CN100335112C - Chinese medicine for treating kidney vacuity lumbar pain and preparation method of its capsule - Google Patents

Chinese medicine for treating kidney vacuity lumbar pain and preparation method of its capsule Download PDF

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CN100335112C
CN100335112C CNB2004100653911A CN200410065391A CN100335112C CN 100335112 C CN100335112 C CN 100335112C CN B2004100653911 A CNB2004100653911 A CN B2004100653911A CN 200410065391 A CN200410065391 A CN 200410065391A CN 100335112 C CN100335112 C CN 100335112C
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chinese medicine
cold
kidney
pain
lumbar
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CNB2004100653911A
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CN1650945A (en
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孙悦典
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Hefei Shenlu Shuanghe Pharmaceutical Co Ltd
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Hefei Shenlu Shuanghe Pharmaceutical Co Ltd
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Abstract

The present invention relates to a Chinese medicine for treating lumbar pain caused by kidney vacuity due to cold wetness and a preparation method of a capsule thereof, which belongs to the technical field of a Chinese preparatory medicine and a preparation method thereof. The present invention aims to solve the technical problem of difficultly providing a Chinese medicine for treating lumbar pain caused by kidney vacuity due to cold wetness and a preparation method of a capsule thereof, wherein the Chinese medicine has the efficiency of warming kidney for dispelling cold and activating meridians to stop pain. The present invention has the technical key point that the Chinese medicine is made of the raw materials of the weight percentage: 30 to 50 of epimedium, 2 to 10 of nux vomica, 20 to 40 corydalis tubers, 10 to 30 of earthworm, and 1 to 5 of dragon blood. The Chinese medicine of the present invention has the efficiency of warming kidney for dispelling cold and activating meridians to stop pain and is used for treating lumbago caused by renal deficiency due to cold wetness, lumbar degenerative change, lumbar muscle strain, etc., and the diseases with the clinical manifestation of cold pain on waist, soreness and weakness of waist and knees, heavy joints, exacerbation in fatigue and in cold days, unfavorable turning, tinnitus, frequent nocturia, pale tongue, thin tongue coating and forceless deep pulse. The present invention has the advantages of conspicuous curative effect, no obvious toxicity, no obvious side effects and safe administration.

Description

The Chinese medicine of treatment kidney vacuity lumbar pain and the preparation method of capsule thereof
Technical field: a kind of Chinese patent medicine of the present invention and preparation method thereof, particularly a kind of preparation method for the treatment of the Chinese medicine and the capsule thereof of kidney vacuity lumbar pain.
Background technology: lumbago is common clinical, frequently-occurring disease.Many experience because of suffering from a deficiency of the kidney cold-damp, wound lose and control, excessively heavy burden or fatigue cause qi and blood stagnation, passages through which vital energy circulates obstructed due to.University teaching material " Chinese Internal Medicine " is divided into lumbago due to cold-damp, lumbago due to damp-heat, congestion lumbago and lumbago due to renal deficiency with lumbago.It is several that the national essential drugs catalogue is divided into rheumatism resistance network card, blood-vessel obstructive card, deficiency of kidney yin, insufficiency of kidney-YANG card and syndrome of deficiency of both yin and yang of kidney bitterly with medicine.Right clinically see that so that syndrome of cold-dampness due to kidney deficiency more promptly suffering from a deficiency of the kidney is this, experiences the heresy of cold-damp.Lid is the kidney mansion because of waist, kidney storing essence master bone, and the vital essence of kidney is lost empty, and then spinal column loses and supports; The damp and hot all heresies of affection of exogenous wind-cold, with damp pathogen being sticky and stagnant in nature, the easiest numbness work waist, numbness resistance muscle arteries and veins; The vital essence of suffering from a deficiency of the kidney deficiency is the susceptible cold-damp then, and the heresy of experiencing cold-damp easily consumes impairment of YANG gas again and causes insufficiency of kidney-YANG, and it is sick, endlessly continuous each other mutually with the heresy of experiencing cold-damp to suffer from a deficiency of the kidney.As a kind of lumbar degenerative pathological changes of degenerative spondylitis, be a kind of osteoarthritis that causes because of the cartilage degeneration based on hyperosteogeny, be mainly in middle-aged and elderly people, its cause of disease is still not exclusively clear and definite.It is generally acknowledged that belonging to senile bone changes, on the basis of the various tissue generation of lumbar vertebra regression, in addition vertebra bears a heavy burden for a long time, and self endocrine regulation causes that mucopolysaccharide content reduces in the substrate of cartilage, and fibre composition increases, and cartilage follows the string and the pathological changes that produces.Its treatment mainly is physical therapy, massage and medicine etc., and medicine mainly contains external and nonsteroidal anti inflammatory medicine for oral administration, but because the not good enough and stomach side effects of curative effect, can not get satisfied treatment after making the patient ill, and it is difficult to cause delay.Warm pain relieved by pressing is liked in its clinical the show as aching and limp pain of waist, outbreaks, endlessly continuous repeatedly more, and it is unfavorable to change one's position, and meets tired or sombre weather and increases the weight of, and Chinese medical discrimination belongs to the kidney vacuity lumbar pain category, the rule of treatment yes warming kidney for dispelling cold, removing obstruction in the collateral to relieve pain.Medicine mostly is external cream, tincture and medicated wine for oral administration among carrying in right present commercially available Chinese medicine and the national essential drugs catalogue, and the person is less to belong to the syndrome of cold-dampness due to kidney deficiency at lumbago.
Summary of the invention: technical problem to be solved by this invention is: a kind of Chinese medicine of the treatment kidney vacuity lumbar pain with warming kidney for dispelling cold, removing obstruction in the collateral to relieve pain effect and the preparation method of capsule thereof are provided.Its technical scheme is: a kind of Chinese medicine for the treatment of kidney vacuity lumbar pain is characterized in that it is to be made by following raw materials by weight percent medicine:
Herba Epimedii 30-50 Semen Strychni 2-10 Rhizoma Corydalis 20-40
Pheretima 10-30 Sanguis Draxonis 1-5.
In the side, Herba Epimedii is monarch, and Xin Ganwen goes into Liver and kidney two warps, kidney invigorating and YANG supporting, bone and muscle strengthening, expelling wind and removing dampness; Cure mainly weakness of the waist and knees, rheumatic arthralgia, extremity are meciless, and " book on Chinese herbal medicine justice " says its " Gu kidney-reinforcing Yang-strengthening not only, and the passages through which vital energy circulates removing cold and wind arthralgia chiefly caused by damp pathogen of passing through ".One medicine and embody warming kidney for dispelling cold, damp-clearing pain-relieving, so the function of bone and muscle strengthening, and recipe quantity maximum are when being monarch drug.
Semen Strychni, hardship is warm, and the merit of removing obstruction in the collateral to relieve pain, detumescence is arranged, and controls migratory arthralgia pain, its bitter energy dampness, temperature can be dispelled the heat, and to help Herba Epimedii expelling cold and dampness, other has the merit of remarkable removing obstruction in the collateral to relieve pain, can mend the deficiency of principal agent pain relieving again, is ministerial drug.
Rhizoma Corydalis, arduous temperature is gone into liver stomach warp, and effect is a promoting blood circulation to remove blood stasis, and regulating QI to relieve pain is controlled trusted subordinate, all pains of waist knee joint, traumatic injury.Compendium of Material Medica say its can " all over the body up and down all pains are specially controlled in the stagnation of QI in the promoting the circulation of blood, stasis in the gas, with among, simply fantastic ".Match with Semen Strychni, can strengthen the merit of its pain relieving." book on Chinese herbal medicine is looked for the truth " cloud: " reason is all pains all over the body up and down, and the merit of often walking alone is many, so this both not had QI invigorating clear, multiple few justice of supporting battalion, the hot temperature of battle is attacked and coagulated by stagnating on foot, empty people is when the same usefulness of tonic of holding concurrently, otherwise damage is unhelpful on foot ".Match with Herba Epimedii and keep away Xin Wen and hinder just worry; Pheretima, salty in the mouth is returned liver, spleen, urinary bladder channel, and promoting blood circulation to remove obstruction in the collateral can be used for arthralgia, numb limbs and tense tendons; The flat sweet-salty of Sanguis Draxonis is gone into conscience kidney three warps, the dissipating blood stasis analgesic therapy, and hemostasis, life are controlled traumatic injury, waist thigh bone pain; Be retarded by silt in three's row arteries and veins, regulating QI to relieve pain is adjuvant altogether.
The merit that full side plays warming kidney for dispelling cold, removing obstruction in the collateral to relieve pain altogether.
The preparation method of its capsule is:
Semen Strychni, Sanguis Draxonis powder are broken into fine powder;
Herba Epimedii, Pheretima decoct with water three times, and each 1 hour, collecting decoction filtered, filtrate is concentrated into the clear paste that relative density is 1.15-1.20, adds ethanol and makes and contain alcohol amount and reach 70%, stirs evenly, and leaves standstill 24 hours, filter, behind the recovery ethanol, be concentrated into the thick paste that relative density is 1.25-1.30;
Rhizoma Corydalis is with 70% alcohol reflux three times, and each 1 hour, filter, merging filtrate, decompression recycling ethanol is concentrated into the thick paste that relative density is 1.25-1.30;
The thick paste and the Rhizoma Corydalis thick paste that merge above-mentioned Herba Epimedii and Pheretima add Semen Strychni, fine powder of dragons blood, mixing, and drying under reduced pressure becomes dry extract, is ground into fine powder, and mixing is granulated, drying, sterilization incapsulates.
According to the Clinical Researches of New Drugs official written reply 2001ZL126 of National Drug Administration, " clinical drug trial management regulation (GCP) ", " new Chinese medicine clinical research guideline ", the prescription of this Chinese medicinal capsule agent is formed, function cures mainly, pharmacodynamics, toxicologic study data and " specification requirement of new Chinese medicine clinical research ", year August in January, 2002 to 2003, in No.1 Hospital of Guiyang Traditional Chinese Medicine College, China Academy of TCM's bone injury institute, Fujian Institute of Traditional Chinese Medicine and The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine, capsule with this Chinese medicine is treated the kidney vacuity lumbar pain patient, and observes its safety and curative effect.
One, experimenter's selection
The mode that adopts disease to combine, the selection Western medicine diagnose is that lumbar muscle strain, Chinese medical discrimination are that lumbago (syndrome of cold-dampness due to kidney deficiency) patient is the object of observation.
1, the Western medicine diagnose standard of lumbar muscle strain:
(1) convalescent period of acute injury, or accumulation property, chronic mild damage, or posture or occupational are because compulsive position chronic injury due to the work down.
(2) lumbar soft tissue has a place or many places pressure pain point.
(3) ache of the spinal column is weak, can not be lasting.
(4) lumbar spine is movable normal or slightly impaired.
(5) the lumbar X line is normal or degenerative change arranged.
2, Chinese medical discrimination
Syndrome of cold-dampness due to kidney deficiency:
Primary symptom: the waist cold type of pain, soreness of the waist and knees is weighing.
Inferior disease: tinnitus, nocturia are frequently met labor or are sombrely increased the weight of, and it is unfavorable to change one's position.
Tongue pulse condition: light red tongue, tongue book, deep and weak pulse.
3, include the case standard in:
(1) has the clinical manifestation of typical lumbar muscle strain, meet the Western medicine diagnose standard of lumbar muscle strain and Chinese medical discrimination and belong to lumbago (syndrome of cold-dampness due to kidney deficiency: possess 2 of primary symptoms, more than the inferior disease 1-3 item) person.
(2) age is at 18-65 between year.
Two, therapeutic scheme:
(1) investigational agent: the agent of this Chinese medicinal capsule, specification: 0.4 gram/grain.
(2) administrated method: oral Chinese medicinal capsule of experimenter, every day secondary, each 2, warm water delivery service.Be subjected to one month examination phase.
Three, efficacy assessment standard
Clinical cure: lumbago and related symptoms all disappear, and do not influence activity and work.Follow up a case by regular visits to and do not have recurrence in one month.Therapeutic index reaches more than 95%.
Produce effects: lumbago be close to disappear, and only mild pain is arranged when fatigue or Changes in weather, and functional rehabilitation does not influence routine work or the state of an illness is transferred to slightly by severe.Therapeutic index reaches more than 70%.
Effectively: the symptom of lumbago and sign have and alleviate or improve, but unstable condition has recurrence after the drug withdrawal, and be influential to heavy physical labour.Therapeutic index reaches more than 30%.
Invalid: clinical symptoms and sign no change, even the person of increasing the weight of.Therapeutic index is less than 30%.
Four, traditional Chinese medical science disease efficacy evaluation and single symptom efficacy evaluation
Traditional Chinese medical science disease efficacy evaluation
Clinical recovery: symptom, sign disappear or basic the disappearance, and therapeutic index reaches more than 95%.
Produce effects: symptom, sign are obviously improved, and therapeutic index reaches more than 70%.
Effectively: symptom, sign all take a favorable turn, and therapeutic index reaches more than 30%.
Invalid: symptom, sign do not have obvious improvement, and therapeutic index is less than 30%.
Integration * 100% before therapeutic index=(integration before the treatment-treatment back integration)/treatment.
Single symptom efficacy evaluation
Clinical recovery: single Sx treatment back grade is 0 grade.
Marked improvement: 2 grades relatively descend before treatment single Sx in back and the treatment.
Effectively: 1 grade relatively descends before treatment single Sx in back and the treatment.
Invalid: the single Sx in treatment back is preceding more constant with treatment.
Five, safety evaluatio
1 grade, safety does not have any untoward reaction.
2 grades, relatively safety has mild adverse effects, does not need any processing can continue administration.
3 grades, safety issue is arranged, moderate untoward reaction is arranged, can continue administration after processing.
4 grades, because of the untoward reaction termination test.
Six, untoward reaction: adverse drug reaction is meant produce harmful but not desired, with pharmaceutical applications causal reaction is arranged in prescribed dose normal use medicine process.
Seven, result
1, clinical efficacy: clinical 106 examples, clinical recovery 18 examples, produce effects 44 examples, effective 37 examples, invalid 7 examples, total effective rate is 93.40%.
2, traditional Chinese medical science disease curative effect: clinical 106 examples, clinical recovery 8 examples, produce effects 47 examples, effective 43 examples, invalid 8 examples, total effective rate is 92.45%.
3, through to waist cold type of pain, the soreness of the waist and knees of the cold-damp patient clinical manifestation of suffering from a deficiency of the kidney, weighing, meeting labor and the treatment of individual event symptoms such as unfavorable, the tinnitus of increasing the weight of, change one's position in sombre day, nocturia frequency is added up and shown, all have clear improvement.
4, safety: through whole observation crowd routine blood tests, large and small just routine, liver function, renal function, the interpretation of result of electrocardiogram treatment before and after look are shown that this Chinese medicinal capsule is clinical safe in utilization, no obvious toxic-side effects.Safety analysis crowd vital sign comprises that blood pressure, heart rate, pulse, breathing, body weight check result treatment front and back have clear improvement, and all within normal range.
In sum, Chinese medicine of the present invention has the effect of warming kidney for dispelling cold, removing obstruction in the collateral to relieve pain, be used for the treatment of diseases such as kidney vacuity lumbar pain, moving back property of lumbar vertebra row pathological changes, lumbar muscle strain, clinical manifestation is waist cold type of pain, soreness of the waist and knees, weighing, meeting labor and unfavorable, the tinnitus of increasing the weight of, change one's position in sombre day, nocturia frequency, light red tongue, thin fur deep and weak pulse evident in efficacy, and do not have tangible toxic and side effects, take safety.
The specific embodiment:
Embodiment 1.Get Semen Strychni 2kg, Sanguis Draxonis 1kg is ground into fine powder; Herba Epimedii 50kg, Pheretima 10kg decoct with water three times, and each 1 hour, collecting decoction filtered, it is 1.15 clear paste that filtrate is concentrated into relative density, adds ethanol and makes and contain the alcohol amount and reach 70%, stirs evenly, and leaves standstill 24 hours, filter, reclaim ethanol after, be concentrated into relative density and be 1.25 thick paste; Rhizoma Corydalis 20kg is with 70% alcohol reflux three times, and each 1 hour, filter, merging filtrate, decompression recycling ethanol is concentrated into relative density and is 1.25 thick paste; The thick paste and the Rhizoma Corydalis thick paste that merge above-mentioned Herba Epimedii and Pheretima add Semen Strychni, fine powder of dragons blood, mixing, and drying under reduced pressure becomes dry extract, is ground into fine powder, and mixing is granulated, drying, sterilization incapsulates, and gets capsule.
Embodiment 2.Get Semen Strychni 6kg, Sanguis Draxonis 3kg is ground into fine powder; Herba Epimedii 40kg, Pheretima 20kg decoct with water three times, and each 1 hour, collecting decoction filtered, it is 1.20 clear paste that filtrate is concentrated into relative density, adds ethanol and makes and contain the alcohol amount and reach 70%, stirs evenly, and leaves standstill 24 hours, filter, reclaim ethanol after, be concentrated into relative density and be 1.30 thick paste; Rhizoma Corydalis 30kg is with 70% alcohol reflux three times, and each 1 hour, filter, merging filtrate, decompression recycling ethanol is concentrated into relative density and is 1.30 thick paste; The thick paste and the Rhizoma Corydalis thick paste that merge above-mentioned Herba Epimedii and Pheretima add Semen Strychni, fine powder of dragons blood, mixing, and drying under reduced pressure becomes dry extract, is ground into fine powder, and mixing is granulated, drying, sterilization incapsulates, and gets capsule.
Embodiment 3.Get Semen Strychni 10kg, Sanguis Draxonis 5kg is ground into fine powder; Herba Epimedii 30kg, Pheretima 30kg decoct with water three times, and each 1 hour, collecting decoction filtered, it is 1.15 clear paste that filtrate is concentrated into relative density, adds ethanol and makes and contain the alcohol amount and reach 70%, stirs evenly, and leaves standstill 24 hours, filter, reclaim ethanol after, be concentrated into relative density and be 1.25 thick paste; Rhizoma Corydalis 40kg is with 70% alcohol reflux three times, and each 1 hour, filter, merging filtrate, decompression recycling ethanol is concentrated into relative density and is 1.25 thick paste; The thick paste and the Rhizoma Corydalis thick paste that merge above-mentioned Herba Epimedii and Pheretima add Semen Strychni, fine powder of dragons blood, mixing, and drying under reduced pressure becomes dry extract, is ground into fine powder, and mixing is granulated, drying, sterilization incapsulates, and gets capsule.

Claims (2)

1, a kind of Chinese medicine for the treatment of kidney vacuity lumbar pain is characterized in that it is to be made by following raw materials by weight percent medicine:
Herba Epimedii 30-50 Semen Strychni 2-10 Rhizoma Corydalis 20-40
Pheretima 10-30 Sanguis Draxonis 1-5.
2, a kind of preparation method of Chinese medicine for the treatment of kidney vacuity lumbar pain as claimed in claim 1 is characterized in that:
Semen Strychni, Sanguis Draxonis powder are broken into fine powder;
Herba Epimedii, Pheretima decoct with water three times, and each 1 hour, collecting decoction filtered, filtrate is concentrated into the clear paste that relative density is 1.15-1.20, adds ethanol and makes and contain alcohol amount and reach 70%, stirs evenly, and leaves standstill 24 hours, filter, behind the recovery ethanol, be concentrated into the thick paste that relative density is 1.25-1.30;
Rhizoma Corydalis is with 70% alcohol reflux three times, and each 1 hour, filter, merging filtrate, decompression recycling ethanol is concentrated into the thick paste that relative density is 1.25-1.30;
The thick paste and the Rhizoma Corydalis thick paste that merge above-mentioned Herba Epimedii and Pheretima add Semen Strychni, fine powder of dragons blood, mixing, and drying under reduced pressure becomes dry extract, is ground into fine powder, and mixing is granulated, drying, sterilization incapsulates.
CNB2004100653911A 2004-11-28 2004-11-28 Chinese medicine for treating kidney vacuity lumbar pain and preparation method of its capsule Expired - Fee Related CN100335112C (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1171263A (en) * 1997-07-20 1998-01-28 迟经惠 Plaster for rheumatism
CN1175441A (en) * 1997-07-10 1998-03-11 迟经惠 Medicine for releasing wind-heat toxin in blood
CN1424024A (en) * 2001-10-23 2003-06-18 罗明新 External used paste for orthopedic diseases

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1175441A (en) * 1997-07-10 1998-03-11 迟经惠 Medicine for releasing wind-heat toxin in blood
CN1171263A (en) * 1997-07-20 1998-01-28 迟经惠 Plaster for rheumatism
CN1424024A (en) * 2001-10-23 2003-06-18 罗明新 External used paste for orthopedic diseases

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