Angong bezoar pill and preparation process thereof

Abstract

The invention discloses a uterus-calming bezoar pill which is prepared from the following raw material components in parts by weight: 80 to 120 parts of bezoar, 150 to 250 parts of buffalo horn concentrated powder, 20 to 30 parts of artificial musk, 40 to 60 parts of pearl, 80 to 120 parts of cinnabar, 80 to 120 parts of realgar, 80 to 120 parts of coptis chinensis, 80 to 120 parts of scutellaria baicalensis, 80 to 120 parts of gardenia, 80 to 120 parts of curcuma aromatica, 20 to 30 parts of borneol, 80 to 120 parts of ligusticum wallichii, 60 to 100 parts of safflower, 80 to 120 parts of gastrodia elata and 60 to 100 parts of fructus viticis. The traditional Chinese medicines for promoting blood circulation to remove blood stasis and guiding medicines to move upwards are added on the basis of an original prescription, and the obvious effect on treating acute cerebral infarction caused by phlegm-heat internal closure is achieved by clearing away heat and toxic materials, eliminating phlegm and inducing resuscitation, promoting blood circulation to remove blood stasis, guiding medicines to move upwards and calming the nerves.

Description

Technical Field

[0001] The invention relates to an Angong Niuhuang Pill and a preparation method thereof, in particular to an improved Angong Niuhuang Pill for treating acute cerebral infarction and a preparation method thereof. Background Art

[0002] Stroke is a general term for acute cerebrovascular diseases in traditional Chinese medicine. Its causes can be divided into two categories: "external wind and internal wind". The so-called external wind refers to the stroke caused by the invasion of the six evils on the body surface; the so-called internal wind refers to one of the five endogenous evils formed by the imbalance of yin and yang in the internal organs and the disorder of qi and blood. Clinically, internal wind is the main cause, and those with sudden fainting, hemiplegia, etc. as the main manifestations are true strokes. With the development of the aging population and the change of people's living habits, the incidence of stroke in my country has increased significantly. At present, stroke has become one of the primary diseases that endanger human health. Epidemiological surveys show that there are about 2 million new stroke patients in my country every year, and the trend is increasing year by year. Therefore, it is necessary to develop a drug for treating acute cerebral infarction with significant efficacy and no toxic side effects to relieve patients' pain and shorten hospitalization time. CN104840903B discloses a Chinese medicine composition for treating acute cerebral infarction. The Chinese medicine composition is composed of the following medicines: Herba Lycopodii, Herba Tonifici, Herba Achyranthis Bidentatae, Herba Trichosanthis, Herba Pheretimae, Herba Curcumae, Herba Arisaematis, Herba Caulis Piperis, Herba Lucidae, Herba Violae, Herba Violae, Herba Violae, Herba Violae, Herba Violae, Herba Violae, Herba Violae, Herba Lycopodii, Herba Lycopodii, Herba Violae ... Angong Niuhuang Wan produced by Nanjing Tongrentang Pharmaceutical Co., Ltd. contains bezoar, buffalo horn concentrated powder, artificial musk, pearl, cinnabar, realgar, coptis root, scutellaria, gardenia, curcuma, and borneol, which can clear away heat and detoxify, calm the nerves and open the mind. It is used for fever, evil entering the pericardium, high fever convulsions, coma and delirium; stroke coma and encephalitis, meningitis, toxic encephalopathy, cerebral hemorrhage, sepsis with the above symptoms. However, the above technical solution does not lead the drug upward for acute cerebral infarction with phlegm-heat internal closure syndrome, and cannot better promote nerve cell regeneration and functional recovery; the effect of promoting blood circulation and unblocking collaterals is not thorough enough. Summary of the invention

[0003] In view of the above defects in the prior art, the present invention provides an improved Angong Niuhuang Pill for acute cerebral infarction, which can improve the patient's neurological function score and improve the patient's coagulation function. The present invention also provides a preparation method of the improved Angong Niuhuang Pill, and the use of the improved Angong Niuhuang Pill in the preparation of a drug for treating acute cerebral infarction, especially in the preparation of a drug for treating acute cerebral infarction caused by phlegm-heat internal closure.

[0004] In order to achieve the above-mentioned purpose, the first aspect of the present invention provides an Angong Niuhuang Pill, which is composed of the following raw material components in parts by weight: 80-120 parts of bezoar, 150-250 parts of buffalo horn concentrated powder, 20-30 parts of artificial musk, 40-60 parts of pearls, 80-120 parts of cinnabar, 80-120 parts of realgar, 80-120 parts of coptis chinensis, 80-120 parts of scutellaria baicalensis, 80-120 parts of gardenia jasminoides, 80-120 parts of curcuma, 20-30 parts of borneol, 80-120 parts of chuanxiong, 60-100 parts of safflower, 80-120 parts of gastrodia elata, and 60-100 parts of vitex rotundus.

[0005] The Angong Niuhuang Pills are composed of the following raw material components in parts by weight: 100 parts of bezoar, 200 parts of buffalo horn concentrated powder, 25 parts of artificial musk, 50 parts of pearls, 100 parts of cinnabar, 100 parts of realgar, 100 parts of coptis root, 100 parts of scutellaria baicalensis, 100 parts of gardenia, 100 parts of curcuma, 25 parts of borneol, 100 parts of chuanxiong, 80 parts of safflower, 100 parts of gastrodia elata, and 80 parts of vitex rotundus.

[0006] The preparation method of the Angong Niuhuang Pill is as follows:

[0007] (1) For the above Chinese medicines, pearls are ground into very fine powders, cinnabar and realgar are ground into very fine powders respectively; coptis root, scutellaria root, gardenia and tulip are crushed into fine powders; bezoar, buffalo horn concentrated powder, artificial musk and borneol are ground into fine powders, mixed with the above powders, sieved and mixed;

[0008] (2) Take Chuanxiong and Carthamus tinctorius, extract the volatile oil, carry out cyclodextrin inclusion complexation, mix the residue after the volatile oil extraction with Gastrodia elata and Vitex mandibulariae, add water to boil, then keep it at a low boil for 1-2 hours, take the decoction, add water to the residue to boil again, take the decoction, combine the two decoctions, concentrate, concentrate the filtrate to a clear paste with a relative density of 1.11-1.21 at 75°C, add ethanol to an alcohol content of 85% v / v, let it stand for 24 hours, take the supernatant, recover the ethanol, concentrate, dry and grind into powder, mix with the volatile oil cyclodextrin inclusion complex and the powder prepared in step (1), add appropriate amount of refined honey to make large honey pills, and obtain.

[0009] In the preparation method of Angong Niuhuang Pills, the amount of water added during the two decoctions in step (2) is 10-20 times the weight of the medicinal materials.

[0010] The application of the Angong Niuhuang Pill in preparing a medicine for treating acute cerebral infarction.

[0011] The application of Angong Niuhuang Pills in preparing medicine for treating acute cerebral infarction caused by phlegm-heat internal stasis syndrome.

[0012] It is proposed to add Chuanxiong, Carthamus tinctorius, Gastrodia elata, and Vitex rotundus, and the traditional Chinese medicine theory is explained as follows:

[0013] Chuanxiong is the dried rhizome of Ligusticum chuanxiong Hort. of the genus Ligusticum of the Apiaceae family. It has the effects of promoting blood circulation and qi, dispelling wind and relieving pain. It is mainly used for chest pain caused by heart blood stasis, flank pain caused by liver depression and qi stagnation, chest and flank stabbing pain caused by liver blood stasis, injuries caused by falls, sores and swelling caused by blood stasis, irregular menstruation, amenorrhea and dysmenorrhea, postpartum blood stasis and pain, lochia retention, various headaches and rheumatic pain, etc. Ligustrazine can dilate coronary arteries, increase coronary blood flow, improve myocardial blood oxygen supply, and reduce myocardial oxygen consumption; Ligustrazine can dilate cerebral blood vessels, reduce vascular resistance, significantly increase brain and limb blood flow, and improve microcirculation; it can reduce platelet surface activity, inhibit platelet aggregation, and prevent thrombosis; the neutral component of ferulic acid contained in it promotes uterine smooth muscle in small doses and inhibits it in large doses; the decoction has a sedative effect on the central nervous system of animals and has a significant and lasting antihypertensive effect; it can accelerate the absorption of local hematoma in fractures and promote callus formation; it has an anti-vitamin E deficiency effect; it can inhibit a variety of bacilli; it has anti-histamine and choleretic effects. It contains alkaloids (such as Ligustrazine), volatile oils (mainly Ligustilide, Ligustilide, etc.), phenolic substances (such as ferulic acid), visfatin, vitamin A, folic acid, sucrose, sterols, fatty oils, etc.

[0014] Safflower is the dried flower of Carthamus tinctorius L., a plant of the genus Carthamus in the Asteraceae family. It is widely cultivated in North China, Northeast my country, Northwest China, Zhejiang, Shandong, Sichuan, Guizhou, Tibet and other places in China. It has the effects of promoting blood circulation and menstruation, removing blood stasis and relieving pain. It is mainly used to treat blood stasis, amenorrhea, dysmenorrhea, abdominal pain due to blood stasis after childbirth, accumulation of lumps and masses, chest pain, abdominal pain due to blood stasis, hypochondriasis, traumatic injury, swelling and pain due to blood stasis, and dark color of stasis macules. It contains safflower quinone glycosides, new safflower glycosides, safflower glycosides, safflower yellow pigment and yellow pigment. It also contains safflower oil, which includes palmitic acid, myristic acid, lauric acid, stearic acid, arachidic acid, oleic acid and the like.

[0015] Gastrodia elata is the dried tuber of Gastrodia elata Bl., a plant of the genus Gastrodia in the orchid family. It has the effects of calming wind and stopping spasms, calming liver yang, and dispelling wind and unblocking meridians. It is mainly used to treat internal liver wind movement, epilepsy and convulsions, dizziness, headache, limb numbness, limb paralysis, rheumatic pain, etc. It contains gastrodia glycosides, gastrodia aglycones, β-sitosterol, carotene, citric acid, monomethyl ester, palmitic acid, succinic acid and sucrose, etc.; it also contains gastrodia polysaccharides, vitamin A, various amino acids, trace alkaloids, and various trace elements, such as chromium, manganese, iron, cobalt, nickel, copper, zinc, etc.

[0016] Vitex trifolia L.var.simplicifoliaCham or Vitex trifolia L., a plant of the Verbenaceae family, has the effects of dispersing wind-heat, clearing the head and eyes, and removing dampness from the joints. It is mainly used to treat wind-heat colds, dizziness and headaches, red and swollen eyes, tinnitus and deafness, and dispel wind and relieve pain. It contains volatile oils, the main components of which are camphene and pinene, as well as vitex flavonoids, fatty oils, alkaloids and vitamin A.

[0017] Beneficial effects: In this prescription, bezoar clears the heart and detoxifies, clears phlegm and opens the orifices, buffalo horn clears the heart, cools the blood, and detoxifies, and musk opens the orifices and refreshes the mind. These three flavors are the main medicines; scutellaria, coptis, and gardenia help bezoar and rhinoceros horn to relieve pericardial fire and clear away heat and toxicity, realgar helps bezoar to clear phlegm and detoxify, and then the fragrance of turmeric and borneol is used to remove filth and open the orifices, and help bezoar and musk to penetrate the inner envelope. In particular, Chuanxiong and safflower are added to increase the function of promoting blood circulation and removing blood stasis, taking the meaning of "treating wind by treating blood first, and blood circulation will eliminate wind by itself", and they are all ministerial medicines. Among them, "Zhongzhong Canxi Lu" says: Chuanxiong has a fragrant and penetrating smell, warm in nature, and warm and penetrating at the same time. Its power rises and falls, and it reaches outside and penetrates inside, and it is everywhere. Its specialty is that it can lead the clear and light air of the human body to the brain, and treat headaches caused by wind attack on the brain, headaches caused by floating heat rushing up the brain, and headaches caused by brain congestion. Its warming power can also promote blood circulation and treat cramps throughout the body, and amenorrhea and childlessness in women. "Compendium of Materia Medica": Safflower is a medicine that breaks blood, promotes blood circulation, harmonizes blood, and regulates blood. Moreover, Chuanxiong can promote blood circulation, promote qi circulation, dispel wind and relieve pain. It can be combined with Gastrodia elata and Vitex mangifera to guide the medicine upward to the head. "Medicine Use Method Image" says that Gastrodia elata "treats wind-heat headaches in adults; wind epilepsy and palpitations in children; paralysis and insensitivity due to wind; and speech disorders due to wind heat." "Compendium of Materia Medica": Gastrodia elata "treats wind in the head, headaches, dizziness, epilepsy, spasms, cramps in the limbs, speech disorders, all strokes, and wind phlegm." "Famous Doctors' Records": Vitex mangifera "removes long worms, treats wind-heat headaches, brain ringing, and tears in the eyes. It replenishes qi and makes people shiny and fat." It reaches the top of the head directly to treat cerebral infarction, and is combined with cinnabar and pearls to calm the mind and soothe the nerves, all of which are adjuvant drugs. The medicinal properties of Vitex Mangqie are to promote hair growth and clear the head. Vitex Mangqie and Chuanxiong are good at dispelling wind and relieving pain; Chuanxiong is good at promoting blood circulation and removing blood stasis, dispelling wind and relieving pain. The combination of the two has the effect of promoting blood circulation, dispelling wind and relieving pain. It is often used to treat headaches, toothaches, and joint pains caused by exogenous wind evil. The above medicines are used together to form the effects of clearing away heat and detoxification, removing phlegm and opening the orifices, promoting blood circulation and removing blood stasis, guiding the upward movement of medicine, and calming the mind, which is a better treatment for acute cerebral infarction caused by phlegm-heat internal closure.

[0018] In the clinical study of the present invention, the results of Table 1 show that the clinical efficacy of Study Groups 1 and 2 after treatment is significantly higher than that of the control group, and Study Group 1 (Improved Angong Niuhuang Pills) is better than Study Group 2 (Original Angong Niuhuang Pills); the results of Tables 2-3 show that in the clinical study of the present invention, the neurological deficit scores (NIHSS) of Study Groups 1 and 2 were lower than those of the control group, and the scores of the Mini-Mental State Examination (MMSE) were higher than those of the control group, and Study Group 1 was better than Study Group 2, indicating that the application of Angong Niuhuang Pills has a significant improvement effect on the neurocognitive function of patients. In the comparison of coagulation function, the PLT, FIB, and DD levels of Treatment Groups 1 and 2 were lower than those of the control group, and Study Group 1 was better than Study Group 2, indicating that the application of Angong Niuhuang Pills can improve the coagulation state of patients and promote the dissolution of cerebral thrombus, indicating that adding blood circulation and blood stasis-inducing Chinese medicine to the original prescription can achieve more obvious effects in the treatment of acute cerebral infarction with phlegm-heat internal closure syndrome by clearing away heat and detoxification, removing phlegm and opening the orifices, promoting blood circulation and blood stasis-inducing, and calming the mind. DETAILED DESCRIPTION

[0019] 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.

[0020] Embodiment 1:

[0021] Take 100g of bezoar, 200g of concentrated buffalo horn powder, 25g of artificial musk, 50g of pearl, 100g of cinnabar, 100g of realgar, 100g of coptis root, 100g of scutellaria root, 100g of gardenia, 100g of curcuma, 25g of borneol, 100g of chuanxiong, 80g of safflower, 100g of gastrodia elata, and 80g of vitex rotundus. The preparation method is as follows:

[0022] (1) For the above Chinese medicines, pearls are ground into very fine powders, cinnabar and realgar are ground into very fine powders respectively; coptis root, scutellaria root, gardenia and tulip are crushed into fine powders; bezoar, buffalo horn concentrated powder, artificial musk and borneol are ground into fine powders, mixed with the above powders, sieved and mixed;

[0023] (2) Take Chuanxiong and Carthamus tinctorius, extract the volatile oil, carry out cyclodextrin inclusion complexation, mix the residue after the volatile oil extraction with Gastrodia elata and Vitex mandibulariae, add 15 times the amount of water of the medicinal materials and boil, then keep it at a slight boil for 1.5 hours, take the decoction, add 15 times the amount of water of the medicinal materials to the residue and boil it, take the decoction, combine the two decoctions, concentrate, concentrate the filtrate to a clear paste with a relative density of 1.15 at 75°C, add ethanol to an alcohol content of 85% v / v, let it stand for 24 hours, take the supernatant, recover the ethanol, concentrate, dry and grind it into powder, mix it with the volatile oil cyclodextrin inclusion complex and the powder prepared in step (1), add an appropriate amount of refined honey to make large honey pills, a total of 600 pills, and obtain No. 1 Angong Niuhuang Pills.

[0024] Embodiment 2:

[0025] Take 80g of bezoar, 250g of concentrated buffalo horn powder, 20g of artificial musk, 60g of pearl, 80g of cinnabar, 120g of realgar, 80g of coptis root, 120g of scutellaria, 80g of gardenia, 120g of curcuma, 20g of borneol, 120g of chuanxiong, 60g of safflower, 120g of gastrodia, and 60g of vitex rotundus. The preparation method is as follows:

[0026] (1) For the above Chinese medicines, pearls are ground into very fine powders, cinnabar and realgar are ground into very fine powders respectively; coptis root, scutellaria root, gardenia and tulip are crushed into fine powders; bezoar, buffalo horn concentrated powder, artificial musk and borneol are ground into fine powders, mixed with the above powders, sieved and mixed;

[0027] (2) Take Chuanxiong and Carthamus tinctorius, extract the volatile oil, carry out cyclodextrin inclusion complexation, mix the residue after the volatile oil extraction with Gastrodia elata and Vitex mandibulariae, add 10 times the amount of water of the medicinal materials and boil, then keep it at a slight boil for 1 hour, take the decoction, add 10 times the amount of water of the medicinal materials to the residue and boil it, take the decoction, combine the two decoctions, concentrate, concentrate the filtrate to a clear paste with a relative density of 1.21 at 75°C, add ethanol to an alcohol content of 85% v / v, let it stand for 24 hours, take the supernatant, recover the ethanol, concentrate, dry and grind it into powder, mix it with the volatile oil cyclodextrin inclusion complex and the powder prepared in step (1), add an appropriate amount of refined honey to make large honey pills, a total of 600 pills, and obtain the product.

[0028] Embodiment 3:

[0029] Take 120g of bezoar, 150g of concentrated buffalo horn powder, 30g of artificial musk, 40g of pearl, 120g of cinnabar, 80g of realgar, 120g of coptis root, 80g of scutellaria, 120g of gardenia, 80g of curcuma, 30g of borneol, 80g of chuanxiong, 100g of safflower, 80g of gastrodia, and 100g of vitex rotundus. The preparation method is as follows:

[0030] (1) For the above Chinese medicines, pearls are ground into very fine powders, cinnabar and realgar are ground into very fine powders respectively; coptis root, scutellaria root, gardenia and tulip are crushed into fine powders; bezoar, buffalo horn concentrated powder, artificial musk and borneol are ground into fine powders, mixed with the above powders, sieved and mixed;

[0031] (2) Take Chuanxiong and Carthamus tinctorius, extract the volatile oil, carry out cyclodextrin inclusion complexation, mix the residue after the volatile oil extraction with Gastrodia elata and Vitex mandibulariae, add 20 times the amount of water of the medicinal materials and boil, then keep it at a slight boil for 2 hours, take the decoction, add 20 times the amount of water of the medicinal materials to the residue and boil it, take the decoction, combine the two decoctions, concentrate, concentrate the filtrate to a clear paste with a relative density of 1.11 at 75°C, add ethanol to an alcohol content of 85% v / v, let it stand for 24 hours, take the supernatant, recover the ethanol, concentrate, dry and grind it into powder, mix it with the volatile oil cyclodextrin inclusion complex and the powder prepared in step (1), add an appropriate amount of refined honey to make large honey pills, a total of 600 pills, and obtain the product.

[0032] Comparative Example 1:

[0033] Take 100g of bezoar, 200g of concentrated buffalo horn powder, 25g of artificial musk, 50g of pearl, 100g of cinnabar, 100g of realgar, 100g of coptis root, 100g of scutellaria root, 100g of gardenia, 100g of curcuma, and 25g of borneol, and prepare the mixture as follows:

[0034] For the above Chinese medicines, pearl is ground into extremely fine powder with water, cinnabar and realgar are ground into extremely fine powder with water separately; coptis root, scutellaria root, gardenia and tulip are crushed into fine powder; bezoar, buffalo horn concentrated powder, artificial musk and borneol are ground into fine powder, mixed with the above powders, sieved, mixed, and appropriate amount of refined honey is added to make large honey pills, a total of 600 pills, to obtain No. 2 Angong Niuhuang Pills.

[0035] Example 4: Clinical study

[0036] General information: A total of 150 patients with cerebral infarction admitted to the Department of Neurology, Nanjing Hospital of Traditional Chinese Medicine from January 2022 to December 2023 were selected and randomly divided into three groups, with 50 cases in each group; this study was approved by the hospital ethics committee, and the patients signed informed consent.

[0037] Diagnostic criteria: All meet the diagnostic criteria for acute cerebral infarction caused by heat-closure syndrome

[0038] TCM diagnostic criteria: refer to the "Guidelines for Diagnosis and Treatment of Common Diseases in Internal Medicine of TCM" issued by the Chinese Association of Traditional Chinese Medicine in 2008. Clinical manifestations include: confusion, hemiplegia, crooked mouth and tongue, slurred speech or inarticulate speech, or even silence, hemiplegia; or headache, dizziness, pupil changes, choking when drinking water, unsteady gait, etc. It often has an acute onset in a quiet state, gradually worsens, or has a history of repeated similar symptoms. A small number of patients may have a sudden onset, rapid progression of the disease, accompanied by confusion. There are often inducements before the onset of the disease, and there are often prodromal symptoms. Dizziness, headache, tinnitus, sudden onset of transient speech difficulties or limb numbness, blurred vision, several attacks within 1 day, or multiple recurrences within a few days. The age of onset is mostly over 40 years old. With the above clinical manifestations, combined with the onset form, inducements, prodromal symptoms, and age, stroke can be diagnosed. Combined with imaging examinations (head CT or MRI), the diagnosis of ischemic stroke can be confirmed.

[0039] Western medicine diagnostic criteria: refer to the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2014" developed by the Cerebrovascular Disease Group of the Neurology Branch of the Chinese Medical Association. (1) Acute onset; (2) Focal neurological deficits, with a few cases of global neurological deficits; (3) Symptoms and signs persisting for more than 24 hours; (4) Exclusion of non-vascular brain lesions; (5) Brain CT or MRI excludes cerebral hemorrhage and other lesions, with ischemic lesions.

[0040] Syndrome diagnosis: It belongs to the syndrome of internal phlegm-heat obstruction: impaired consciousness, hemiplegia, crooked mouth and tongue, slurred speech or silence, snoring and sputum, or limb stiffness, or restlessness, or fever, or bad breath, or convulsions, or vomiting blood, red tongue, yellow and greasy tongue coating, and stringy, slippery and rapid pulse.

[0041] Treatment method: The control group of patients with cerebral infarction took aspirin enteric-coated tablets (National Medicine Standard H43021814, manufacturer: Shutaishen (Beijing) Biopharmaceutical Co., Ltd., 100 mg per tablet) 100 mg / d orally, once a day. Study group 1 was treated with No. 1 Angong Niuhuang Pills prepared by the method of Example 1 above on the basis of the control group, and study group 2 was treated with No. 2 Angong Niuhuang Pills prepared by the method of Example 4 above on the basis of the control group, 1 pill (3 g per pill), once a day, for a total of 15 days, the results are shown in Table 1.

[0042] Efficacy judgment criteria: 1) Markedly effective: All symptoms of the patient completely disappeared, and the cardiac function grade improved to grade 2 or above; 2) Effective: The patient's clinical symptoms improved significantly, and the cardiac function grade improved by 1 grade; 3) Ineffective: The patient's clinical symptoms did not improve significantly, and the cardiac function grade did not improve. The total effective rate of clinical treatment = markedly effective rate + effective rate.

[0043] Observation indicators: The clinical efficacy and adverse reaction rates of the three groups were statistically compared. The neurological deficits of the patients before and after treatment were evaluated by the National Institutes of Health Scale (NIHSS), which ranged from 0 to 42 points. The higher the score, the more severe the neurological deficits of the patients. The Mini-Mental State Examination (MMSE) was used to evaluate the cognitive function of the three groups before and after treatment. The score range was 0-30 points. The higher the score, the better the cognitive function. About 3 mL of fasting venous blood was collected from the patients before and after treatment. The platelet count (PLT), fibrinogen (FIB), and D-dimer (DD) levels of the three groups were detected and compared using the Hitachi 008α fully automatic biochemical analyzer (Hitachi China Co., Ltd.). The results are shown in Tables 2 and 3.

[0044] Experimental results:

[0045] Table 1 Comparison of clinical efficacy among three groups (n=50)

[0046] Group Significant effect efficient invalid Total effective rate (%) Control group 16 20 14 72 Study 1 28 19 3 <![CDATA[94 **# ]]> Study 2 23 18 9 <![CDATA[82 * ]]>

[0047] Compared with the control group * P<0.05, ** P<0.01, compared with study group 2: # P<0.05, ## P<0.01

[0048] Table 2 Comparison of NIHSS and MMSE scores among the three groups before and after treatment

[0049]

[0050] Compared with the control group * P<0.05, ** P<0.01, compared with study group 2: # P<0.05, ## P<0.01

[0051] Table 3 Comparison of coagulation function indicators among the three groups before and after treatment

[0052]

[0053] Compared with the control group * P<0.05, ** P<0.01, compared with study group 2: # P<0.05, ## P<0.01

[0054] In the clinical study of the present invention, the results of Table 1 show that the clinical efficacy of Study Groups 1 and 2 after treatment is significantly higher than that of the control group, and Study Group 1 (Improved Angong Niuhuang Pills) is better than Study Group 2 (Original Angong Niuhuang Pills); the results of Tables 2-3 show that in the clinical study of the present invention, the neurological deficit scores (NIHSS) of Study Groups 1 and 2 were lower than those of the control group, and the scores of the Mini-Mental State Examination (MMSE) were higher than those of the control group, and Study Group 1 was better than Study Group 2, indicating that the application of Angong Niuhuang Pills has a significant improvement effect on the neurocognitive function of patients. In the comparison of coagulation function, the PLT, FIB, and DD levels of Treatment Groups 1 and 2 were lower than those of the control group, and Study Group 1 was better than Study Group 2, indicating that the application of Angong Niuhuang Pills can improve the coagulation state of patients and promote the dissolution of cerebral thrombus, indicating that adding blood circulation and blood stasis-inducing Chinese medicine to the original prescription can achieve more obvious effects in the treatment of acute cerebral infarction with phlegm-heat internal closure syndrome by clearing away heat and detoxification, removing phlegm and opening the orifices, promoting blood circulation and blood stasis-inducing, and calming the mind.

[0055] Unless otherwise indicated, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail.

[0056] 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.

[0057] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

Claims

1. An Angong Niuhuang Pill, characterized in that: The invention is prepared from the following raw material components in parts by weight: 80-120 parts of bezoar, 150-250 parts of buffalo horn concentrated powder, 20-30 parts of artificial musk, 40-60 parts of pearl, 80-120 parts of cinnabar, 80-120 parts of realgar, 80-120 parts of coptis root, 80-120 parts of scutellaria root, 80-120 parts of gardenia, 80-120 parts of curcuma, 20-30 parts of borneol, 80-120 parts of ligusticum chuanxiong, 60-100 parts of safflower, 80-120 parts of gastrodia elata and 60-100 parts of vitex rotundus.

2. Angong Niuhuang Pills as claimed in claim 1, characterized in that: The invention is prepared from the following raw material components in parts by weight: 100 parts of bezoar, 200 parts of buffalo horn concentrated powder, 25 parts of artificial musk, 50 parts of pearl, 100 parts of cinnabar, 100 parts of realgar, 100 parts of coptis root, 100 parts of scutellaria root, 100 parts of gardenia, 100 parts of curcuma, 25 parts of borneol, 100 parts of ligusticum chuanxiong, 80 parts of safflower, 100 parts of gastrodia elata and 80 parts of vitex rotundus.

3. Angong Niuhuang Pills as claimed in claim 1, characterized in that: The preparation method is: (1) For the above Chinese medicines, pearls are ground into very fine powders, cinnabar and realgar are ground into very fine powders respectively; coptis root, scutellaria root, gardenia and curcuma are crushed into fine powders; bezoar, buffalo horn concentrated powder, artificial musk and borneol are ground into fine powders, mixed with the above powders, sieved and mixed; (2) Take Chuanxiong and Carthamus tinctorius, extract the volatile oil, carry out cyclodextrin inclusion complexation, mix the residue after the volatile oil extraction with Gastrodia elata and Vitex mandibulariae, add water to boil, then keep it at a low boil for 1-2 hours, take the decoction, add water to the residue to boil again, take the decoction, combine the two decoctions, concentrate, concentrate the filtrate to a clear paste with a relative density of 1.11-1.21 at 75°C, add ethanol to an alcohol content of 85% v / v, let it stand for 24 hours, take the supernatant, recover the ethanol, concentrate, dry and grind into powder, mix with the volatile oil cyclodextrin inclusion complex and the powder prepared in step (1), add appropriate amount of refined honey to make large honey pills, and obtain.

4. Angong Niuhuang Pills as claimed in claim 3, characterized in that: In the preparation method step (2), the amount of water added during the two decoctions is 10-20 times the weight of the medicinal material.

5. Use of Angong Niuhuang Pills as claimed in claim 1 in preparing a medicine for treating acute cerebral infarction.

6. Use of Angong Niuhuang Pills as claimed in claim 1 in the preparation of a drug for treating acute cerebral infarction due to phlegm-heat internal stasis syndrome.

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