CN105687192A

CN105687192A - Medicine composition for treating dizziness and preparing technology of medicine composition

Info

Publication number: CN105687192A
Application number: CN201610146932.6A
Authority: CN
Inventors: 林凡儒; 郭增光; 王丽娟; 付君叶
Original assignee: SHANDONG KERNEL AND HALL PHARMACEUTICAL INDUSTRY Co Ltd
Current assignee: SHANDONG KERNEL AND HALL PHARMACEUTICAL INDUSTRY Co Ltd
Priority date: 2016-03-15
Filing date: 2016-03-15
Publication date: 2016-06-22

Abstract

The invention relates to a medicine composition for treating dizziness. The medicine composition is prepared from 10 kg of difenidol hydrochloride, 30 kg of active ingredients of Chinese medicine, 22.5 kg of dextrin, 22.5 kg of saccharose, 36 kg of starch, 6 kg of carboxymethyl starch sodium, 17.05 kg of 95% ethyl alcohol and 9.95 kg of purified water, all the raw materials are taken and granulated with a conventional method, and 1.50 million tablets are prepared. The difenidol hydrochloride tablets prepared through the method have a remarkable effect on dizziness, are free of toxicity or harm to the human body, free of side effects, low in price, and easy and convenient to prepare, and have wide application prospects.

Description

A kind of pharmaceutical composition for treating dizziness and preparation technology thereof

Technical field

The invention belongs to pharmaceutical technology field, specifically relate to a kind of pharmaceutical composition treating dizziness and preparation technology thereof。

Background technology

Dizziness, is generally also named head rotation dim eyesight, is a kind of common symptom clinically。The lighter is as sat journey, and the time of outbreak is of short duration, and namely the flat sleeping order that closes pacifies a moment；Namely severe one feels very dizzy, it is impossible to stand, and the symptom such as companion sees nausea and vomiting, is in a cold sweat, hand shaking, especially easy generation is with fat, the poor person of body and old people。The feature of its characteristic irregularly shown effect and rear easily recurrence, is called difficult miscellaneous diseases by medical circle。Drug intoxication, motion sickness, arteriosclerosis, hypertension, hypotension, arrhythmia etc., all can cause dizziness。The mistake that spatial orientation sensation subjectivity is known from experience by patient, patient feels surrounding objects or from rotation, or for oscilaltion, the sensation that rolls。It is one of modal main suit in outpatient。Data shows: in crowd, the prevalence of dizziness is 5 ‰, and in general medicine out-patient, about 5% has dizziness, and in department of otorhinolaryngology patient about 7%～15%, Neurology Clinic has 5%～15%, and inpatient has 6%～8% to have vertigo symptoms；In over-65s out-patient, 30% has dizziness, more than 80 years old about 40%；What cause because of dizziness falls in a swoon and accounts for the 6th in the cause of the death of gerontal patient。

Dizziness is the 3rd of outpatient service common sympton, and vast majority of people all experiences this disease in life。The patient suffering from vertigo generally has following symptom: blood pressure, perspires, pale complexion, diarrhoea；Deafness, tinnitus, ear is vexed；Dark and dim eyesight, diplopia, blurred vision；Neck portion or shoulder arm pain, upper limb numbness, limitation of activity；Headache, disturbance of consciousness, sensorimotor obstacle, language or dysarthria etc., in the medicine preventing and treating dizziness, domestic at present primarily focus on antiallergic and relaxing smooth muscle medicine, example hydrochloric acid diphenidol, but great majority have the side effect such as drowsiness, xerostomia, are abroad normally applied revitalizer, such as amfetamine or methylphenidate coupling east henbane alkali or dimenhydrinate, but also there is more side effect。

Motherland's medical science has complete theory and therapy system in treatment vertigo, and has original curative effect。Dizziness disease, successive dynasties doctor's nationality is recorded a lot of, as: " Plain Questions the most pure virginity to be discussed greatly " is thought: " all wind trembling and dizziness, come under liver "；" the big puzzled opinion of bier " is pointed out: " in item in old pathogen, because meeting the void of its body ... enter brain then vertigo, it is anxious that vertigo then draws order system, and order system is anxious then dizzy to turn; " pathogenic factor long term in cervical vertebra, general debility with deficiency of QI in addition, skeleton regression, causing neck blood stasis, passages through which vital energy circulates loses supports, and causes dizzy

All diseases such as dizzy, stiffness of the nape occur；" Ling Shu Miraculous Pivot or Divine Axis defends gas " is thought: " deficiency of the upper causing dizziness ", also has " QI of the upper portion of the body being insufficient " in Miraculous Pivot, and " deficiency of marrow-reservoir " etc. causes dizzy because of void。Han dynasty Zhang Zhongjing thinks that phlegm retention is one of reason of dizziness morbidity, has again six climate exopathogens, damaged by excess of seven emotions to cause later dizzy, and dificiency in lower-JIAO causes dizzy etc.。According to clinical practice, dizziness is in close relations with the liver of theory of Chinese medical science。Excessive rising of liver-YANG can directly send out dizziness, or because of melancholy angry for a long time, stagnated QI transforming into fire, make liver-yin secretly consume, wind sun rises dynamic, pathogen upward attacking orifices in head, and sending out is dizziness, or chronic deficiency of kidney-YIN, the liver failing to be nourished, so that deficiecny of liver-YIN, excessive rising of liver-YANG, sends out as dizziness。

Western medicine is theoretical: dizziness needs, from improving cerebral cortex regulatory function, regulate and control autonomic excitement and suppress function, promotes that neural relative equilibrium reaches to control the treatment of dizziness angle；From tcm theory: mainly entering Liver Channel, fire, suppressing the hyperactive liver to relieve the wind syndrome are let out in liver heat removing。Therefore seek a kind of high-efficiency low-toxicity, the Chinese medicine and western medicine compound drug for the treatment of both the principal and secondary aspects of a disease is a pendulum technical problem in face of medical circle。

Summary of the invention

It is an object of the invention to provide that a kind for the treatment of both the principal and secondary aspects of a disease, side effect be little, safe ready, cheap pharmaceutical composition and preparation technology thereof for treating dizziness。Its purpose is to solve treatment vertigo, overcome Western medicine difenidol hydrochloride effect not notable, and easily repeatedly, the problem that toxic and side effects is big, reach the purpose for the treatment of both the principal and secondary aspects of a disease。

The present invention is with reference to invaluable experience to the pathogenetic understanding of vertigo and treatment of motherland medical science, consult existing reasonable formula, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, according to Chinese Pharmacopoeia and pharmacology compatibility, pushing away Chen Zhixin gain to some extent, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs is always up the core theory of Chinese medicine disease, how to take into account secondary pathogenesis for main pathogenesis medication simultaneously, taking into account the treatment of general character and individual character, thus at utmost embodying intension and the extension of Chinese traditional treatment disease, being a realistic problem of Chinese patent medicine compatibility。Inventor, for the main pathogenesis characteristics of dizziness, puts into practice according to doctor's row for many years in conjunction with a large amount of formula, by the research to Chinese medicine, and in conjunction with dialectical demonstration, in many ways collect the length of many families, seek therapeutic regimen, obtaining technical solution of the present invention, its all medicine share, and brings out the best in each other。

For realizing the object of the invention, the technical solution used in the present invention is as follows:

A kind of pharmaceutical composition for treating dizziness, it is prepared by following raw material and obtains:

Difenidol hydrochloride 37.5kg, dextrin 22.5kg, sucrose 22.5kg, starch 36kg, carboxymethyl starch sodium 6kg, 95% ethanol 17.05kg, purified water 9.95kg。

Take above-mentioned raw materials, conventionally pelletize, prepare 1,500,000, tablet。

Preferably, the pharmaceutical composition of the present invention, it is prepared by following raw material and obtains:

Difenidol hydrochloride 10kg, active ingredient of Chinese herbs 30kg, dextrin 22.5kg, sucrose 22.5kg, starch 36kg, carboxymethyl starch sodium 6kg, 95% ethanol 17.05kg, purified water 9.95kg。

Described active ingredient of Chinese herbs, it is prepared by the raw material of following weight and obtains:

Radix Salviae Miltiorrhizae 35 parts, 35 parts of Flos Carthami, Ramulus Uncariae Cum Uncis 35 parts, Herba Taraxaci 35 parts, Rhizoma Imperatae 30 parts,

Poria cum Radix Pini 30 parts, Caulis Polygoni Multiflori 30 parts, Fructus Ligustri Lucidi 30 parts, Radix Puerariae 28 parts, Semen Cassiae 28 parts,

Radix Polygoni Multiflori 25 parts, Cortex Moutan 25 parts, the Rhizoma Anemarrhenae 25 parts, Semen Cuscutae 25 parts, Myrrha 20 parts,

Radix Paeoniae Rubra 20 parts, Semen oryzae sativae 20 parts, Semen Coicis 20 parts, Semen Citri Reticulatae 20 parts, Cortex Cinnamomi 20 parts,

Radix Aconiti Lateralis Preparata 18 parts, Folium Perillae 15 parts, Radix Morindae Officinalis 15 parts。

The preparation method of described active ingredient of Chinese herbs is:

(1) above-mentioned raw materials is weighed standby；

(2) Flos Carthami, Herba Taraxaci, Rhizoma Imperatae, Poria cum Radix Pini, Semen Cassiae, Cortex Moutan, Myrrha, Semen oryzae sativae, Semen Coicis, Semen Citri Reticulatae, Cortex Cinnamomi, Folium Perillae boiling are taken, first time adds 4 times of weight water, decoct 1 hour, obtain filtrate and medicinal residues after filtration, medicinal residues are added 3 times of weight water and decocts 1 hour, after filtration, obtain filtrate, merge twice filtrate, filtrate after merging is condensed into the extractum that density is 1.2g/ml, and 60 DEG C dried, pulverizes and obtains composite I；

(3) take surplus stock and add 2 times of weight 75%(volume ratios) ethanol, reflux, extract, 2 times, each 1 hour, extracting solution merged, and is concentrated into the extractum that density is 1.2g/ml, and 60 DEG C are dried, pulverizes and obtains Complex II；

(4) namely Homogeneous phase mixing composite I, II obtain active ingredient of Chinese herbs。

The medicine of the present invention can adopt the conventional method in existing pharmaceutical field to produce, it is necessary to time can add various pharmaceutically acceptable carrier。Described carrier includes the conventional excipient of pharmaceutical field, filler, binding agent, wetting agent, disintegrating agent, absorption enhancer, surfactant, absorption carrier, lubricant etc.。

Usage and dosage, one time 1,3 times on the one。

Technical solutions according to the invention are on the clinical experience basis of Chinese traditional treatment dizziness, in conjunction with modern pharmacy achievement develop with the compound preparation of Integrated TCM。Chinese medicine and Western medicine are effectively combined, there is dispelling wind and removing obstruction in the collateral very strongly, flat dizzy dizzy effect of dispelling, symptom can be improved rapidly, stop disease, dizziness is had effect of healing, overcomes prior art Chinese medicine onset slow and the shortcoming such as toxicity is big, reach the purpose for the treatment of both the principal and secondary aspects of a disease。

The component of medicine of the present invention all adopts natural raw material of Chinese medicine, and it prepares simplicity, and medicine source is extensive, with low cost, it adopts different extracting method to obtain its effective ingredient to greatest extent, it then follows the prescriptions principle of the traditional Chinese medical science, all medicines share, and bring out the best in each other, and invention formulation dose is little, effective ingredient is prone to release, absorbs fast, and bioavailability is high, enabling drug effect to give full play to, verify by clinic application, it is evident in efficacy reliably, mild in medicine property and, toxic and side effects does not occur, has a extensive future。

Detailed description of the invention

Embodiment 1

A kind of pharmaceutical composition for treating dizziness and preparation technology thereof, it is prepared by following raw material and obtains:

Usage and dosage, one time 1,3 times on the one, 7 days be a course for the treatment of。

Embodiment 2

The preparation method of described active ingredient of Chinese herbs is:

(1) above-mentioned raw materials is weighed standby；

Embodiment 3

One, toxicity test

This experiment adopts healthy SD rat 40, it is divided into two groups, often group 20, the medicine of oral administration embodiment 1, embodiment 2 preparation respectively, successive administration 30 days, during it be observed that rat administration and after drug withdrawal, within 1 week, growth of animal state, movable diet, hematology, blood biochemical analysis, organs and tissues structure and routine urinalysis etc. all have no significant effect, it was shown that clinical drug safety is reliable。

Two, after rat is rotated by the preparation of embodiment 2 preparation, property nystagmus has obvious inhibitory action, the tolerance time of vestibule irriate can be extended, alleviate vestibule autonomic nervous dysfunction, expansion blood vessel can be played, improve microcirculation, increase blood flow, alleviate dizziness and tinnitus, deaf effect；

Embodiment 4

Clinical data

1. choose outpatient's totally 90 example with complete case。Being randomly divided into two groups, 1 group of 45 example of embodiment, 2 group of 45 example of embodiment, between above each group。No significant difference (P > 0.05), has comparability。

2. diagnostic criteria adopts Cervical Spondylosis diagnostic criteria and the typing standard of State Administration of Traditional Chinese Medicine's nineteen ninety-five promulgation, with reference to " new Chinese medicine guideline of clinical investigations " (trying): (1) cervical vertigo, history of can dampinging off；(2) rotation neck levies the positive；(3) X-ray film has abnormal finding；(4) accompany sympathetic symptoms more。

Exclusion standard (1) eye source property, aural vertigo；(2) basilar artery insufficiency and neurosis and intracranial tumor etc. caused by vertebral artery I section and III section of pressurized of vertebral artery。

3. Therapeutic Method:

Embodiment 1 group, give embodiment 1 preparation tablet, one time 1,3 times on the one, 7 days be a course for the treatment of。

Embodiment 2 groups, give embodiment 2 preparation tablet, one time 1,3 times on the one, 7 days be a course for the treatment of。

4. criterion of therapeutical effect is with reference to " new Chinese medicine guideline of clinical investigations " (trying)。

Curing: clinical symptoms, sign disappear or substantially disappear, syndrome integral reduces >=95%;Effective: clinical symptoms, sign change

Kind obvious, syndrome integral reduces >=70%;Effective: clinical symptoms, sign all take a favorable turn, syndrome integral reduces >=30%;Invalid: clinical symptoms, sign are not improved, even increase the weight of, syndrome integral is less than 30%。

Criterion of therapeutical effect with reference to State Administration of Traditional Chinese Medicine's nineteen ninety-five is quantified, observe two groups of comparisons to main symptom and time card improvement degree, represent with integration method, complying with weight degree in gently different: primary symptom is dizzy, dizzy remembers 2 points, 4 points, 6 points respectively, secondary disease is had a headache, item is tight, shoulder back of the body distending pain etc. remembers 1 point, 2 points, 3 points respectively。

Statistical method measurement data represents with mean ± standard deviation, compares and use paired t-test in group。All data use SPSS10.0 software to carry out statistical analysis, if P < 0.05 is that difference is statistically significant。Two groups of clinical efficacies are in Table 1:

Table 1: efficacy result

Group	Example time	Cure	Effective	Effectively	Invalid	Total effective rate
							Embodiment 2 groups	45	19	13	12	1	97.8%
Embodiment 1 group	45	15	9	7	14	68.9%

Above-mentioned each Chinese medicine and western medicine that the present invention adopts makes compatibility mutually, its collaborative effect of curing the disease can be played, there is between each composition of raw material of Chinese medicine used drug effect be interweaved and mutually promote and coordinate usefulness, according to clinical verification, dizziness is had good adjuvant treatment effect, in the applicant's medical practice for many years, the case Numerous cured, all obtain good effect, and with low cost, alleviate the burden of patient。

Claims

1., for treating a pharmaceutical composition for dizziness, it obtains according to the preparation of following technique:

Take difenidol hydrochloride 37.5kg, dextrin 22.5kg, sucrose 22.5kg, starch 36kg, carboxymethyl starch sodium 6kg, 95% ethanol 17.05kg, purified water 9.95kg, conventionally pelletize, prepare 1,500,000, tablet。

2., for treating a pharmaceutical composition for dizziness, it obtains according to the preparation of following technique:

Take difenidol hydrochloride 10kg, active ingredient of Chinese herbs 30kg, dextrin 22.5kg, sucrose 22.5kg, starch 36kg, carboxymethyl starch sodium 6kg, 95% ethanol 17.05kg, purified water 9.95kg, conventionally pelletize, prepare 1,500,000, tablet。

3. the pharmaceutical composition described in claim 1-2, it is characterised in that described active ingredient of Chinese herbs is prepared by the raw material of following weight parts and obtained:

4. the pharmaceutical composition described in claim 1-3, it is characterised in that the preparation method of described active ingredient of Chinese herbs is:

(1) above-mentioned raw materials is weighed standby；

(2) Flos Carthami, Herba Taraxaci, Rhizoma Imperatae, Poria cum Radix Pini, Semen Cassiae, Cortex Moutan, Myrrha, Semen oryzae sativae, Semen Coicis, Semen Citri Reticulatae, Cortex Cinnamomi, Folium Perillae are taken, mixing, boiling, first time adds 4 times of weight water, decoct 1 hour, obtain filtrate and medicinal residues after filtration, medicinal residues are added 3 times of weight water and decocts 1 hour, after filtration, obtain filtrate, merge twice filtrate, filtrate after merging is condensed into the extractum that density is 1.2g/ml, and 60 DEG C dried, pulverizes and obtains composite I；

(3) take surplus stock mixing, add 2 times of weight 75%(volume ratios) ethanol, reflux, extract, 2 times, each 1 hour, extracting solution merged, and is concentrated into the extractum that density is 1.2g/ml, and 60 DEG C are dried, pulverized acquisition Complex II；