CN100560089C - Be used for the treatment of osteoporotic Chinese medicine preparation - Google Patents

Abstract

The invention discloses a kind of osteoporotic Chinese medicine preparation that is used for the treatment of, contain following crude medicinal materials in every 100g preparation: Cornu Cervi Degelatinatum 8g, Caulis Lonicerae 10g, Caulis Spatholobi 10g, Rhizoma Drynariae 8g, Radix Gentianae Macrophyllae 6g, Radix Saposhnikoviae 6g, Nidus Vespae 8g, Rhizoma Chuanxiong 8g, Cortex Cinnamomi 4g, Cortex Eucommiae 6g, Radix Dipsaci 12g, Radix Astragali 12g, preferred dosage form is a granule.Determined curative effect of the present invention, standard criterion have good effect to the treatment osteoporosis.

Description

Be used for the treatment of osteoporotic Chinese medicine preparation

Technical field

The invention belongs to the field of Chinese medicines, particularly relate to a kind of osteoporotic Chinese medicine preparation that is used for the treatment of.

Background technology

Along with The development in society and economy and growth in the living standard, progressively go into aging society, osteoporotic prevalence increases year by year.The prevalence women of China's senile osteoporosis is 90%, and the male is 61%, occupies the 6th of commonly encountered diseases in the whole world.WHO (World Health Organization (WHO)) thinks that osteoporosis is after the cardiovascular disease, second largest lethal health care problem.The quality of life that the osteodynia that this disease caused, osteopathia even fracture have seriously reduced middle-aged and elderly people, and increased patient's medical expense greatly, thereby enjoy medical treatment and scientific research personnel's attention.In recent years, osteoporotic etiology and Study on Pathogenesis are gradually goed deep into.At present Western medicine is more at the treatment of bone resorption, mainly contains the medicines such as alternative medicine, Diphosphonate, calcitonin of hormone; And Chinese medicine has had certain progress to the mechanism research of osteoporosis and the research of Therapeutic Method, Therapeutic Method substantially can be divided into the kidney invigorating warming YANG, nourishing YIN for benefiting the kidney, invigorating the spleen and replenishing QI, qi and blood tonifying, strengthening the tendons and bones, promoting blood circulation and stopping pain etc., and centering is senile and menopause the patient have good curative effect.Reason understanding differs because due to illness centering cures the desease, and causes clinical pattern of syndrome, each family of the traditional Chinese medical science rule of treatment to differ.

Summary of the invention

The purpose of this invention is to provide osteoporotic Chinese medicine preparation of being used for the treatment of of a kind of determined curative effect, standard criterion.

The inventor finds by secular clinical research, the simple Gaierqi D (vitamin D3 and calcium carbonate) of simple oral can not obviously improve bone density value, can not eliminate pain, just replenish the calcium and can not treat osteoporosis.Though calcium is the main component of skeleton, because calcium can not suppress brokenly the activity of bone C, the absorption of calcium should be based on high calcium diet; And excessive replenishing the calcium may increase the burden of body even have side effects.WHO thinks that calcium preparation is not the osteoporosis therapy medicine, the main source high calcium diet that calcium is taken in, and NIH (U.S. sanitary institute) thinks that then calcium is most important nutrient, replenishing of calcium should be based on high calcium diet.In non-drug therapy, replenishing the calcium is the important measures of osteoporosis non-drug therapy, and high calcium diet is the main path of replenishing the calcium.Osteoporosis is not a calcium deficiency, is metabolic osteopathy; Replenish the calcium merely and can not treat osteoporosis.

Based on above understanding, the technical solution used in the present invention is such: be used for the treatment of osteoporotic Chinese medicine preparation, it is characterized in that: the effective ingredient in every 100g preparation is made by following crude medicinal materials:

Cornu Cervi Degelatinatum 7-9g Caulis Lonicerae 9-11g Caulis Spatholobi 9-11g Rhizoma Drynariae 7-9g

Radix Gentianae Macrophyllae 5-7g Radix Saposhnikoviae 5-7g Nidus Vespae 7-9g Rhizoma Chuanxiong 7-9g

Cortex Cinnamomi 3-5g Cortex Eucommiae 5-7g Radix Dipsaci 10-14g Radix Astragali 10-14g

Its dosage form can be said any dosage form on the pharmaceutics.

Preferred dosage form is a granule.

Further, the effective ingredient in every 100g preparation is made by following crude medicinal materials:

Cornu Cervi Degelatinatum 8g Caulis Lonicerae 10g Caulis Spatholobi 10g Rhizoma Drynariae 8g

Radix Gentianae Macrophyllae 6g Radix Saposhnikoviae 6g Nidus Vespae 8g Rhizoma Chuanxiong 8g

Cortex Cinnamomi 4g Cortex Eucommiae 6g Radix Dipsaci 12g Radix Astragali 12g.

The present invention can be prepared as follows:

A. all medical materials are placed pot, add water to and do not have group's medicine, decoct, keep boiling 45 minutes, taking liquid;

B. remain medical material and decoct with water once more, method is with step a;

C. twice gained medicinal liquid merges, with 85% ethanol precipitate with ethanol;

D. precipitate with ethanol once more;

E. concentrate, under 50 ℃-70 ℃, dry to moisture content and be lower than 5%, pulverize;

F. powder is mixed with excipient and other auxiliary agents of set amount, make granule.

Decoction described in the present invention, precipitate with ethanol, step such as concentrate, be the common method of formulation art, part is to the greatest extent all handled in a usual manner.

Described excipient can be selected not sacchariferous dextrin for use, and its main component is a starch.

The present invention has the kidney invigorating, bone strengthening, strong muscle, analgesic function, wherein Rhizoma Drynariae, Cornu Cervi Degelatinatum, the Cortex Eucommiae are reused invigorating the kidney and strengthening the bones, muscles and bones alive, be equipped with the Radix Astragali, Rhizoma Chuanxiong, Caulis Spatholobi, Cortex Cinnamomi, QI invigorating restores menstrual flow and invigorates blood circulation, the smooth blood of gas is lived, and skeleton is able to nutrition, and assistant makes with Nidus Vespae, Radix Angelicae Pubescentis, Radix Gentianae Macrophyllae, Radix Saposhnikoviae bone and muscle strengthening stopping numbness pain, all medicine phases 5, bring out the best in each other, deficiency of the kidney must be mended, blood stasis must be capable, pain must be ended, transform in bone thereby reach the calcium of better transferring body faster, the immunity of enhancing body is avoided the minimizing of bone amount simultaneously.Modern medicine study is learnt: Rhizoma Drynariae, Cornu Cervi Degelatinatum have increases the bone amount, improve bone mass, keep bone micro-structure integrated degree, increase the osteoblast activity, promote effects such as calcium deposition, and can alleviate back and extremity osteodynia, microcirculation improvement, improve bone density, regulate the hypothalamic pituitary gonadal axis function, improve bone and regulate the disturbance state of hormone and the cytokine in the bone metabolism process, suppress bone resorption.

The specific embodiment

Embodiment one

Medicaments preparation

Get Cornu Cervi Degelatinatum 80g, Caulis Lonicerae 100g, Caulis Spatholobi 100g, Rhizoma Drynariae 80g, Radix Gentianae Macrophyllae 60g, Radix Saposhnikoviae 60g, Nidus Vespae 80g, Rhizoma Chuanxiong 80g, Cortex Cinnamomi 40g, Cortex Eucommiae 60g, Radix Dipsaci 120g, Radix Astragali 120g, place pot, add water to and do not have group's medicine, decoct, keep boiling 45 minutes, taking liquid; Decoct with water once more, keep boiling 45 minutes, taking liquid; Twice medicinal liquid merged, and it is centrifugal to add 85% ethanol, taking precipitate; It is centrifugal to add 85% ethanol once more, taking precipitate; Precipitate is condensed into cream, under 50 ℃-70 ℃, dries to moisture content and be lower than 5%, be crushed to granule less than 60 orders, medicated powder 500g; Add the 500g dextrin and make granule, be distributed into the 10g/ bag.

Embodiment two

Clinical trial

1, data and method

1.1 clinical data, is divided into 2 groups (test group and matched groups) at random at primary osteoporosis patient 64 examples: 1. test group 32 examples, male 15 examples, woman's 17 examples, in age 42-81 year, average 64 years old, all meet Chinese's primary osteoporosis and the diagnostic criteria of WHO primary osteoporosis ^[1]The patient has thoracic dorsal, extremity or whole body pain, X-ray film shows that hyperosteogeny even wedge shape vertebra (judge the method for compression fracture of vertabral body: when C/A and C/P ratio by Japanese good fortune Yongren husband, one of them is less than 0.8, or A/P ratio is less than 0.75, promptly diagnose compression fracture of vertabral body) and knee joint osteoarthritis, the inspection of CUBA ultrasonic bone density instrument is all less than peak bone density (T-value) 2.5S.7 year; 2. matched group 32 examples, male 13 examples, women 19 examples, age 41-84 year, average 62.3 years old.2 groups of physical data comparing differences do not have significantly.

1.2 method: test group is with the granule of embodiment one, and every day 2 times is decoction being taken warmly sooner or later, each one bag; Caltrate D tablet, every day 1 time, each 1.Matched group is with Caltrate D tablet, every day 1 time, each 1.Be 3 months the course of treatment.

1.3 evaluation criteria ^[2]1. pain: 0 grade, no pain, but orthobiosis; 1 grade, feel pain, but can stand, can influence daily life; 2 grades, pain is obvious, is impatient at sometimes, and the part life is affected; 3 grades, pain is impatient at, and needs bed, and life obviously is affected.2. curative effect: produce effects, bone density increases＞2.5%, and no fresh fracture takes place, the pain disappearance; Effectively, bone density increases＜2.5%, and whole body does not have new fracture to be taken place, and pain is partly alleviated or disappeared; Invalid, bone density descends, and has fresh fracture to take place, pain no change even increase the weight of.

1.4 the statistical procedures data are with (χ ± s) expression, t checks.

2 results

Test group patient takes 1 month symptom and obviously alleviates, and pain disappears substantially after 3 months; Bone density value also obviously rises.Most of patient's pain symptom of matched group and bone density value all do not have obvious improvement,

2.1 pain and bone density index relatively see Table 1 before and after two groups of treatments.

Pain and the comparison of bone density index before and after 2 groups of treatments of table 1 (χ ± s)

Annotate: * and * * represent that respectively test group treatment back pain disappears and bone density (g/cm ³) amount of increase of value.

Test group and matched group pain disappear and bone density (g/cm ³) value increase relatively Ridit analyze, P＜0.01 illustrates that the curative effect of test group obviously is better than matched group.

2.2 effective percentage relatively sees Table 2 before and after two groups of treatments

Effective percentage compared [example (%)] before and after table 2 was respectively organized two groups of treatments of patient

Group	The example number	Produce effects	Effectively	Invalid	Cure-remarkable-effectiveness rate	Total effective rate
							Test group	32	25(76.19)	6(19.05)	1(4.76)	76.19	95.24
Matched group	32	5(14.29)	9(28.59)	18(55.02)	14.29	42.76

Annotate: cure-remarkable-effectiveness rate=clinical recovery rate+obvious effective rate (as follows), total effective rate=clinical recovery rate+obvious effective rate+effective percentage (as follows).

Test group and matched group relatively Ridit are analyzed

μ=3.3768, P＜0.01 illustrates that the curative effect of test group obviously is better than matched group.

From table 1,2 clinical symptoms, bone density (g/cm ³) value, cure-remarkable-effectiveness rate and total effective rate curative effect relatively, test group produce effects 25 examples as can be seen, effective 6 examples, invalid 1 example, total effective rate 95.24%; Matched group is respectively 5,9,18 and 42.76%, and the test group curative effect obviously is better than matched group (p＜0.01).The heating at night appears in test group 2 examples during the treatment, adjusts spontaneous remission, not drug withdrawal by diet.

Claims (4)

1. be used for the treatment of osteoporotic Chinese medicine preparation, it is characterized in that: the effective ingredient in every 100g preparation is made by following crude medicinal materials:

Cornu Cervi Degelatinatum 7-9g Caulis Lonicerae 9-11g Caulis Spatholobi 9-11g Rhizoma Drynariae 7-9g

Radix Gentianae Macrophyllae 5-7g Radix Saposhnikoviae 5-7g Nidus Vespae 7-9g Rhizoma Chuanxiong 7-9g

Cortex Cinnamomi 3-5g Cortex Eucommiae 5-7g Radix Dipsaci 10-14g Radix Astragali 10-14g

Its dosage form can be said any dosage form on the pharmaceutics.

2. Chinese medicine preparation as claimed in claim 1 is characterized in that: its dosage form is a granule.

3. Chinese medicine preparation as claimed in claim 2 is characterized in that: the effective ingredient in every 100g preparation is made by following crude medicinal materials:

Cornu Cervi Degelatinatum 8g Caulis Lonicerae 10g Caulis Spatholobi 10g Rhizoma Drynariae 8g

Radix Gentianae Macrophyllae 6g Radix Saposhnikoviae 6g Nidus Vespae 8g Rhizoma Chuanxiong 8g

Cortex Cinnamomi 4g Cortex Eucommiae 6g Radix Dipsaci 12g Radix Astragali 12g.

4. Chinese medicine preparation as claimed in claim 3 is characterized in that: it be prepare by the following method and:

A. all medical materials are placed pot, add water to and do not have group's medicine, decoct, keep boiling 45 minutes, taking liquid;

B. remain medical material and decoct with water once more, method is with step a;

C. twice gained medicinal liquid merges, with 85% ethanol precipitate with ethanol;

D. precipitate with ethanol once more;

E. concentrate, under 50 ℃-70 ℃, dry to moisture content and be lower than 5%, pulverize;

F. powder is mixed with excipient and other auxiliary agents of set amount, make granule.