CN105343475A - Method for preparing traditional Chinese medicine preparation for treating female postmenopausal osteoporosis - Google Patents
Method for preparing traditional Chinese medicine preparation for treating female postmenopausal osteoporosis Download PDFInfo
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Abstract
The invention discloses a method for preparing a traditional Chinese medicine preparation for treating female postmenopausal osteoporosis and belongs to the technical field of traditional Chinese medicines. The method for preparing the traditional Chinese medicine preparation comprises the steps that ginkgo leaves, rhizoma drynariae, pyrite, salvia miltiorrhiza, radix rehmanniae praeparata, hawthorns, fructus ligustri lucidi, rhizoma anemarrhenae, belvedere fruits, roots of straight ladybell and licorice are cleaned, dried, evenly mixed and smashed into coarse powder, water is added to perform decoction, filtration and concentration, ethanol is added into filter residues to perform extraction, distillation and concentration, and after the extracted liquids are mixed, drying, smashing, grinding and screening are performed to obtain the Chinese native medicine preparation. The traditional Chinese medicine preparation prepared by means of the method adopts the pure natural traditional Chinese medicines, has small toxic and side effects, is simple in preparation process, has the effects of strengthening tendons and bones, activating blood circulation, stimulating meridians, nourishing yin, supplementing blood and tonifying spleen and qi and can effectively treat the female postmenopausal osteoporosis.
Description
Technical field
The invention belongs to technical field of Chinese medicines, particularly relate to a kind of method preparing the Chinese medicine preparation for the treatment of female postmenopausal osteoporosis.
Background technology
Postmenopausal osteoporosis, belong to primary osteoporosis I type, it is multifactor property disease, heredity, life style, nutrition etc. are all relevant with morbidity, as osteoporosis family history, calcium Deficiency of Intake, lack physical exertion, a large amount of smoking and drink, early menopause or menopause move ahead Bilateral oophorectomy patient more susceptible disease.This disease mainly occurs in postmenopausal women's (50-70 year), because estrogen deficiency causes bone amount to reduce and bone structure change, the increase of bone fragility is made to be easy to fracture, and by fracture cause pain, textured bone, there is complication, and even the problems such as death, seriously affect the healthy of old people and quality of life, even shorten the life-span, increase country and family's financial resources and manpower burden.
Traditional Chinese medical theory is thought " kidney governing bones, store essential substances, essence raw marrow battalion bone ", " The spleen has the function to transport and transform nutrients for liver governing tendons, store blood, spleen governing muscles, extremity, system blood ".In view of the feature of menopausal woman " multiple deficiency and stasis ", paid attention at clinical middle use strengthening spleen, tonifying kidney, HuoXueTongLuo oral Liquor and widely used.
The medicine of postmenopausal osteoporosis is used for the treatment of disclosed in Chinese invention patent application 201510238699.X, be prepared from by following raw medicinal material: Semen Cuscutae, Semen Euryales, Massa Medicata Fermentata, Rhizoma Drynariae, Caulis Spatholobi, Caulis Sargentodoxae, Fructus Liquidambaris, Ramulus Sambuci Williamsii, Pericarpium Citri Reticulatae Viride, Radix Curcumae, but the Chinese medicine preparation effect of existing treatment menopause osteoid osteoporosis is not remarkable.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of Chinese medicine preparation for the treatment of female postmenopausal osteoporosis, it is made to give full play to the opsonic action of Chinese medicine, significant therapeutic effect is had to treatment postmenopausal osteoporosis, and be made into and facilitate easy-to-use finished product preparation, the rhythm of the modern life can be adapted to.
For realizing object of the present invention, technical solution of the present invention is as follows:
Chinese medicine preparation of the present invention is prepared from by the Chinese crude drug of following weight portion: Folium Ginkgo 10-25 part, Rhizoma Drynariae 9-15 part, Pyritum 6-12 part, Radix Salviae Miltiorrhizae 6-12 part, Radix Rehmanniae Preparata 6-12 part, Fructus Crataegi 3-10 part, Fructus Ligustri Lucidi 3-10 part, Rhizoma Anemarrhenae 3-10 part, Fructus Kochiae 3-8 part, Radix Adenophorae (Radix Glehniae) 3-8 part and Radix Glycyrrhizae 1-12 part.
Preferably, described Chinese medicine preparation is prepared from by the Chinese crude drug of following parts by weight: Folium Ginkgo 10 parts, Rhizoma Drynariae 9 parts, Pyritum 6 parts, Radix Salviae Miltiorrhizae 6 parts, Radix Rehmanniae Preparata 6 parts, Fructus Crataegi 3 parts, Fructus Ligustri Lucidi 3 parts, the Rhizoma Anemarrhenae 3 parts, the Fructus Kochiae 3 parts, Radix Adenophorae (Radix Glehniae) 3 parts and 1 part, Radix Glycyrrhizae.
Preferably, described Chinese medicine preparation is prepared from by the Chinese crude drug of following parts by weight: Folium Ginkgo 18 parts, Rhizoma Drynariae 12 parts, Pyritum 9 parts, Radix Salviae Miltiorrhizae 9 parts, Radix Rehmanniae Preparata 9 parts, Fructus Crataegi 8 parts, Fructus Ligustri Lucidi 8 parts, the Rhizoma Anemarrhenae 8 parts, the Fructus Kochiae 6 parts, Radix Adenophorae (Radix Glehniae) 6 parts and 6 parts, Radix Glycyrrhizae.
Preferably, described Chinese medicine preparation is prepared from by the Chinese crude drug of following parts by weight: Folium Ginkgo 16 parts, Rhizoma Drynariae 14 parts, Pyritum 10 parts, Radix Salviae Miltiorrhizae 10 parts, Radix Rehmanniae Preparata 10 parts, Fructus Crataegi 7 parts, Fructus Ligustri Lucidi 7 parts, the Rhizoma Anemarrhenae 7 parts, the Fructus Kochiae 5 parts, Radix Adenophorae (Radix Glehniae) 5 parts and 7 parts, Radix Glycyrrhizae.
Preferably, described Chinese medicine preparation is prepared from by the Chinese crude drug of following parts by weight: Folium Ginkgo 25 parts, Rhizoma Drynariae 15 parts, Pyritum 12 parts, Radix Salviae Miltiorrhizae 12 parts, Radix Rehmanniae Preparata 12 parts, Fructus Crataegi 10 parts, Fructus Ligustri Lucidi 10 parts, the Rhizoma Anemarrhenae 10 parts, the Fructus Kochiae 8 parts, Radix Adenophorae (Radix Glehniae) 8 parts and 12 parts, Radix Glycyrrhizae.
Preferably, described Chinese medicine preparation is tablet, pill, powder or capsule.
The present invention discloses a kind of method preparing the Chinese medicine preparation for the treatment of female postmenopausal osteoporosis, comprises the following steps:
S1: take Folium Ginkgo, Rhizoma Drynariae, Pyritum, Radix Salviae Miltiorrhizae, Radix Rehmanniae Preparata, Fructus Crataegi, Fructus Ligustri Lucidi, the Rhizoma Anemarrhenae, the Fructus Kochiae, Radix Adenophorae (Radix Glehniae) and Radix Glycyrrhizae, decontamination, cleans, and dries, mixing is ground into coarse powder, add the purified water of described coarse powder total amount 8-12 times amount, decoct 1-3 time, each 1-3 hour, filter, merging filtrate also retains filtering residue, and when being condensed into 55 DEG C-60 DEG C, relative density is the water extracting liquid of 1.15-1.25, for subsequent use;
S2: the ethanol adding described filtering residue total amount 3-8 times amount 70-85% toward above-mentioned filtering residue, reflux, extract, 1-3 time, each 3-5 hour, merge alcohol extract, distilling under reduced pressure, removing ethanol, filtrate is concentrated into the alcohol extraction concentrated solution that relative density under 55 DEG C of-60 DEG C of environment is 1.15-1.25, for subsequent use;
S3: merge described water extracting liquid and described alcohol extraction concentrated solution, drying under reduced pressure, pulverizes grinding, crosses 100-120 mesh sieve, obtains Chinese medicine preparation of the present invention.
The present invention also asks to protect the purposes of above-mentioned Chinese medicine preparation in treatment female postmenopausal osteoporosis.
Source, the nature and flavor of Chinese prescription of the present invention Chinese crude drug used, return through and effect:
Folium Ginkgo: this product is the dried leaves of Ginkgoaceae plant Ginkgo biloba; Property is put down; Sweet in the mouth, hardship, puckery; GUIXIN, lung meridian; Blood circulation promoting and blood stasis dispelling, removing obstruction in the collateral to relieve pain, astringes the lung and relievings asthma, and changes turbid blood fat reducing.
Rhizoma Drynariae: this product is the dry rhizome of Plants of Polypodiaceae Mongolian oak Herba pteridii latiusculi; Bitter in the mouth, warm in nature; Return kidney, Liver Channel; The kidney invigorating bone strengthening, continues and hinders pain relieving.
Pyritum: this product is sulfide-based mineral yellow iron mine race pyrite; Acrid in the mouth, property is put down; Return Liver Channel; Dissipating blood stasis, synthetism, pain relieving.
Radix Salviae Miltiorrhizae: this product is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae; Bitter in the mouth, cold nature; GUIXIN, Liver Channel; Stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness.
Radix Rehmanniae Preparata: this product is the rhizome of scrophulariaceae rehmannia glutinosa plant or bosom celebrating Radix Rehmanniae; Sweet in the mouth, slightly warm in nature; Return liver, kidney channel; Nourishing YIN and supplementing blood, beneficial essence fills out marrow.
Fructus Crataegi: this product is the dry mature fruit of rosaceous plant Fructus Pyri Pashiae or Fructus Crataegi; Nature and flavor are sour, sweet, tepor; Return spleen, stomach, Liver Channel; Promoting digestion and invigorating the stomach, circulation of qi promoting dissipating blood stasis.
Fructus Ligustri Lucidi: this product is the dry mature fruit of Oleaceae plants Fructus Ligustri Lucidi; Sweet in the mouth, hardship, cool in nature; Return liver, kidney channel; Nourishing the liver and kidney, improving eyesight black hair.
The Rhizoma Anemarrhenae: this product is the dry rhizome of the liliaceous plant Rhizoma Anemarrhenae; Bitter in the mouth, sweet, cold in nature; Return lung, stomach, kidney channel; Clearing away heat-fire, promotes the production of body fluid and moisturizes.
The Fructus Kochiae: this product is the dry mature fruit of chenopod Fructus Kochiae; Acrid in the mouth, hardship, cold in nature; Return kidney, urinary bladder channel; Clearing away heat-damp and promoting diuresis, dispelling wind for relieving itching.
Radix Adenophorae (Radix Glehniae): this product is campanulaceae Lady bell plant four leaf Radix Adenophorae (Radix Glehniae), Folium Pruni Radix Adenophorae (Radix Glehniae) or its congener dry root; Nature and flavor are sweet, cool; Clearing away heat and nourishing YIN, nourishing the lung to arrest cough.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L.; Sweet in the mouth, property is put down; GUIXIN, lung, spleen, stomach warp; Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
The compatibility analysis of Chinese prescription of the present invention:
Chinese prescription of the present invention to the dialectical cognition of menopause, osteoporosis, follows the compatibility theory of Chinese medicine according to the traditional Chinese medical science, facilitating the easy-to-use and preparation of stable curative effect, enhancing the use amount of medical material to make.This prescription is with Folium Ginkgo and Rhizoma Drynariae for monarch drug, liver and kidney tonifying, bone and muscle strengthening, Chong and Ren Meridians regulating, continuously hinders pain relieving; With Pyritum, Radix Salviae Miltiorrhizae, Radix Rehmanniae Preparata for ministerial drug, eliminating stasis to stop pain, nourishing YIN and supplementing blood, promoting blood circulation to restore menstrual flow, beneficial essence fills out marrow; With Fructus Crataegi, Fructus Ligustri Lucidi, the Rhizoma Anemarrhenae, the Fructus Kochiae and Radix Adenophorae (Radix Glehniae) for adjuvant drug, soothing the liver dispelling the stagnated QI, removing food stagnancyization is stagnant, clearing away heat-damp and promoting diuresis, and nourishing the liver and kidney promotes the production of body fluid and moisturizes, clearing away heat and nourishing YIN; With Radix Glycyrrhizae for making medicine, heat-clearing and toxic substances removing, invigorating the spleen and replenishing QI, the coordinating the actions of various ingredients in a prescription property of medicine, all medicines coordinate, and complement each other, synergism, plays bone and muscle strengthening altogether, promoting blood circulation to restore menstrual flow, nourishing YIN and supplementing blood, the effects such as invigorating the spleen and replenishing QI, has very significant curative effect to female postmenopausal osteoporosis.
Compared with prior art, Chinese medicine preparation of the present invention has good effect, treating both the principal and secondary aspects of a disease, stresses treatment advantages such as nursing one's health, toxic and side effects is little, and, Chinese medicine preparation of the present invention can also make universality strong, facilitate easy-to-use finished product preparation, overcome the shortcomings such as Chinese medicine compound preparation is not portablely taken, individual variation is large, its preparation technology is simple and easy to do, preparation efficacy stability, be easy to apply.
Detailed description of the invention
Below will the present invention is described further by specific embodiment, it will be understood by those skilled in the art that the present invention also can make other similar changes and obtains similar result and do not depart from content of the present invention and scope except following examples.
embodiment one
Described Chinese medicine preparation is prepared from by the Chinese crude drug of following parts by weight: Folium Ginkgo 10 parts, Rhizoma Drynariae 9 parts, Pyritum 6 parts, Radix Salviae Miltiorrhizae 6 parts, Radix Rehmanniae Preparata 6 parts, Fructus Crataegi 3 parts, Fructus Ligustri Lucidi 3 parts, the Rhizoma Anemarrhenae 3 parts, the Fructus Kochiae 3 parts, Radix Adenophorae (Radix Glehniae) 3 parts and 1 part, Radix Glycyrrhizae.
Preparation method is as follows:
S1: take Folium Ginkgo, Rhizoma Drynariae, Pyritum, Radix Salviae Miltiorrhizae, Radix Rehmanniae Preparata, Fructus Crataegi, Fructus Ligustri Lucidi, the Rhizoma Anemarrhenae, the Fructus Kochiae, Radix Adenophorae (Radix Glehniae) and Radix Glycyrrhizae, decontamination, cleans, and dries, mixing is ground into coarse powder, add the purified water of described coarse powder total amount 8 times amount, decoct 1 time, each 1 hour, filter, merging filtrate also retains filtering residue, and when being condensed into 55 DEG C, relative density is the water extracting liquid of 1.15, for subsequent use;
S2: add the ethanol of described filtering residue total amount 3 times amount 70%, reflux, extract, 1 time toward above-mentioned filtering residue, each 3 hours, merges alcohol extract, distilling under reduced pressure, removing ethanol, and filtrate is concentrated into the alcohol extraction concentrated solution that relative density under 55 DEG C of environment is 1.15, for subsequent use;
S3: merge described water extracting liquid and described alcohol extraction concentrated solution, drying under reduced pressure, pulverizes grinding, crosses 120 mesh sieves, adds suitable adjuvant, makes clinical required capsule with modern Chinese medicine preparation common process.
embodiment two
Described Chinese medicine preparation is prepared from by the Chinese crude drug of following parts by weight: Folium Ginkgo 18 parts, Rhizoma Drynariae 12 parts, Pyritum 9 parts, Radix Salviae Miltiorrhizae 9 parts, Radix Rehmanniae Preparata 9 parts, Fructus Crataegi 8 parts, Fructus Ligustri Lucidi 8 parts, the Rhizoma Anemarrhenae 8 parts, the Fructus Kochiae 6 parts, Radix Adenophorae (Radix Glehniae) 6 parts and 6 parts, Radix Glycyrrhizae.
Preparation method is as follows:
S1: take Folium Ginkgo, Rhizoma Drynariae, Pyritum, Radix Salviae Miltiorrhizae, Radix Rehmanniae Preparata, Fructus Crataegi, Fructus Ligustri Lucidi, the Rhizoma Anemarrhenae, the Fructus Kochiae, Radix Adenophorae (Radix Glehniae) and Radix Glycyrrhizae, decontamination, cleans, and dries, mixing is ground into coarse powder, add the purified water of described coarse powder total amount 10 times amount, decoct 2 times, each 2 hours, filter, merging filtrate also retains filtering residue, and when being condensed into 60 DEG C, relative density is the water extracting liquid of 1.20, for subsequent use;
S2: add the ethanol of described filtering residue total amount 5 times amount 75%, reflux, extract, 2 times toward above-mentioned filtering residue, each 4 hours, merges alcohol extract, distilling under reduced pressure, removing ethanol, and filtrate is concentrated into the alcohol extraction concentrated solution that relative density under 60 DEG C of environment is 1.20, for subsequent use;
S3: merge described water extracting liquid and described alcohol extraction concentrated solution, drying under reduced pressure, pulverizes grinding, crosses 100 mesh sieves, adds suitable adjuvant, makes clinical required tablet with modern Chinese medicine preparation common process.
embodiment three
Described Chinese medicine preparation is prepared from by the Chinese crude drug of following parts by weight: Folium Ginkgo 16 parts, Rhizoma Drynariae 14 parts, Pyritum 10 parts, Radix Salviae Miltiorrhizae 10 parts, Radix Rehmanniae Preparata 10 parts, Fructus Crataegi 7 parts, Fructus Ligustri Lucidi 7 parts, the Rhizoma Anemarrhenae 7 parts, the Fructus Kochiae 5 parts, Radix Adenophorae (Radix Glehniae) 5 parts and 7 parts, Radix Glycyrrhizae.
Preparation method is as embodiment two.
embodiment four
Described Chinese medicine preparation is prepared from by the Chinese crude drug of following parts by weight: Folium Ginkgo 25 parts, Rhizoma Drynariae 15 parts, Pyritum 12 parts, Radix Salviae Miltiorrhizae 12 parts, Radix Rehmanniae Preparata 12 parts, Fructus Crataegi 10 parts, Fructus Ligustri Lucidi 10 parts, the Rhizoma Anemarrhenae 10 parts, the Fructus Kochiae 8 parts, Radix Adenophorae (Radix Glehniae) 8 parts and 12 parts, Radix Glycyrrhizae.
Preparation method is as embodiment two.
chinese medicine preparation pharmacodynamic study of the present invention
test example one: Chinese medicine preparation of the present invention is to the influence research of rat bone amount
1, test objective and method
Object: according to the requirement of " new Chinese medicine pharmaceutical research guide ", studies the Pharmacodynamics of Chinese medicine preparation of the present invention at treatment postmenopausal osteoporosis.Take the embodiment of the present invention two, three gained tablet, pulverize, add water, furnishing pasty state, by gastric infusion, observe the high, medium and low dosage of the embodiment of the present invention two, three tablet to the impact of rat bone amount, bone amount evaluates osteoporosis treatment effect " goldstandard " at present.Bone density and calcium content of bone can distinguish never ipsilateral reflection bone amount, are the objective quantizating index of osteoporosis clinical diagnosis and assess disease degree.
Method: get 90 female sd inbred rats, body weight 240-300g, be divided into 9 groups at random, often organizes 10, and each component cage is fed.Wherein 8 groups of excision bilateral ovaries, the postoperative penicillin that gives is protected from infection; The other each one piece of fatty tissue of other one group of SD rat excision bilateral ovaries makes sham operated rats, and the postoperative penicillin that gives is protected from infection.Postoperative 45 days, 8 groups of SD rats of ovary will be removed, be labeled as the embodiment of the present invention two Chinese medicine preparation high dose group (3.4g/Kg) respectively, middle dosage group (1.7g/Kg), low dose group (0.8g/Kg), the embodiment of the present invention three Chinese medicine preparation high dose group (3.4g/Kg), middle dosage group (1.7g/Kg), low dose group (0.8g/Kg), positive controls and model group (isometric(al) normal saline), wherein positive controls is removed photoresist and to be added water that (Guizhou Tongjitang Pharmaceutical Co., Ltd produces for the XIANLING GUBAO JIAONANG of furnishing pasty state after softgel shell, the accurate word Z20025337 of traditional Chinese medicines), gastric infusion (3.4g/Kg), below respectively organize every day gastric infusion once, continuous 60 days, sham operated rats isometric(al) normal saline gastric infusion, once a day, continuous 60 days.
Collection of specimens, at duration of test, is weighed in weekly once.After last administration, fasting put to death animal after 24 hours, and stripping left and right bilateral femur, tibia measure.The mensuration of bone calcium content of femur adopts atomic absorption spectrophotometry, from the bone ash of femur, take out about 30mg-40mg, accurately weighed, measures with after dissolving with hydrochloric acid standardize solution; Bone densitometry (DEXA method), application XR-36 type Dual-energy X-rays absorptionmetry, resolution is 1.0 × 1.0mm, and speed is 40mm/s, the bone density of the in vitro femur of thickness measuring.
2, result of the test: as shown in table 1, table 2.
Table 1 medicine is to rat body bone mineral density result
Note: compare with sham operated rats,
▲p < 0.05,
▲ ▲p < 0.01; Compare with model group,
*p < 0.05,
*p < 0.05; Compare with positive controls,
#p < 0.05.
Table 2 medicine is on the impact of rat femur dry weight and bone calcium
Note: compare with sham operated rats,
▲p < 0.05,
▲ ▲p < 0.01; Compare with model group,
*p < 0.05,
*p < 0.05; Compare with positive controls,
#p < 0.05.
3, conclusion
This experiment judges the curative effect of Chinese medicine preparation of the present invention in bone amount by the research embodiment of the present invention two, the impact of embodiment three Chinese medicine preparation tablet high, medium and low dosage group on rat bone amount.First, this experiment makes experimental animal with 90 rats.Administration in continuous 60 days, none is dead for mice, put to death each internal organs of mice anatomic observation and do not find toxic reaction, the embodiment of the present invention two, embodiment three Chinese medicine preparation tablet high, medium and low dosage group and sham operated rats mice, without any difference, illustrate that Chinese medicine preparation of the present invention has better safety.
Model group (ovariectomized female rats) femur dry weight, calcium content of bone and bone density all significantly reduce (P < 0.01) compared with sham operated rats, illustrate that ovariectomized rats bone calcium is lost serious.In Mouse Bone density, compared with model group, the high, medium and low dosage group of the embodiment of the present invention two, embodiment three Chinese medicine preparation and positive controls all can increase the bone density (P < 0.05) of osteoporosis rat significantly, and the effect of high, the middle dosage group of the embodiment of the present invention two, embodiment three Chinese medicine preparation is all better than positive controls; In mouse femur dry weight and bone calcium, compared with model group, the high, medium and low dosage group of the embodiment of the present invention two, embodiment three Chinese medicine preparation and positive controls all significantly can increase femur dry weight and the bone calcium of osteoporosis rat, and high, the middle dosage group of the embodiment of the present invention two, embodiment three Chinese medicine preparation is all better than positive controls, visible, three dosage groups of Chinese medicine preparation of the present invention all can increase the bone density of rat, femur dry weight and calcium content of bone, have the osteoporotic effect of good treatment.
clinical observation on the therapeutic effect
One, case and diagnostic criteria
1, Western medicine diagnose standard
It is basic foundation that Diagnosis of osteoporosis should reduce more than 2 standard deviations with bone density, must differentiate it is primary osteoporosis or secondary osteoporosis.Can consider with reference to age, medical history, fracture and lab testing etc. during clinical diagnosis.
With reference to the diagnostic criteria that the World Health Organization (WHO) is recommended, measure based on DEXA: bone density value belongs to normal lower than the peak bone mass of same sex, agnate adult normal less than 1 standard deviation; Reducing between 1-2.5 standard deviation is bone amount low (bone amount minimizing); It is osteoporosis that reduction degree is equal to and greater than 2.5 standard deviations; Bone density reduces degree and meets Criteria of Osteoporosis simultaneously with when a place or multiple fracture being severe osteoporosis.Bone density represents with T-Score (T value) usually, T value=(measured value-peak bone mass)/adult normal's bone density standard deviation.T value >=-1.0 are normal;-2.5 < T value <-1.0 are that bone amount is low; T value≤-2.5 are osteoporosis.T value is for representing postmenopausal women and the BMD being greater than 50 years old male.
Diagnostic criteria, for possessing overall pain, is main mainly with lumbar and back pain, and aching and limp unable, increase the weight of gradually, microtrauma can cause fracture; Scheuermann kyphosis deformity; Bone density reduces by 2 above persons of standard deviation.
2, tcm diagnosis standard
Require to formulate according to the evaluation of " guideline of clinical investigations of new Chinese medicine treatment osteoporosis " of " new Chinese medicine guideline of clinical investigations " (2002).Show as: lumbar vertebrae pain, aching and limp few power, walk with difficulty, the vertigo, can not be prudent, body of the tongue or partially red or light, the symptoms such as thin lingual fur or thin white, deep-thready pulse, osteoporosis is shown in above-mentioned disease person.
Two, clinical trial
1, physical data
Sufferers of osteoporosis face is clinical volunteers 400, is postclimacteric female patient.Age is 46 years old-75 years old, 61.5 years old mean age.Be equally divided into 5 groups immediately, often organize 80 people, be respectively embodiment 1-4 group and matched group, respectively organize the influence factor such as age, symptom, through statistical procedures, there was no significant difference, meets a point set condition.
2, Therapeutic Method
Embodiment one group: take gained Traditional Chinese medicine preparation capsule agent in the embodiment of the present invention one, each 3, one day 3 times, serve on 90 days;
Embodiment two groups: take gained Chinese medicine preparation tablet in the embodiment of the present invention two, each 3, one day 3 times, serve on 90 days;
Embodiment three groups: take gained Chinese medicine preparation tablet in the embodiment of the present invention three, each 3, one day 3 times, serve on 90 days;
Embodiment four groups: take gained Chinese medicine preparation tablet in the embodiment of the present invention four, each 3, one day 3 times, serve on 90 days;
Matched group: take Caltrate D tablet (the accurate word H10950029 of traditional Chinese medicines, Jiangsu Wyeth Wyeth pharmaceuticals produce), one time 3,2 times on the one, serve on 90 days.
3, evaluation of clinical curative effect standard
Osteoporosis bone density efficacy determination:
First calculating bone density changing value=(after treatment the front bone density of bone density-treatment)/treat front bone density × 100%.
Effective: bone density rate of change is more than or equal to the minimum significant change value of bone density;
Effective: bone density rate of change is between the minimum significant change value of positive and negative bone density;
Invalid: bone density rate of change is less than the minimum significant change value of negative bone density.
Wherein bone density minimum significant change value=2.77 × (%CV), the CV-coefficient of variation.
Total effective rate=(effective+effectively)/total case load × 100%
Safety observations index: blood, routine urinalysis and Liver and kidney function, electrocardiogram etc., respectively detects 1 time before medication and at the end of the course for the treatment of.
4, therapeutic outcome, as shown in table 3.
Table 3 therapeutic effect
5, conclusion
The clinical volunteers patient of this clinical trial is postclimacteric female patient, the patients with osteoporosis not comprising male patient or cause due to other reason, postmenopausal women generally over 46 years old, therefore select age bracket 46-75 year between; The drug main for the treatment of osteoporosis at present on the market will comprise calcium preparation, chemical drugs and Chinese patent medicine, and calcium is taked in this test, and you are strange as a control group.Also can find out from obvious effective rate and total effective rate, the obvious effective rate of Chinese medicine preparation of the present invention is all greater than 85%, and total effective rate is all greater than 90%, far above obvious effective rate and the total effective rate of matched group, wherein best with the therapeutic effect of embodiment two, therefore embodiment two is preferred embodiment.As can be seen here, Chinese medicine preparation of the present invention, relative to Western medicine, has significant curative effect to treatment postmenopausal osteoporosis.All experimenters are through physical examination, and hepatic and renal function is normal, and without endocrinopathy and Ca,P metabolism disorder, it is safe and effective that further proved invention is used for the treatment of postmenopausal osteoporosis, has the value applied.
Claims (6)
1. prepare a method for the Chinese medicine preparation for the treatment of female postmenopausal osteoporosis, it is characterized in that comprising the following steps:
S1: take Folium Ginkgo 10-25 part of weight portion, Rhizoma Drynariae 9-15 part, Pyritum 6-12 part, Radix Salviae Miltiorrhizae 6-12 part, Radix Rehmanniae Preparata 6-12 part, Fructus Crataegi 3-10 part, Fructus Ligustri Lucidi 3-10 part, Rhizoma Anemarrhenae 3-10 part, Fructus Kochiae 3-8 part, Radix Adenophorae (Radix Glehniae) 3-8 part and Radix Glycyrrhizae 1-12 part, decontamination, clean, dry, mixing is ground into coarse powder, add the purified water of described coarse powder total amount 8-12 times amount, decoct 1-3 time, each 1-3 hour, filter, merging filtrate also retains filtering residue, and when being condensed into 55 DEG C-60 DEG C, relative density is the water extracting liquid of 1.15-1.25, for subsequent use;
S2: the ethanol adding described filtering residue total amount 3-8 times amount 70-85% toward above-mentioned filtering residue, reflux, extract, 1-3 time, each 3-5 hour, merge alcohol extract, distilling under reduced pressure, removing ethanol, filtrate is concentrated into the alcohol extraction concentrated solution that relative density under 55 DEG C of-60 DEG C of environment is 1.15-1.25, for subsequent use;
S3: merge described water extracting liquid and described alcohol extraction concentrated solution, drying under reduced pressure, pulverizes grinding, crosses 100-120 mesh sieve, obtains this Chinese medicine preparation.
2. the method for the Chinese medicine preparation of preparation treatment female postmenopausal osteoporosis according to claim 1, it is characterized in that, described Chinese medicine preparation is prepared from by the Chinese crude drug of following weight portion: Folium Ginkgo 10 parts, Rhizoma Drynariae 9 parts, Pyritum 6 parts, Radix Salviae Miltiorrhizae 6 parts, Radix Rehmanniae Preparata 6 parts, Fructus Crataegi 3 parts, Fructus Ligustri Lucidi 3 parts, the Rhizoma Anemarrhenae 3 parts, the Fructus Kochiae 3 parts, Radix Adenophorae (Radix Glehniae) 3 parts and 1 part, Radix Glycyrrhizae.
3. the method for the Chinese medicine preparation of preparation treatment female postmenopausal osteoporosis according to claim 1, it is characterized in that, described Chinese medicine preparation is prepared from by the Chinese crude drug of following weight portion: Folium Ginkgo 18 parts, Rhizoma Drynariae 12 parts, Pyritum 9 parts, Radix Salviae Miltiorrhizae 9 parts, Radix Rehmanniae Preparata 9 parts, Fructus Crataegi 8 parts, Fructus Ligustri Lucidi 8 parts, the Rhizoma Anemarrhenae 8 parts, the Fructus Kochiae 6 parts, Radix Adenophorae (Radix Glehniae) 6 parts and 6 parts, Radix Glycyrrhizae.
4. the method for the Chinese medicine preparation of preparation treatment female postmenopausal osteoporosis according to claim 1, it is characterized in that, described Chinese medicine preparation is prepared from by the Chinese crude drug of following weight portion: Folium Ginkgo 16 parts, Rhizoma Drynariae 14 parts, Pyritum 10 parts, Radix Salviae Miltiorrhizae 10 parts, Radix Rehmanniae Preparata 10 parts, Fructus Crataegi 7 parts, Fructus Ligustri Lucidi 7 parts, the Rhizoma Anemarrhenae 7 parts, the Fructus Kochiae 5 parts, Radix Adenophorae (Radix Glehniae) 5 parts and 7 parts, Radix Glycyrrhizae.
5. the method for the Chinese medicine preparation of preparation treatment female postmenopausal osteoporosis according to claim 1, it is characterized in that, described Chinese medicine preparation is prepared from by the Chinese crude drug of following weight portion: Folium Ginkgo 25 parts, Rhizoma Drynariae 15 parts, Pyritum 12 parts, Radix Salviae Miltiorrhizae 12 parts, Radix Rehmanniae Preparata 12 parts, Fructus Crataegi 10 parts, Fructus Ligustri Lucidi 10 parts, the Rhizoma Anemarrhenae 10 parts, the Fructus Kochiae 8 parts, Radix Adenophorae (Radix Glehniae) 8 parts and 12 parts, Radix Glycyrrhizae.
6. the method for the Chinese medicine preparation of the preparation treatment female postmenopausal osteoporosis according to any one of claim 1-5, is characterized in that: described Chinese medicine preparation is tablet, pill, powder or capsule.
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| CN1208626A (en) * | 1997-08-19 | 1999-02-24 | 高志海 | Traditional Chinese medicine bolus for strengthening bones of human body and method for preparing same |
| CN101653526A (en) * | 2008-08-20 | 2010-02-24 | 桂林三金药业股份有限公司 | Application of Chinese medicinal composition in preparing medicament for inhibiting activation of nuclear factor |
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