CN1250239C - Medicine for treating backache and its prepn. method - Google Patents

Medicine for treating backache and its prepn. method Download PDF

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Publication number
CN1250239C
CN1250239C CN 200310105348 CN200310105348A CN1250239C CN 1250239 C CN1250239 C CN 1250239C CN 200310105348 CN200310105348 CN 200310105348 CN 200310105348 A CN200310105348 A CN 200310105348A CN 1250239 C CN1250239 C CN 1250239C
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weight portion
medicine
radix achyranthis
herba epimedii
treatment
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CN1537618A (en
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刘代成
冯娟娟
闫仲丽
王伟
韩立英
朱令仁
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Shandong Normal University
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Shandong Normal University
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Abstract

The present invention provides a medicine for treating backache and a preparation method thereof. The medicine is prepared from the Chinese herbal medicine raw materials of the following proportion according to weight portions: 8 to 20 portions of epimedium herb and 8 to 20 portions of radix achyranthis bidentatae. The preparation method of the medicine comprises the steps that the raw materials are decocted with water conventionally, and filter liquor is concentrated, deposited in alcohol with the concentration of 50 to 70% and filtered; 1 to 2 wt% of talcum powder, 4 to 6 wt% of filter paper fibre and 1 to 2 wt% of tween-80 are added into the filter liquor; then, the filter liquor is heated to boiling and filtered; the new filter liquor is sterilized and bottled to obtain an oral medicinal liquid; or 1/5 to 1 wt% of edible wine is added into the filter liquor, and then the filter liquor is bottled to obtain a wine preparation; or water of the epimedium herb and the radix achyranthis bidentatae or leaching liquor of edible alcohol is concentrated into paste; after auxiliary materials are added, the paste is lumped with water and the edible alcohol, granulated and baked to obtain granules. Capsules can be prepared by encapsulating the obtained granules.

Description

A kind of medicine and preparation method for the treatment of lumbago diseases
Technical field
The present invention relates to a kind of medicine for the treatment of lumbago diseases, especially a kind of is the medicine of raw material with the Chinese herbal medicine, the invention still further relates to the preparation method of this medicine.
Technical background
Lumbago is a kind of common frdquently encountered disease, it also is clinical one of the most common disease, belong to arthralgia due to cold-dampness or obstruction of collaterals by blood stasis or owing to suffer from a deficiency of the kidney more, according to incompletely statistics, be engaged in the society among the personnel of every profession and trade, have among 80% the personnel and suffer from the different lumbago diseases of degree, account for about 20% of hospital surgery outpatient service prescription on individual diagnosis number, account for Orthopaedics Clinic pact half.There is the scholar to estimate that average each family of five just has a lumbago patient.Also there is the expert to point out that lumbago everyone all can live through in life, directly endangers people's health.General lumbago mostly occurs at live acoustic, and sickness rate also increases gradually with age, and particularly middle-aged and elderly people and the workman that needs often low waist operation are as the flower-grower etc., and the sickness rate of lumbago is especially high.Motherland's medical science think rheumatism, to suffer from a deficiency of the kidney, damage be the principal element that causes lumbago, when lumbago developed into the order of severity, then therapeutic effect is not good, and was not only time-consuming but also uneconomical, there is 1% people to adopt operative treatment approximately, visible " lumbago " serious threat and infringement people's physical and mental health.
The medicine of treatment lumbago is more at present, and Chinese prescription is as mending the strong kidney cream of waist etc., Chinese patent medicine such as YAOTONGNING JIAONANG etc., medicine for external use such as SHEXIANG ZHUANGGU GAO etc., Western medicine such as prednisone etc.But the most flavour of a drug of the prescription of these medicines are more, and cost is higher, and taste is difficult for being accepted by consumer.Lose time when Chinese prescription decocts, and carry, take inconvenience.Therefore vast lumbago patient looks forward to that a kind of cost is lower, taking convenience, side effect is little, taste is good, and can effectively treat the new formulation listing of lumbago.
The invention task
One of purpose of the present invention provides that the used flavour of a drug of a kind of prescription are few, and cost is low, and taste is good, conveniently executes the medicine of controlling and effectively treating lumbago diseases, and two of purpose provides that the technology that one of achieves the goal is simple, the process for preparing medicine of easy operating.
One of purpose of the present invention can realize by following technical measures:
Medicine of the present invention is made (consumption is a weight portion) by following component:
Herba Epimedii 8~20 Radix Achyranthis Bidentataes 8~20
Formula optimization weight (part) ratio range of preparation medicine of the present invention is:
Herba Epimedii 9~15 Radix Achyranthis Bidentataes 9~15
The optimum weight of medicine of the present invention (part) proportioning is:
Herba Epimedii 15 Radix Achyranthis Bidentataes 15
The said dosage form of the present invention is oral liquid, medicated wine, granule or capsule.
Two of purpose of the present invention can realize by following technical measures:
With Herba Epimedii, Radix Achyranthis Bidentatae is raw material, conventional decocting boils, concentrating filter liquor, 50-70% concentration of alcohol precipitate with ethanol filters, in filtrate, add the Pulvis Talci of 1-2% weight portion, the filter paper fibre of 4-6% weight portion, the tween 80 of 1-2% weight portion, be heated to and boil, filter, filtrate is through sterilization, bottling is oral liquid; Or
Add the edible wine of 1/5-1 times of weight portion in described filtrate, bottling or be raw material with Herba Epimedii, Radix Achyranthis Bidentatae adds 6~10 times of weight portion Chinese liquor lixiviate a couple of days of raw material, filters, and bottling is medicated wine; Or
The water of Herba Epimedii, Radix Achyranthis Bidentatae or the lixiviating solution of edible ethanol are concentrated into cream, add batching, water and edible ethanol and agglomerating, pelletize, oven dry is granule;
The described granule that makes is incapsulated, be capsule.
Two of purpose of the present invention also can realize by following technical measures:
Described batching comprises the paste of 3-7 weight portion, the maltodextrin of 40-60 weight portion, the soluble starch of 6-10 weight portion, the bone meal of 0.3-0.8 weight portion, the sodium bicarbonate of 0.5-1 weight portion, the face sugar of 2-4 weight portion, 0.3-1 the lecithin of weight portion, the citric acid of 0.3-0.7 weight portion, the food coloring lemon yellow of 0.01-0.05 weight portion, the edible wine of 3-20 weight portion, the water of 1-6 weight portion.
The present invention utilizes the natural pharmaceutical resources in the Nature, choose needed raw material according to the Pharmacopoeia of People's Republic of China standard, provide the used flavour of a drug of a kind of prescription few for suffering from the lumbago patient, cost is low, and taste is good, does not need operation, conveniently execute the medicine of controlling and effectively treating lumbago diseases, the present invention is made up of Herba Epimedii, Radix Achyranthis Bidentatae, and Herba Epimedii is monarch in the side, and Radix Achyranthis Bidentatae is a minister.Take a broad view of full side, the side is smart, and the medicine letter is imitated grandly, and power is special, prescription science, reasonable mixture ratio.Play strengthening vital QI to eliminate pathogenic factors altogether, the effect for the treatment of both the principal and secondary aspects of a disease has reached the purpose for the treatment of lumbago diseases.
The present invention presses icariine in the described thin layer chromatography method qualitative detection product of Xie Peishan etc. " the colored atlas of Pharmacopoeia of People's Republic of China Chinese medicine thin layer chromatography ", as a qualitative index of this drug quality.Utilize icariine in the thin slice scan quantitative assay product.Condition determination: measure wavelength X=270nm, linear parameter SX=5.0, slit 1.20mm * 1.20mm, transversal scanning X=6.0mm, longitudinal scanning Y=15.0mm adopts single wavelength dual-beam bounce technique zigzag scanning.Mottle stability experiment: draw icariine titer 1.0 μ l points on lamellae, launch and colour developing by selected chromatographic condition, place after the 10min, put and measure the peak area integrated value on the scanner, survey once every 1h, the mottle color is more stable in the 6h as a result, the peak area integrated value, survey once every 1h, the mottle color is more stable in the 6h as a result, and the peak area integrated value is constant substantially.The drafting of standard curve: the accurate icariine titer 0.5,1.0,1.5 of drawing, 2.0,3.0,4.0,5.0 μ l point is on same chromatoplate, by above-mentioned chromatographic condition operation and mensuration peak area integrated value, (μ l) is abscissa with the point sample amount, is vertical coordinate with peak area integrated value (A), the drawing standard curve, found that working curve is a straight line, the point sample amount is good linear relationship with the peak area integrated value in 0.25-2.75 μ g scope.Its regression equation is y=166.33 ± 16.21, correlation coefficient r=0.9995.
The assay of sample: accurately draw each 1.50 μ l point sample of oral liquid, medicated wine sample liquid, dissolved granule sample liquid and Herba Epimedii test liquid, the point of each sample five equal volume of point on same block of plate, and a certain amount of Herba Epimedii standard substance of retinue point, by selected condition exhibition journey, colour developing, location.With the content of a bit directly measuring Herba Epimedii in the sample on the scanner with external standard.
The present invention system is that primary raw material is prepared from according to the theory of the traditional Chinese medical science " waist is a house of kidney, belongs to kidney in the spinal column, and all warps of outer network are so lumbago and kidney relation are the closest " with Herba Epimedii, Radix Achyranthis Bidentatae.Herba Epimedii, property suffering, temperature are returned liver, and kidney channel has the effect of kidney invigorating and YANG supporting, strengthening the tendons and bones, expelling wind and removing dampness.Be usually used in diseases such as rheumatic arthralgia, numb limbs and tense tendons, waist knee flaccidity, muscles and bones flaccidity are soft, lower extremity paralysis.Radix Achyranthis Bidentatae, bitter in the mouth, acid, property is flat, returns liver, kidney channel, has the effect of activating blood and removing stasis, conducting blood to flow downwards, invigorating the liver and kidney, treating stranguria puckery, bone and muscle strengthening.Be usually used in diseases such as the waist gonalgia, joint stuffiness.Two drug matchings have strengthened the effect for the treatment of lumbago.
The present invention is in preparation during oral liquid, adds Pulvis Talci, filter paper fibre, tween 80 behind the water extract-alcohol precipitation and handles, and obtains that character is stable, clear, no sedimentary product.Wherein excessive undissolved volatile oil and pigment in the Pulvis Talci energy adsorption aqueous solution improves filtering velocity, obtains clear and bright solution.Filter paper helps filter and decolorization, and adsorbable macromolecular substances is applicable to the medicinal liquid that is difficult to filtering.Tween 80 belongs to nonionic surfactant, is a kind of solubilizing agent preferably that contains the volatile oil component Chinese herbal and crude drugs preparations.The three share, and is respond well.
Dissolved granule that the present invention is prepared and capsule, added lecithin with alimentary health-care function, citric acid, bone meal etc. in the prescription, wherein lecithin can improve blood circulation, removes peroxide, improve the active component absorption in vivo, the effect of intensive treatment lumbago.Calcic in the bone meal, but prevention of osteoporosis also play the effect of blood circulation promoting and blood stasis dispelling.Add citric acid dough-making powder sugar, regulate the carbonic acid ratio, can make product have pleasant taste, and citric acid also has the health-care effect of invigorating blood circulation, strengthened drug effect.
Owing to adopt technique scheme, the present invention compared with present treatment lumbago common drug have following advantage:
(1) medicine employing Chinese herbal medicine of the present invention is a raw material, utilize returning of two flavor Chinese herbal medicine through effect comprehensive function treatment lumbago, be pure Chinese medicinal preparation, evident in efficacy, the used flavour of a drug of filling a prescription few (only with Herba Epimedii, Radix Achyranthis Bidentatae two flavor Chinese medicines), the medicine cost is lower, through clinical observation, does not have other any toxic and side effects.
(2) preparation method of the present invention is simple, and equipment needed thereby is simple and easy, easy operating, and producing cost is low.
(3) medicine treating both the principal and secondary aspects of a disease of the present invention, simultaneous elimination and reinforcement, good effect, especially short term effect is remarkable, nontoxic to human body, have functions such as kidney invigorating and YANG supporting, promoting blood circulation and stopping pain, strengthening the tendons and bones, expelling wind and removing dampness, can treat all kinds of lumbagos and senile lumbagos such as renal deficiency type, blood stasis type, cold-dampness type, Qi-stagnation type.
(4) added lecithin, citric acid, bone meal in granular preparation of the present invention and the capsule, had blood fat reducing, dredging vascellum, sharp qi and blood circulation promotion and alimentary health-care function, in addition, also help effect of drugs keep and stable.The medicated wine product has effects such as promoting blood circulation, row medicine gesture, warming intestines and stomach, imperial wind and cold with the wine qi and blood circulation promotion, but the accelerate blood circulation, and the drug effect performance is fast.
(5) medicine of the present invention medicine taste has than before had very big improvement, is easy to be accepted by consumer.
(6) drug administration of the present invention is convenient, and side effect is little, and therapeutic effect is good.
The present invention is an example to use oral liquid, through clinical observation 57 examples (wherein male 40 examples, women 17 examples), matched group is taken " wolfberry fruit and broomrape tonic wine ", totally 25 examples (wherein male 17 examples, women 8 examples), observation group and matched group the range of age are 43~79 years old, two groups of administrated methods are all identical with dosage, every day three times, each 10ml, 1 month course of treatment, clinical observation 3 months, most of cases are cured in 1 or 2 months, last till individually 3 months.
Clinical results is by following criterion of therapeutical effect (taking medicine 1~3 month):
Cure: lumbago disappears, and moves freely, and drug withdrawal is recurrence after 3 months.
Produce effects: lumbago disappears, and the waist movement situation is obviously improved, but sometimes because of suffering from cold or mild pain appears in fatigue, obeys medicine of the present invention again and promptly take a turn for the better, so need discontinuity is taken medicine.
Effectively: lumbago obviously alleviates, and need continue to take medicine.
Invalid: lumbago does not have obvious improvement.
Clinical results
Age (year) 43~53 54~64 65~7 5 〉=76 total percentage rate total effective rates
16 people, 22 people, 14 people, 5 people, 57 people of observation group
Matched group 7 people 11 people 2 people 2 people 25 people
Observation group takes that total effective rate is 96.4% behind the medicine of the present invention, invalidly accounts for 3.5%, and it is 88% that matched group is taken " wolfberry fruit and broomrape tonic wine " back total effective rate, invalidly accounts for 12%, two group of contrast notable difference (p<0.01) is arranged, and observation group obviously is better than matched group.
Model case
Grandson XX, man, 60 years old, cadre.Lumbago, every because of suffering from cold or tired back sx limitation of activity.Come to go to a doctor at the beginning of 2002, the waist film making shows lumbar muscle strain, and waist 4,5 vertebra hypertrophy are taken medicine of the present invention, and each 10ml serve on 1 month every day three times, further consultation in 45 days after the drug withdrawal, and clinical symptoms disappears substantially, and activity is freely.
The specific embodiment
Embodiment 1: take by weighing Herba Epimedii, each 54 gram of Radix Achyranthis Bidentatae, decoct according to a conventional method three times, each water consumption is 800ml, and decocting time is respectively 1h, 30min, 15min, and filter respectively, filtrate merged three times, be concentrated into 1: 1 (g/ml), add the 108ml dehydrated alcohol, precipitate with ethanol 24h, filtrate recycling ethanol, filter, filter paper fibre 5g, 2 tween 80s that filtrate adds Pulvis Talci 2g, and oven dry broken through tissue mashing machine stir post-heating, filter, filtrate is through 100 ℃ of sterilization 1h, bottling, every bottle of 10ml is the oral liquid product.
Embodiment 2: take by weighing Herba Epimedii, each 54 gram of Radix Achyranthis Bidentatae, water decocts three times, and each water consumption is 800ml, decocting time is respectively 1h, 30min, 15min, and filter respectively, merge three times filtrate, be concentrated into 1: 1 (g/ml), add the 108ml dehydrated alcohol, precipitate with ethanol 24h, filter, filtrate recycling ethanol filters, and filtrate adds filter paper fibre 5g, 2 tween 80s of Pulvis Talci 2g, and oven dry broken through tissue mashing machine, stir post-heating, filter, filtrate adds edible wine 200ml, bottling, every bottle of 10ml is medicated wine product one.
Embodiment 3: take by weighing Herba Epimedii, each 27 gram of Radix Achyranthis Bidentatae, soaked 7 days with Chinese liquor 400ml, steeping in wine liquid is bottled after filtration, and every bottle of 10ml is medicated wine product two.
Embodiment 4: take by weighing Herba Epimedii, each 27 gram of Radix Achyranthis Bidentatae, steep three times with the edible steeping in wine of 400ml respectively, each soak time is no less than 3h, filters, filtrate is concentrated into cream, or respectively with 400ml water logging bubble and decoct 3 times, the time is respectively 1h, 30min, 15min filters, and merging filtrate also is concentrated into cream.Add lecithin 1g, soluble starch 8g, maltodextrin 45g, citric acid 0.4g, face sugar 3g, sodium bicarbonate 0.8g, bone meal 0.5g, edible wine 4ml, water 1ml in the paste successively, rub into dough, pelletize in 105 ℃ of oven dry down, is the dissolved granule product.
Embodiment 5: embodiment 4 gained dissolved granulies are incapsulated, be capsule product.

Claims (6)

1, a kind of medicine for the treatment of lumbago diseases is characterized in that it is the medicament of being made by following weight parts proportioning herbal raw material
Herba Epimedii 8~20 Radix Achyranthis Bidentataes 8~20.
2, a kind of medicine for the treatment of lumbago diseases according to claim 1, wherein the weight proportion of each raw material is
Herba Epimedii 9~15 Radix Achyranthis Bidentataes 9~15.
3, a kind of medicine for the treatment of lumbago diseases according to claim 1, wherein the weight proportion of each raw material is
Herba Epimedii 15 Radix Achyranthis Bidentataes 15.
4, a kind of medicine for the treatment of lumbago diseases according to claim 1 is characterized in that said medicament is oral liquid, medicated wine, granule or capsule.
5, the preparation method of the medicine of the described treatment lumbago diseases of claim 1, it is characterized in that with Herba Epimedii, Radix Achyranthis Bidentatae be raw material, conventional decocting boils, concentrating filter liquor, 50-70% concentration of alcohol precipitate with ethanol, filter, in filtrate, add the Pulvis Talci of 1-2% weight portion, the filter paper fibre of 4-6% weight portion, the tween 80 of 1-2% weight portion, be heated to and boil, filter, filtrate is through sterilization, and bottling is oral liquid; Or in described filtrate, add the edible wine of 1/5-1 times of weight portion, and bottling or be raw material with Herba Epimedii, Radix Achyranthis Bidentatae adds 6~10 times of weight portion Chinese liquor lixiviate a couple of days of raw material, filters, and bottling is medicated wine; Or the water of Herba Epimedii, Radix Achyranthis Bidentatae or the lixiviating solution of edible ethanol is concentrated into cream, and add batching, water and edible ethanol and agglomerating, pelletize, oven dry is granule;
The described granule that makes is incapsulated, be capsule.
6, a kind of preparation method for the treatment of the medicine of lumbago diseases according to claim 5, it is characterized in that described batching is the paste of 3-7 weight portion, the maltodextrin of 40-60 weight portion, the soluble starch of 6-10 weight portion, 0.3-0.8 the bone meal of weight portion, 0.5-1 the sodium bicarbonate of weight portion, the face sugar of 2-4 weight portion, 0.3-1 the lecithin of weight portion, 0.3-0.7 the citric acid of weight portion, 0.01-0.05 the food coloring lemon yellow of weight portion, the edible wine of 3-20 weight portion, the water of 1-6 weight portion.
CN 200310105348 2003-10-24 2003-10-24 Medicine for treating backache and its prepn. method Expired - Fee Related CN1250239C (en)

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Application Number Priority Date Filing Date Title
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CN1250239C true CN1250239C (en) 2006-04-12

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CN105106271B (en) * 2015-09-15 2018-03-13 昆药集团股份有限公司 A kind of Chinese medicine composition and preparation method thereof, purposes and preparation

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