CN101953972A - Chinese medicinal compound prescription having effect of resisting osteoporosis and preparation method and application thereof - Google Patents
Chinese medicinal compound prescription having effect of resisting osteoporosis and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a Chinese medicinal compound prescription having an effect of resisting osteoporosis. The Chinese medicinal compound comprises the following components in part by weight: 12 to 25 parts of astragalus, 10 to 20 parts of rehmanniae vaporata, 10 to 18 parts of indian buead, 12 to 25 parts of Chinese yam rhizome, 10 to 35 parts of tuber fleece flower root, 12 to 25 parts of epimedium herb, 10 to 20 parts of common macrocarpium fruit, 12 to 25 parts of glossy privet fruit, 12 to 20 parts of yerbadetajo herba ecliptae, and 12 to 20 parts of lentil. The invention also discloses a preparation method and application of the Chinese medicinal compound prescription having the effect of resisting the osteoporosis. The Chinese medicinal compound prescription having the effect of resisting the osteoporosis comprises the raw materials which are selected according to a traditional Chinese medicine theory and the nosogenesis of the osteoporosis and are blended together, all the components have scientific and reasonable proportioning, and clinical observations and researches show that the Chinese medicinal compound prescription has the effects of strengthening the spleen and replenishing qi, and nourishing kidney and replenishing essence, has the function of preventing and treating the osteoporosis, and has no adverse reaction for long-term use.
Description
Technical field
The present invention relates to a kind of Chinese medicine compound, be specifically related to a kind of Chinese medicine compound and preparation method thereof and application with anti-osteoporosis function.
Background technology
(Osteoporosis is a kind of because of the bone amount is low, bone micro-structure destroys OP) to osteoporosis, causes the increase of bone fragility, easily generation fracture to be the general osteopathia of feature.It is with the disease of skeletal system that bone strength descends, risk of bone fracture increases to feature that calendar year 2001 NIH (NIH) proposes osteoporosis, two main aspects of bone strength reflection skeleton, i.e. bone mineral density and bone mass.Pain, deformation of spinal column and generation fragility fractures are the most typical clinical manifestations of osteoporosis.The patient can have aching pain in waist and back or malasia, and pain increased the weight of or limitation of activity when load increased, and stands up, sits up and walk and have any problem when serious.The osteoporosis severe patient can have height to shorten and be bow-backed.The cone compression fracture can cause chest deformity, and the abdominal part pressurized influences cardio-pulmonary function etc.After slight wound or the daily routines fragility fractures takes place, common site is breast, lumbar vertebra, hip, oar, ulna far-end and proximal humerus, fragility fractures took place after, the risk that fracture takes place once more obviously increases.But early stage normal the no tangible subjective symptoms of many patients with osteoporosis often takes place after X line or bone density are just found existing osteoporosis change when checking in fracture.Along with the aging of society, its sickness rate also increases year by year, and threatens more and more people's health, has caused that everybody extensively payes attention to, and osteoporosis prevention and treatment have become one of hot issue of Recent study.
Osteoporosis can be divided into constitutional and Secondary cases two big classes.Primary osteoporosis is divided into three kinds of postmenopausal osteoporosis (I type), senile osteoporosis (II type) and idiopathic osteoporosis diseases (comprising the teenager type) again.Postmenopausal osteoporosis generally occurred in behind the postmenopausal women in 5～10 years; Senile osteoporosis refers generally to the osteoporosis of generation after 70 years old; And idiopathic osteoporosis mainly occurs in teenager, and the cause of disease is still not clear.Secondary osteoporosis is owing to the metabolic osteopathy that the bone amount due to the reasons such as disease, medicine, organ transplantation reduces, bone micro-structure destroys, bone fragility increases and is easy to fracture.The cause of disease that causes secondary osteoporosis is a lot, sees with incretion metabolism disease, connective tissue disease, kidney disease, digestive tract disease and drug-induced person clinically more.
Osteoporosis is a health problem with clear and definite Pathophysiology, social mentality and economic consequences.The serious consequence of osteoporosis is that osteoporotic fracture (fragility fractures) takes place, and this is because bone strength descends, and can fracture in being subjected to minor trauma or daily routines.Osteoporotic fracture has caused heavy social economy's burden, and the disability rate and the mortality rate that have increased the old people greatly.Nineteen ninety-five causes 4.32 ten thousand patients to be admitted to hospital in the U.S., sees a doctor number of times 2,500,000 times nearly, and about 180,000 needs of patients home cares, 17,000,000,000 dollars of the annual costs of medical health system, and one-sided Hip Fracture spends 40,000 dollars.According to estimates, the year two thousand forty the Hip Fracture number and correlative charges will increase more than 3 times.Therefore primary disease increases the mankind's threat, and effectively treatment and prevention and health care have become great public health problem.
The medicine of western medicine OP can be divided into 3 classes at present: 1. anti-bone resorption medicine comprises estrogen, calcitonin, diphosphate preparation etc.; 2. promote osteoplastic medicine to be mainly fluoride, parathyroid hormone (PTH); 3. bone mineralising medicine is mainly calcium preparation, Vitamin D preparation.Wherein estrogen is applicable to after the menopause and the gonad function low patient of glucocorticoid due to using, but the possibility that causes systemic lupus erythematosus (sle), endometrial bleeding, breast carcinoma, cardiovascular accident is arranged.The side effect of diphosphate preparation: comprise gastrointestinal upset, dysphagia, esophageal regurgitation, esophagitis and gastric ulcer are arranged.The mandibular bone necrosis (especially behind the intravenous injection diphosphate) of minority report is arranged, and visual disorder etc.; Fluoride can be carried high bone mass, but bone fragility do not reduce, thereby still can not the prevention of osteoporosis fracture; Parathyroid hormone (PTH) is owing to intravenous administration and expensive expenses for medicine, and other side effect, does not promote the use of as yet.
Research according to modern Chinese medicine thinks that osteoporosis can belong to " rheumatism involving the bone " " bone withers " category for motherland's medical science.Understanding to primary disease is based on " kidney storing essence, main bone give birth to marrow ", and " element asks YIN YANG classification of natural phenomena a big opinion piece of writing " says " kidney producing bone marrow, then bone marrow biochemistry is active for the kidney essense abundance ", thinks the kidney essense abundance, and medullization is given birth to active, and the bone ilium is strong effectively; Deficiency of kidney-essence, then bone marrow loses and supports, and the bone ilium is crisp, even fracture; So suffer from a deficiency of the kidney is the main cause that osteoporosis takes place.
And spleen governing limbs is the foundation of acquired constitution, and source of generating QI and blood not only has female quiet moral, also has the energy that the universe is built, and strong fortune is mediated, about the traffic, and the transporting the nutrient-fluids to various parts of the body." element ask vital QI of the body connecting with natural QI opinion " said: " carefully coordinating five kinds of flavor in foodstuff hereat, solid skeleton and pliable tendons then, QI-blood circulating regularly, one's pores will be fine in texture, sound skeleton and pure essence QI then in this way, careful road such as method, long have a longevity." illustrate that the growth of bone and spleen and stomach function are in close relations." Ling Shu Miraculous Pivot or Divine Axis Benshen " points out: " deficiency of spleen-QI is flaccidity of the limbs then ".Spleen master bones of the body collectively is changed anger, blood, essence, Tianjin Yi Ru nourishing bone bone.If spleen and stomach function is feeble and exhausted, disturbance in functioning of QI, dysfunction of acting as a pivot, blood are not changed essence, and congenital kidney loses in nourishing, the kidney essense scarcity, the bone ilium loses supports, thereby quickens osteoporotic generation.The achievement of clinical research in recent years, zoopery and relevant pharmacological research has tentatively disclosed the curative effect mechanism of Chinese medicine osteoporosis.
The present invention carries out scientific composition according to the pathogenesis of Chinese medicine principle and osteoporosis, develops the Chinese medicine compound that has the Chinese medicine characteristic and have good anti-osteoporosis function.
Summary of the invention
Technical problem to be solved by this invention is to be on the increase at patient's number of present osteoporosis, person due to after wherein glucocorticoid is used, also account for significant proportion, and the raising that patient required quality of life, the medicine present situation that clinical shortage is authentic and valid, untoward reaction is low simultaneously, the advantage of performance Chinese medicine aspect the treatment osteoporosis provides a kind of Chinese medicine compound with anti-osteoporosis function under Chinese medical theory instructs.
The technical problem that the present invention also will solve provides the preparation method of above-mentioned Chinese medicine compound.
The technical problem that the present invention also will solve provides the application of above-mentioned Chinese medicine compound in the preparation osteosporosis resistant medicament.
For solving the problems of the technologies described above, the technical solution used in the present invention is as follows:
A kind of Chinese medicine compound with anti-osteoporosis function, it comprises the component of following parts by weight: 12～25 parts of the Radixs Astragali, 10～20 parts in Radix Rehmanniae Preparata, 10～18 parts in Poria, 12～25 parts of Rhizoma dioscoreaes, 10～35 parts of Radix Polygoni Multiflori, 12～25 parts of Herba Epimedii, 10～20 parts of Fructus Corni, 12～25 parts of Fructus Ligustri Lucidi, 12～20 parts of Herba Ecliptaes, 12～20 parts in Seem Lablab Album.
Above-mentioned Chinese medicine compound with anti-osteoporosis function, the component that preferably comprises following parts by weight: 15～20 parts of the Radixs Astragali, 12～15 parts in Radix Rehmanniae Preparata, 12～15 parts in Poria, 15～20 parts of Rhizoma dioscoreaes, 15～30 parts of Radix Polygoni Multiflori, 15～20 parts of Herba Epimedii, 10～15 parts of Fructus Corni, 15～20 parts of Fructus Ligustri Lucidi, 15～20 parts of Herba Ecliptaes, 15～20 parts in Seem Lablab Album.
Above-mentioned preparation method with Chinese medicine compound of anti-osteoporosis function, the Radix Astragali, Radix Rehmanniae Preparata, Poria, Rhizoma dioscoreae, Radix Polygoni Multiflori, Herba Epimedii, Fructus Corni, Fructus Ligustri Lucidi, Herba Ecliptae, the Seem Lablab Album of formula ratio are mixed, decocting with 8～10 times of weight of total medical material weight boils 2～3 times, each 30～60 minutes, merge the water extract, the water extract obtains extract at 60 ℃ of concentrating under reduced pressure, promptly.
The present invention is according to osteoporotic pathogenesis, choose raw material according to Chinese medical theory, Chinese medicine compound of the present invention has the effect of invigorating the spleen and benefiting QI, nourishing kidney replenishing essence, and selecting the Radix Astragali, Radix Rehmanniae Preparata, Poria, Rhizoma dioscoreae, Radix Polygoni Multiflori, Herba Epimedii, Fructus Corni, Fructus Ligustri Lucidi, Herba Ecliptae, Seem Lablab Album for use is the Chinese medicine compound that feedstock production obtains having anti-osteoporosis function.
The foundation of the selected raw material of the present invention is: the Radix Astragali and Radix Rehmanniae Preparata two medicines are combined into monarch drug, the key medicine of Radix Astragali air making-up and spleen enlivening in the component; The Radix Rehmanniae Preparata nourishing YIN and supplementing blood, beneficial essence is filled out marrow, is the key medicine of tonifying kidney-yin, and two medicines are the good merchantable brand of tonifying speen and tonifying kidney.Rhizoma Dioscoreae has the merit of invigorating spleen and kidney concurrently, both mended also help the day after tomorrow to supplement nutrition congenital; The Poria sweet in the mouth is apt to into spleen channel, and the spleen invigorating invigorating middle warmer can strengthen the merit of Radix Astragali QI invigorating; The bitter the kidney invigorating of the Radix Polygoni Multiflori, the temperature compensation liver puckeryly can be restrained vital essence, thus the liver benefiting that can nourish blood, controlling nocturnal emission with astringent drugs kidney tonifying, strengthening the tendons and bones; The sweet suffering of Herba Epimedii is warm in nature, and benefit is smart, and mend among the marrow can warming and recuperating the kidney-YANG, with the product of all nourishing kidney yins 5 effects that " treating YIN within YANG " arranged mutually, is ministerial drug altogether.Fructus Ligustri Lucidi, Herba Ecliptae nourishing the liver and kidney, Compendium of Material Medica is said: " reinforcing YIN-essence, strong waist knee joint ", and the Fructus Corni liver and kidney tonifying can be beneficial smart, again can be supporing yang, be the key medicine of flat nourishing YIN sun, and the three is adjuvant drug altogether.The Semen Lablab Album QI invigorating is with spleen invigorating, property of medicine gentleness, and tonify without causing stagnation, coordinating the actions of various ingredients in a prescription is messenger drug.
There is above Chinese medicine to rest on a scientific basis and chooses raw material and scientific matching raw material, can coordinate mutually between each component, mutually promote, play the effect of Synergistic, effect with good invigorating the spleen and benefiting QI, nourishing kidney replenishing essence, can obviously alleviate soreness of the waist and knees, back pain, abdominal distension and anorexia, symptoms such as spiritlessness and weakness, and have the high bone mass of carrying, promote osteoplastic effect.
The application of Chinese medicine compound in the preparation osteosporosis resistant medicament with anti-osteoporosis function of the present invention.
Chinese medicine compound with anti-osteoporosis function of the present invention is taken application in the medicine for treating osteoporosis of glucocorticoid secondary for a long time in the anti-systemic lupus erythematosus (sle) of preparation.
Wherein, described medicine comprises that the Chinese medicine compound that will have anti-osteoporosis function combines the medicine of the various dosage forms made from pharmaceutically acceptable carrier, and described dosage form is tablet, capsule, granule or injection.
Chinese medicine compound with anti-osteoporosis function of the present invention the extract of Chinese medicine compound raw material and carrier lactose or corn starch, is granulated when making tablet, and drying adds magnesium stearate lubricant when needing, mix homogeneously, and tabletting is made tablet then.
Chinese medicine compound with anti-osteoporosis function of the present invention when making capsule, the extract of Chinese medicine compound raw material and carrier lactose or corn starch mix homogeneously, granulate, the encapsulated then capsule of making.
Chinese medicine compound with anti-osteoporosis function of the present invention when making granule, the extract of Chinese medicine compound raw material and diluent lactose or corn starch mix homogeneously, granulate, drying is made granule.
Chinese medicine compound with anti-osteoporosis function of the present invention is when making injection, and the extract of getting the Chinese medicine compound raw material adds physiological saline solution, is heated to cold preservation after 30 minutes more than 950 ℃, makes impurity be the precipitation of colloid dispersity and removes.Add then and use 0.1～1.0% pin activated carbon through 150 ℃ of dry activation 3～4h, stir, 80 ℃ of heating 30 minutes, cold slightly after-filtration, regulate pH value, with filter paper just filter the back with sintered glass funnel (method commonly used) or other filter (non-common have relatively high expectations as the microporous filter membrane filter, the microporous filter membrane below the 0.22 μ m can be used for aseptic filtration.) be filtered to clear and brightly, fill was made injection with boiling sterilization in 30 minutes 100～115 ℃ of sterilizations.
Beneficial effect: the Chinese medicine compound with anti-osteoporosis function provided by the invention is compared with prior art and is had the following advantages:
1, the Chinese medicine compound with osteoporosis of the present invention, choose the material combination prescription according to Chinese medical theory and osteoporotic pathogenesis, each set of dispense is than scientific and reasonable, studies show that by clinical observation, Chinese medicine compound of the present invention has the effect of invigorating the spleen and benefiting QI, nourishing kidney replenishing essence, clearing heat, purging intense-heat, effect with prevention and treatment osteoporosis, and life-time service has no adverse reaction.
2, the preparation method of Chinese medicine compound of the present invention, technological design is reasonable, and is not with an organic solvent, pollution-free in the preparation process, can realize industrialized great production.
3, the Chinese medicine compound with anti-osteoporosis function of the present invention can become the medicine of various dosage forms easily with pharmaceutically acceptable preparing carriers, the convenient use.
The specific embodiment
According to following embodiment, the present invention may be better understood.Yet, those skilled in the art will readily understand that embodiment is described only to be used to illustrate the present invention, and should also can not limit the present invention described in detail in claims.
Embodiment 1:
A kind of Chinese medicine compound with anti-osteoporosis function, it comprises the component of following parts by weight:
12 parts of the Radixs Astragali, 12 parts in Radix Rehmanniae Preparata, 10 parts in Poria, 12 parts of Rhizoma dioscoreaes, 10 parts of Radix Polygoni Multiflori, 12 parts of Herba Epimedii, 10 parts of Fructus Corni, 12 parts of Fructus Ligustri Lucidi, 12 parts of Herba Ecliptaes, 12 parts in Seem Lablab Album.
Preparation method is as follows:
Ratio is chosen 12 parts of the Radixs Astragali by weight, 12 parts in Radix Rehmanniae Preparata, 10 parts in Poria, 12 parts of Rhizoma dioscoreaes, 10 parts of Radix Polygoni Multiflori, 12 parts of Herba Epimedii, 10 parts of Fructus Corni, 12 parts of Fructus Ligustri Lucidi, 12 parts of Herba Ecliptaes, 12 parts in Seem Lablab Album mixes, decocting with 10 times of weight of total medical material boils 3 times, each 30 minutes, merges the water extract, the water extract obtains the Chinese medicine compound extract at 60 ℃ of concentrating under reduced pressure, pulverizes, and crosses 60 mesh sieves, incapsulate, or get said extracted thing adding corn starch, the granulate tabletting is made tablet.
Embodiment 2:
A kind of Chinese medicine compound with anti-osteoporosis function, it comprises the component of following parts by weight:
25 parts of the Radixs Astragali, 20 parts in Radix Rehmanniae Preparata, 18 parts in Poria, 25 parts of Rhizoma dioscoreaes, 30 parts of Radix Polygoni Multiflori, 25 parts of Herba Epimedii, 20 parts of Fructus Corni, 25 parts of Fructus Ligustri Lucidi, 20 parts of Herba Ecliptaes, 20 parts in Seem Lablab Album.
Preparation method is as follows:
Ratio is chosen 25 parts of the Radixs Astragali by weight, 20 parts in Radix Rehmanniae Preparata, 18 parts in Poria, 25 parts of Rhizoma dioscoreaes, 30 parts of Radix Polygoni Multiflori, 25 parts of Herba Epimedii, 20 parts of Fructus Corni, 25 parts of Fructus Ligustri Lucidi, 20 parts of Herba Ecliptaes, 20 parts of mixing of Seem Lablab Album, decocting with 10 times of weight of total medical material boils 3 times, each 60 minutes, merges the water extract, the water extract obtains the Chinese medicine compound extract in 60 ℃ of concentrating under reduced pressure, add an amount of Icing Sugar and stabilizing agent, crosses 40 mesh sieves, granulate promptly gets granule, and packing promptly.
Embodiment 3:
A kind of Chinese medicine compound with anti-osteoporosis function, it comprises the component of following parts by weight:
15 parts of the Radixs Astragali, 12 parts in Radix Rehmanniae Preparata, 12 parts in Poria, 15 parts of Rhizoma dioscoreaes, 15 parts of Radix Polygoni Multiflori, 15 parts of Herba Epimedii, 10 parts of Fructus Corni, 15 parts of Fructus Ligustri Lucidi, 15 parts of Herba Ecliptaes, 15 parts in Seem Lablab Album.
Preparation method is as follows:
Ratio is chosen 15 parts of the Radixs Astragali by weight, 12 parts in Radix Rehmanniae Preparata, 12 parts in Poria, 15 parts of Rhizoma dioscoreaes, 15 parts of Radix Polygoni Multiflori, 15 parts of Herba Epimedii, 10 parts of Fructus Corni, 15 parts of Fructus Ligustri Lucidi, 15 parts of Herba Ecliptaes, 15 parts of mixing of Seem Lablab Album, decocting with 10 times of weight of total medical material boils 3 times, each 50 minutes, merge the water extract, the water extract obtains the Chinese medicine compound extract at 60 ℃ of concentrating under reduced pressure.
Embodiment 4:
A kind of Chinese medicine compound with anti-osteoporosis function, it comprises the component of following parts by weight:
20 parts of the Radixs Astragali, 15 parts in Radix Rehmanniae Preparata, 15 parts in Poria, 20 parts of Rhizoma dioscoreaes, 30 parts of Radix Polygoni Multiflori, 20 parts of Herba Epimedii, 15 parts of Fructus Corni, 20 parts of Fructus Ligustri Lucidi, 20 parts of Herba Ecliptaes, 20 parts in Seem Lablab Album.
Preparation method is as follows:
Ratio is chosen 20 parts of the Radixs Astragali by weight, 15 parts in Radix Rehmanniae Preparata, 15 parts in Poria, 20 parts of Rhizoma dioscoreaes, 30 parts of Radix Polygoni Multiflori, 20 parts of Herba Epimedii, 15 parts of Fructus Corni, 20 parts of Fructus Ligustri Lucidi, 20 parts of Herba Ecliptaes, 20 parts of mixing of Seem Lablab Album, decocting with 10 times of weight of total medical material boils 3 times, each 60 minutes, merge the water extract, the water extract obtains the Chinese medicine compound extract at 60 ℃ of concentrating under reduced pressure.
Embodiment 5: osteoporosis clinical observation research.
1, the object of observation:
1.1 diagnosing osteoporosis standard
1.1.1 Western medicine diagnose standard (the osteoporosis standard that meets WHO formulation in 1994)
The bone amount is normal: BMD deducts in 1 standard deviation in women of the same age (peak bone mass ± average); The bone amount reduces: BMD is between 1～2.4 standard deviation below the women of the same age (peak bone mass ± average); Following 2.5 more than the standard deviation of osteoporosis: BMD in women of the same age (peak bone mass ± average).
1.1.2 osteoporosis feelings standards of grading
The patient mainly is that skeleton pain reaches the influence degree to daily life to the evaluation of body function, adopts range estimation line staging to calculate, and is divided into 10 grades.The serious pain that 0 grade of no pain of expression, 10 grades of expressions can be imagined; 1～3 grade of expression mild pain does not influence daily routines; 4～6 grades of expression moderate pains influence normal activity, but still can stand; Serious pain is compared in 7～9 grades of expressions, carries out daily routines reluctantly, often needs to have a rest to alleviate; 10 grades of expression pain are serious, can't stand, and can not carry out daily routines.
Effective percentage (nimodipine method)=(integration before (integration before the treatment-treatment back integration)/treatment) * 100%
Clinical recovery: effective percentage 〉=95%
Produce effects: 70%≤effective percentage＜95%
Effectively: 30%≤effective percentage＜70%
Invalid: effective percentage＜30%
1.1.3 tcm syndrome diagnostic criteria (with reference to 2002 " new Chinese medicine clinical research guideline ")
The dialectical standard that meets SLE criteria for classification that American Rheumatism Association nineteen eighty-two formulates and the insufficiency of the spleen mistake fortune of the traditional Chinese medical science, deficiency of kidney-YIN card:
(1) primary symptom: dysphoria with feverish sensation in the chest palms and soles, insomnia night sweat, flushed face, face red spot, joint, skeleton pain are done when mouth is burst.
(2) inferior disease: edema over the face puffiness due to deficiency, abdominal distension and anorexia, spiritlessness and weakness, deficiency of QI with disinclination to talk.
(3) tongue arteries and veins: light red tongue HongShaoJin(SIC), thready and weak pulse or count accurately.
1.1.4 tcm clinical practice syndrome scalar quantization standard
Table 1
(continuous table 1)
Effective percentage (nimodipine method)=(integration before (integration before the treatment-treatment back integration)/treatment) * 100%
Clinical recovery: effective percentage 〉=95%
Produce effects: 70%≤effective percentage＜95%
Effectively: 30%≤effective percentage＜70%
Invalid: effective percentage＜30%
1.1.5 include the case standard in
1. meet above-mentioned diagnostic criteria;
2. at 18～65 years old age, bone densitometry meets the bone amount to be reduced or osteoporotic patient;
3. can be by the curer course of treatment;
4. differential diagnosis in tcm belongs to insufficiency of the spleen mistake fortune, deficiency of kidney-YIN card person.
1.1.6 exclusion standard
1. taking estrogen, androgen, anticoagulant etc. influences the medicine of bone metabolism;
2. merge the other diseases that influences bone metabolism, as diabetes, renal function injury, hyperthyroidism etc.;
3. the anemia of pregnant woman or just preparing gestation women and women breast-feeding their children;
4. not according to therapeutic scheme medication or therapy discontinued person midway.
1.1.7 reject the case standard
1. because of the necessary drug withdrawal person of serious adverse reaction;
2. patient can not adhere to clinical trial, and drug withdrawal or add with other treatment osteoporotic medicine person voluntarily;
3. can not finish clinical trial person because of other reasons.
Choose the sufferers of osteoporosis face of the SLE secondary in Jiangsu TCM Hospital's rheumatism immunity section's outpatient service and ward with reference to above standard, select to meet patient's 30 examples of the standard of including in altogether, 30 routine patients are divided into Chinese medicine compound of the present invention (embodiment 3) fiting chemical therapies (hormone+immunosuppressant) treatment group (being called for short the treatment group) 15 examples and single matched group 15 examples with chemotherapy (hormone+immunosuppressant) treatment, are the women.
The treatment group: prednisone and cyclophosphamide group, hormone add Chinese medicine compound of the present invention (embodiment 3), and prednisone is by per kilogram of body weight 0.5-1mg/d, cyclophosphamide gives by per 2 all 0.4g intravenous drips, Chinese traditional medicine water extract of the present invention, day potion divides take 1 hour after meal twice of morning and afternoon;
Matched group: only with Western medicine prednisone and cyclophosphamide treatment, prednisone is by per kilogram of body weight 0.5-1mg/d, and cyclophosphamide gives by per 2 all 0.4g intravenous drips.
Two groups of patient's age, the courses of disease relatively, there was no significant difference (P＞0.05) has comparability (see Table 2, table 3).
Table 2 a liang group patient age distributes and the mean age
The matched group patient mean age is 34.67 ± 25.88 years old, minimum 18 years old, and maximum 53 years old; Treatment group patient's mean age is 36.56 ± 23.35 years old, minimum 20 years old, and maximum 61 years old.Two groups of patient ages distribute and the mean age comparison, and the former checks with x2, and the latter checks with t, and difference does not have significance meaning (P＞0.05), has comparability.
Table 3 liang group patient's course of disease situation and average course of disease
Matched group patient average course of disease is 67.67 ± 52.33 months, and the shortest is 25 months, and the longest is 120 months; Treatment group patient average course of disease is 69.46 ± 46.27 months, and the shortest is 30 months, and the longest is 120 months.Two groups of patient's course of disease distribution situations and average course of disease relatively, the former checks with x2, the latter checks with t, difference does not have significance meaning (P＞0.05), has comparability.
Compare before and after the treatment of table 4 patient tcm clinical practice primary symptom
(continuous table 4)
Annotate: compare #P＜0.05, ##P＜0.01 before and after the treatment; Compare △ P＜0.05, △ △ P＜0.01 with matched group.
Table 5 a liang group patient estimates integration (branch) relatively
Annotate: compare #P＜0.05, ##P＜0.01 before and after the treatment; Compare △ P＜0.05, △ △ P＜0.01 with matched group.
From table 4 and table 5 as seen: before and after the treatment of treatment group significant difference (P＜0.01) is being arranged all aspect the tcm clinical practice primary symptom, and with treatment of control group after more variant (P＜0.05), point out the tonifying speen and tonifying kidney granular agent can obviously improve SLE patient's clinical symptoms.
2. Therapeutic Method
2.1 treatment group: prednisone and cyclophosphamide hormone add Chinese medicine compound of the present invention (embodiment 3), prednisone is by per kilogram of body weight 0.5-1mg/d, and cyclophosphamide gives by per 2 all 0.4g intravenous drips, Chinese medicine compound water extract of the present invention, day potion divides take 1 hour after meal twice of morning and afternoon;
Matched group: only with Western medicine prednisone and cyclophosphamide treatment, prednisone is by per kilogram of body weight 0.5-1mg/d, and cyclophosphamide gives by per 2 all 0.4g intravenous drips.
2.2 treat the course of treatment
Two groups identical, was 1 with 3 months and treats the course of treatment, and two groups are carried out therapeutic evaluation respectively before and after treatment.
2.3 observation index
2.3.1 blood calcium, serium inorganic phosphorus, blood alkaline phosphatase enzyme level
2.3.2 parathyroid hormone level
2.3.3 bone densitometry
2.3.4 tcm clinical practice therapeutic effect of syndrome criterion
(1) clinical recovery: tcm clinical practice symptom, sign disappear or basic the disappearance, and the syndrome integration reduces 〉=95%.
(2) produce effects: tcm clinical practice symptom, sign are clearly better, and the syndrome integration reduces 〉=75%.
(3) effective: tcm clinical practice symptom, sign all take a favorable turn, and the syndrome integration reduces 〉=30%.
(4) invalid: tcm clinical practice symptom, sign all have or not and are clearly better, and the syndrome integration reduces less than 30%.
Annotate: computing formula (nimodipine method): curative effect rate=(value before and after score value before the treatment-treatment)/(score value before the treatment) * 100%.
2.3.5 leading indicator efficacy determination
To main curative effect observation index, comprise that symptom, sign and laboratory detect index etc. and carry out efficacy evaluation according to the clinical observation purpose.
2.4 statistical procedures method
Clinical symptoms, sign and laboratory observation index before and after the statistics treatment adopt the analysis of SPSS11.5 software kit, measurement data with mean add and subtract standard deviation (± S), two batch total amount data relatively adopt the t check, enumeration data adopts X
2Check, ranked data are analyzed with Ridit, test level a=0.05, two-sided test.
3, therapeutic outcome
3.1 treatment group and matched group blood alkaline phosphatase enzyme level are relatively more as shown in table 6:
Table 6 liang group patient's ALP level (IU/L) comparison (X ± S)
Annotate: compare #P＜0.05, ##P＜0.01 before and after the treatment; Compare △ P＜0.05, △ △ P＜0.01 with matched group.
3.2 treatment group and matched group calcium level are relatively more as shown in table 7:
Table 7 liang group patient's calcium level (mmol/L) comparison (X ± S)
Annotate: compare #P＜0.05, ##P＜0.01 before and after the treatment; Compare △ P＜0.05, △ △ P＜0.01 with matched group.
3.3 treatment group and matched group serium inorganic phosphorus level are relatively more as shown in table 8:
Table 8 liang group patient's serium inorganic phosphorus level (mmol/L) comparison (X ± S)
Annotate: compare #P＜0.05, ##P＜0.01 before and after the treatment; Compare △ P＜0.05, △ △ P＜0.01 with matched group.
3.4 treatment group and matched group parathyroid hormone level are relatively more as shown in table 9:
Table 9 liang group patient's parathyroid hormone level (ng/ml) comparison (X ± S)
Annotate: compare #P＜0.05, ##P＜0.01 before and after the treatment; Compare △ P＜0.05, △ △ P＜0.01 with matched group.
Table 10 liang group patient's bone density (g/mm) comparison (X ± S)
Annotate: compare #P＜0.05, ##P＜0.01 before and after the treatment; Compare △ P＜0.05, △ △ P＜0.01 with matched group.
Before and after quantitatively treating, table 11:ESR, RF, serum G, ANA compare
Annotate: compare #P＜0.05, ##P＜0.01 before and after the treatment; Compare △ P＜0.05, △ △ P＜0.01 with matched group.
Table 12: compare before and after the immunoglobulin therapy
From table 11,12 as seen: two groups have significant difference (P＜0.05) before and after ESR, CRP, serum GLB, immunoglobulin, ANA quantitatively treat, but because of the patient uses hormone and immunosuppressant simultaneously, so the improvement of these indexs can not only consider it is the curative effect of tonifying speen and tonifying kidney side's water extract, need objective consideration the therapeutical effect of hormone and immunosuppressant to be arranged interior.
Table 13: compare before and after the routine blood test treatment
Table 14: compare before and after the hepatic and renal function treatment
From table 13,14 as seen: safety indexes such as hepatic and renal function, two groups of there are no significant differences before and after treatment
(P＞0.05) points out prescription of the present invention that good safety is arranged.
As seen above-mentioned, Chinese medicine compound life-time service provided by the invention, untoward reaction is few, can be developed into the new drug into a new generation's treatment osteoporosis.
Claims (6)
1. Chinese medicine compound with anti-osteoporosis function, it is characterized in that it comprises the component of following parts by weight: 12～25 parts of the Radixs Astragali, 10～20 parts in Radix Rehmanniae Preparata, 10～18 parts in Poria, 12～25 parts of Rhizoma dioscoreaes, 10～35 parts of Radix Polygoni Multiflori, 12～25 parts of Herba Epimedii, 10～20 parts of Fructus Corni, 12～25 parts of Fructus Ligustri Lucidi, 12～20 parts of Herba Ecliptaes, 12～20 parts in Seem Lablab Album.
2. the Chinese medicine compound with anti-osteoporosis function according to claim 1, it is characterized in that it comprises the component of following parts by weight: 15～20 parts of the Radixs Astragali, 12～15 parts in Radix Rehmanniae Preparata, 12～15 parts in Poria, 15～20 parts of Rhizoma dioscoreaes, 15～30 parts of Radix Polygoni Multiflori, 15～20 parts of Herba Epimedii, 10～15 parts of Fructus Corni, 15～20 parts of Fructus Ligustri Lucidi, 15～20 parts of Herba Ecliptaes, 15～20 parts in Seem Lablab Album.
3. the described preparation method of claim 1 with Chinese medicine compound of anti-osteoporosis function, it is characterized in that the Radix Astragali, Radix Rehmanniae Preparata, Poria, Rhizoma dioscoreae, Radix Polygoni Multiflori, Herba Epimedii, Fructus Corni, Fructus Ligustri Lucidi, Herba Ecliptae, the Seem Lablab Album of formula ratio are mixed, decocting with 8～10 times of weight of total medical material weight boils 2～3 times, each 30～60 minutes, merge the water extract, the water extract obtains extract at 60 ℃ of concentrating under reduced pressure, promptly gets the Chinese medicine compound extract.
4. the described application of Chinese medicine compound in the preparation osteosporosis resistant medicament of claim 1 with anti-osteoporosis function.
5. the described Chinese medicine compound with anti-osteoporosis function of claim 4 is taken application in the medicine for treating osteoporosis of glucocorticoid secondary for a long time in the anti-systemic lupus erythematosus (sle) of preparation.
6. application according to claim 4, it is characterized in that described medicine comprises that the Chinese medicine compound that will have anti-osteoporosis function combines the medicine of the various dosage forms made from pharmaceutically acceptable carrier, described dosage form is tablet, capsule, granule or injection.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104826003A (en) * | 2015-04-23 | 2015-08-12 | 孙刚 | Traditional Chinese medicine granules for treating osteoporosis and preparation method thereof |
| CN105456621A (en) * | 2015-11-05 | 2016-04-06 | 郭珈宜 | Traditional Chinese medicated diet for preventing osteoporosis and preparation method thereof |
| CN107006681A (en) * | 2016-01-28 | 2017-08-04 | 柳泓善 | Animal feed composition containing Chinese medicinal material extract |
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| Title |
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| 《中华中医药学刊》 20090331 李建英等 中医药改善慢性肾衰竭营养不良研究近况 633-636 1-6 第27卷, 第3期 2 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104826003A (en) * | 2015-04-23 | 2015-08-12 | 孙刚 | Traditional Chinese medicine granules for treating osteoporosis and preparation method thereof |
| CN105456621A (en) * | 2015-11-05 | 2016-04-06 | 郭珈宜 | Traditional Chinese medicated diet for preventing osteoporosis and preparation method thereof |
| CN107006681A (en) * | 2016-01-28 | 2017-08-04 | 柳泓善 | Animal feed composition containing Chinese medicinal material extract |
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