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CN109200203A - Chinese medicine composition and its application for treating primary osteoporosis - Google Patents

Chinese medicine composition and its application for treating primary osteoporosis Download PDF

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Publication number
CN109200203A
CN109200203A CN201811405280.9A CN201811405280A CN109200203A CN 109200203 A CN109200203 A CN 109200203A CN 201811405280 A CN201811405280 A CN 201811405280A CN 109200203 A CN109200203 A CN 109200203A
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chinese medicine
medicine composition
osteoporosis
primary osteoporosis
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林晓生
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    • A61K36/80Scrophulariaceae (Figwort family)
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Abstract

The invention belongs to the field of Chinese medicines, a kind of Chinese medicine composition for treating primary osteoporosis is provided, is grouped as by the group of following parts by weight: 5-15 parts of deer horn glue, 5-12 parts of Herba Cistanches, 5-15 parts of Rehmannia glutinosa, 5-12 parts of radix cyathulae, 5-12 parts of Semen Cuscutae, 5-12 parts of pawpaw, 5-12 parts of Cortex Eucommiae, 5-12 parts of Rhizoma Gastrodiae.Chinese medicine composition of the invention can be obviously improved the symptom, sign, skeleton metabolism of Osteoporosis, and bone mineral density can be improved, clinical efficacy is definite, not only there is benign adjustment effect to improvement and alleviation primary osteoporosis, and take nothing for a long time and have no adverse reaction.The present invention also provides the preparation method and applications of the Chinese medicine composition.

Description

Chinese medicine composition and its application for treating primary osteoporosis
Technical field
The invention belongs to the field of Chinese medicines more particularly to a kind of Chinese medicine composition for treating primary osteoporosis and its answer With.
Background technique
Primary osteoporosis is the common disease of orthopaedics, is apt to occur in postmenopausal women and elderly men, is with bone strength Decline, the disease of skeletal system that risk of bone fracture increase is characterized.National Institutes of Health is defined as with bone within 2001 The skeletal diseases that intensity decline and risk of bone fracture increase are characterized.Especially postmenopausal women is easily involved, and is to seriously endanger women The disease of health.The risk (40%) that osteoporotic fracture occurs in all one's life for women is higher than breast cancer, carcinoma of endometrium and ovum The summation of nest cancer is one of the main reason for gerontal patient disables and is lethal.As aging of population number of patients increases year by year, WHO is classified as one of three big diseases of old people.Osteoporotic fracture and its complication drastically influence the life matter of the middle-aged and the old Amount, becomes global one of public health problem.Therefore, effective prevention and treatment of osteoporosis has become when business It is anxious.This disease is mainly shown as whole body ostalgia, deformation of spinal column, or even the consequences such as osteoporotic fracture occur.According to primary bone The clinical manifestation of matter osteoporosis is belonged to " atrophic debility of bones " of Chinese medicine, " heumatism ", " bone is withered ", " bone exhaustion ", " bone erosion " etc. more now Scope, mainly since kidney essence deficiency, bone lose the chronic degenerative diseases of whole body bone caused by nourishing.Kidney essence deficiency, marrow Loss, bone dystrophy are the key points of developing osteoporosis.Therefore, kidney deficiency marrow subtract be postmenopausal osteoporosis occur root This reason plays important regulating and controlling effect to the development of its course of disease.
Summary of the invention
It is an object of the invention to overcoming above-mentioned the deficiencies in the prior art, a kind of primary osteoporosis for the treatment of is provided Chinese medicine composition.
The invention is realized in this way a kind of Chinese medicine composition for treating primary osteoporosis, by following parts by weight Several groups are grouped as: 5-15 parts of deer horn glue, 5-12 parts of Herba Cistanches, 5-15 parts of Rehmannia glutinosa, 5-12 parts of radix cyathulae, Semen Cuscutae 5-12 Part, 5-12 parts of pawpaw, 5-12 parts of Cortex Eucommiae, 5-12 parts of Rhizoma Gastrodiae.
Preferably, Chinese medicine composition of the invention is grouped as by the group of following parts by weight: 15 parts of deer horn glue, Herba Cistanches 10 Part, 15 parts of Rehmannia glutinosa, 10 parts of radix cyathulae, 10 parts of Semen Cuscutae, 10 parts of pawpaw, 10 parts of Cortex Eucommiae, 10 parts of Rhizoma Gastrodiae.
Specifically, the Chinese medicine composition is decoction, powder, pill, capsule or granule.
The present invention also provides application of the foregoing Chinese medicine composition in treatment primary osteoporosis.
Chinese medicine composition of the invention can be obviously improved the symptom, sign, bone metabolism of Osteoporosis Index, and bone mineral density can be improved, clinical efficacy is definite, not only has to improvement and alleviation primary osteoporosis benign Adjustment effect, and take for a long time without having no adverse reaction.
Specific embodiment
A kind of Chinese medicine composition for treating primary osteoporosis provided by the invention, by the component of following parts by weight Composition: 5-15 parts of deer horn glue, 5-12 parts of Herba Cistanches, 5-15 parts of Rehmannia glutinosa, 5-12 parts of radix cyathulae, 5-12 parts of Semen Cuscutae, pawpaw 5- 12 parts, 5-12 parts of Cortex Eucommiae, 5-12 parts of Rhizoma Gastrodiae.
Preferably, Chinese medicine composition of the invention is grouped as by the group of following parts by weight: 10-15 parts of deer horn glue, meat desert 10-12 parts of Rong, 10-15 parts of Rehmannia glutinosa, 10-12 parts of radix cyathulae, 10-12 parts of Semen Cuscutae, 10-12 parts of pawpaw, 10-12 parts of Cortex Eucommiae, 10-12 parts of Rhizoma Gastrodiae.
The pharmacology and effect of Chinese medicine composition each component of the invention are as follows:
Deer horn glue: warm nourishing liver and kidney, replenishing blood and vital energy, production of sperm marrow;
Herba Cistanches: kidney-replenishing, benefiting essence-blood;
Rehmannia glutinosa: enrich blood moist, beneficial to spirit and marrow;
Radix cyathulae: nourishing liver and kidney, strengthening the bones and muscles, blood circulation;
Semen Cuscutae: nourishing liver and kidney, benefiting quintessence;
Pawpaw: relaxing tendons and activating collaterals, removing dampness to restore normal functioning of the stomach;
Cortex Eucommiae: nourishing liver and kidney, strengthening the bones and muscles;
Rhizoma Gastrodiae: breath liver wind, and Pinggan Yang, dispelling wind and removing obstruction in the meridians.
Above-mentioned kinds of traditional Chinese medicines is followed to the principles of formulating prescriptions of Chinese medicine " monarch ", wherein deer horn glue, Herba Cistanches, Rehmannia glutinosa are Monarch drug in a prescription, for kidney tonifying, essence replenishing, mends marrow fill bone must with medicine;Radix achyranthis bidentatae, Cortex Eucommiae, Semen Cuscutae, Rhizoma Gastrodiae be ministerial drug, with enhance nourishing liver and kidney, The effect of strong marrow;Pawpaw is adjuvant, and pawpaw enters liver with strengthening tendons.All medicines share plays the function of " kidney tonifying marrow facilitating, strengthening muscles and bones " altogether Effect has good preventive and therapeutic effect to primary osteoporosis.
Following embodiment further illustrates the contents of the present invention, but should not be construed as limiting the invention.
Embodiment 1
A kind of Chinese medicine composition for treating primary osteoporosis that the embodiment of the present invention 1 provides, by following parts by weight Several groups are grouped as: 5 parts of deer horn glue, 5 parts of Herba Cistanches, 5 parts of Rehmannia glutinosa, 5 parts of radix cyathulae, 5 parts of Semen Cuscutae, 5 parts of pawpaw, Cortex Eucommiae 5 Part, 5 parts of Rhizoma Gastrodiae.
The preparation method of the Chinese medicine composition of the embodiment of the present invention 1, includes the following steps:
(1) Herba Cistanches of above-mentioned parts by weight, Rehmannia glutinosa, radix cyathulae, Semen Cuscutae, pawpaw, Cortex Eucommiae and Rhizoma Gastrodiae are mixed equal It is even to obtain mixture, the mixture and water are mixed according to the ratio of weight ratio 1: 5, impregnated 30 minutes in water;
(2) mixture in step (1) is decocted together with water and the second filtrate and filter residue is obtained by filtration after sixty minutes;
(3) gained filter residue in step (2) and water are mixed according to the ratio of weight ratio 1: 4, then decocts 60 minutes, then mistake Filter obtains third filtrate and filter residue, and the second filtrate is mixed with third filtrate, obtains the 4th filtrate;
(4) the deer horn glue molten of above-mentioned parts by weight is entered in the 4th filtrate, obtains the decoction of drug.
Embodiment 2
A kind of Chinese medicine composition for treating primary osteoporosis that the embodiment of the present invention 2 provides, by following parts by weight Several groups are grouped as: 10 parts of deer horn glue, 8 parts of Herba Cistanches, 10 parts of Rehmannia glutinosa, 9 parts of radix cyathulae, 9 parts of Semen Cuscutae, 8 parts of pawpaw, Cortex Eucommiae 11 parts, 8 parts of Rhizoma Gastrodiae.
The preparation method is the same as that of Example 1 for the Chinese medicine composition of the embodiment of the present invention 2.
Embodiment 3
A kind of Chinese medicine composition for treating primary osteoporosis that the embodiment of the present invention 3 provides, by following parts by weight Several groups are grouped as: 15 parts of deer horn glue, 12 parts of Herba Cistanches, 15 parts of Rehmannia glutinosa, 12 parts of radix cyathulae, 12 parts of Semen Cuscutae, 12 parts of pawpaw, 12 parts of Cortex Eucommiae, 12 parts of Rhizoma Gastrodiae.
The preparation method is the same as that of Example 1 for the Chinese medicine composition of the embodiment of the present invention 3.
Embodiment 4
A kind of Chinese medicine composition for treating primary osteoporosis that the embodiment of the present invention 4 provides, by following parts by weight Several groups are grouped as: 6 parts of deer horn glue, 7 parts of Herba Cistanches, 6 parts of Rehmannia glutinosa, 8 parts of radix cyathulae, 8 parts of Semen Cuscutae, 7 parts of pawpaw, Cortex Eucommiae 12 Part, 10 parts of Rhizoma Gastrodiae.
The preparation method is the same as that of Example 1 for the Chinese medicine composition of the embodiment of the present invention 4.
Embodiment 5
A kind of Chinese medicine composition for treating primary osteoporosis that the embodiment of the present invention 5 provides, by following parts by weight Several groups are grouped as: 9 parts of deer horn glue, 10 parts of Herba Cistanches, 8 parts of Rehmannia glutinosa, 9 parts of radix cyathulae, 10 parts of Semen Cuscutae, 11 parts of pawpaw, Du Secondary 7 parts, 8 parts of Rhizoma Gastrodiae.
The preparation method is the same as that of Example 1 for the Chinese medicine composition of the embodiment of the present invention 5.
Embodiment 6
A kind of Chinese medicine composition for treating primary osteoporosis that the embodiment of the present invention 6 provides, by following parts by weight Several groups are grouped as: 10 parts of deer horn glue, 11 parts of Herba Cistanches, 9 parts of Rehmannia glutinosa, 10 parts of radix cyathulae, 12 parts of Semen Cuscutae, 10 parts of pawpaw, 9 parts of Cortex Eucommiae, 10 parts of Rhizoma Gastrodiae.
The preparation method is the same as that of Example 1 for the Chinese medicine composition of the embodiment of the present invention 6.
Embodiment 7
A kind of Chinese medicine composition for treating primary osteoporosis that the embodiment of the present invention 7 provides, by following parts by weight Several groups are grouped as: 15 parts of deer horn glue, 10 parts of Herba Cistanches, 15 parts of Rehmannia glutinosa, 10 parts of radix cyathulae, 10 parts of Semen Cuscutae, 10 parts of pawpaw, 10 parts of Cortex Eucommiae, 10 parts of Rhizoma Gastrodiae.
The preparation method of the Chinese medicine composition of the embodiment of the present invention 7, includes the following steps:
(1) 10 parts of Herba Cistanches, 15 parts of Rehmannia glutinosa, 10 parts of radix cyathulae are impregnated 30 minutes in water;
(2) decocting 50 minutes again, take pan-fried juice, form the adhesive of water-soluble liquid;
(3) take again 15 parts of deer horn glue, 10 parts of Semen Cuscutae, 10 parts of pawpaw, 10 parts of Cortex Eucommiae, 10 parts of Rhizoma Gastrodiae break into fine powder, with step Suddenly the adhesive mixing in (2), is made decoction pill in the method for pelletization of dripping.
Treat primary osteoporosis clinical observation research
For the therapeutic effect for showing drug of the present invention, Shenzhen in October, -2018 in June, 2016 is collected in this clinical observation research The orthopaedics of the hospitals of traditional Chinese and western medicine of city be hospitalized, out-patient, standard compliant osteoporosis 40, according to Double-blind Principle, be divided into two groups using computer random digits table, wherein intervention group 20, control group 20, two groups in the state of an illness, property Not, age etc. is statistically analyzed no significant difference, is comparable.All patients for being included in research sign Informed consent form, and through institute's Medical Ethics Committee examining testimony meet ethics relevant regulations.
Diagnostic criteria: the Western medicine diagnostic criteria, " Chinese formulated referring to WHO osteoporosis standard and Aged in China association Osteoporosis suggests diagnostic criteria ", according to dual energy X-ray absorptiometry measuring instrument (Dual-energy X-ray Absorptiometry measurement instrument, DXA) measurement waist 1 to 4 centrum of waist (L1-4) normotopia bone density (BMD), diagnostic criteria is recommended according to WHO, value≤- 2.5 T is determined as osteoporosis, tcm diagnosis standard is referring to " Chinese medicine Drugs in Therapy osteoporosis clinical observation guideline ".
It is included in standard: the age 50-70 years old, Osteoporosis;Without great organic disease and psychiatric Disease;There is lumbago;Without osteosporosis resistant medicament systematic treating.
Exclusion criteria: multi viscera lesion patient, the heart, lung, liver, kidney, thyroid gland etc. Disease and serious heart and brain The patient of vascular diseases etc.;The diseases such as serious liver and kidney dysfunction, coagulation disorders, digestive tract ulcer;It is used in nearly half a year Influence bone metabolism drug, such as vitamin D, calcium preparation, estrogen, Diphosphonate, fluoride preparation;Psychiatric patient;Not according to Provide medication, the not congruent influence result judgement person of data.
Treatment method: patient is divided into control group and treatment group according to random principle, it is odd that control group gives oral calcium that D, Alfacalcidol soft capsule;Oral Caltrate D is given by treatment group, on the basis of Alfacalcidol soft capsule, takes orally the present invention Chinese medicine composition (nourshing kidney strong bone side), Chinese materia medica preparation come from Drug Manufacturing Room, daily administration 2 times, 250mL are administered every time, cooperation is taken Alfacalcidol soft capsule (being administered once daily, 0.5 μ g is administered every time) and Caltrate D (are administered once daily, are administered every time 600mg), observing time 4 weeks.
Clinical efficacy: evaluation criterion develops and publishes " new Chinese medicine clinic referring to Ministry of Health of the People's Republic of China in 1997 Study guideline " it formulates.Effective: lumbar vertebrae pain symptom completely disappears, and bone density inspection shows that bone density increases.It is effective: waist Ridge pain symptom is relieved, and bone density checks bone density without increase.It is invalid: to compare various aspects without improvement with before treatment.
Pain measurement: VAS scoring, i.e. pain visual imitation assessment: the horizontal line of standardized 10cm on paper, the one of horizontal line End is 0, is indicated painless;The other end is 10, indicates severe pain;Middle section indicates different degrees of pain.
Bone densitometry: 1~4 bone density of patient's normotopia lumbar vertebrae is measured using dual energy X-ray absorptiometry measuring instrument before and after treatment.
Skeleton metabolism measurement: two groups of patients will terminate for one day with this research before administration under fasting state Afterwards second day, under early morning fasting state, 5mL venous blood is acquired, takes out serum, sets -70 DEG C of refrigerators storages until measurement.It is enzyme-linked Immuno absorbence (ELISA) method detects serum Bone markers β-type i collagen c-terminal peptides (β-CTx) and total type i collagen amino End extends peptide (T-PINP).
Safety evaluation: two groups of patients equal promoting circulation of blood routine, electrocardiogram and hepatic and renal function inspection before and after treatment.
Statistical analysis: being handled using 22.0 statistics software of SPSS, in continuous data group before and after treatment and between group Mean compares to be examined with t, and enumeration data uses non-parametric test, indicates that difference is statistically significant with P < 0.05.
Clinical efficacy comparison after two groups of patients intervene: statistical test calculates the clinical efficacy of two groups of patients, two groups of treatments The results show that treatment group and control group total effective rate are 100.00%, 80.00% respectively, satisfaction is obtained after two groups of treatments Curative effect;Two groups of curative effects are statistically analyzed P < 0.05, statistically significant, it is seen that two groups of therapeutic effects there are statistical difference, The curative effect for the treatment of group is preferable.
Note: total effective rate=obvious effective rate+effective percentage;Comparison among groups are examined using Mann-whitney U.
Two groups of patient's patients before and after intervention VAS scorings are compared: patient VAS scoring (P < can be substantially reduced after two groups of case interventions 0.05) compare for two groups, and after intervening, scoring reduces obvious after treatment group's treatment, is better than control group (P < 0.05), i.e. treatment group It can be obviously improved pain, difference has statistical significance.
Note: compared with before intervening with this group,**P < 0.05;Two comparison among groups after intervention,P < 0.05.
Two groups of patient's patients before and after intervention bone densities (BMD) are compared: can significantly improve waist before relatively intervening with group after two groups of interventions Vertebra BMD (g/cm2), especially treatment group (P < 0.05).But treatment group's no statistical difference compared with the control group after intervention Meaning, but have raised trend.This may with intervention time is still short a relationship, consider in next research, extend dry The pre- time observes the influence to bone density.
Note: compared with before intervening with this group,**P < 0.05;Two comparison among groups after intervention,P < 0.05.
The comparison of two groups of patient patients before and after intervention β-CTx, T-PINP: two groups of cases can be obvious before relatively intervening with group after intervening Reduce patient β-CTx expression (P < 0.05), and after intervening two groups compare, β-CTx value reduces obvious after treatment group's treatment, is better than Control group (P < 0.05), difference have statistical significance.T-PINP expression (P < 0.05) can be significantly improved after two groups of interventions. But treatment group's no significant difference compared with the control group after intervening, but have raised trend, when this may be with intervening Between it is still short have a relationship, consider in next research, extend intervention time to observe the influence to bone density.
Note: compared with before intervening with this group,**P < 0.05;Two comparison among groups after intervention,P < 0.05.
Safety indexes: two groups of follow-up of patients the result shows that, unreported hepatic and renal function, electrocardiogram in two groups of patients treatment Etc. indexs exception, have no the adverse reactions such as medicamentosus diarrhea, abdominal pain, Chinese medicine compound prescription of the invention as a result prompted to have preferable peace Quan Xing, long-term use have no adverse reaction.
Clinical observation result shows that Chinese medicine composition of the invention can be obviously improved Osteoporosis Symptom, sign, skeleton metabolism, and bone mineral density can be improved, clinical efficacy is definite, not only to improvement and alleviation primary bone Matter osteoporosis has benign adjustment effect, and takes nothing for a long time and have no adverse reaction.

Claims (4)

1. a kind of Chinese medicine composition for treating primary osteoporosis, which is characterized in that be grouped by the group of following parts by weight At: 5-15 parts of deer horn glue, 5-12 parts of Herba Cistanches, 5-15 parts of Rehmannia glutinosa, 5-12 parts of radix cyathulae, 5-12 parts of Semen Cuscutae, pawpaw 5-12 Part, 5-12 parts of Cortex Eucommiae, 5-12 parts of Rhizoma Gastrodiae.
2. Chinese medicine composition as described in claim 1, which is characterized in that be grouped as by the group of following parts by weight: deer horn glue 15 parts, 10 parts of Herba Cistanches, 15 parts of Rehmannia glutinosa, 10 parts of radix cyathulae, 10 parts of Semen Cuscutae, 10 parts of pawpaw, 10 parts of Cortex Eucommiae, 10 parts of Rhizoma Gastrodiae.
3. Chinese medicine composition as described in claim 1, which is characterized in that the Chinese medicine composition be decoction, powder, pill, Capsule or granule.
4. a kind of application of Chinese medicine composition as described in claims 1 or 2 or 3 in treatment primary osteoporosis.
CN201811405280.9A 2018-11-22 2018-11-22 Chinese medicine composition and its application for treating primary osteoporosis Pending CN109200203A (en)

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* Cited by examiner, † Cited by third party
Title
卞玉群: "补肾法治疗原发性骨质疏松症的理论与实验研究", 《中国优秀硕士学位论文全文数据库 医药卫生科技辑》 *
顿宝生: "《中医用药精华》", 31 July 1999, 世界图书出版西安公司 *

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Application publication date: 20190115