WO2022257693A1 - 一种治疗高血压的中药组合物及其制备方法 - Google Patents
一种治疗高血压的中药组合物及其制备方法 Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/26—Iron; Compounds thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/08—Vasodilators for multiple indications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Definitions
- the invention relates to a traditional Chinese medicine composition for treating hypertension and a preparation method thereof, belonging to the field of application of Chinese herbal medicines, and is used for treating hypertension, tinnitus and insomnia which belong to the syndrome of hyperactivity of liver-yang.
- the curative effect is very good since six years of clinical application, and can obviously relieve Headache, dizziness, dizziness, dim vision, tinnitus and deafness, insomnia, dreaminess, irritability and other symptoms, and no obvious adverse reactions.
- Hypertension is a common clinical syndrome characterized by elevated systemic arterial blood pressure, and is the primary risk factor for cardiovascular and cerebrovascular diseases and even cardiovascular death.
- the disease belongs to the category of "dizziness" and "headache” in traditional Chinese medicine.
- the fertile body is full of yang, and the liver yang is hyperactive.
- Lin Peiqin in the Qing Dynasty said: "The head is the meeting place of all yang, and the yang is disturbed by fatigue.
- the liver is the organ of wind and wood, and it is internally sent by fire, and it is active to ascend, and long-term emotional stimulation will cause dizziness.
- vertigo is "caused by phlegm” and “caused by stasis”, such as Zhu Danxi in the Yuan Dynasty said in “Danxi Xinfa”: "Dizziness with qi and fire is the main treatment for phlegm, and qi invigorating medicine And fire-reducing medicine.
- Emotional insufficiency is most likely to lead to stagnation of liver qi, turning fire to generate yang and changing wind, which is a syndrome of vertigo. It can be seen that phlegm retention and blood stasis can also cause vertigo, but they are inseparable from disturbance of liver yang.
- Excess syndromes are mainly yang hyperactivity, internal fire, internal heat, phlegm turbidity, liver wind, blood stasis, and qi depression; deficiency syndromes are mainly yin deficiency and qi deficiency. It can be seen that various factors such as prolonged illness, infirmity, appetite for food, and emotional stimulation lead to stagnation of liver qi, hyperactivity of liver yang, stagnation of qi and body fluid, and changes in phlegm and blood stasis over time, resulting in dizziness and hyperactivity of liver yang syndrome. It is one of the most important syndrome types of hypertension.
- Tinnitus refers to the subjective perception of sounds in the ears or in the brain without external sources or external stimuli, which are often described by patients as electric bells, cicadas, hissing or other noises.
- the liver governs catharsis and loss of control, liver qi is reversed, disturbing the circulation of qi, blood and body fluid throughout the body, the circulation of qi and blood in the ears is blocked, the liver fails to moisten and nourish, or the liver yin is insufficient, and the hyperactivity of liver yang reverses and disrupts clearing the orifices, resulting in tinnitus and deafness.
- liver governs ascending hair, dredging and venting, internal memory is fire, and ascending is active; pathologically, liver yang is prone to hyperactivity, liver wind is easy to move, and liver yin cannot restrain liver yang and liver qi, resulting in hyperactivity of liver yang and uncontrolled liver qi. If it is too much, a series of uncomfortable symptoms will appear clinically, such as headache, dizziness, tinnitus and deafness.
- Insomnia is defined as a subjective experience of dissatisfaction with the duration and/or quality of sleep, despite appropriate sleep opportunities and environments, and affects daytime social functioning. This disease belongs to the category of "insomnia" in traditional Chinese medicine.
- the pathogenesis of insomnia syndrome is nothing more than both deficiency and excess. In excess, stagnation of liver qi and hyperactivity of liver yang, deficiency of liver blood, depression of liver qi, deficiency of liver blood, and deficiency of liver yang Yi Yang is closely related to insomnia.
- liver yang is mostly due to the deficiency of yin in the liver and kidney, and the yin does not control yang, which causes the yang qi of the liver to rise and move, hyperactivity, or the liver fails to dredge and vent, stagnation of qi stagnation due to stagnation of the liver, and the pathology of hyperactivity of yang qi Performance, the viscera are responsible for the liver, and are closely related to the heart, kidney, and spleen.
- liver yang is a common pathogenesis of dizziness, insomnia and tinnitus, and it is of great significance to improve the clinical curative effect and treatment level of such diseases by calming the liver and suppressing yang, calming the nerves and treating different diseases with the same treatment.
- the pharmaceutical composition of the present invention is based on the empirical prescription accumulated by the inventor for many years in clinical practice. It is made by adding and subtracting Shenqu Wan in Sun Simiao's "Preparation for Emergency Qianjin Yaofang" in the Tang Dynasty. It is used for the treatment of hypertension, tinnitus, and insomnia.
- the syndrome of hyperactivity of liver yang has been clinically used for six years and has a very good curative effect. It can significantly relieve headache, dizziness, dizziness, blurred vision, tinnitus and deafness, insomnia, dreaminess, irritability and other symptoms, and has no obvious adverse reactions.
- the prescription theory is unique, the preparation technology is advanced, the clinical curative effect is remarkable, the clinical application is safe, and it has good development and application prospects.
- Medicinal pearls calm the liver and subdue the yang, calm the heart and calm the nerves. Combined with the magnet of the important town of subsiding the yang, take its spirituality, increase its effect of calming the liver and suppressing the yang, calm the nerves, clear the head and ears, calm the nerves and help sleep.
- it has been used to treat patients with hypertension, tinnitus, and insomnia with hyperactivity of liver-yang syndrome, calming the liver and subsiding the yang, calming the nerves, causing headaches, dizziness, dim vision, tinnitus and deafness, insomnia, dreaminess, and irritability. All the symptoms of anger can be eliminated, and the clinical curative effect is very good.
- Pearl sweet, salty, cold, Guixin, Liver Meridian. It has the effects of calming the liver and suppressing the yang, calming the heart and calming the nerves.
- This prescription takes pearls as the king, and the curative effect is remarkable.
- the pharmaceutical technology of pearls in this group draws on the experience of ancient doctors in processing, crushing and sieving the pearls and then using them as medicines to play a role in calming the heart and tranquilizing the nerves, nourishing the yin of the liver and kidney, so as to calm the liver and subdue yang. , the combination of the two medicines can clear the head and ears, and has the effect of calming the nerves and helping sleep.
- Magneto salty in the mouth, cold, returns liver, heart, kidney meridian. It has the effects of calming the liver, suppressing yang, calming the nerves.
- This group of square magnetite is used as medicine after being crushed and sieved. It nourishes the yin of the liver and kidney, calms the liver and suppresses yang to treat the root, calms the nerves and calms the nerves, calms the wind and eliminates annoyance, and treats the symptoms.
- the yin of the liver and kidney can be nourished, and the liver yang can be suppressed.
- the liver wind can be extinguished, the mind can be calmed, the ears can be cleared to stop dizziness, and liver depression can be relieved, so headaches, dizziness, dizziness, tinnitus and deafness, irritability, restlessness and insomnia can be eliminated.
- Zhenling Capsule aims at the pathogenesis characteristics of liver-yang hyperactivity syndrome, and pays attention to calming the liver and subduing yang, calming the nerves and calming the nerves in the treatment.
- Pearls and magnets are compatible with each other, nourishing the liver and kidney and treating the root cause, the yin of the liver and kidney is filled, the liver yang is submerged, the liver wind is extinguished, and the mind is at ease.
- Jianxiaohong helps to improve symptoms such as headache, dizziness, blurred vision, tinnitus and deafness, insomnia and dreaminess, irritability and irritability, and improve the quality of life of patients.
- the traditional Chinese medicine composition of the invention comprises the following components in parts by weight: 300-700 parts of pearls and 300-700 parts of magnets.
- the traditional Chinese medicine composition of the present invention includes the following components in parts by weight: 400-600 parts of pearls, and 400-600 parts of magnets.
- the traditional Chinese medicine composition of the present invention includes the following components in parts by weight: 400 parts of pearls and 600 parts of magnets.
- the traditional Chinese medicine composition of the present invention may also preferably include the following components in parts by weight: 600 parts of pearls and 400 parts of magnets.
- the traditional Chinese medicine composition of the present invention may also preferably include the following components in parts by weight: 500 parts of pearls and 500 parts of magnets.
- the dosage forms of the traditional Chinese medicine composition of the present invention are capsules, tablets, pills, oral liquids, freeze-dried powder injections, granules or powders.
- the active ingredient of the composition of the present invention is made by following steps:
- A take pearl by weighing, be pulverized into fine powder, 60Co irradiation sterilization, standby;
- the preparation technology of Chinese medicine composition capsule of the present invention is:
- A take pearl by weighing, be pulverized into fine powder, 60Co irradiation sterilization, standby;
- step C The fine powder obtained in step A and the fine powder obtained in step B are added with pharmaceutically acceptable excipients for granulation, and the whole particles can be packed into capsules.
- the preferred preparation process is that the irradiation dose of pearl powder 60Co is 4KGy, and the irradiation dose of magnetite powder 60Co is 6KGy.
- the crushing particle size of the pearl powder and the magnetite powder is 80-120 mesh.
- the preferred crushing particle size of the pearl powder is 120 mesh, and the crushing particle size of the magnetite powder is 100 mesh.
- the hypertension treated by the traditional Chinese medicine composition of the present invention is hypertension of liver-yang hyperactivity type.
- the traditional Chinese medicine composition of the present invention is preferably used for improving headache, dizziness, dizziness, dim vision, tinnitus and deafness, insomnia, dreaminess or irritability.
- the preparation of the traditional Chinese medicine composition of the present invention is preferably capsules. Pearls and magnetite are powdered for use as medicine. Capsules are selected, which have the characteristics of convenient carrying and taking, stable properties, controllable quality, low cost, simple preparation process and convenient industrial production.
- the pearls and magnets were crushed through sieves with different meshes, and the crushing frequency and powder yield were investigated. Also refer to bulk density and angle of repose data.
- Magnet 80 mesh has the highest powder yield, but the particle size is too large, and it is easy to separate after mixing with pearl powder.
- the crushing particle size of the magnet is selected as 100 mesh.
- Example 1 In order to illustrate the efficacy of the pharmaceutical composition of the present invention, the samples prepared in Example 1 were used for functional test.
- the drug composition of the present invention was given to spontaneously hypertensive rats (SHR rats) by intragastric administration, and the antihypertensive effect of the pharmaceutical composition of the present invention on spontaneously hypertensive rats was observed.
- [method] select 48 rats to be randomly divided into 4 groups by systolic blood pressure: vehicle control group, pharmaceutical composition group of the present invention, every day 2 times, each 2 capsules, pearl powder group every day 2 times, each 2g, Apocynum antihypertensive tablets, 3 times a day, 4 tablets each time, 12 tablets in each group.
- the administration began, and the systolic blood pressure (SBP) and diastolic blood pressure (DBP) of the animals in each group were measured weekly with the BP-2000 non-invasive blood pressure measuring instrument.
- SBP systolic blood pressure
- DBP diastolic blood pressure
- Table 3 The experimental dosage and grouping of the antihypertensive effect of the pharmaceutical composition of the present invention by intragastric administration for 4 weeks on spontaneously hypertensive rats
- Table 4 The grouping data of the antihypertensive effect of the pharmaceutical composition of the present invention by intragastric administration for 4 weeks on spontaneously hypertensive rats
- Table 5 The antihypertensive effect of the pharmaceutical composition of the present invention by intragastric administration for 4 weeks on spontaneously hypertensive rats
- Hebei Yiling Medicine has collected a total of 153 medical records from 2015 to 2020, including 67 cases with hypertension as the main diagnosis, 41 cases with tinnitus as the main diagnosis, and 43 cases with insomnia as the main diagnosis.
- the report is as follows:
- TCM Syndrome Differentiation Hyperactivity of Liver-Yang Syndrome
- Hypertension Diagnosed according to the "Guidelines for the Prevention and Treatment of Hypertension in China” (2010/2018), in the absence of antihypertensive drugs, the systolic blood pressure (SBP) ⁇ 140mmHg and (or) diastolic blood pressure (DBP) ⁇ 90mmHg.
- SBP systolic blood pressure
- DBP diastolic blood pressure
- Tinnitus subjective tinnitus with unknown cause, with tinnitus as the first complaint. It often manifests as unilateral or bilateral tinnitus, which is intermittent or persistent. The tinnitus sound may present cicadas, whistles, whistles, rumblings, etc., with or without sensorineural hearing loss and vertigo, often accompanied by There are varying degrees of anxiety, insomnia, depression and other symptoms.
- insomnia refers to frequent and persistent difficulties in falling asleep and/or maintaining sleep and leading to insomnia.
- a sleep disorder characterized by dissatisfaction.
- the pharmaceutical composition of the present invention is given, two capsules each time, twice a day.
- the medical records contain records of multiple visits to the doctor, and the description of the medical history contains descriptions such as "improved”, “better”, and “relieving" of the main clinical symptoms of the chief complaint.
- insomnia caused by severe physical or mental diseases (such as schizophrenia, depression, anxiety, etc.), or those who have failed repeated treatment with other sleeping pills for severe insomnia.
- ALT liver and kidney function
- TCM symptom scoring table was formulated and scored. Symptoms were scored quantitatively, with scores of 1, 2, and 3 according to mild, moderate, and severe degrees.
- this prescription can effectively treat patients with clinical syndromes of hyperactivity of liver-yang type primary hypertension grade I-II, tinnitus, insomnia, symptoms such as headache, dizziness, dizziness, and blurred vision , tinnitus and deafness, insomnia and dreaminess, irritability, red tongue with yellow or white fur, stringy pulse, etc.
- the prescription is aimed at the syndrome of hyperactivity of liver yang. It is based on the addition and subtraction of Shenqu Wan in Sun Simiao's "Preparation for Emergency Qianjin Yaofang" in the Tang Dynasty.
- the medicinal pearl calms the liver and suppresses yang, calms the heart and calms the nerves. , increase the effect of calming the liver and suppressing yang, calming the nerves, clearing the head and ears, calming the nerves and helping sleep.
- the two supplement each other, on the top it can calm the liver and subdue yang, on the bottom it can nourish the yin of the liver and kidney, and help subdue the yang. Faintness, tinnitus and deafness, insomnia, dreaminess, irritability and other symptoms can be eliminated.
- Raw material formula pearl 500g, magnet 500g.
- A take pearl by weighing, be pulverized into fine powder, 60Co irradiation sterilization, standby;
- step C Mix the fine powder obtained in step A and step B evenly, wet granulate with povidone K30 as a binder, dry, granulate, and pack into capsules.
- A take pearl by weighing, be pulverized into fine powder, 60Co irradiation sterilization, standby;
- step C Mix the fine powder obtained in step A and step B evenly, wet granulate with povidone K30 as a binder, dry, granulate, and pack into capsules.
- A take pearl by weighing, be pulverized into fine powder, 60Co irradiation sterilization, standby;
- step C Mix the fine powder obtained in step A and step B evenly, and make a pill according to the conventional preparation method.
- A take pearl by weighing, be pulverized into fine powder, 60Co irradiation sterilization, standby;
- step C Mix the fine powder obtained in step A and step B evenly, wet granulate with povidone K30 as a binder, dry, granulate, and make granules.
- Raw material formula pearl 600g, magnet 400g.
- A take pearl by weighing, be pulverized into fine powder, 60Co irradiation sterilization, standby;
- step C Mix the fine powder obtained in step A and step B evenly, wet granulate with povidone K30 as a binder, dry, granulate, and tablet.
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Abstract
本发明提供了一种治疗高血压的药物组合物及其制备方法。由珍珠、磁石等药材组成，本发明运用中医络病理论探讨高血压的病因病机，依据肝阳上亢为高血压、耳鸣、失眠的共性病机特点，制定平肝潜阳，镇静安神治法。经临床和药理学试验证实，本发明治疗高血压有很好的治疗效果。
Description
相关申请的交叉引用
本申请要求于2021年6月7日提交中国专利局的申请号为202110628606.X，发明名称为“一种治疗高血压的中药组合物及其制备方法”的中国专利申请的优先权，这些申请的全部内容通过引用结合在本申请中。
本发明涉及一种治疗高血压的中药组合物及其制备方法，属于中草药应用领域，用于治疗高血压、耳鸣、失眠属肝阳上亢证，临床应用六年以来疗效甚佳，可明显缓解头痛头胀、头目眩晕、视物昏花、耳鸣耳聋、失眠多梦、急躁易怒等症状，且无明显的不良反应。
高血压是一种临床常见的体循环动脉血压升高为主的综合征，是罹患心脑血管疾病乃至造成心血管死亡的首要危险因素。该病属于中医学“眩晕”“头痛”范畴，素体阳盛，肝阳偏亢，日久化火生风，风升阳动；或因长期忧郁恼怒，肝气郁结，气郁化火，阴血暗耗，阴虚阳亢，风阳升动，上扰清窍，发为眩晕、头痛诸症。清代林佩琴《类证治裁》谓：“头为诸阳之会，烦劳伤阳，阳升风动，上扰巅顶。耳目乃清空之窍，风阳旋沸，斯眩晕作焉”，指出肝乃风木之脏，相火内寄，主动主升，长期情志刺激则会导致眩晕。另有眩晕“因痰致眩”“因瘀致眩”之说，如元代朱丹溪在《丹溪心法》中谓：“头眩挟气并火，治痰为主，挟补气药及降火药。无痰则不作眩，痰因火动，以有痰湿者”，指出眩晕症的发生是肝阳上亢，化而为肝火，火灼津液成痰，再或因脾胃运化失常，未能化生成精微而生痰浊，发为眩晕。明代虞抟首次在《医读》中论述了“瘀血停蓄，上冲作逆”，指出情志不遂，肝气郁结，气滞津停，久而生瘀，上逆横冲。情志不遂最易导致肝气郁结，化火生阳变风，发为眩晕之证，可见痰饮、瘀血亦可导致眩晕，但均与肝阳上扰密不可分。
实证主要为阳亢、内火、内热、痰浊、肝风、血瘀、气郁；虚证主要为阴虚、气虚等。可见，久病体弱、嗜食肥甘、情志刺激等各种因素导致肝气郁滞，肝阳偏亢，气滞津阻，久而生痰瘀之变，从而发为眩晕，肝阳上亢证是高血压病最主要的证型之一。
耳鸣是指在无外界生源或外界刺激的情况下，主观上感觉耳内或颅内有响声，常被患者描述成电铃声、蝉鸣声、嘶嘶声或其他杂音。肝主疏泄失司，肝气上逆，扰乱全身气血津 液运行，耳部气血运行受阻，肝失濡养，或肝阴不足，肝阳上亢逆乱清窍，而致耳鸣耳聋。生理上肝主升发、疏泄，内存相火，主升主动；病理上肝阳易亢，肝风易动，肝阴无法制敛肝阳和肝气，则导致肝阳亢奋无制，肝气生发太过，临床上则会出现一系列不适症状，如头痛头晕、耳鸣耳聋等。
失眠是指尽管有合适的睡眠机会和睡眠环境，依然对睡眠时间和(或)质量感到不满足，并且影响日间社会功能的一种主观体验。该病属于中医“不寐”范畴，不寐证的病机不外乎虚实两端，实者肝气郁结、肝阳上亢，虚者肝血不足，肝气易郁、肝血易虚、肝阳易扬，均与不寐密切相关。
综上所述，肝阳上亢多为肝肾之阴不足，阴不制阳，使肝之阳气升动、亢逆，或肝失疏泄，肝郁气滞，阳气偏亢的病理表现，脏腑责之于肝，并与心、肾、脾密切相关。久病体虚、情志刺激或不良生活方式导致肝气郁滞，阴阳失衡，阴不敛阳，肝阳上亢，肝风上扰，或郁而化火，上扰清窍，发为眩晕、耳鸣和不寐，临床可见头痛头胀、头目眩晕、视物昏花、耳鸣耳聋、失眠多梦、急躁易怒诸症，日久易生痰瘀之变，加重上述疾病进程。由此可见，肝阳上亢是眩晕、不寐和耳鸣共性病机，采用平肝潜阳，镇静安神治法异病同治，对于提高该类疾病临床疗效和治疗水平具有重要意义。
发明内容
本发明药物组合物是发明人基于临床实践多年积累的经验方，在唐代孙思邈《备急千金要方》神曲丸的基础上加减化裁而成，用于治疗高血压、耳鸣、失眠属肝阳上亢证，临床应用六年以来疗效甚佳，可明显缓解头痛头胀、头目眩晕、视物昏花、耳鸣耳聋、失眠多梦、急躁易怒等症状，且无明显的不良反应。该处方组方理论独具特色，制剂工艺先进，临床疗效显著，临床应用安全，具有较好的开发应用前景。
药用珍珠平肝潜阳、镇心安神，联合重镇潜阳之磁石，取其灵性，增其平肝潜阳、镇静安神之效，使头清耳聪，安神助眠。临床应用六年以来，分别治疗高血压、耳鸣、失眠肝阳上亢证患者，平肝潜阳、镇静安神，使头痛头胀、头目眩晕、视物昏花、耳鸣耳聋、失眠多梦、急躁易怒诸症得消，临床疗效甚佳。
珍珠，味甘、咸、寒，归心、肝经。具有平肝潜阳、镇心安神的功效。该方以珍珠为君，疗效显著，该组方中珍珠的药学工艺借鉴古代医家炮制经验，采用粉碎过筛后入药，发挥镇心安神、滋养肝肾之阴，以达平肝潜阳之功，二药合用，头清耳聪，安神助眠之效峻。
磁石，味咸、寒，归肝、心、肾经。具有平肝潜阳、镇静安神的功效。该组方磁石采用粉碎过筛后入药，取其滋养肝肾之阴、平肝潜阳治其本，镇惊安神、熄风除烦治其标，肝 肾之阴得补，肝阳得抑，肝风得熄，心神得安，聪耳止眩，肝郁得疏，故头痛头胀、头目眩晕、耳鸣耳聋、急躁易怒、心烦失眠诸症得除。
综上所述，珍灵胶囊针对肝阳上亢证的病机特点，在治疗上注意平肝潜阳、镇静安神。珍珠和磁石相互配伍，滋养肝肾治其本，肝肾之阴得充，肝阳得潜，肝风得熄，心神得安，对于高血压、耳鸣、失眠属肝阳上亢证，组方药简效宏，有助于改善患者的头痛头胀、头目眩晕、视物昏花、耳鸣耳聋、失眠多梦、急躁易怒等症状，提高生活质量。
本发明中药组合物包括如下重量份的组分：珍珠300-700份，磁石300-700份。
优选的，本发明中药组合物包括如下重量份的组分：珍珠400-600份，磁石400-600份。
更优选的，本发明中药组合物包括如下重量份的组分：珍珠400份，磁石600份。
本发明中药组合物还可优选为包括如下重量份的组分：珍珠600份，磁石400份。
本发明中药组合物也可优选为包括如下重量份的组分：珍珠500份，磁石500份。
本发明中药组合物的制剂剂型为胶囊剂、片剂、丸剂、口服液、冻干粉针、颗粒剂或散剂。
本发明组合物的活性组分是由以下步骤制成：
A、称取珍珠，粉碎成细粉，60Co辐照灭菌，备用；
B、称取磁石、粉碎成细粉，60Co辐照灭菌，备用；
步骤A所得的细粉，步骤B所得的细粉共同构成了本发明药物组合物的活性组分。
本发明中药组合物胶囊剂的制备工艺为：
A、称取珍珠，粉碎成细粉，60Co辐照灭菌，备用；
B、称取磁石、粉碎成细粉，60Co辐照灭菌，备用；
C、将步骤A所得细粉、步骤B所得细粉加入药学上允许的辅料进行制粒，整粒装胶囊即可。
本发明中药组合物胶囊剂制备中，优选的制备工艺为珍珠粉60Co照射剂量为4KGy，磁石粉60Co照射剂量为6KGy。
本发明中药组合物胶囊剂制备中，珍珠粉和磁石粉的粉碎粒度为80-120目。
本发明中药组合物胶囊剂制备中，优选的珍珠粉的粉碎粒度为120目，磁石粉的粉碎粒度为100目。
本发明中药组合物治疗的高血压为肝阳上亢型高血压。
本发明中药组合物，其优选用于改善头痛头胀、头目眩晕、视物昏花、耳鸣耳聋、失眠多梦或急躁易怒。
本发明中药组合物的制剂选择优选为胶囊剂，珍珠、磁石打粉入药，选择胶囊剂，其具有携带服用方便、性质稳定、质量可控、成本低廉、制备工艺简单便于工业化生产等特点。
根据珍珠和磁石中所含有效成分的化学性质，且为了使药材中有效成分充分释放，保证药效，同时省工节能，降低生产成本并提高原料收率，进行了制剂工艺的研究。
珍珠、磁石的粉碎工艺研究
根据珍珠和磁石中所含有效成分的化学性质，且为了使药材中有效成分充分释放，保证药效，同时省工节能，降低生产成本并提高原料收率，进行粉碎工艺的小试研究。
1、粉碎粒度的选择
(1)试验设计
将珍珠、磁石粉碎过不同目数的药筛，考察粉碎次数和出粉率。同时参考堆密度和休止角数据。
(2)试验方法
称取250g原料，用粉碎机进行粉碎，粉碎后过筛，将未过筛的原料继续粉碎。
(3)试验结果：结果见表1、表2。
表1 珍珠粉碎结果
表2 磁石粉碎结果
(4)结果分析
结果表明，珍珠80-120目的粉碎粒度出粉率较高，粉碎次数均为3次。150目粒度出粉率较低且粉碎次数为4次，从节能的角度不考虑150目粒度。参考堆密度和休止角数据，选择珍珠的粉碎粒度为120目。
磁石80目出粉率最高，但粒度太大，与珍珠粉混合后易分层。选择磁石的粉碎粒度为100目。
功能性试验：
为了说明本发明药物组合物的功效，用实施例1制备的样品进行了功能性试验。
【目的】本实验通过灌胃给予自发性高血压大鼠(SHR大鼠)本发明药物组合物，观察本发明药物组合物对自发性高血压大鼠的降压作用。
【方法】选择48只大鼠按收缩压随机分为4组：溶媒对照组、本发明药物组合物组，每日2次，每次2粒、珍珠粉组每日2次，每次2g、罗布麻降压片，每日3次，每次4片，每组12只。分组后开始给药，给药后每周用BP-2000无创血压测定仪测量各组动物收缩压(SBP)、舒张压(DBP)。
表3 本发明药物组合物灌胃4周对自发性高血压大鼠的降压作用实验剂量与分组
表4 本发明药物组合物灌胃4周对自发性高血压大鼠的降压作用分组数据
【结果】本发明药物组合物给药4周后收缩压及舒张压降低，与模型对照组比较，高剂量组收缩压降低具有统计学差异(P<0.01)，效果与罗布麻降压片作用相当。
表5 本发明药物组合物灌胃4周对自发性高血压大鼠的降压作用
*与模型对照组比较，*P＜0.05，**P＜0.01。
临床试验总结：
为验证本发明药物组合物的临床效果，特将临床使用情况总结如下。在河北以岭医药先后共收集2015-2020年病历共计153份，其中以高血压为主要诊断者67例，以耳鸣为主要诊断者41例，以失眠为主要诊断者43例。现报告如下：
1.诊断标准
中医辨证：肝阳上亢证
辨证要点：头胀、头痛、眩晕、失眠、耳鸣、听力下降、视物昏花、急躁易怒、舌红苔黄或白，脉弦。
西医诊断：
高血压：参照《中国高血压防治指南》(2010/2018)诊断，在未使用降压药物的情况下，诊室收缩压(SBP)≥140mmHg和(或)舒张压(DBP)≥90mmHg。
耳鸣：以耳鸣为第一主诉，且原因不明的主观性耳鸣。常表现为单侧或双侧耳鸣，呈间断性或持续性，耳鸣声可呈现蝉鸣声、哨音、汽笛声、隆隆声等，伴或不伴感音神经性听力下降及眩晕，常伴有不同程度的焦虑、失眠、抑郁等症状。
失眠：参照《中国成人失眠诊断与治疗指南》(2012)、《中国失眠症诊断和治疗指南》(2017)诊断，失眠症指以频繁而持续的入睡困难和(或)睡眠维持困难并导致睡眠感不满意为特征的睡眠障碍。
2.治疗方法
针对辨证属于肝阳上亢证的患者，给予本发明药物组合物，每次两粒，每日两次。
3.临床观察结果
3.1首先我们对自2015年来的153份临床病历进行了总体的临床有效性判断，因前期部分病历缺乏系统观察，因此针对全部病历制定了较为宽泛的有效性判定标准，具体标准及结果如下：
有效：病历中含有多次就诊记录，病史描述中对主诉主要临床症状含有“改善”、“好转”、“减轻”等描述。
无效：单纯一次就诊；多次就诊但无明显主诉症状的“改善”、“好转”、“减轻”等描述记录。
临床病例统计表
临订有效率统计表
3.2自2019年始我院使用门诊观察病历对该处方的临床使用进行了较为详细的临床记 录，制定相应的纳排标准以期更为准确的评价该处方的临床有效性及安全性。
纳入标准：
符合中医肝阳上亢证证候诊断标准。
符合原发性高血压I-II级，且现有治疗效果不佳或肝阳上亢表现突出且符合高血压诊断标准者，以及失眠或耳鸣任一疾病诊断标准。
年龄18岁以上。
排除标准：
因肾病综合征、甲状腺机能减退、痛风、急性或慢性肝胆疾病、糖尿病等所致的继发性高血压、不稳定型心绞痛、脑血管意外、心肌梗死或心力衰竭者。
严重躯体疾病或严重精神疾病(如精神分裂症、抑郁症、焦虑症等)而致失眠者，或严重失眠症用其他安眠药反复治疗无效者。
伴有耳部异物、炎症、畸形、外伤、肿瘤等器质性疾病引发的耳鸣、耳聋或血管系统疾病引发的搏动性耳鸣者。
合并肝、肾、造血系统、恶性肿瘤等严重原发性疾病者。
肝肾功能明显异常(ALT、AST超过正常值3倍以上，Cr超过正常值2倍以上者)者。
可能影响临床观察的其他病变或情况。
病历书写中参照中医肝阳上亢证辨证标准，制定了中医症候评分表并进行评分。对症状进行量化评分，根据轻、中、重程度以1分、2分、3分进行计分。
(1)临床痊愈：中医临床症状、体征消失或基本消失，证候积分减少≥95％。
(2)显效：中医临床症状、体征明显改善，证候积分减少70％≤n＜95％。
(3)有效：中医临床症状、体征均有好转，证候积分减少50％≤n＜70％。
(4)无效：中医临床症状、体征均无明显改善，甚或加重，证候积分减少不足50％。
经整理原153份病历中共计病历60份具有详细的中医症候评分表单，统计结果如下：
中医症候有效率统计表
| 证型名型 | 临床痊愈率(％) | 显效(％) | 有效(％) | 无效(％) | 总有效率(％) |
| 肝阳上亢证 | 5 | 28.3 | 50 | 16.7 | 83.3 |
不良反应观察：自2019年以来我院对该处方的不良反应进行了观察，以服药间隔周期1-4周不等进行药物安全性观察，拥有较为完整记录者54例，以血尿常规、肝肾功能、心电图结果等为主要评价标准，结果显示该药未见明确与药物相关的不良反应，临床问诊未见明确的消化道不良反应。
通过对临床病历的总结，我们认为该处方能够有效治疗临床证型属于肝阳上亢型原发性高血压I-II级、耳鸣、失眠患者，症见头痛头胀、头目眩晕、视物昏花、耳鸣耳聋、失眠多梦、急躁易怒，舌红苔黄或白，脉弦等。
4.讨论：
该处方针对肝阳上亢证候，汲取唐代孙思邈《备急千金要方》神曲丸加减化裁，药用珍珠平肝潜阳、镇心安神，联合重镇潜阳之磁石，取其灵性，增其平肝潜阳、镇静安神之效，使头清耳聪，安神助眠。二者相辅相成，上可平肝潜阳，下可滋养肝肾之阴，助潜阳之效峻，共奏镇静安神，聪耳清窍之功，药简效宏，头痛头胀、头目眩晕、视物昏花、耳鸣耳聋、失眠多梦、急躁易怒诸症得消。
实施例1：
1.原料药配方：珍珠500g，磁石500g。
A、称取珍珠，粉碎成细粉，60Co辐照灭菌，备用；
B、称取磁石、粉碎成细粉，60Co辐照灭菌，备用；
C、将步骤A和步骤B所得细粉混合均匀，以聚维酮K30作为粘合剂湿法制粒，干燥，整粒，装入胶囊即得。
实施例2：
2.原料药配方：珍珠300g，磁石700g。
制备工艺：
A、称取珍珠，粉碎成细粉，60Co辐照灭菌，备用；
B、称取磁石、粉碎成细粉，60Co辐照灭菌，备用；
C、将步骤A和步骤B所得细粉混合均匀，以聚维酮K30作为粘合剂湿法制粒，干燥，整粒，装入胶囊即得。
实施例3：
3.原料药配方：珍珠400g，磁石600g。
A、称取珍珠，粉碎成细粉，60Co辐照灭菌，备用；
B、称取磁石、粉碎成细粉，60Co辐照灭菌，备用；
C、将步骤A和步骤B所得细粉混合均匀，按常规制剂方法，制成丸剂即得。
实施例4：
原料药配方：
4.原料药配方：珍珠700g，磁石300g。
A、称取珍珠，粉碎成细粉，60Co辐照灭菌，备用；
B、称取磁石、粉碎成细粉，60Co辐照灭菌，备用；
C、将步骤A和步骤B所得细粉混合均匀，以聚维酮K30作为粘合剂湿法制粒，干燥，整粒，制成颗粒剂即得。
实施例5：
5.原料药配方：珍珠600g，磁石400g。
A、称取珍珠，粉碎成细粉，60Co辐照灭菌，备用；
B、称取磁石、粉碎成细粉，60Co辐照灭菌，备用；
C、将步骤A和步骤B所得细粉混合均匀，以聚维酮K30作为粘合剂湿法制粒，干燥，整粒，压片即得。
Claims (13)
- 一种治疗高血压的中药组合物，其特征在于该组合物包括如下重量份的组分：珍珠300-700份，磁石300-700份。
- 根据权利要求1所述的中药组合物，其特征在于该组合物包括如下重量份的组分：珍珠400-600份，磁石400-600份。
- 根据权利要求1所述的中药组合物，其特征在于该组合物包括如下重量份的组分：珍珠400份，磁石600份。
- 根据权利要求1所述的中药组合物，其特征在于该组合物包括如下重量份的组分：珍珠600份，磁石400份。
- 根据权利要求1所述的中药组合物，其特征在于该组合物包括如下重量份的组分：珍珠500份，磁石500份。
- 根据权利要求1-5任一所述的中药组合物，其特征在于该组合物的制剂剂型为胶囊剂、片剂、丸剂、口服液、冻干粉针、颗粒剂或散剂。
- 根据权利要求1-5任一所述的中药组合物，其特征在于该组合物的活性组分是由以下步骤制成：A、称取珍珠，粉碎成细粉，60Co辐照灭菌，备用；B、称取磁石、粉碎成细粉，60Co辐照灭菌，备用；步骤A所得的细粉，步骤B所得的细粉共同构成了本发明药物组合物的活性组分。
- 根据权利要求7所述的中药组合物，其特征在于胶囊剂的制备工艺为：A、称取珍珠，粉碎成细粉，60Co辐照灭菌，备用；B、称取磁石、粉碎成细粉，60Co辐照灭菌，备用；C、将步骤A所得细粉、步骤B所得细粉加入药学上允许的辅料进行制粒，整粒装胶囊即可。
- 根据权利要求7所述的中药组合物，其特征在于步骤A和步骤B优选为珍珠粉60Co照射剂量为4KGy，磁石粉60Co照射剂量为6KGy。
- 根据权利要求7所述的中药组合物，其特征在于步骤A或步骤B粉碎的粒度为80-120目。
- 根据权利要求10所述的中药组合物，其特征在于步骤A粉碎粒度为120目，步骤B粉碎的粒度为100目。
- 根据权利要求1-5任一所述的中药组合物，其特征在于所述高血压为肝阳上亢型高血压。
- 根据权利要求1-5任一所述的中药组合物，其特征在于本发明药物组合物在改善头痛头胀、头目眩晕、视物昏花、耳鸣耳聋、失眠多梦或急躁易怒中的应用。
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