CN1857495A - Compound chinese preparation for treating pain symptom and its preparing process - Google Patents
Compound chinese preparation for treating pain symptom and its preparing process Download PDFInfo
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- CN1857495A CN1857495A CNA200610024563XA CN200610024563A CN1857495A CN 1857495 A CN1857495 A CN 1857495A CN A200610024563X A CNA200610024563X A CN A200610024563XA CN 200610024563 A CN200610024563 A CN 200610024563A CN 1857495 A CN1857495 A CN 1857495A
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Abstract
The present invention belongs to the field of Chinese medicine technology, and especially a kind of compound Chinese medicine preparation for treating headache and/or dysmenorrhea caused by stagnation of Qi and blood stasis and its preparation process. The compound Chinese medicine preparation is developed based on the Chinese medicine theory of promoting blood circulation and dispersing blood clots to stop pain, and is prepared with corydalis tuber, trogopterus dung, frankincense, myrrh and evodia fruit and through grinding or extracting, adding medicinal supplementary material and further processing to prepare granule, tablet, capsule, etc. Clinical application shows that the compound Chinese medicine preparation has high pain relieving effect and no adverse reaction. The compound Chinese medicine preparation may be also used for treating pain caused by other causes.
Description
Technical field
The invention belongs to the field of Chinese medicines, relate to the compound Chinese medicinal preparation for the treatment of the pain card.Be specifically related to a kind of headache due to the stagnation of QI-blood and/or compound Chinese medicinal preparation of dysmenorrhea and preparation method thereof for the treatment of.
Background technology
The disease that causes pain clinically is hundreds of, usually causes patient's body misery and psychic pain, influences patient's work or life, and quality of life.
Dysmenorrhea is a kind of common gynecological disease, be the women in menstruation menstrual period or before and after passing through based on the comprehensive symptom of the general of hypogastralgia.Britain authorities,medical mechanism investigation report points out that the women in the whole world 80% has dysmenorrhea in various degree.According to Chinese women's menstrual physiology constant cooperative groups in 1978 to of the investigation and analysis of 29 provinces 130,000 woman months in the whole nation through physical constants, have dysmenorrhea person to reach 33.2%, wherein the constitutional person accounts for 53.2%, dysmenorrhea has a strong impact on the worker and accounts for 13.55%.Epidemiological study shows that the dysmenorrhea incidence rate has the trend that rises year by year.Modal in the dysmenorrhea have two kinds of endometriosis and primary dysmenorrhea, and dysmenorrhea takes place adolescence about 50%.Wherein part dysmenorrhea patient has had a strong impact on women's physical and mental health and quality of life also with the symptom of headache.
So far, doctor trained in Western medicine does not still have the specific drug of treatment dysmenorrhea.Nonsteroidal antiinflammatory drug such as piroxicam, indomethacin are mainly adopted in clinical treatment at primary dysmenorrhea at present; Contraceptive such as lng; Calcium ion channel blocker such as nifedipine and vitamin B
6, E
]Deng.The effective percentage of the medicine of inhibition prostaglandin such as ibuprofen, shot pain is 30% ~ 80%.This class medicine late result is dissatisfied, and side effect such as gastrointestinal reaction are in various degree all arranged.At the treatment with the endometriosis of dysmenorrhea, useful long-acting depomedroxy progesterone acetate (MPA) is with antagonism estrogen; Compete estrogen receptor with danazol; With arimedex with the activity that suppresses the outer aromatase of gland, stop estradiol generation etc.Though these Drug therapy endometriosis have certain effect, be difficult to bring into play instant analgesic effect, and side effect such as estradiol bone loss, ovary inhibitory reaction, low estrogen symptom and androgen assimilation easily take place.
According to relevant investigation, have 36.1% among the dysmenorrhea patient with headache.Headache is a kind of commonly encountered diseases, also can be the signal or the complication of some organic disease of body, and especially with the quickening pace of modern life, the sickness rate of headache is in rising trend.Wherein, migraine and tension headache account for more than half.
Migraine women divides typical case, plain edition and complexity more than the male, and wherein common migraine accounts for 70%-80%.US and European large quantities of census of population results show, about 40% people once suffered from serious headache in certain period of life, and wherein half is a migraine.Relevant migraine Epidemiological study shows its prevalence average out to 6.3 ‰.Other has statistics to show, China's migraine prevalence is 985.2/10 ten thousand people, and annual morbidity is 79.7/10 ten thousand people, and the sickness rate of age group below 30 years old has the trend that increases year by year.The doctor trained in Western medicine clinical treatment, sedation-analgesia agent commonly used has certain effect to light, moderate pain, but often takes as stable, APC, somedon, acetaminophen etc., and then analgesic effect is worse and worse.Calcium ion antagonist Thebe woods has certain curative effect, but it is many to take side reaction for a long time.Other also has multiple symptomatic treatment methods such as nonsteroidal antiinflammatory drug, Ergotamine therapy, beta-blocker etc., and shortcoming is that gastrointestinal side effect is many, and prolonged and repeated medication can influence hemopoietic function of bone marrow, causes peripheral blood leucocyte to reduce.
Tension headache is in the chronic headache modal one type, is more common in the women, accounts for 75%, often by spirit such as anxiety, depression, psychentonia stress or unreasonable posture cause head, musculi colli to shrink lastingly and cause.Conventional muscle relaxation agent, the antianxiety drug etc. used of western medical treatment.Muscle relaxation flesh clinical efficacy is not satisfactory, and heavy dose of this type of medicine side reaction of application is obvious; The antianxiety drug scope of application is narrow, and analgesic effect is undesirable.
Non_steroidal anti_inflammatory drug is that one of maximum medicament categories is used in the whole world at present, and about 3,000 ten thousand people take every day, and global user reaches 500,000,000.Show according to the result of study that in June, 2005, Univ Nottingham UK announced at " BMJ ", nearly all nonsteroidal antiinflammatory drug (NSAIDs, common analgesic) is taken for a long time and is all had the side effect that increases user's cardiovascular disease incidence probability, wherein dioxygen divides acid (Diclofenac claims " diclofenac " again) to increase ill probability up to 55%.Studies show that any nonsteroidal anti-inflammatory analgetic thing is taken all for a long time can the risk that causes the cardiovascular disease incidence probability to increase.Taking ibuprofen for a long time will increase and suffer from a heart complaint the probability of cardiovascular disease such as apoplexy 24%.In October, 2004, Merck company announces medicine ten thousand networks (Vioxx) of Recall voluntarily treatment of arthritis and acute pain in the world, and being doubted because of this medicine increases that the user suffers from a heart complaint and the apoplexy probability.U.S. food Drug Administration (FDA) has also issued caution statement and the additional management orderliness that comprises 21 kinds of nonsteroidal antiinflammatory drug rational Application on April 7th, 2005, " statement " relates to all non-steroidal anti-inflammatory class medicines, comprise prescribed and non prescribed medicine, should use minimum effective dose when NSAIDs is taken in suggestion, and be limited within the shortest effective course of treatment.
Though treatment by Chinese herbs dysmenorrhea and headache have obtained certain curative effect, the Chinese medicine decoction decocts, taking medicine and carrying all has inconvenience; Though commercially available Chinese patent medicine taking convenience, or of less types, and perhaps curative effect is not good enough, still can not satisfy clinical demand.
Summary of the invention
The purpose of this invention is to provide a kind of compound Chinese medicinal preparation for the treatment of the pain card.Be specifically related to a kind of compound Chinese medicinal preparation for the treatment of the pain card due to the stagnation of QI-blood and preparation method thereof.
Pain of the present invention card relates to the pain card due to primary dysmenorrhea, endometriosis dysmenorrhea or common migraine, tension headache or other blood stasis pathogenesis due to the stagnation of QI-blood.
Theory of Chinese medical science thinks, though that pain has is cold, hot, empty, the branch of reality and edema caused by disorder of QI, blood system, pathogenesis is mainly nothing more than two aspects: the one, because qi and blood stagnation makes the meridians blocking barrier; The 2nd, because the cold coagulation spasm, blood vessels are contracted curl up inadequate urgency, coagulate tears and can not unobstructedly move.Both reach the same goal by different routes, and all cause " stagnation of QI and blood may bring about pain ".So should promoting blood circulation to disperse blood clots and relieves pain for controlling.The present invention adopts the superfine grinding product of Chinese crude drug Rhizoma Corydalis, Oletum Trogopterori, Olibanum, Myrrha and Fructus Evodiae or extract to add the compound Chinese medicinal preparation that the medicine adjuvant is made treatment pain card.Described preparation is made granule, tablet or capsule oral solid formulation.
Chinese crude drug of the present invention, wherein, Rhizoma Corydalis " stagnation of QI in the energy promoting the circulation of blood, stasis in the gas " is the key medicine of blood-activating and qi-promoting pain relieving, " going up purgation pain all over the body so specially control " is monarch drug.Oletum Trogopterori, Olibanum (processed), Myrrha (processed) power have a monopoly blood vessels and dissipating blood stasis blood, promoting blood circulation and stopping pain is ministerial drug, strengthens the effect of monarch drug promoting blood circulation and stopping pain, and the merit of mutual reinforcement between is arranged." element is asked the regulating menstruation opinion " cloud: " Wen Ze disappears and goes it for vim and vigour person, happiness temperature and aversion to cold is cold then puckery not fluence "; " element ask lift pain opinion " cloud: " cold go into through and check late, tears and not all right, visitor's insufficiency of blood outside arteries and veins, visitor's flow of QI being obstructed then in arteries and veins, so yet the soldier bitterly "; " element is asked the numbness opinion " be cloud again: " so how also pain person's cold have cold bitterly also ".Hereat again with the supporing yang cold expelling of Fructus Evodiae, warm promoting blood circulation more can be strengthened the analgesic effect, is adjuvant.All medicines share, and are hot with eliminating stagnation, and bitter temperature is apt to into the Liver Channel blood system to activate yang to let out painful abdominal mass, the stasis of the QI and blood of loosing, and the numbness resistance of the network of promoting blood circulation, the effect of playing stasis-dispelling and pain-killing altogether, its power is special, and its effect is grand.
Preparation of the present invention has vital energy regualting and blood circulation-promoting, promoting the flow of QI in the collateral by warming the meridian, and the effect of stasis-dispelling and pain-killing cures mainly all pains all by due to the stagnation of blood stasis venation, is used for the treatment of dysmenorrhea due to the stagnation of QI and blood, headache, and card bitterly such as chronic gastritis pain, hypochondriac pain, light moderate cancer pain.
Modern pharmacological research shows: Rhizoma Corydalis mainly contains compositions such as Rhizoma Corydalis first element, tetrahydropalmatine, can suppress electrical activity under cerebral cortex and the cortex, has obvious analgesic activity; Suppress gastric secretion, prevent gastric ulcer; The two-ways regulation smooth muscle has relaxed muscle and spasmolysis, can be used in treatment migraine, superficial gastritis, acute and chronic contusion, puerperal abdonimal pain etc.Oletum Trogopterori mainly contains compositions such as resin, carbamide, uric acid, has antiinflammatory, analgesic effect, can treat primary dysmenorrhea etc.Myrrha mainly contains the resin of compositions such as myrrholic acid, commiphorinic acid, Myrrha phenol and contains the natural gum of arabinose, galactose and xylose, also has 2.5～9% volatile oil, have effects such as antibiotic, blood fat reducing, can treat soft tissue injury, mastitis, painful and swollen testis etc.Olibanum mainly contains the resin of composition such as boswellic acid and contains the calcium salt of arabitic acid and the natural gum of magnesium salt, also has 3～8% volatile oil, and significant analgesia and bacteriostasis are arranged, and can treat mastitis, burn, skin infection pain, fracture etc.Fructus Evodiae mainly contains compositions such as rutaecarpin, rutaecarpine, xanthoxylic acid, has effects such as excited uterus, two-ways regulation intestinal tube, antiulcer, antibiotic, antiviral and parasite, can treat the stomachache of tooth pain, hernia, gastric qi cold caused by deficiency.
The present invention has used the orthogonal test drug screening on the basis of theory of Chinese medical science and clinical practice, desirable prescription of the present invention and preparation method have been determined in craft screening and clinical trial.
The present invention is made by following weight parts proportion raw material medicine and pharmaceutic adjuvant:
Rhizoma Corydalis 1-6 part, Oletum Trogopterori 1-5 part, Olibanum 1-4 part, Myrrha 1-4 part, Fructus Evodiae 1-2 part, surplus is pharmaceutic adjuvant.
Preferred weight part proportioning is: 1 part of Rhizoma Corydalis 1-2 part, Oletum Trogopterori 1-2 part, Olibanum 1-2 part, Myrrha 1-2 part, Fructus Evodiae.
Medicine of the present invention also adopts Cortex Cinnamomi 1-2 part to substitute the Fructus Evodiae promoting the flow of QI in the collateral by warming the meridian.
The present invention prepares by following method:
Get Rhizoma Corydalis, Oletum Trogopterori, Olibanum, Myrrha and Fructus Evodiae by weight, superfine grinding packing according to a conventional method; Or:
Get Rhizoma Corydalis, Oletum Trogopterori, Olibanum, Myrrha, Fructus Evodiae by weight, the extraction process of frying in shallow oil is closed in employing, promptly soaked 1 hour, add 8～10 times in water, extract three times, after aqueous extract is concentrated into relative density 1.08～1.12 (80 ℃), adopt ethanol precipitation, centrifuging or chitosan fining process to carry out purification process, obtain water extract, or:
Get Rhizoma Corydalis, Oletum Trogopterori, Olibanum, Myrrha, Fructus Evodiae by weight, use 80% ethanol, 8 times of amounts, reflux, extract, 2.5 hours, medicinal liquid leaves standstill, and gets the clear paste that supernatant concentration to relative density is 1.15～1.35 (65 ℃);
Above-mentioned water is carried or the alcohol extraction extract, adds proper pharmaceutical excipients, and the drying technology is made extract powder, and the reuse conventional method is made solid oral dosage form.
Described dry technology comprises vacuum drying, spray drying and lyophilization.
The molding adjuvant that described preparation adopts is medicinal specification adjuvant.Be selected from microcrystalline cellulose, Pulvis Talci, dextrin, lactose, sodium bicarbonate, citric acid, Sodium Hydroxymethyl Stalcs, micropowder silica gel, starch, soluble starch or magnesium stearate.
Described dosage form preparation method can adopt: or get 1 part of extract powder, add 0.7 part of microcrystalline cellulose, to mix thoroughly, vacuum drying was pulverized 60 mesh sieves, added Pulvis Talci 70 grams in dry extract, and mixing incapsulates; Or the adding dextrin, spray drying makes into fine powder, makes granule through dry granulation; Or: add Sodium Hydroxymethyl Stalcs, micropowder silica gel, soluble starch, lactose and magnesium stearate, mix homogeneously is with 95% ethanol system granule; 80 ℃ of dry back tablet agents; Or: the part fine powder adds citric acid, starch is made granule, and all the other fine powders add sodium bicarbonate, starch is made granule, after two kinds of granules add magnesium stearate, mix homogeneously, tabletting.
Medicine of the present invention is through clinic trial, and the result shows, to the treatment pain relieving of dysmenorrhea and/or headache hold time, pain relieving total effective rate, especially complete remission rate etc. are apparently higher than traditional known drug YUANHU ZHITONG KELI, and do not have obvious adverse reaction.Pharmaceutical preparation good analgesic effect of the present invention, indication is wide, dose is little, easy to use, with low cost, safe.
Description of drawings
Fig. 1 is VAS score value scale line chart (the line writing-method of pain, a VAS method).
The specific embodiment
Embodiment 1
Get it filled 6 parts of material Rhizoma Corydalis, 1 part of Oletum Trogopterori, 1 part of Olibanum, 1 part of Myrrha, 1 part of Fructus Evodiae were soaked 1 hour, added 8 times in water, extracted three times, after aqueous extract is concentrated into relative density 1.08～1.12 (80 ℃), adopted centrifuging to obtain water extract.Add microcrystalline cellulose 40% (press product and calculate, calculating by the medical material amount is 7%) at water extract, mix thoroughly, vacuum drying adds the dextrin dry granulation and makes granule;
Embodiment 2
Get it filled 1 part of material Rhizoma Corydalis, 1 part of Oletum Trogopterori, 1 part of Olibanum, 1 part of Myrrha, 1 part of Fructus Evodiae adopt 80% ethanol, 8 times of amounts, and reflux, extract, 2.5 hours, medicinal liquid leaves standstill, and gets the clear paste that supernatant concentration to relative density is 1.15～1.35 (65 ℃).1 part of qinghuo reagent adds 0.7 part of microcrystalline cellulose, mixes thoroughly, and vacuum drying was pulverized 60 mesh sieves, adds Pulvis Talci 70 grams in dry extract, and mixing incapsulates.
Embodiment 3
Get it filled 3 parts of material Rhizoma Corydalis, 2 parts of Oletum Trogopteroris, 1 part of Olibanum, 1 part of Myrrha, 1 part of Cortex Cinnamomi, soaked 1 hour, and added 10 times in water, extract three times, after aqueous extract is concentrated into relative density 1.08～1.12 (80 ℃), adopts the chitosan fining process to carry out purification process and obtain water extract.Add dextrin at water extract, mix spray drying, the powder of must spraying thoroughly.Get that the part powder adds citric acid, starch is made granule, all the other fine powders add sodium bicarbonate, starch is made granule, after two kinds of granules add magnesium stearate, and mix homogeneously, tabletting.
Embodiment 4
Get it filled 1 part of material Rhizoma Corydalis, 1 part of Oletum Trogopterori, 1 part of Olibanum, 1 part of Myrrha, 1 part of Cortex Cinnamomi are ground into 120-150 purpose powder, add dextrin, mix thoroughly, incapsulate.
Embodiment 5
Get it filled 1 part of material Rhizoma Corydalis, 2 parts of Oletum Trogopteroris, 2 parts of Olibanums, 2 parts of Myrrhas, 1 part of Fructus Evodiae adopt 80% ethanol, 8 times of amounts, and reflux, extract, 2.5 hours, medicinal liquid leaves standstill, and gets supernatant and reclaims ethanol, and being concentrated into relative density is 1.30 (65 ℃); It is an amount of to add starch, and mixing is granulated, and drying adds Pulvis Talci and magnesium stearate, tabletting.
Embodiment 6
Get it filled 1 part of material Rhizoma Corydalis, 5 parts of Oletum Trogopteroris, 4 parts of Olibanums, 4 parts of Myrrhas, 2 parts of Fructus Evodiaes were soaked 1 hour, added 8 times in water, extracted three times, after aqueous extract is concentrated into relative density 1.08～1.12 (80 ℃), adopted ethanol precipitation to obtain water extract.Add microcrystalline cellulose 40% (press product and calculate, calculating by the medical material amount is 7%) at water extract, spray drying, it is an amount of to add Pulvis Talci, encapsulated.
Embodiment 7 medicament capsule preparation for treating dysmenorrheas of the present invention
Dysmenorrhea patient's 141 examples use pharmaceutical preparation capsule of the present invention (abbreviation Capsules group) and YUANHU ZHITONG KELI (being called for short the Rhizoma Corydalis group) to treat respectively by the table of random number method, and the result shows:
The curative effect of 1 pharmaceutical preparation Capsules group of the present invention and YUANHU ZHITONG KELI group relatively
(1) taking medicine back 2 hours in, two groups of analgesic effects significantly strengthen along with the prolongation of the back time of taking medicine; After taking medicine 1 hour, the analgesic effect of pharmaceutical preparation Capsules group of the present invention obviously is better than the YUANHU ZHITONG KELI group.
(2) pharmaceutical preparation Capsules group of the present invention is to the YUANHU ZHITONG KELI group that is better than evident in efficacy of medium above pain degree dysmenorrhea.
(3) reduce by half abovely as effective with the back pain degree of taking medicine, the total effective rate of pharmaceutical preparation Capsules group then of the present invention, YUANHU ZHITONG KELI group is respectively 74.1%, 44.4%, has marked difference.
(4) pharmaceutical preparation Capsules group of the present invention also is better than the YUANHU ZHITONG KELI group for the improvement of reflection autonomic nervous dysfunctions' such as having a headache and be in a cold sweat dysmenorrhea simultaneous phenomenon.
2 take pharmaceutical preparation Capsules group of the present invention hyper-menorrhea 2 examples occur, with medication " may be relevant ".The YUANHU ZHITONG KELI group dysmenorrhea degree occurs and aggravates 1 example, with medication " suspicious relevant ".Through judging that pharmaceutical preparation of the present invention does not have obvious adverse reaction.
Diagnostic criteria: according to the diagnostic criteria of " department of obstetrics and gynecology conventional treatment " relevant dysmenorrhea.
Table 1 is a case physical data table.
Table 1
| Capsules group | The Rhizoma Corydalis group | |
| Accept for medical treatment the date (year. month) case source example scope in the age several years (course of disease of x ± SD) (diagnosis (routine number, %) the functional dysmenorrhea endometriosis adenomyosis pain degree of x ± SD)*(example is inferior, and %) slight moderate is seriously the most serious | 04.12 64 17～40 years old (22.8 ± 4.2) 0.5～14 year (5.7 ± 3.5) 62 (96.9) 1 (1.6) 1 (1.6) 21 (18.8) 57 (50.9) 26 (23.2) 8 (7.1) of～05.4 student of Shanghai Univ. of Traditional Chinese Medicine and minority SHUGUANG HOSPITAL clinic case | 04.12 77 19～31 years old (23.2 ± 2.4) 0.5～15 year (6.2 ± 3.3) 77 (100.0) 30 (22.2) 72 (53.3) 32 (23.7) 1 (0.7) of～05.4 student of Shanghai Univ. of Traditional Chinese Medicine and minority SHUGUANG HOSPITAL clinic case |
Therapeutic Method
Capsules group:, be equivalent to eat crude drug 2.7 grams with the embodiment of the invention 2 pharmaceutical preparation capsules, 0.5 gram/grain.Each 2, instant warm water is swallowed when pain.64 routine patients take medicine 112 routine times altogether.
The Rhizoma Corydalis group: with YUANHU ZHITONG KELI (5 gram/bags, Shenyang flying dragon pharmaceutical Co. Ltd produces, the accurate word Z10930041 of traditional Chinese medicines), each 2 bags, instant warm water is taken after mixing it with water when pain.77 routine patients take medicine 135 routine times altogether.
The variation of (0 minute) and back 30 minutes, 60 minutes, 90 minutes, the 120 minutes pain degrees of taking medicine before record is taken medicine respectively.
The pain degree classification
Reference literature, with visual simulation (visual analogue scale, VAS), digital classification (numericrating scale, NRS) and 6 behavior scorings (the 6-point behavioral ratingscale, BRS-6) three kinds of pain assessment methods are fused into one.
Table 2 is pain degree hierarchical table (basis for estimation).
Table 2
| Classification | Pain degree | Numerical value | Clinical manifestation, General Symptoms and ability to work |
| 0 grade 1 grade 2 grades 3 grades 4 grades | The severe pain of no pain mild pain moderate pain severe pain | 0 1 2 3 4 5 6 7 8 9 10 | All normal no a bit pain pain are extremely slight; if do not have if having; it is slight to ignore pain; it is lighter to be ignored pain easily; be difficult to ignore; but do not disturb orthobiosis pain to ignore; but can not disturb orthobiosis pain obvious through restraining oneself; painful sensation is arranged; it is fairly obvious to carry out normal activity pain reluctantly; disturbance of concentration; be difficult to finish normal activity or heavier work pain very; daily life is affected; need analgesic not stay away from work without leave or very play of pain absent from school as far as possible; activity is obviously limited; often with the autonomic nervous system symptom; as tired; feel sick; vomiting; diarrhoea etc.; can't work or learn sharp ache; to standing the intolerable pain of the limit; need absolute bed rest; pale complexion is often arranged; be in a cold sweat; the limbs being moist and cold; palpitating speed, even the sensation of shock sample |
The pain therapeutic evaluation
VAS scoring * 100% before the percentage rate of pain relief=(VAS scoring after the VAS scoring-medication before the medication)/medication.
Alleviate fully: the percentage rate of pain relief=100%;
The basic alleviation: the percentage rate of pain relief 〉=75%;
Significantly alleviate: the percentage rate of pain relief 〉=50% and＜75%;
Part is alleviated: the percentage rate of pain relief 〉=25% and＜50%;
Do not alleviate: the percentage rate of pain relief＜25%.
Routine time/total routine time * 100% of total effective rate=(alleviation fully+basic alleviation the+remarkable the alleviation).
The pain relieving onset time and the judgement of holding time after taking medicine
Pain relieving onset time=from the beginning of taking medicine is to the required time of conscious pain relief.
Pain relieving hold time=do not take medicine dysmenorrhea continues time-back to the pain of taking medicine disappears the required time.
The symptom curative effect is judged
The back subjective symptoms of taking medicine all disappears and is designated as " disappearance "; More preceding improvement or alleviate and be designated as " alleviating "; Do not have obviously to change and be designated as " constant "." disappearance " and " alleviating " are designated as effectively.
Untoward reaction
Observe and recording medicine after untoward reaction, and the cause effect relation of untoward reaction and medicine judged.It is relevant certainly, relevant, possible relevant, suspicious and impossible relevant probably that judged result is divided into, and wherein " relevant certainly " can think the caused untoward reaction of medicine with " relevant probably ".
Therapeutic outcome
1) baseline of Capsules group and Rhizoma Corydalis group is relatively: two groups except that the age, the course of disease, mainly diagnose and treat before the equal no significant difference of pain degree.Table 3 is baseline comparative results of Capsules group and Rhizoma Corydalis group.
Table 3
| Capsules group (64 example) | Rhizoma Corydalis group (77 example) | |
| Age (course of disease of x ± SD) (primary dysmenorrhea of x ± SD) (routine number, the %) (x ± SE) of pain degree before the treatment | 22.8 ± 4.2 years old *5.7 ± 3.5 years 62 (96.9) 5.43 ± 0.21 | 23.2 ± 2.4 years old 6.2 ± 3.3 years 77 (100.0) 5.18 ± 0.17 |
*P＜0.05
2) comparison of Capsules group and Rhizoma Corydalis group pain palliation efficacy
Taking medicine back 2 hours in, each time point pain degree of each group patient all had significance decline (P＜0.001) than preceding 30 minutes.Take medicine back 90 minutes, 120 minutes the time, the pain degree of Capsules group is starkly lower than Rhizoma Corydalis group (P＜0.01, P＜0.001), and promptly the analgesic effect of Capsules group after taking medicine 90 minutes is more remarkable.The total effective rate of Capsules group treatment dysmenorrhea is 74.1%, and the Rhizoma Corydalis group is 44.4%, and the pain palliation efficacy of Capsules group is significantly higher than Rhizoma Corydalis group (P＜0.001).The alleviation fully and the basic remission rate of Capsules group treatment dysmenorrhea also are significantly higher than the Rhizoma Corydalis group.Pain degree shows curative effects before taking medicine: Capsules group treatment effective percentage serious, moderate pain degree dysmenorrhea is respectively 61.5%, 78.9%, the Rhizoma Corydalis group is respectively 28.1%, 40.3%, (P＜0.05, P＜0.001), shows that Capsules group is better than the Rhizoma Corydalis group to the pain palliation efficacy of serious and moderate pain.Pain relieving onset time and the comparative result of holding time show: the pain relieving onset time average out to of Capsules group, Rhizoma Corydalis group 44.3 ± 28.6 minutes, 49.2 ± 33.8 minutes, there was no significant difference between two groups.Hold time average out to 17.5 ± 16.6 hours, 13.2 ± 15.1 hours of the pain relieving of Capsules group, Rhizoma Corydalis group, also no significant difference between two groups.2 groups of capsule are after treatment, and the improvement degree of most dysmenorrhea simultaneous phenomenons all has the tendency that is better than the Rhizoma Corydalis group, wherein to have a headache, be in a cold sweat, anus weighs down sense, pale complexion and bloated curative effect and the Rhizoma Corydalis group of waist acid relatively have significant difference (P＜0.05).
Table 4 is take medicine dynamic change (x ± SE) of back dysmenorrhea pain degree of Capsules group and Rhizoma Corydalis group.
Table 5 be Capsules group and Rhizoma Corydalis group treatment dysmenorrhea total effective rate comparative result (example time, %).
Table 6 is that (effective routine time/total example is inferior, %) to the efficient comparative result of different pain degrees with the Rhizoma Corydalis group for Capsules group.
Table 7 is pain relieving onset time of Capsules group and Rhizoma Corydalis group and the comparison of holding time (x ± SD).
Table 8 be the frequency that the dysmenorrhea simultaneous phenomenon occurs before the treatment (routine number, %)
Table 9 be Capsules group and Rhizoma Corydalis group the dysmenorrhea simultaneous phenomenon curative effect relatively (effective example time/total example time, %)
Table 4
| Medicine time | The pain degree scoring | |
| Capsules group | The Rhizoma Corydalis group | |
| 0 minute 30 minutes 60 minutes 90 minutes 120 minutes | 5.43±0.21 3.94±0.24 * 3.08±0.23 *# 2.46±0.22 *#※☆ 2.02±0.20 *#※△☆☆ | 5.18±0.17 4.18±0.18 * 3.57±0.18 *# 3.28±0.19 *#※ 3.10±0.19 *#※△ |
* P＜0.001, VS.0 minute; #P＜0.001, VS. took medicine back 30 minutes; ※ P＜0.001, VS. took medicine back 60 minutes; △ P＜0.001, VS. took medicine back 90 minutes; ☆ P＜0.01, VS. Rhizoma Corydalis group 90 minutes; ☆ ☆ P＜0.001, VS. Rhizoma Corydalis group 120 minutes.
Table 5
| The alleviation degree | Group | |
| Capsules group (112 examples are inferior) | Rhizoma Corydalis group (135 examples are inferior) | |
| Alleviate significantly alleviation part of basic alleviation fully and alleviate alleviation | 33(29.5) * 22(19.6) *** 28(25.0) 16(14.3) ** 13(11.6) * | 22(16.3) 6(4.4) 32(23.7) 43(31.9) 32(23.7) |
| Total effective rate | 83(74.1) *** | 60(44.4) |
*P＜0.05；**P＜0.01；***P＜0.001，
Table 6
| Pain degree | Group | |
| Capsules group | The Rhizoma Corydalis group | |
| The most serious pain of the serious pain of mild pain moderate pain | 17/21(81.0) 45/57(78.9) ** 16/26(61.5) * 5/8(62.5) | 22/30(73.3) 29/72(40.3) 9/32(28.1) 0/1 |
| Total effective rate | 83/112(74.1) | 60/135(44.4) |
*P＜0.05；**P＜0.001。
Effectively: comprise fully and alleviate, alleviate substantially and significantly alleviate (percentage rate of pain relief 〉=50%)
Table 7
| Group | Pain relieving onset time (minute) | Pain relieving hold time (hour) |
| Capsules group Rhizoma Corydalis group | 44.3±28.6 49.2±33.8 | 17.5±16.6 13.2±15.1 |
Table 8
| Symptom | Capsules group | The Rhizoma Corydalis group |
| Through the happiness of clot pain De Rezeshu spiritlessness and weakness waist acid distending pain by the pale complexion swollen breasts anus pendant sense diarrhoea indigestion and loss of appetite dizziness headache vomiting pain tenderness hectic fever low-heat of feeling sick that is in a cold sweat | 40(62.5) 39(60.9) 36(56.3) 36(56.3) 29(45.3) 17(26.6) 16(25.0) 12(18.8) 17(26.6) 13(20.3) 8(12.5) 7(10.9) 10(15.6) 9(14.1) 6(9.4) 6(9.4) 4(6.3) 5(7.8) | 56(72.7) 49(63.6) 44(57.1) 40(51.9) 44(57.1) 26(33.8) 31(40.3) 22(28.6) 28(36.4) 26(33.8) 20(26.0) 16(20.8) 16(20.8) 10(13.0) 10(13.0) 13(16.9) 11(14.3) 4(5.2) |
Table 9
| Symptom | Capsules group | The Rhizoma Corydalis group |
| The headache anus that is in a cold sweat weighs down the sense dizziness and nausea | 9/9(100.0) * 13/13(100.0) * 12/12(100.0) * 9/10(90.0) 7/8(87.5) | 7/10(70.0) 20/26(76.9) 11/22(50.0) 11/16(68.8) 14/20(70.0) |
| The swollen hectic fever diarrhoea of vomiting low-heat pale complexion waist acid swollen breasts spiritlessness and weakness is liked by the pain tenderness indigestion and loss of appetite through clot pain De Rezeshu bitterly | 5/6(83.3) 4/5(80.0) 14/17(82.4) * 28/36(77.8) * 3/4(75.0) 11/17(64.7) 9/16(56.3) 22/36(61.1) 15/29(51.7) 3/6(50.0) 4/7(57.1) 11/33(33.3) 15/39(38.5) | 7/10(70.0) 3/4(75.0) 13/26(50.0) 20/40(50.0) 8/11(72.7) 15/28(53.6) 16/31(51.6) 24/44(54.5) 19/44(40.9) 6/13(46.2) 7/16(43.8) 18/46(39.1) 22/49(44.9) |
*P＜0.05
Embodiment 8 pharmaceutical preparation powder treatment dysmenorrheas of the present invention
Dysmenorrhea patient's 77 examples use pharmaceutical preparation powder of the present invention (being called for short the powder group) and YUANHU ZHITONG KELI (being called for short the Rhizoma Corydalis group) to treat at random respectively, and the result shows:
(1) pain palliation efficacy of pharmaceutical preparation powder group of the present invention each time point after taking medicine 30 minutes significantly is better than YUANHU ZHITONG KELI;
(2) pharmaceutical preparation powder group total effective rate, especially complete remission rate of the present invention are apparently higher than YUANHU ZHITONG KELI;
(3) pharmaceutical preparation powder group of the present invention obviously is better than YUANHU ZHITONG KELI to the pain palliation efficacy of serious pain;
(4) pharmaceutical preparation powder group of the present invention pain relieving is held time and significantly is longer than YUANHU ZHITONG KELI;
(5) " dizziness " 1 example appears in pharmaceutical preparation powder group of the present invention in drug administration process, with medication " suspicious relevant ".The Rhizoma Corydalis group dysmenorrhea degree occurs and aggravates 1 example, with medication " suspicious relevant ".Through judging the well-informed no obvious adverse reaction of loosing.
Diagnostic criteria: according to the diagnostic criteria of " department of obstetrics and gynecology conventional treatment " relevant dysmenorrhea.
Table 10 is ordinary circumstance tables.
Table 10
| The powder group | The Rhizoma Corydalis group | |
| Case source example scope in the age several years (course of disease of x ± SD) (diagnosis (routine number, %) the functional dysmenorrhea endometriosis pain degree of x ± SD)*(example is inferior, and %) slight moderate is seriously the most serious | 33 15～50 years old (31.0 ± 9.1) 1～35 year (10.0 ± 7.6) 20 (60.6) 13 (39.4) 4 (6.7) 24 (40.0) 32 (53.3) of SHUGUANG HOSPITAL outpatient service | The student of Shanghai Univ. of Traditional Chinese Medicine 44 19～31 years old (23.1 ± 2.3) 0.5～13 year (6.1 ± 3.4) 44 (100.0) 7 (8.8) 41 (51. 3) 31 (38.8) 1 (1.3) |
Therapeutic Method
The powder group: with pharmaceutical preparation powder of the present invention, every bag 2 grams.Each 1 bag, instant warm water is taken after mixing it with water when pain.33 routine patients take medicine 60 routine times altogether.
The Rhizoma Corydalis group: with YUANHU ZHITONG KELI (every bag 5 grams, Shenyang flying dragon pharmaceutical Co. Ltd produces, the accurate word Z10930041 of traditional Chinese medicines), each 2 bags, instant warm water is taken after mixing it with water when pain.44 routine patients take medicine 80 routine times altogether.
The variation of (0 minute) and back 30 minutes, 60 minutes, 90 minutes, the 120 minutes pain degrees of taking medicine before record is taken medicine respectively.
The pain degree classification, the pain therapeutic evaluation, the pain relieving onset time and the judgement of holding time after taking medicine, the symptom curative effect is judged and the untoward reaction judgement: with embodiment 7.
Therapeutic outcome
1) powder group and Rhizoma Corydalis group baseline characteristic are relatively
Pain degree no significant difference before two groups of treatments.Table 11 is that the baseline of powder group and Rhizoma Corydalis group compares
Table 11
| Powder group (33 example) | Rhizoma Corydalis group (44 example) | |
| Age (course of disease of x ± SD) (x ± SD) diagnosis (routine number, the %) (x ± SE) of pain degree before the treatment of functional dysmenorrhea endometriosis | 31.0 ± 9.1 years old **10.0 ± 7.6 years * 20(60.6) ** 13(39.4) 6.57±0.21 | 23.1 ± 2.3 years old 6.1 ± 3.4 years 44 (100.0) 6.12 ± 0.20 |
*P＜0.01；**P＜0.001
2) comparison of powder group and Rhizoma Corydalis group pain palliation efficacy
Taking medicine back 2 hours in, each time point pain degree of powder group and Rhizoma Corydalis group all had significance to descend than preceding 30 minutes; At back 30 minutes, 60 minutes, 90 minutes, 120 minutes each time points of taking medicine, the analgesic effect of powder group all obviously is better than Rhizoma Corydalis group (P＜0.05-0.01).Alleviate to treat the back pain degree 〉=50% or more (promptly more than " significantly alleviate ") as effective, then to treat the total effective rate of dysmenorrhea be 60.0% to the powder group, the Rhizoma Corydalis group is 35.0%; The pain relieving effective percentage of powder group is significantly higher than Rhizoma Corydalis group (P＜0.001).The alleviation fully of powder group treatment dysmenorrhea also is significantly higher than Rhizoma Corydalis group (P＜0.05).Powder group treatment effective percentage serious, moderate pain degree dysmenorrhea is respectively 65.6%, 50.0%, the Rhizoma Corydalis group is respectively 29.0%, 36.6%, wherein the analgesic effect powder group to serious pain significantly is better than the Rhizoma Corydalis group, and two groups relatively have significant difference (P＜0.001).The pain relieving onset time average out to of powder group, Rhizoma Corydalis group 60.6 ± 36.4 minutes, 52.6 ± 38.6 minutes, there was no significant difference between two groups.Hold time average out to 29.1 ± 21.8 hours, 10.8 ± 14.7 hours of the pain relieving of powder group, Rhizoma Corydalis group has notable difference (P＜0.001) between two groups.The powder group is after treatment, and the improvement degree of most dysmenorrhea simultaneous phenomenons all has the tendency that is better than the Rhizoma Corydalis group.
Table 12 is take medicine dynamic change (x ± SE) of back dysmenorrhea pain degree of powder group and Rhizoma Corydalis group
Table 13 be powder group and Rhizoma Corydalis group treatment dysmenorrhea total effective rate comparison (example time, %)
Table 14 is that (effective routine time/total example is inferior, %) to the efficient comparison of different pain degrees with the Rhizoma Corydalis group for the powder group
Table 15 is pain relieving onset time of powder group and Rhizoma Corydalis group and the comparison of holding time (x ± SD)
Table 12
| Medicine time | The pain degree scoring | |
| The powder group | The Rhizoma Corydalis group | |
| 0 minute 30 minutes 60 minutes 90 minutes 120 minutes | 6.57±0.22 4.18±0.25 *☆☆ 3.56±0.27 *#☆ 3.38±0.29 *#☆ 2.98±0.30 *#※△☆ | 6.12±0.19 5.11±0.22 * 4.42±0.23 *# 4.17±0.25 *#※ 3.91±0.26 *#※※△△ |
P＜0.001, VS.0 minute; #P＜0.001, VS. took medicine back 30 minutes; ※ P＜0.01, VS. took medicine back 60 minutes; ※ ※ P＜0.001, VS. took medicine back 60 minutes; △ P＜0.01, VS. took medicine back 90 minutes; △ △ P＜0.001, VS. took medicine back 90 minutes; ☆ P＜0.05, VS. Rhizoma Corydalis group; ☆ ☆ P＜0.01, VS. Rhizoma Corydalis group.
Table 13
| The alleviation degree | Group | |
| Powder group (60 examples are inferior) | Rhizoma Corydalis group (80 examples are inferior) | |
| Alleviate significantly alleviation part of basic alleviation fully and alleviate alleviation | 12(20.0) * 6(10.0) 18(30.0) 11(18.3) ** 13(21.7) | 7(8.8) 3(3.8) 18(22.5) 31(38.8) 21(26.3) |
| Total effective rate | 36(60.0) *** | 28(35.0) |
*P＜0.05；**P＜0.01；***P＜0.001
Effectively: treatment back pain degree alleviates 〉=50% or more (promptly more than " remarkable alleviation ").
Table 14
| Pain degree | Group | |
| The powder group | The Rhizoma Corydalis group | |
| The most serious pain of the serious pain of mild pain moderate pain | 3/4(75.0) 12/24(50.0) 21/32(65.6) * | 4/7(57.1) 15/41(36.6) 9/31(29.0) 0/1 |
| Total effective rate | 36/60(60.0) * | 28/80(35.0) |
*P＜0.001
Table 15
| Group | Pain relieving onset time (minute) | Pain relieving hold time (hour) |
| The powder constituent element is organized recklessly | 60.6±36.4 52.6±38.6 | 29.1±21.8 * 10.8±14.7 |
*P＜0.001
Embodiment 9 pharmaceutical preparation capsule for treating headaches of the present invention
Headache patient 100 examples use pharmaceutical preparation capsule of the present invention (abbreviation Capsules group) and YUANHU ZHITONG KELI (being called for short the Rhizoma Corydalis group) to treat at random respectively, and the result shows:
[1] pain palliation efficacy of pharmaceutical preparation Capsules group of the present invention each time point after taking medicine 30 minutes significantly is better than the YUANHU ZHITONG KELI group;
[2] pharmaceutical preparation Capsules group pain relieving total effective rate of the present invention, complete remission rate are apparently higher than the YUANHU ZHITONG KELI group;
[3] pharmaceutical preparation Capsules group of the present invention obviously is better than the YUANHU ZHITONG KELI group to the pain palliation efficacy of moderate pain and serious pain.
Table 16 is ordinary circumstance tables.
Table 16
| Well-informed Capsules group | The Rhizoma Corydalis group | |
| Case source example scope in the age several years (course of disease of x ± SD) (diagnosis (the routine number of x ± SD); %) (example is inferior, and %) slight moderate is seriously the most serious for antimigraine tension headache pain degree | 52 20～85 years old (52.1 ± 17.5) 0～300 month (62.8 ± 77.1) 52 (100.0) 25 (48.1) 27 (51.9) 89 (100.0) 8 (9.0) 57 (64.0) 23 (25.8) 1 (1.1) of SHUGUANG HOSPITAL outpatient service | 48 14～79 years old (51.8 ± 16.6) 0～360 month (60.6 ± 83.8) 48 (100.0) 29 (60.0) 19 (40.0) 89 (100.0) 13 (14.6) 47 (52.8) 28 (31.5) 1 (1.1) of SHUGUANG HOSPITAL outpatient service |
Diagnostic criteria: according to the diagnostic criteria of " internal disease diagnostic criteria " relevant headache
Therapeutic Method
Capsules group:, be equivalent to eat crude drug 2.7 grams with the embodiment of the invention 2 pharmaceutical preparation capsules, 0.5 gram/grain.Each 2, instant warm water is swallowed when pain.52 routine patients take medicine 89 routine times altogether.
The Rhizoma Corydalis group: with YUANHU ZHITONG KELI (every bag 5 grams, Shenyang flying dragon pharmaceutical Co. Ltd produces, the accurate word Z10930041 of traditional Chinese medicines), each 2 bags, instant warm water is taken after mixing it with water when pain.48 routine patients take medicine 89 routine times altogether.The variation of (0 minute) and back 30 minutes, 60 minutes, 90 minutes, the 120 minutes pain degrees of taking medicine before record is taken medicine respectively.
The pain degree classification, the pain therapeutic evaluation, the pain relieving onset time and the judgement of holding time after taking medicine, the symptom curative effect is judged and the untoward reaction judgement: with embodiment 7.
Therapeutic outcome
1) Capsules group and Rhizoma Corydalis group baseline comparison sheet.
Age, the course of disease, diagnosis and the equal no significant difference of pain degree before two groups of treatments.
Table 17 is that the baseline of pharmaceutical preparation Capsules group of the present invention and Rhizoma Corydalis group compares.
Table 17
| Well-informed Capsules group (52 example) | Rhizoma Corydalis group (48 example) | |
| Age (course of disease of x ± SD) (x ± SD) diagnosis (routine number, the %) (x ± SE) of pain degree before the treatment of antimigraine tension headache | 52.1 ± 17.5 years old 62.8 ± 77.1 months 52 (100.0) 25 (48.1) 27 (51.9) 5.49 ± 0.19 | 51.8 ± 16.6 years old 60.6 ± 83.8 months 48 (100.0) 29 (60.0) 19 (40.0) 5.58 ± 0.19 |
2) Capsules group and Rhizoma Corydalis group pain palliation efficacy are relatively
Taking medicine back 2 hours in, each time point pain degree of every group of patient all had significance to descend than preceding 30 minutes; Except that starting point, relatively, two groups all have significant difference between the group of each time point.Prompting Capsules group analgesic effect is better than the Rhizoma Corydalis group.The total effective rate of Capsules group treatment headache is 70.8%, and the Rhizoma Corydalis group is 37.1%, two group significant difference (P＜0.001); Aspect alleviation fully, two groups have significant difference (P＜0.001).The effective percentage of capsule, the headache of Rhizoma Corydalis group group treatment moderate pain degree is respectively 75.4% and 48.9%, two group significant difference (P＜0.01).The effective percentage that capsule, Rhizoma Corydalis group group are treated the headache of serious pain degree is respectively 60.9% and 3.6%, two group significant difference (P＜0.001).
Table 18 is take medicine dynamic change (x ± SE) of back pain pain degree of Capsules group and Rhizoma Corydalis group
Table 19 be the efficient comparison of Capsules group and Rhizoma Corydalis group treatment headache analgesic (example time, %)
Table 20 is that (effective routine time/total example is inferior, %) to the efficient comparison of different pain degrees with the Rhizoma Corydalis group for Capsules group
Table 18
| Medicine time | The pain degree scoring | |
| Capsules group | The Rhizoma Corydalis group | |
| 0 minute 30 minutes 60 minutes 90 minutes 120 minutes | 5.49±0.19 3.60±0.23 *☆ 2.85±0.23 *#☆ 2.28±0.24 *#※☆ 2.02±0.25 *#※△☆ | 5.58±0.19 4.95±0.21 * 4.51±0.24 *# 4.15±0.25 *#※ 3.93±0.26 *#※◇ |
* P＜0.001, VS.0 minute; #P＜0.001, VS. took medicine back 30 minutes; ※ P＜0.001, VS. took medicine back 60 minutes; △ P＜0.001, VS. took medicine back 90 minutes; ◇ P＜0.01, VS. took medicine back 90 minutes; ☆ P＜0.001, VS. Rhizoma Corydalis group.
Table 19
| The alleviation degree | Group | |
| Capsules group (89 examples are inferior) | Rhizoma Corydalis group (89 examples are inferior) | |
| Alleviate significantly alleviation part of basic alleviation fully and alleviate alleviation | 38(42.7) * 6(6.7) 19(21.3) 5(5.6) * 21(23.6) | 4(4.5) 4(4.5) 25(28.1) 23(25.8) 33(37.1) |
| Total effective rate | 63(70.8) * | 33(37.1) |
*P＜0.001
Effectively: treatment back pain degree alleviates 〉=50% or more (promptly more than " remarkable alleviation ").
Table 20
| Pain degree | Group | |
| Capsules group | The Rhizoma Corydalis group | |
| The most serious pain of the serious pain of mild pain moderate pain | 5/8(62.5) 43/57(75.4) * 14/23(60.9) # 1/1(100.0) | 9/13(69.2) 23/47(48.9) 1/28(3.6) 0/1(0) |
| Total effective rate | 63/89(70.8) # | 33/89(37.1) |
*P＜0.01；#P＜0.001
Embodiment 10 pharmaceutical preparation powder treatment headaches of the present invention
Headache patient 86 examples use pharmaceutical preparation powder of the present invention (being called for short the powder group) and YUANHU ZHITONG KELI (being called for short the Rhizoma Corydalis group) to treat at random respectively, and the result shows:
1, the curative effect of pharmaceutical preparation powder group of the present invention and YUANHU ZHITONG KELI group relatively
[1] pharmaceutical preparation powder group of the present invention was being taken medicine back 90 minutes and the pain palliation efficacy of 120 minutes time points significantly is better than the YUANHU ZHITONG KELI group;
[2] pain relieving of pharmaceutical preparation powder group total effective rate, especially complete remission rate of the present invention are apparently higher than the YUANHU ZHITONG KELI group;
[3] pharmaceutical preparation powder group of the present invention obviously is better than the YUANHU ZHITONG KELI group to the pain palliation efficacy of serious pain;
[4] pharmaceutical preparation powder group of the present invention pain relieving is held time and significantly is longer than the YUANHU ZHITONG KELI group;
[5] pharmaceutical preparation powder group of the present invention is better than the YUANHU ZHITONG KELI group for the improvement of headache simultaneous phenomenons such as giddy, photophobia, phonophobia, anxiety, agitation;
2, pharmaceutical preparation powder group of the present invention 1 example of feeling sick occurs, with medication " suspicious relevant " in drug administration process; 2 examples of feeling sick appear in the Rhizoma Corydalis group, with medication " suspicious relevant ".Through judging the diffusing no obvious adverse reaction of spirit pain.Table 21 is ordinary circumstance tables.
Table 21
| Pharmaceutical preparation group of the present invention | The Rhizoma Corydalis group | |
| Case source example scope in the age several years (course of disease of x ± SD) (diagnosis (the routine number of x ± SD); %) (example is inferior, and %) slight moderate is seriously the most serious for antimigraine tension headache pain degree * | 43 13～81 years old (49.3 ± 18.4 years old) 0.01～30 year (4.8 ± 7.7 year) 24 (55.8) 19 (44.2) 37 (30.6) 84 (69.4) of SHUGUANG HOSPITAL outpatient service | 43 13～88 years old (53.1 ± 17.5 years old) 0.2～40 year (3.6 ± 6.1 year) 28 (65.1) 15 (34.9) 30 (24.3) 72 (58.4) 20 (16.3) 1 (1.0) of SHUGUANG HOSPITAL outpatient service |
Diagnostic criteria: according to the diagnostic criteria of " internal disease diagnostic criteria " relevant headache.
Therapeutic Method
The powder group: with pharmaceutical preparation powder of the present invention, every bag 2 grams.Each 1 bag, instant warm water is taken after mixing it with water when pain.43 routine patients take medicine 121 routine times altogether.
The Rhizoma Corydalis group: with YUANHU ZHITONG KELI (every bag 5 grams, Shenyang flying dragon pharmaceutical Co. Ltd produces, the accurate word Z10930041 of traditional Chinese medicines), each 2 bags, instant warm water is taken after mixing it with water when pain.43 routine patients take medicine 123 routine times altogether.The variation of (0 minute) and back 30 minutes, 60 minutes, 90 minutes, the 120 minutes pain degrees of taking medicine before record is taken medicine respectively.
The pain degree classification, the pain therapeutic evaluation, the pain relieving onset time and the judgement of holding time after taking medicine, the symptom curative effect is judged and the untoward reaction judgement: with embodiment 7.
Therapeutic outcome
1) powder group and Rhizoma Corydalis group baseline are relatively
Powder group pain degree is than Rhizoma Corydalis group height before the treatment.
Table 22 is that the baseline of pharmaceutical preparation group of the present invention and Rhizoma Corydalis group compares.
Table 22
| Pharmaceutical preparation group of the present invention (43 example) | Rhizoma Corydalis group (43 example) | |
| Age (course of disease of x ± SD) (x ± SD) | 49.3 ± 18.4 years old 4.8 ± 7.7 years | 53.1 ± 17.5 years old 3.6 ± 6.1 years |
| Migraine (routine number, %) pain degree (x ± SE) before the treatment | 24(55.8) 6.69±0.11 * | 28(65.1) 4.78±0.16 |
*P＜0.001
2) powder group and Rhizoma Corydalis group pain palliation efficacy are relatively
Pharmaceutical preparation powder group pain degree of the present invention was being taken medicine back 2 hours in than Rhizoma Corydalis group height before the treatment, and the powder group all had significance to descend with each time point pain degree of Rhizoma Corydalis group than preceding 30 minutes; Took medicine back 90 minutes, 120 minutes, powder group pain degree all is starkly lower than the Rhizoma Corydalis group.The total effective rate of powder group treatment headache is 79.3%, and the Rhizoma Corydalis group is 46.3%; The pain relieving effective percentage of pharmaceutical preparation of the present invention is significantly higher than the Rhizoma Corydalis group.The alleviation fully of pharmaceutical preparation group treatment headache of the present invention also is significantly higher than the Rhizoma Corydalis group.The treatment of powder group is serious, the effective percentage of moderate pain degree headache is respectively 79.8%, 78.4%, the Rhizoma Corydalis group is respectively 5.0%, 63.9%, wherein the analgesic effect to serious pain significantly is better than the Rhizoma Corydalis group with pharmaceutical preparation of the present invention, and two groups relatively have significant difference (P＜0.001).The pain relieving onset time average out to of powder group, Rhizoma Corydalis group 49.8 ± 26.7 minutes, 54.0 ± 28.9 minutes, there was no significant difference between two groups.Hold time average out to 22.9 ± 18.8 hours, 9.2 ± 8.5 hours of the pain relieving of pharmaceutical preparation group of the present invention, Rhizoma Corydalis group has notable difference between two groups.The powder group is after treatment, and the improvement degree of overwhelming majority headache simultaneous phenomenon all has the tendency that is better than the Rhizoma Corydalis group, wherein giddy, photophobia, phonophobia, anxiety, irritated curative effect and Rhizoma Corydalis group is relatively had significant difference (P＜0.05).
Table 23 is take medicine dynamic change (x ± SE) of back pain pain degree of powder group and Rhizoma Corydalis group.
Table 24 be powder group and Rhizoma Corydalis group treatment headache effective percentage relatively (example time, %).
Table 25 is that (effective routine time/total example is inferior, %) to the efficient comparison of different pain degrees with the Rhizoma Corydalis group for the powder group.
Table 26 is pain relieving onset time of powder group and Rhizoma Corydalis group and the comparison of holding time (x ± SD).
Table 27 be powder group and Rhizoma Corydalis group treatment headache simultaneous phenomenon curative effect relatively (effective example time/total example time, %).
Table 23
| Medicine time | The pain degree scoring | |
| Pharmaceutical preparation group of the present invention | The Rhizoma Corydalis group | |
| 0 minute 30 minutes 60 minutes 90 minutes 120 minutes | 6.69±0.11 ☆5.01±0.12 *☆3.66±0.14 *#2.37±0.16 *#※☆1.65±0.17 *#※△☆ | 4.78±0.16 4.13±0.16 * 3.60±0.17 *# 3.19±0.18 *#※ 2.93±0.19 *#※△ |
* P＜0.001, VS.0 minute; #P＜0.001, VS. took medicine back 30 minutes; ※ P＜0.001, VS. took medicine back 60 minutes; △ P＜0.001, VS. took medicine back 90 minutes; ☆ P＜0.001, VS. Rhizoma Corydalis group.
Table 24
| The alleviation degree | Group | |
| Pharmaceutical preparation group of the present invention | The Rhizoma Corydalis group | |
| Alleviate significantly alleviation part of basic alleviation fully and alleviate alleviation | 47(38.8) ** 17(14.0) 32(26.4) 16(13.2) * 9(7.4) ** | 11(8.9) 14(11.4) 32(26.0) 31(25.2) 35(28.5) |
| Total effective rate | 96(79.3) ** | 57(46.3) |
**P＜0.05；**P＜0.001；
Annotate: alleviate to treat the back pain degree 〉=50% or more (promptly more than " significantly alleviation ") as effective.
Table 25
| Pain degree | Group | |
| Pharmaceutical preparation group of the present invention | The Rhizoma Corydalis group | |
| The most serious pain of the serious pain of mild pain moderate pain | 29/37(78.4) 67/84(79.8) * | 10/30(33.3) 46/72(63.9) 1/20(5.0) 0/1(0.0) |
| Total effective rate | 96/121(79.3) * | 57/123(46.3) |
*P＜0.001
Table 26
| Group | Pain relieving onset time (minute) | Pain relieving hold time (hour) |
| Pharmaceutical preparation constituent element of the present invention is organized recklessly | 49.8±26.7 54.0±28.9 | 22.9±18.8 * 9.2±8.5 |
*P＜0.001
Table 27
| Symptom | Pharmaceutical preparation group of the present invention | The Rhizoma Corydalis group |
| The visual impairment photophobia of feeling dizzy phonophobia conjunctival congestion the feel depressed insomnia and dreamful sleep complexion rolling of n and V anxiety and tense agitation of shedding tears is in vain forgetful | 16/32(50.0) * 9/16(56.3) 2/3(66.7) 8/12(66.7) * 7/10(70.0) ** 2/3(66.7) 1/2(50.0) 16/22(72.7) 10/10(100.0) 10/18(55.6) * 5/15(33.3) 16/25(64.0) * 4/7(57.1) 2/16(12.5) 4/20(20.0) 3/15(20.0) 4/16(25.0) | 13/51(25.5) 8/25(32.0) 0/6(0.0) 2/13(15.4) 0/12(0.0) 1/1(100.0) 3/5(60.0) 20/32(62.5) 14/18(77.8) 2/13(15.4) 6/31(19.4) 8/28(28.6) 1/2(50.0) 2/28(7.1) 4/28(14.2) 0/5(0.0) 0/11(0.0) |
*P＜0.05；**P＜0.01
Claims (9)
1, a kind of compound Chinese medicinal preparation for the treatment of the pain card, it is characterized in that it is to be made by following raw materials in weight portion medicine and pharmaceutic adjuvant: Rhizoma Corydalis 1-6 part, Oletum Trogopterori 1-5 part, Olibanum 1-4 part, Myrrha 1-4 part, Fructus Evodiae 1-2 part, surplus is pharmaceutic adjuvant.
2, compound Chinese medicinal preparation according to claim 1, wherein the weight portion of each crude drug is:
1 part of Rhizoma Corydalis 1-2 part, Oletum Trogopterori 1-2 part, Olibanum 1-2 part, Myrrha 1-2 part, Fructus Evodiae.
3, compound Chinese medicinal preparation according to claim 1, wherein crude drug adopts Cortex Cinnamomi to substitute Fructus Evodiae.
4,, it is characterized in that by following method preparation according to the preparation method of claim 1 or 2 or 3 described compound Chinese medicinal preparation:
Get Rhizoma Corydalis, Oletum Trogopterori, Olibanum, Myrrha and Fructus Evodiae by weight, superfine grinding adds medicinal adjuvant packing according to a conventional method, or water extraction or alcohol extracting method extract extract and add medicinal adjuvant, and drying is made solid oral dosage form.
5, according to the preparation method of the described compound Chinese medicinal preparation of claim 4, it is characterized in that described water extraction is by following step: get Rhizoma Corydalis, Oletum Trogopterori, Olibanum, Myrrha, Fructus Evodiae by weight, close and fry in shallow oil, soaked 1 hour, add 8～10 times in water, extract three times, after aqueous extract is concentrated into relative density 1.08～1.12 (80 ℃), adopt ethanol precipitation, centrifuging or chitosan fining process to carry out purification process; Above-mentioned water is carried extract and is added medicinal adjuvant, and drying is made solid oral dosage form.
6, according to the preparation method of the described compound Chinese medicinal preparation of claim 4, it is characterized in that described alcohol extracting method is by following step: get Rhizoma Corydalis, Oletum Trogopterori, Olibanum, Myrrha, Fructus Evodiae by weight, 8 times of amounts of 80% ethanol reflux, extract, 2.5 hours, medicinal liquid leaves standstill, get the clear paste that supernatant concentration to relative density is 1.15～1.35 (65 ℃), above-mentioned alcohol extraction extract adds medicinal adjuvant, and drying is made solid oral dosage form.
7,, it is characterized in that described pharmaceutic adjuvant is selected from microcrystalline cellulose, Pulvis Talci, dextrin, lactose, sodium bicarbonate, citric acid, Sodium Hydroxymethyl Stalcs, micropowder silica gel, starch, soluble starch or magnesium stearate according to the preparation method of claim 5 or 6 described compound Chinese medicinal preparation.
8,, it is characterized in that described preparation makes granule, tablet or capsule according to the described compound Chinese medicinal preparation of claim 1.
9,, it is characterized in that described pain card is type of QI-stagnation and blood stasis dysmenorrhea and/or headache according to the described compound Chinese medicinal preparation of claim 1.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104971336A (en) * | 2015-07-15 | 2015-10-14 | 唐冬香 | Traditional Chinese medicine for activating blood to relieve pain |
| CN105056129A (en) * | 2015-08-17 | 2015-11-18 | 青岛云天生物技术有限公司 | Traditional Chinese medicine preparation for treating endometriosis and preparation method thereof |
| CN106074660A (en) * | 2016-08-11 | 2016-11-09 | 南京中医药大学 | Olibanum and Myrrha application in preparation preventing and treating neuropathic pain disease medicament |
| CN111840420A (en) * | 2020-08-20 | 2020-10-30 | 上海市第一康复医院(上海市杨浦区老年医院) | Traditional Chinese medicine external application, preparation method and use method thereof and application of traditional Chinese medicine external application in relieving liver cancer pain |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1047087C (en) * | 1993-08-11 | 1999-12-08 | 江苏省中医药研究所 | Dysmenorrhoea powder and its production technology |
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2006
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104971336A (en) * | 2015-07-15 | 2015-10-14 | 唐冬香 | Traditional Chinese medicine for activating blood to relieve pain |
| CN105056129A (en) * | 2015-08-17 | 2015-11-18 | 青岛云天生物技术有限公司 | Traditional Chinese medicine preparation for treating endometriosis and preparation method thereof |
| CN106074660A (en) * | 2016-08-11 | 2016-11-09 | 南京中医药大学 | Olibanum and Myrrha application in preparation preventing and treating neuropathic pain disease medicament |
| CN111840420A (en) * | 2020-08-20 | 2020-10-30 | 上海市第一康复医院(上海市杨浦区老年医院) | Traditional Chinese medicine external application, preparation method and use method thereof and application of traditional Chinese medicine external application in relieving liver cancer pain |
| CN111840420B (en) * | 2020-08-20 | 2021-11-05 | 上海市第一康复医院(上海市杨浦区老年医院) | A Chinese medicinal topical plaster and its preparation method |
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