blood stasis. Curcuma, Ligusticum chuanxiong, Pollen Typhae, and Soybean Yellow Roll are used to clear the meridians and activate the collaterals; 3. Treat from the perspective of fire. The so-called "no fire, no phlegm". Buffalo horn concentrated powder, antelope horn, and cinnabar are used to clear the liver and purge fire, calm the mind; in addition, musk and borneol are used to open the mind and wake up the brain. Licorice can not only replenish qi with ginseng, Poria, and Atractylodes macrocephala, but also detoxify and harmonize the medicines.

[0027] In the clinical study of the present invention, the results in Table 1 show that after treatment, the number of epileptic seizures in Study Groups 1 and 2 was significantly reduced, the clinical effective rate was significantly higher than that of the control group, and the effect of Study Group 1 (Improved Niuhuang Qingxin Pills) was better than that of Study Group 2 (Original Niuhuang Qingxin Pills); NSE is an acidic protease unique to neurons and neuroendocrine cells, which is significantly increased when neuroendocrine tumors and nerve cells are damaged and destroyed; hs-CRP is one of the most commonly used acute phase response proteins in clinical practice to reflect the degree of inflammation and tissue trauma; studies have shown that NSE and hs-CRP will increase to varying degrees after repeated or prolonged epileptic attacks. The results in Table 2 show that in the clinical study of the present invention, the NSE and hs-CRP levels of patients in Study Groups 1 and 2 were lower than those in the control group, and the effect of Study Group 1 (Improved Niuhuang Qingxin Pills) was better than that of Study Group 2 (Original Niuhuang Qingxin Pills). Pills), indicating that the application of Niuhuang Qingxin Pills has a therapeutic effect on epilepsy in patients; the results in Table 3 show that in the control group, 15 cases were basically controlled, 21 cases were significantly effective, 14 cases were effective, and 10 cases were invalid, with an effective rate of 83.3%; in the study group 1, 19 cases were basically controlled, 23 cases were significantly effective, 15 cases were effective, and 3 cases were invalid, with an effective rate of 95.0%; in the study group 2, 15 cases were basically controlled, 19 cases were significantly effective, 18 cases were effective, and 8 cases were invalid, with an effective rate of 86.7%, indicating that the clinical effect of the study group 1 (improved Niuhuang Qingxin Pills) was better than that of the treatment group 2 (original Niuhuang Qingxin Pills), and the clinical effect of the treatment group 2 (original Niuhuang Qingxin Pills) was better than that of the control group. In short, the present invention adds gentian to the original prescription to clear away heat and dampness, purge liver and gallbladder fire, turmeric to relieve qi and relieve depression, Fritillaria cirrhosa, Arisaema consanguineum, and Pinellia ternata to resolve phlegm and open the orifices, so as to descend the adverse qi, and achieve more obvious effects in the treatment of epilepsy of phlegm-fire disturbing mind type. DETAILED DESCRIPTION

[0028] 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.

[0029] Embodiment 1:

[0030] Take 25.7g of bezoar, 50g of gentian, 50g of turmeric, 45g of fritillaria, 45g of biliary arisaema, 35g of pinellia, 45g of angelica, 39g of chuanxiong, 150g of licorice, 210g of yam, 45g of scutellaria, 37.5g of stir-fried bitter almond, 57g of soybean yellow roll, 90g of pitted jujube, 75g of stir-fried atractylodes, 48g of tuckahoe, 39g of platycodon, 45g of siler, 100g of licorice, 200g of yam, 45g of scutellaria, 37.5g of stir-fried bitter almond, 57g of soybean yellow roll, 90g of pitted jujube, 75g of stir-fried atractylodes, 48g of tuckahoe, 39g of platycodon, 45g of siler g, bupleurum 39g, donkey-hide gelatin 51g, dried ginger 25g, white peony root 75g, ginseng 75g, stir-fried Liushenqu 75g, cinnamon 54g, ophiopogon 44g, white peony root 22.5g, stir-fried pollen 7.5g, musk 6.4g, borneol 16.1g, buffalo horn concentrated powder 28.5g, antelope horn 28.4g, cinnabar 69.7g, realgar 24g, the preparation method is:

[0031] (1) For the above thirty-four ingredients, except bezoar, musk, borneol, and buffalo horn concentrated powder, cinnabar and realgar are separately ground into very fine powders; antelope horn is filed into fine powder; the remaining twenty-seven ingredients including yam are crushed into fine powders; bezoar, musk, borneol, and buffalo horn concentrated powder are ground into fine powders, mixed with the above powders, sieved, and mixed evenly;

[0032] (2) Add 100g of refined honey to every 100g of powder to make large honey pills.

[0033] Comparative Example 1:

[0034] Take 25.7g of bezoar, 45g of angelica, 39g of chuanxiong, 150g of liquorice, 210g of yam, 45g of scutellaria, 37.5g of bitter almond (fried), 57g of soybean yellow roll, 90g of jujube (pitted), 75g of atractylodes (fried), 48g of tuckahoe, 39g of platycodon, 45g of saposhnikovia, 39g of bupleurum, 51g of donkey-hide gelatin, 25g of dried ginger, 75g of white peony root, 75g of ginseng, 75g of Liushenqu (fried), 54g of cinnamon, 44g of ophiopogon, 22.5g of white peony root, 7.5g of pollen (fried), 6.4g of musk, 16.1g of borneol, 28.5g of buffalo horn concentrated powder, 28.4g of antelope horn, 69.7g of cinnabar, and 24g of realgar. The preparation method is as follows:

[0035] Of the above 29 ingredients, except for bezoar, musk, borneol, and buffalo horn concentrated powder, cinnabar and realgar are separately water-frozen into very fine powder; antelope horn is filed into fine powder; the remaining 22 ingredients such as yam are crushed into fine powder; bezoar, musk, borneol, and buffalo horn concentrated powder are finely ground, mixed with the above powders, sieved, and mixed. Add 100g of refined honey to every 100g of powder to make large honey pills, and you will get No. 2 Niuhuang Qingxin Pills (original Niuhuang Qingxin Pills).

[0036] Example 2: Clinical study

[0037] General information: 180 patients with phlegm-fire disturbing epilepsy type admitted to the Department of Neurology, Nanjing Hospital of Traditional Chinese Medicine from April 2022 to May 2024 were selected and randomly divided into 3 groups, 60 cases in each group, namely control group, study group 1 and study group 2; this study was approved by the hospital ethics committee, and the patients signed informed consent.

[0038] Western medicine diagnostic standards: Western medicine diagnostic standards are consistent with the relevant diagnostic standards recommended by the International League Against Epilepsy Committee on the diagnostic scheme for epileptic seizures and epilepsy patients. Patients have repeated seizures and a clear course of disease. Epileptic waveforms such as sharp waves, spike waves, sharp-slow waves, and spike-slow waves can be seen through routine electroencephalograms, and neuroimaging shows lesions or abnormalities in brain structures.

[0039] TCM diagnostic standards: All cases meet the diagnostic standards for epilepsy of phlegm-fire disturbing the mind type and are in line with the TCM industry standard "Standards for Diagnosis and Efficacy of TCM Internal Medicine Diseases" issued by the State Administration of Traditional Chinese Medicine in 1995.

[0040] Inclusion criteria:

[0041] 1.1 During a generalized attack, the patient suddenly faints, with stiff neck and back, convulsions in the limbs, or stares with only two eyes, does not respond when called, or has the head drooping and limbs limp.

[0042] 1.2 Partial seizures may occur in many forms, such as local convulsions of the mouth, eyes, hands, etc. without sudden fainting, or hallucinations, or vomiting, sweating, or speech disorders, or unconscious movements.

[0043] 1.3 The onset is sudden, and the patient is like a normal person after waking up, with repeated attacks.

[0044] 1.4 There is often a family history, and the disease is often triggered by fear, fatigue, extreme emotions, etc.

[0045] 1.5 There are often precursors such as dizziness and chest tightness before an attack.

[0046] 1.6 If the EEG examination shows positive results, CT or MRI examinations can be performed if conditions permit.

[0047] 1.7 Care should be taken to differentiate it from stroke, syncope, spasm, etc.

[0048] Symptom diagnosis: belongs to the type of phlegm-fire disturbing the mind, with sudden collapse, unconsciousness, strong spasms and cramps in the limbs, sounds in the mouth, foaming at the mouth, irritability, high-pitched and rough breathing, gurgling phlegm, bad breath and dry stool. The tongue is red or dark red, the tongue coating is yellow and greasy, and the pulse is stringy and slippery.

[0049] Treatment method: The control group was given oral sodium valproate sustained-release tablets [Sanofi (Hangzhou) Pharmaceutical Co., Ltd., National Medicine Standard H20010595] to patients with systemic seizures, with a dosage of 0.5 g, once a day, for a total of 30 days; patients with partial seizures were given oral carbamazepine tablets (Qilu Pharmaceutical Co., Ltd., National Medicine Standard H37021328), with a dosage of 0.2 g, twice a day, for a total of 30 days. The above drug dosages can be adjusted according to the condition. Study Group 1 was treated with No. 1 Niuhuang Qingxin Pills prepared by the method of Example 1 above on the basis of the control group, 1 pill (3 g per pill), once a day, for a total of 30 days; Study Group 2 was treated with No. 2 Niuhuang Qingxin Pills prepared by the method of Comparative Example 1 above on the basis of the control group, 1 pill (3 g per pill), once a day, for a total of 30 days.

[0050] Efficacy judgment criteria: observe the number of epileptic seizures of patients in the two groups. During the treatment period, monitor the number of epileptic seizures of patients according to the course of treatment and compare it with the data of the number of seizures before treatment. Follow-up was conducted once a month in both groups for six consecutive months, and the efficacy of both groups was evaluated after six months. Efficacy judgment: (1) basic control: the number of seizures of patients decreased by ≥3 times compared with before treatment, and the interval between each seizure was prolonged to 3 times before treatment; (2) marked effect: the number of seizures decreased by 1-3 times, and the interval was prolonged by 1 time; (3) effective: the number of epileptic seizures decreased by 1-2 times, and the interval was prolonged by 5-10h; (4) ineffective: the number of seizures increased and the interval was shortened. Total effective rate = (basic control + marked effect + effective) / total number of cases × 100%. Serum NSE and hs-CRP levels were detected by enzyme-linked immunosorbent assay (ELISA), and the kit (Jiangsu Kejing Biotechnology Co., Ltd.) was used for quantitative detection in HBS-1096A fully automatic microplate reader. The results are shown in Tables 1, 2 and 3.

[0051] Experimental results:

[0052] Table 1 Comparison of the number of attacks among the three groups of patients before and after treatment (times)

[0053] Group Before treatment 1 month after treatment 2 months after treatment 3 months after treatment 6 months after treatment Control group 6.36±1.28 5.98±1.47 5.76±1.53 5.23±1.65 4.56±1.27 Study 1 6.12±1.76 5.32±1.65 4.65±1.32 <![CDATA[3.76±1.21 *# ]]> <![CDATA[1.32±1.03 **## ]]> Study 2 6.27±1.45 6.09±1.43 5.13±1.45 4.76±1.87 <![CDATA[3.98±1.75 * ]]>

[0054] Compared with the control group * P<0.05, ** P<0.01, compared with study group 2: # P<0.05, ## P<0.01

[0055] Table 2 Comparison of NSE and hs-CRP levels in the three groups of patients before and after treatment (6 months later)

[0056]

[0057] Compared with the control group * P<0.05, ** P<0.01, compared with study group 2: # P<0.05, ## P<0.01

[0058] Table 3 Comparison of clinical efficacy among the three groups

[0059] Group Basic Controls Significant effect efficient invalid Effectiveness (%) Control group 15 21 14 10 83.3 Study 1 19 23 15 3 95.0 Study 2 15 19 18 8 86.7

[0060] In the clinical study of the present invention, the results in Table 1 show that after treatment, the number of epileptic seizures in Study Groups 1 and 2 was significantly reduced, the clinical effective rate was significantly higher than that of the control group, and the effect of Study Group 1 (Improved Niuhuang Qingxin Pills) was better than that of Study Group 2 (Original Niuhuang Qingxin Pills); NSE is an acidic protease unique to neurons and neuroendocrine cells, which is significantly increased when neuroendocrine tumors and nerve cells are damaged and destroyed; hs-CRP is one of the most commonly used acute phase response proteins in clinical practice to reflect the degree of inflammation and tissue trauma. Studies have shown that NSE and hs-CRP will increase to varying degrees after repeated or prolonged epileptic attacks. The results in Table 2 show that in the clinical study of the present invention, the NSE and hs-CRP levels of patients in Study Groups 1 and 2 were lower than those in the control group, and the effect of Study Group 1 (Improved Niuhuang Qingxin Pills) was better than that of Study Group 2 (Original Niuhuang Qingxin Pills). Pills), indicating that the application of Niuhuang Qingxin Pills has a therapeutic effect on epilepsy in patients; the results in Table 3 show that in the control group, 15 cases were basically controlled, 21 cases were significantly effective, 14 cases were effective, and 10 cases were invalid, with an effective rate of 83.3%; in the study group 1, 19 cases were basically controlled, 23 cases were significantly effective, 15 cases were effective, and 3 cases were invalid, with an effective rate of 95.0%; in the study group 2, 15 cases were basically controlled, 19 cases were significantly effective, 18 cases were effective, and 8 cases were invalid, with an effective rate of 86.7%, indicating that the clinical effect of the study group 1 (improved Niuhuang Qingxin Pills) was better than that of the treatment group 2 (original Niuhuang Qingxin Pills), and the clinical effect of the treatment group 2 (original Niuhuang Qingxin Pills) was better than that of the control group. In short, the present invention adds gentian to the original prescription to clear away heat and dampness, purge liver and gallbladder fire, turmeric to relieve qi and relieve depression, Fritillaria cirrhosa, Arisaema consanguineum, and Pinellia ternata to resolve phlegm and open the orifices, so as to descend the adverse qi, and achieve more obvious effects in the treatment of epilepsy of phlegm-fire disturbing mind type.

[0061] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments of the present invention description without departing from the scope or spirit of the present invention. Other embodiments derived from the present invention description will be apparent to those skilled in the art. The present invention description and examples are exemplary only.

[0062] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

Claims

1. A Niuhuang Qingxin Pill, characterized in that: The invention is prepared from the following raw material components in parts by weight: 25.7 parts of bezoar, 50 parts of gentian, 50 parts of curcuma, 45 parts of fritillaria, 45 parts of biliary arisaema, 35 parts of pinellia, 45 parts of angelica, 39 parts of chuanxiong, 150 parts of liquorice, 210 parts of yam, 45 parts of scutellaria, 37.5 parts of stir-fried bitter almonds, 57 parts of soybean yellow rolls, 90 parts of pitted jujube, 75 parts of stir-fried atractylodes, 48 ​​parts of tuckahoe, 39 parts of Platycodon grandiflorum, 45 parts of Saposhnikovia divaricata, 39 parts of Bupleurum chinense, 51 parts of donkey-hide gelatin, 25 parts of dried ginger, 75 parts of white peony root, 75 parts of ginseng, 75 parts of stir-fried Liushenqu, 54 parts of cinnamon bark, 44 parts of Ophiopogon japonicus, 22.5 parts of Bletilla striata, 7.5 parts of stir-fried Pollen Typhae, 6.4 parts of Musk, 16.1 parts of Borneolum, 28.5 parts of concentrated buffalo horn powder, 28.4 parts of antelope horn, 69.7 parts of cinnabar, and 24 parts of realgar.

2. The Niuhuang Qingxin Pill as claimed in claim 1, characterized in that: The preparation method is: (1) For the above thirty-four ingredients, except bezoar, musk, borneol, and buffalo horn concentrated powder, cinnabar and realgar are separately ground into very fine powders; antelope horn is filed into fine powder; the remaining twenty-seven ingredients including yam are crushed into fine powders; bezoar, musk, borneol, and buffalo horn concentrated powder are ground into fine powders, mixed with the above powders, sieved, and mixed evenly; (2) Add 90-110 g of refined honey to every 100 g of powder to make large honey pills.

3. Use of Niuhuang Qingxin Pills as claimed in claim 1 in preparing medicines for treating epilepsy.

4. The use of Niuhuang Qingxin Pills as claimed in claim 1 in preparing a drug for treating epilepsy of the phlegm-fire disturbing mind type.

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