CN1322888C

CN1322888C - Medicine for treating osteoporosis and its preparing method and use

Info

Publication number: CN1322888C
Application number: CNB2005100678491A
Authority: CN
Inventors: 周宁
Original assignee: Guizhou Tongjitang Pharmaceutical Co Ltd
Current assignee: Sinopharm Tongjitang Guizhou Pharmaceutical Co Ltd
Priority date: 2005-04-28
Filing date: 2005-04-28
Publication date: 2007-06-27
Anticipated expiration: 2025-04-28
Also published as: CN1781535A

Abstract

The present invention relates to a medicine for treating osteoporosis and a preparation method thereof, and also relates to the novel application of the medicine in the aspect of treating fracture, osteoarthritis, osteonecrosis and climacteric syndrome. The medicine of the present invention is prepared from epimedium herb, himalayan teasel root, red sage root, common anemarrhena rhizome, malaytea scurfpea fruit and rehmannia root. Clinical and animal experiment research shows that compared with other medicines for treating osteoporosis, the medicine has the advantages of more obvious curative effect, little side effect and long-term taking, and is a good medicine for treating osteoporosis in clinic.

Description

A kind of purposes for the treatment of osteoporotic medicine

Technical field

The present invention relates to the Chinese medicine technical field, be specifically related to osteoporotic medicine of a kind of treatment and its production and use.

Background technology

Osteoporosis mainly is divided into primary osteoporosis and secondary osteoporosis two big classes, and its pathogenic factor is very complicated, but from traditional Chinese medical science angle, osteoporosis belongs to " atrophic debility of bones of suffering from a deficiency of the kidney " scope.Theory of Chinese medical science is thought: " people grasps the gas in the world and gives birth to ", " congenital essence is hidden in kidney, and the kidney being the origin of congenital constitution ", " kidney governing bones spermatogenesis, main reproduction are had one's ideas straightened out in ear and two the moon ", " kidney closes bone at body, main bone is given birth to marrow ", " then marrow is living to some extent for the kidney qi foot, and bone is foster to some extent ".The kidney of said kidney of the traditional Chinese medical science and doctor trained in Western medicine is not the identical concept.Its representative be not a certain organ with specific function, but a system is the system of an abstract conception.Along with the increase at age, the function of this system descends gradually even disappears, and causes the bone amount to reduce, aching pain in waist and back, and limbs fatigue, aversion to cold and cold limbs, the symptom of suffering from a deficiency of the kidney such as the edema of the face has the fracture sign concurrently, the atrophic debility of bones of promptly suffering from a deficiency of the kidney simultaneously.Method of treatment is worked as with invigorating the kidney and strengthening the bones.

Osteoporosis be with unit volume internal skeleton amount reduce, the microstructure of bone deteriorates to feature, thereby cause the fragility of bone to increase and a kind of general skeletal diseases of being easy to fracture.Very easily be referred to as osteoporotic or osteoporosis fracture as the various types of fracture that take place when getting injured by a fall of winnowing with a dustpan, slip of mountain peak by bus after the osteoporosis at microtrauma.Along with being on the rise of aged tendency of population, all kinds of fracture and orthopaedics illness that osteoporosis causes are brought serious threat to the health of worldwide mid-aged population, have become one of the seventh-largest disease that influences middle-aged and elderly people health.Modern medicine thinks that the main cause that causes osteoporosis is: the bone amount that the forfeiture of age growth and postmenopausal estrogen causes reduces, unbalance and other all risk factor of calcium-regulating hormone.No matter be that male or women were that to reach maximum be the peak bone amount to the bone amount at 20～30 years old.With advancing age, the bone amount begins to quicken to lose, 70% when male's bone amount drops to 40 years old during to 70～80 years old, and the women drops to 50%.The quickening that the deficiency of peak bone amount and bone amount reduce speed is the important pathogenic factors of osteoporosis.Press modern medicine classification, osteoporosis can be divided into two big classes: the 1. osteoporosis after climacteric; 2. senile osteoporosis.Its clinical manifestation mostly is waist knee joint, osteoarthrosis etc. and locates symptoms such as cold type of pain, activities adverse, coldness of the body with chills and emaciated physique.

Ancient medicine early has research to osteoporosis, and Miao ethnic group area have the title of " BAICAO is medicine all; everybody can cure ", the Miao people has accumulated the rich experiences of prevention and diseases such as treatment labour damage and fracture in practical experience of life, to the understanding and the treatment of osteoporosis, its unique experience and curative effect are preferably also arranged.Miao ethnic group's medicine has unique theoretical system and medication experience, and it belongs to osteoporosis " impairment caused by overstrain disease " or categories such as " labour's diseases ".Think because overworked, make internal organs, muscles and bones impaired, and suffer from diseases such as bones and muscles pain and fracture.Its character belongs to " slow warp ", and " cold type of pain ", treatment is a principle with " cold febrile disease is controlled "; And theory of Chinese medical science is thought: " people grasps the gas in the world and gives birth to ", " congenital essence is hidden in kidney; the kidney being the origin of congenital constitution ", " kidney governing bones spermatogenesis, main reproduction; have one's ideas straightened out " in ear and two the moon, " kidney closes bone at body, main bone is given birth to marrow ", " then marrow is living to some extent for the kidney qi foot, and bone is foster to some extent ", so think that osteoporosis belongs to " atrophic debility of bones of suffering from a deficiency of the kidney " scope, method of treatment is worked as with invigorating the kidney and strengthening the bones.

The osteoporotic medicine of treatment can be divided into bone resorption inhibitor, bone formulation stimulant and bone mineralising promoter three major types at present.As estrogen, calcitonin, calcium preparation, activated vitamin D etc., but said medicine is taken for a long time and can be caused complication; Or cost an arm and a leg; Or uncertain therapeutic efficacy is cut; The side effect osteoporotic medicines of all nonideal treatment that wait more.The osteoporotic medicine of many relevant treatments is also disclosed in the patent documentation, for example, disclose a kind of among the Chinese patent application CN1200279A with Herba Epimedii 78-80%, Radix Dipsaci 10-15%, Fructus Psoraleae 3-5%, Radix Rehmanniae 3-5%, Radix Salviae Miltiorrhizae 3-5%, RHIZOMA ANEMARRHENAE with peet 3-5% is a raw material, obtain through refining the osteoporotic medicine of control that Preparation Method is made according to conventional decocting in water, the drawback of this application shows, what it adopted is the preparation method that conventional decocting boils, the Herba Epimedii that wherein plays a major role and the effective ingredient of Fructus Psoraleae can't obtain, thereby directly have influence on the effect of the medicine that finally obtains, the drug effect of this medicine is relatively poor in the practical application.

Therefore, develop a kind of evident in efficacy, side effect is little, the medicine that can take has for a long time become medical worker and numerous patients hope.

Summary of the invention

At above-mentioned the deficiencies in the prior art, the invention provides a kind of evident in efficacy, side effect is little, the osteoporotic medicine of treatment that can take for a long time.

The present invention also provides the preparation method of this medicine.

The present invention also provides the new purposes of this medicine aspect treatment fracture, osteoarthritis, osteonecrosis and climacteric syndrome.

Medicine of the present invention is made by being prepared as follows technology by following raw medicaments in portion by weight:

Herba Epimedii 12-20 part Radix Dipsaci 2-8 part Radix Salviae Miltiorrhizae 1-5 part

Rhizoma Anemarrhenae 1-5 part Fructus Psoraleae 1-5 part Radix Rehmanniae 1-5 part

1) takes by weighing the raw material of Chinese medicine of respectively distinguishing the flavor of by proportioning,, cross 80 order to 300 orders or 300 orders, make fine powder or impalpable powder with top sieve with Radix Salviae Miltiorrhizae or Radix Salviae Miltiorrhizae and Radix Dipsaci or Radix Salviae Miltiorrhizae, Radix Dipsaci and Fructus Psoraleae pulverizing;

2) surplus stock fragmentation that will be except that step 1) is raw materials used, extracting in water 1 to 3 time adds 5 to 40 times in water at every turn, extracts 0.5 to 3 hour at every turn, filter or centrifugal, collecting decoction, the water extract;

3) above-mentioned water extract is concentrated;

4) drying, and be ground into 80-300 order or above fine powder or the impalpable powder of 300 orders;

5) add in 0.3 to 5 times dextrin, lactose or the Icing Sugar one or more;

6) add the fine powder or the impalpable powder of step 1) again, mixing, preparation process is made acceptable forms on the pharmaceutics routinely.

Also can making of the application's medicine by following preparation technology:

In above-mentioned preparation technology, omit step 4), all the other steps are with above-mentioned; Perhaps fall " mixing " that step 4) moves in the step 6) and carry out before, all the other steps are with above-mentioned.

In this application, the preferred capsule of acceptable forms, soft capsule, tablet, granule, oral liquid, mixture, effervescent tablet, pill, micropill on the pharmaceutics.Wherein, the preferred 2-5 of consumption of the adjuvant dextrin in the step 5), lactose, Icing Sugar doubly.

The application's medicine can be made capsule by following preparation technology;

1) takes by weighing the raw material of Chinese medicine of respectively distinguishing the flavor of by said ratio, Radix Salviae Miltiorrhizae, Radix Dipsaci and Fructus Psoraleae are pulverized, cross 80 mesh sieves, make fine powder;

2) with the surplus stock fragmentation, extracting in water 3 times adds 30 times in water at every turn, extracted successively 3,2,1 hours, and filtration or centrifugal, collecting decoction gets the water extract;

3) above-mentioned water extract is concentrated into the thick paste that relative density is 1.35-1.38 (30 degree); Add above-mentioned Radix Salviae Miltiorrhizae, Radix Dipsaci and Fructus Psoraleae powder, mixing is made granule, and drying promptly gets the application's capsule.

The weight proportion of the application's crude drug is preferred:

1 part of 2 parts of Radix Salviae Miltiorrhizae of 12 parts of Radix Dipsacis of Herba Epimedii

1 part of 1 portion of Radix Rehmanniae of 1 part of Fructus Psoraleae of the Rhizoma Anemarrhenae

The weight proportion of the application's crude drug is preferred:

5 parts of 2 parts of Radix Salviae Miltiorrhizaes of 20 parts of Radix Dipsacis of Herba Epimedii

5 parts of 5 portions of Radix Rehmanniae of 5 parts of Fructus Psoraleaes of the Rhizoma Anemarrhenae

The weight proportion of the application's crude drug is preferred:

5 parts of 8 parts of Radix Salviae Miltiorrhizaes of 12 parts of Radix Dipsacis of Herba Epimedii

The weight proportion of the application's crude drug is also preferred:

1 part of 8 parts of Radix Salviae Miltiorrhizae of 15 parts of Radix Dipsacis of Herba Epimedii

The application's medicine is researched and developed a kind of modern nationality medicine preparation that forms according to area, southeast of Guizhou Province ethnic groups folk remedy in conjunction with clinical experience for many years, and prolonged application is in clinical, and is evident in efficacy.In the prescription of the application's medicine, monarch drug Herba Epimedii, Radix Dipsaci have invigorating the kidney and strengthening the bones, continue the effect that folding is cured the wound, and the Guizhou authentic medicinal herbs curative effect that adopts southeast of Guizhou Province Miao ethnic group to commonly use is better, perfect square energy temperature male wind-supplying kidney, reunion of bone keeps fit to be good for bone, increase the feelings Fructus Alpiniae Oxyphyllae, curative effect is very remarkable.Be mainly used in prevention and treatment because of various osteoporosises and fracture that the atrophic debility of bones of suffering from a deficiency of the kidney causes, also be used for climacteric syndrome, various osteoarthritis and osteonecrosis.Through Beijing, the clinical uses of ground various big hospital such as Shanghai, Shandong, curative effect obviously, reliable.Good medicine for the above-mentioned disease of clinical treatment.

The application's medicine is on the basis of prior art (CN1200279), different physicochemical properties according to each flavour of a drug, its extraction process is improved, improved the rate that of effective ingredient in the crude drug greatly, the curative effect of the application's medicine is greatly strengthened (contrast experiment who sees below), and the application's processing step easy operating, safety and stability is suitable for industrialized great production.

Empirical tests, the clinical efficacy of the application's medicine is remarkable, and side effect is little.Presided over by the Guizhou Province People ' s Hospital, four tame hospitals of six units such as associating Beijing China Rehabilitation Research Center cooperate from different perspectives and observe 64 examples, and the result shows: male 48 people in case 64 examples, women 16 people.The age reckling is 52 years old, the maximum 85 years old, 64.57 years old mean age. wherein hip femoral head disease is decreased 16 examples, intertrochanteric fracture of the femur 6 examples.Vertebral compression fracture 11 examples, fracture of femoral neck 29 examples.Clinical cure rate 86.36%, effective 11.6%, total effective rate reaches 97.96%.

Begin it is carried out clinical verification in May, 1998 by Shuguang Hospital, Huashan Hospital, Attached to Shanghai Medical Univ. and Zhongshan affiliated hospital of shanghai medical university, 90 routine osteoporosis patients have been made trimestral preliminary observation; Again 73 routine patients have wherein been done six months clinical observation.The result shows that the curative effect when this organizes in 90 examples three months is 86.7% of an aggregate efficiency, and obvious effective rate is 55.6%; The curative effect of 73 examples after six months is 90.4% of a total effective rate, and obvious effective rate is 71.2%, learns by statistics and handles the two zero difference.

Zoopery shows, XIANLING GUBAO ZHIJI can increase osteoblastic derivation and propagation, suppress the absorption activity of osteoclast, shorten the bone resorption cycle, accelerate bone and build activity again, XIANLING GUBAO ZHIJI can make after castration is induced rat bone again the activity of building be the positive balance state, when accelerating the bone conversion, keep the bone amount that castration is induced the back rat effectively.

The XIANLING GUBAO JIAONANG acute toxicity test shows, mice ig administration maximum tolerated dose 28.8g/kg.d is equivalent to 60 kilograms of adults 576 times of clinical consumption per days, illustrates that the clinical use of XIANLING GUBAO JIAONANG is safe.

The XIANLING GUBAO JIAONANG long term toxicity test shows: detect hematology, hepatic and renal function and histopathology microscopy etc. through rat oral gavage administration 0.45, two groups of nursings of 2.25g/kg all in normal range after three months, show oral three months safety non-toxics of XIANLING GUBAO JIAONANG, prompting this product is safe under clinical recommendation consumption.

The application treats the commodity " XIANLING GUBAO " by name of osteoporotic medicine, therefore, all represents the application's medicine with " XIANLING GUBAO " in the application's test.Concrete testing data is as follows:

XIANLING GUBAO is to the morphologic influence of ovariectomized rat osseous tissue

Summary adopts OO method to set up the animal model of primary osteoporosis, observes the influence to indexs such as castrated rats osseous tissue light microscopic, Electronic Speculum and osseous tissue morphometries of Chinese medicine XIANLING GUBAO ZHIJI and Western medicine premarin.The result shows, use after the XIANLING GUBAO treatment, the osseous tissue morphology of rat model takes place obviously to change, bone trabecular volume increases in the unit are, the bone trabecula width increases, but the spacing between the bone trabecula do not reduce, and can observe similar change under light microscopic and Electronic Speculum, similar to the therapeutic effect of application control drug premarin, no difference of science of statistics.Illustrate that XIANLING GUBAO can improve the bone structure of osteoporosis rat to a certain extent, recover the form of osseous tissue, in the treatment of osteoporosis, play a role.

Osteoporosis is to influence the middle-aged and elderly people class important diseases of quality of life, by setting up the animal model of osteoporosis, screens effective medicine, and the mechanism of action of exploring medicine is significant undoubtedly.XIANLING GUBAO JIAONANG is to verify effective Chinese medicine preparation through clinical principium, and we understand the effect of XIANLING GUBAO JIAONANG aspect the recovery bone structure by observing it to the morphologic influence of castrated rats osseous tissue.

1 materials and methods

1.1 medicine XIANLING GUBAO JIAONANG (the accurate word 100019 of medicine is defended in 96 Guizhou Provinces, Guizhou celestial miraculous cure industry company limited product).Premarin (96 defend U.S. Hui Shi Ayerst company big pharmaceutical factory product the accurate word J-35 of medicine number).

1.2 laboratory animal and raise 36 of 10 monthly age Healthy female SD rats, body weight 350 ± 20g (provide, the quality certification number 01597) by laboratory animal portion of Shanghai Univ. of Traditional Chinese Medicine.Each organizes the rat sub-cage rearing, and free picked-up standard rat feed is freely drunk distilled water, 22 ± 2 ℃ of room temperatures.

1.3 the animal grouping is divided into 4 groups with processing at random with experimental rat, the dorsal part otch is adopted in the ketamine intraperitoneal anesthesia, and aseptic condition cuts skin, subcutaneous tissue down, extracts bilateral ovaries.Sham cut is removed group and is only excised a fritter intraabdominal adipose tissue.After the operation, give benzylpenicillin sodium for injection salt 50,000 units every every day, intramuscular injection 3 days.Postoperative carried out Drug therapy in 3 months, and sham cut is removed group and model group, and all to give normal saline oral, and it is oral that premarin group and XIANLING GUBAO group are converted people's dose,equivalent according to the body surface area method.Put to death after each is organized rat and took medicine 3 months, carry out every index and detect.

After 1.4 the om observation rat is put to death, get 3 right side tibias for every group, the soft tissue that removal is adhered to, put into 10% formalin immediately and fix 24 hours, decalcification, paraffin embedding, go up section at YL3 swinging microtome (Shanghai Instruments Factory product), be cut into the section of 10 μ m thickness along the tibia sagittal plane, bone trabecular morphosis is observed in HE dyeing under the Olympus light microscopic.

1.5 the scanning electron microscopic observation rat is put to death the back and gets 3 the 1st lumbar vertebra specimen for every group, remove attaching soft tissue, place 2% glutaraldehyde solution to fix 24 hours, 8% neutral EDTA decalcification 7 days, 10% liquor natrii hypochloritis soaked 8 hours, and 1% osmium tetrachloride solution is fixed 2 hours, ethanol dewaters step by step, isoamyl acetate was preserved 12 hours, and carbon dioxide critical point drying, vacuum metal spraying are observed bone trabecular morphosis on the JMS-840 scanning electron microscope.

1.6 get the left side tibia after osseous tissue morphometry research rat is put to death, remove the soft tissue that adheres to, put into Millonig ' s liquid immediately and fix 24 hours.Ethanol dewaters step by step, and each 24 hours, last dimethylbenzene is saturating inhaled the methyl methacrylate embedding 4 hours.Cut the section of 10 μ m thickness at Polycnt-s type sclerous tissues microtome upper edge tibia sagittal plane.Toluidine blue staining is done in section, with reference to people such as Parfitt (3) bone trabecula parameter metering method, measure by the VIDAS image analysis system, parameter comprises bone trabecular volume (total bone volume, TBV), bone trabecular width (bonetrabecula thickness, Th.T), bone trabecular gap (bone trabecula separation, Th.S).

All (the t check is relatively adopted in ± s) expression between two groups of means with mean ± standard deviation 1.7 statistical procedures is respectively organized all observed results of rat.

2 results

2.1 om observation om observation result as a result shows that sham cut removes group bone trabecula dense arrangement, is interconnected into network structure, bone trabecular thickness is big, and its spacing is little; The rat bone girder is obviously rare after the spay, and the bone trabecular connection point of interruption is many under the same multiple, and bone trabecula obviously attenuates, and spacing is widened, even bigger white space (Figure 1A B) occurs in the subregion.Use after the XIANLING GUBAO treatment, the bone trabecula dense arrangement, between connection obviously increase, thickness broadening, gap turn narrow, three dimensional structure recovers, the performance similar (Fig. 1 CD) that removes group, premarin group with sham cut.

2.2 scanning electron microscopic observation scanning electron microscopic observation result as a result shows that sham cut removes the group bone trabecula and arrange based on vertically, and has horizontal bone trabecula to connect, and constitutes solid nettedly, the bone trabecula spacing is little; The rat bone girder obviously attenuates after the spay, and arrange sparse, the gap broadening between the bone trabecula, fracture appears in the bone trabecula of subregion, stump is free, connects to interrupt, three dimensional structure destroys, and bone trabecular area of absence occurs.After the XIANLING GUBAO treatment, can see improvement in various degree, bone trabecula is arranged comparatively dense, connection showed increased therebetween, space structure be restored (Fig. 2).

2.3 bone morphometry bone morphometry as a result observe to show that after the spay, bone trabecula reduces in the unit volume, thickness narrows down, and spacing is widened, and removes group than apparent property difference is arranged with sham cut; Use after the XIANLING GUBAO treatment, the bone trabecula amount in the unit volume obviously increases, and thickness is obviously widened, and removes group with sham cut and the premarin group compares zero difference; But the spacing between the bone trabecula does not narrow down, and cuts relatively no difference of science of statistics of ovary group.

Subordinate list bone morphometry result

Group m10 ^-1)	Quantity	TBV(％)	Th.T(μm·10 ^-2)	Th.S(μ
Group m10 ^-1)	Quantity	TBV(％)	Th.T(μm·10 ^-2)	Th.S(μ	Sham cut is removed group and is cut ovum group premarin group	6 6 6	38.433±2.391 31.468±1.864# 41.962±9.680 ^*	453.928±88.545 368.445±34.117# 460.879±68.810 ^*	600.321±193.655 806.365±108.930# 657.601±164.340

The XIANLING GUBAO group

6

36.468±6.412 ^*△

453.480±97.123 ^*△

748.109±114.263

Annotate ^*: with cut relatively P＜0.05 of ovary group, apparent property difference is arranged; #: remove relatively P＜0.05 of group with sham cut, apparent property difference is arranged; △ and sham cut are removed relatively P＞0.05 of group, no difference of science of statistics.

3 discuss

The notion of osteoporosis (osteoporosis) was at first proposed by Pommer in 1885, and it means osteopenic a kind of disease.1948, Ibright thought that this disease is because estrogen decrease causes bone trabecula to form minimizing, the unusual a kind of disease of protein metabolism.Understanding to osteoporosis only limits to losing of bone amount in early days, emphasizes to carry high bone mass in treatment.Along with the progress of detection means and going deep into of understanding, research to the notion of osteoporosis begins to expand on the bone structure, emphasize to recover the importance of bone structure, therefore WHO in 1994 organizes the notion to osteoporosis to redefine, point out " osteoporosis is the amount minimizing with osseous tissue; the microstructure of bone is degenerated, and causes the fragility of bone to increase a class disease that is easy to fracture ".The principal element of decision fracture is a bone strength, our another studies show that the change of bone amount and bone strength is also not parallel, and the vertebral body bone density reduced 50% approximately from 20 years old to 80 years old, and vertical compression intensity only reduce to 20 years old 25%, horizontal compressive strength reduces to has only 5%.Modern clinically carry out the observation of bone structure in normal range by the patient that the bone amount is taken place Hip Fracture, find that tangible structural change takes place its bone trabecula, thereby point out to lower caused fracture risk because the increase of the caused fracture risk of degeneration of bone structure will be higher than by the bone amount.

After the oophorectomize, because estrogen level descends rapidly, the osteoclast function is active, and bone resorption increases, and is difficult to remedy the formed bone lacuna of osteoclast by the new bone quantity that osteoblast forms.Simultaneously, exist of short duration bone loss in the bone transformation process, estrogen level reduces the high transition status that causes and not only quickens the bone loss that negative balance causes, has also increased temporary transient bone loss simultaneously, significantly changes thereby cause on the bone structure.Show as Trabecula Bone Volume and reduce on the statics parameter, bone trabecula thickness narrows down, and the gap increases; The connection that is changed between the girder that occurs three dimensional structure under light microscopic, Electronic Speculum reduces, and free-end increases, even the space occurs, causes the damage that is difficult to repair.

The Chinese medicine osteoporosis is many to be main Therapeutic Principle with the kidney invigorating, " kidney governing bones ", and the kidney invigorating promptly is a bone strengthening.XIANLING GUBAO JIAONANG is made up of medicines such as Herba Epimedii, Rhizoma Drynariae, by the performance Herba Epimedii " physical strength profiting, strong will, hard muscles and bones ", thereby makes " Yuanyang is bestirred oneself ", and the bone trabecula amount in the unit volume increases, and girder thickness increases, and structure obtains recovery to a certain degree.According to we experimental result as can be seen, bone structure compensatory has certain limit, no matter be premarin or XIANLING GUBAO, bone trabecular width is increased, can not recover the spacing of broad between the bone trabecula, illustrate when osteoporosis is serious, even increase the bone amount, also can only make bone structure obtain part and recover, and can't return to original state.Therefore the treatment of osteoporosis should be paid attention to prevention, just should not treat when bone structure as yet obvious regression takes place, and the effect of safeguarding bone structure is better than that bone structure is obviously degenerated, treat the serious time side of osteoporosis.

XIANLING GUBAO JIAONANG causes the influence of osteoporotic bone amount to removal ovary

Summary adopts OO method to set up the animal model of experimental rat osteoporosis, and postoperative gave XIANLING GUBAO, premarin treatment in 3 months respectively, observes treatment front and back rat body bone density, femur dry weight and bone calcium and changes.The result shows that XIANLING GUBAO can obviously improve the osteoporosis rat bone density, increases the femur bone mineral content, thus the effect of performance treatment osteoporosis.

Osteoporosis is ached with lower back, is easy to fracture and is main clinical manifestation.Along with the arrival of aging society, the treatment paid more and more attention of osteoporosis.For further inquiring into the mechanism of action of XIANLING GUBAO protect against osteoporosis, we adopt ovariectomized method to set up the animal model of primary osteoporosis, observe the influence of XIANLING GUBAO JIAONANG to animal pattern bone amount.

1 materials and methods

1.1 the medicine XIANLING GUBAO JIAONANG (the accurate word 1996 of medicine is defended No. 100019 in the Guizhou Province, Guizhou celestial miraculous cure industry company limited product, every contains crude drug 0.75g), (96 defend the accurate word J-35 of medicine number premarin, U.S. Hui Shi Ayerst company big pharmaceutical factory product, tablet, synthetic estrogens).

1.2 laboratory animal and raise 48 of 10 monthly age Healthy female SD rats, body weight 350 ± 20g provides (the Shanghai City medical experiment the care of animal committee laboratory animal quality certification number 01597) by laboratory animal portion of Shanghai Univ. of Traditional Chinese Medicine.Each organizes the rat sub-cage rearing, and free picked-up standard rat feed is freely drunk distilled water, 22 ± 2 ℃ of room temperatures.

1.3 the animal grouping is divided into 6 groups with processing at random with experimental rat, the grouping of rat, quantity, administration and execution time see Table 1.Administration time March after the oophorectomize, administration is 3 months altogether; Dosage gives dose,equivalent respectively according to body surface area's method of converting.During operation, the dorsal part otch is adopted in the ketamine intraperitoneal anesthesia, and aseptic condition cuts skin, subcutaneous tissue down, extracts bilateral ovaries.Sham cut is removed group and is only excised a fritter intraabdominal adipose tissue.After the operation, every of every day give penicillin sodium salt 50,000 units, for three days on end.

The grouping of table 1 animal, operation, administration situation

Grouping	The execution time	Number of elements	Operation method	Administration time and dosage
Grouping	The execution time	Number of elements	Operation method	Administration time and dosage	1 sham cut is removed group	Postoperative 3 months	6	The false excision of bilateral	-↓
2 oophorectomize groups	Postoperative 3 months	6	Bilateral oophorectomy	-↓	1 sham cut is removed group	Postoperative 3 months	6	The false excision of bilateral	-↓

3 sham cuts are removed group	Postoperative 6 months	8	The false excision of bilateral	-↓
3 sham cuts are removed group	Postoperative 6 months	8	The false excision of bilateral	-↓	4 oophorectomize groups	Postoperative 6 months	8	Bilateral oophorectomy	-↓
5 premarin groups	Postoperative 6 months	10	Bilateral oophorectomy	Postoperative administration in three months 0.01mg every day, 3 weeks of logotype, stopped using for 1 week, treated altogether 3 months	4 oophorectomize groups	Postoperative 6 months	8	Bilateral oophorectomy	-↓
5 premarin groups	Postoperative 6 months	10	Bilateral oophorectomy		6 XIANLING GUBAO groups	Postoperative 6 months	10	Bilateral oophorectomy	0.11 of postoperative administration in three months every day, logotype 3 months

1.4 bone density test experience animal is with DPX-L type (U.S. LUNAR company product, can compose 38/7akev, high pressure stable ± 0.05%, instrument precision 1%, attached animal whole body bone densitometry software) dual intensity X line borne densitometers is done bone mineral density (BMD) mensuration, fluorescent screen shows measures image, automatically print result.

1.5 rat femur dry weight and calcium content of bone take out femur after detecting and putting to death rat, reject clean muscle and connective tissue, the clean pulp cavity of normal saline flushing, and 120 ℃ of oven dry 1h, Archimedes principle, ten thousand/balance weighs, and measures density.Then femur is placed degreaser (chloroform: methanol=2: 1v/v) 72h, 120 ℃ the baking 6h, cooling is weighed, this heavy comparing with volume is dry weight.The Lanthanum (III) nitrate method is measured the rat femur calcium content of bone, the smart 0.1g ashing bone that claims, 4ml dissolving with hydrochloric acid, 1000 times of 0.2% lanthanum nitrate hexahydrate dilutions, atomic spectrophotometer test.

1.6 statistical procedures is respectively organized all observed results of rat all with mean ± standard deviation x ± s) expression, relatively adopts the t check between two groups of means.

2 results

2.1 DEXA bone density result shown in table 2～3 after the rat ovary excision 3 months, whole body bone density are showing and are being lower than sham cut and remove group " W T B X " (P＜0.05=, prompting osteoporosis animal model is set up.After the rat ovary excision 6 months, bone density was starkly lower than sham cut and removes group (P＜0.025=.Can obviously improve the process that bone loss quickens after using the XIANLING GUBAO treatment, carry high bone mass, remove relatively no significant difference (P " W T B Z "＞0.05) of group with sham cut, similar with the result who uses the premarin treatment, zero difference between each group.

Table 2 removal ovary is to result's (postoperative 3 months) of rat body bone density influence

Group	Quantity	BMD(g·cm-2)
Group	Quantity	BMD(g·cm-2)	Sham cut is removed group oophorectomize group	6 6	0.399±0.017 0.377±0.013△

△ and sham cut are removed group relatively:＜0.05

Table 3 medicine is to result's (postoperative 6 months) of rat body bone density influence

Group	Number of elements	BMD(g·cm-2)
Group	Number of elements	BMD(g·cm-2)	Sham cut is removed group (15 monthly age) oophorectomize group (15 monthly age) XIANLING GUBAO group premarin group	8 8 8 8	0.405±0.019 0.376±0.010▲ 0.397±0.015△ 0.391±0.018△

Annotate: compare P＜0.05 with the oophorectomize group; ▲ remove relatively P＜0.05 of group with sham cut; △ and sham cut are removed relatively P＞0.05 of group

2.2 rat femur dry weight and bone calcium measurement result spay after 6 months rat femur dry weight and calcium content of bone all be starkly lower than sham cut and remove group and medication therapy groups.Each treatment group and sham cut are removed equal no significant difference (seeing Table 4) between group.

Table 4 medicine is to the influence of rat femur dry weight and calcium content of bone

Group	Number of elements	Femur dry weight (gcm-3)	Bone calcium (mgcm-3)
Group	Number of elements	Femur dry weight (gcm-3)	Bone calcium (mgcm-3)	Sham cut is removed group oophorectomize group premarin group XIANLING GUBAO group	8 8 10 10	1.204±0.100 1.050±0.052 1.161±0.094△ 1.241±0.164△	301.69±22.66 263.95±15.63▲ 289.31±27.58▲ 305.33±33.69△

Annotate with sham cut and remove relatively P＜0.05 of group; ▲ compare P＜0.05 with the oophorectomize group; △ and oophorectomize group be P＜0.01 relatively.

3 discuss

Detect by the index of experimental specimen being carried out these three reflections of whole body bone density, femur dry weight and calcium content of bone bone amount, the result shows that the obvious reduction of bone amount can appear later in 3 months in oophorectomize, removing group with sham cut relatively has apparent property difference, and 6 months rat model whole body bone densities, femur dry weight and calcium content of bone obviously reduce after the spay.Use after the XIANLING GUBAO JIAONANG treatment, can obviously improve the rat body bone density, increase femur dry weight and calcium content of bone, carry high bone mass.

Present understanding to the osteoporosis Chinese medicine, Most scholars is with the category of osteoporosis ownership " atrophic debility of bones ", think that its main etiology and pathogenesis is to suffer from a deficiency of the kidney, this and Chinese medicine are to the elaboration of skeletal growth law of development be undivided (2).The Chinese medicine theory is thought, kidney controlling essence storage, and the smart marrow of giving birth to, marrow occupy in the bone, and skeleton depends on marrow to supplement nutrition." element asks YIN YANG classification of natural phenomena big opinion " has " kidney producing bone marrow ... is bone at body, dirty be kidney ... ".If deficiency of kidney-essence, bone and nutrient marrow are not enough and generation skeleton pathological changes.So " Ling Shu Miraculous Pivot or Divine Axis Benshen opinion " has " essence is hindered then bone acid flaccidity with cold limbs ".It points out that the prosperity and decline of strong and essence in kidney of skeleton is closely related, and essence in kidney is full, and negative and positive are coordinated, and then the change of skeleton is given birth to active, strong strong; Lose void as if deficiency of kidney-essence, kidney qi, imbalance of YIN and YANG then bone marrow mistake fills, and skeleton loses foster and causes osteoporosis.The effect that the XIANLING GUBAO JIAONANG principal agent is a Herba Epimedii, and Herba Epimedii has another name called Herba Epimedii, and main product is in Guizhou, Hubei and other places, belongs to the kidney-replenishing medicine, and according to the record of Compendium of Material Medica, Herba Epimedii has " physical strength profiting, strong will, hard muscles and bones, all the Yuanyang merit of bestirring oneself "; Can also synthetism in the time of the Rhizoma Drynariae kidney-replenishing.Effect by above-mentioned two medicines reaches the tonification kidney yang, and congenital essence is replenished, and bone marrow must be supported, and is strong strong.

Calcium is the important component that constitutes bone mineral, and the minimizing of the reduction prompting bone mineral content of calcium content of bone by to premenopausal and postmenopausal women focile Density Detection, shows that its focile mineral content of postmenopausal women obviously reduces, and has compared apparent difference (3) before the menopause.Therefore, calcium content of bone increase for the reduction that improves the bone mineral content that causes because of menopause significant.Ovariectomized rat can obviously improve bone calcium through XIANLING GUBAO treatment after 3 months, but its mechanism that improves calcium content of bone it be unclear that, may to influence the activity of osteoblast, osteoclast relevant with XIANLING GUBAO.Modern study shows, the Herba Epimedii monomer has the ability (4) that suppresses osteoclast propagation and form bone lacuna to the osteoclast of In vitro culture, the cultured osteoblasts in vitro experiment shows that also Herba Epimedii can promote osteoblastic differentiation and propagation (5) again, by influence to two kinds of cells participating in the bone conversion, regulate the content of bone calcium, thereby bringing into play the effect of its treatment osteoporosis.This experimental result confirms that also XIANLING GUBAO has the bone amount of elevation model animal, thereby reaches the purpose of protect against osteoporosis.

Plain clinical observation brief summary to osteoporosis effect behind the traumatic paralysis falls in XIANLING GUBAO and calcium

(attached clinical observation report)

Calcitonin is that modern medicine is treated one of osteoporotic main medicine, is come out by C emiocytosis in the thyroid.Amount and gonadal hormone that it produces have confidential relation, think that in the past gonadal hormone acts on osteocyte by calcitonin, blood calcium is descended reach the effect that the interior calcium phosphorus balance of body plays treatment osteoporosis and other orthopaedics illness, and the osteoporotic method of therapy of combining Chinese and Western medicine, then be to control by dialectical opinion, adopt effective kidney-nourishing tcm drug Herba Epimedii (Epimedium laptorrhizum) to be treated, carry out according to " interior warp " " kidney governing bones " is theoretical.This group clinical observation purpose: observe traditional Chinese medical science kidney-reinforcing drug to osteoporosis, particularly whether disuse osteoporosis is effective after the paraplegia, and observes jointly with calcitonin, understands the osteoporotic effect of the two type in treating this.

Clinical data and observational technique

One, case source: 20 years old to 55 years old patient's 16 examples of male among the existing complete paraplegia patient of spinal cord injury section of Beijing China Rehabilitation Research Center are divided into 3 groups at random: the contrast level, and CT organizes (being the calcitonin group), and KT organizes (being the XIANLING GUBAO JIAONANG group).

Two, observation index and method:

(1) index:

1, erythrocyte sedimentation rate, blood Ca, serium inorganic phosphorus, creatinine, urine Ca, alkali phosphatase.

2, bone density measurement: use X-ray bone density meter (QDR-1000USA Hologic) to carry out the measurement of waist three, neck of femur, femoral shaft bone density.

(2) method: promptly carry out detecting first time above every index after the experiment beginning, later CT group gives CT, the kidney invigorating group and gives each three of KT every day three times (KT is provided by Guiyang College of Traditional Chinese Medicine's orthopedics department research, and duplicate detection is once as a means of contrasting after medication January)

Testing result

(1), paralytic patient uses CT and the kidney invigorating cross-reference in No. 1 January to the results are shown in Table I

Table I complete paraplegia patient uses medicine CT, and ESR, blood Ca, blood P, alkali phosphorus enzyme change after the kidney invigorating No. 1 January.

Table I: the change of treatment front and back in January ESR, blood calcium, phosphorus, alkali phosphatase

		ESR(mm/hr)	Ca(mmol/L)	P(mg％)	AKP(ku)
		ESR(mm/hr)	Ca(mmol/L)	P(mg％)	AKP(ku)	Control	Front and back	7.5±5.56	1.25±0.01	3.90±0.40	76.5±18.7
7.75±7.74	0.99±0.06	3.58±0.65	62.25±8.42					7.5±5.56	1.25±0.01	3.90±0.40	76.5±18.7
7.75±7.74	0.99±0.06	3.58±0.65	62.25±8.42	CT	Front and back			8.25±5.37	1.23±0.07	3.68±0.50	56.5±5.90
6.25±5.90	1.0±0.02	3.56±0.28	66.25±3.90					8.25±5.37	1.23±0.07	3.68±0.50	56.5±5.90
6.25±5.90	1.0±0.02	3.56±0.28	66.25±3.90			KT	Front and back	20.75±11.35	1.21±0.075	4.0±0.42	92.25±14.4
13.75±2.87	1.02±0.01	4.38±0.81	94.0±14.8					20.75±11.35	1.21±0.075	4.0±0.42	92.25±14.4

(2), paralytic patient uses CT and the kidney invigorating cross-reference in No. 1 January to the results are shown in Table II

Table II, the complete paraplegia patient uses medicine (CT, No. 1, the kidney invigorating) front and back in January result

Table II: the change of treatment front and back in January waist three, neck of femur, femoral shaft bone density

		L3	Fem·Head	Fem·shif
		L3	Fem·Head	Fem·shif	Control	Front and back	0.91±0.09	0.69±0.90	0.67±0.58
0.89±0.12	0.66±0.17	0.37±0.01					0.91±0.09	0.69±0.90	0.67±0.58
0.89±0.12	0.66±0.17	0.37±0.01	CT	Front and back			0.87±0.21	0.621±0.07	1.05v0.45
0.87±0.20	0.615±0.07	1.137±0.25					0.87±0.21	0.621±0.07	1.05v0.45
0.87±0.20	0.615±0.07	1.137±0.25			KT	Front and back	0.857±0.11	0.654±0.08	0.924±0.49
0.861±0.08	0.656±0.03	0.831±0.40					0.857±0.11	0.654±0.08	0.924±0.49

(3), paralytic patient uses CT and the kidney invigorating cross-reference in No. 1 January to the results are shown in Table III

Table III, the complete paraplegia patient uses medicine (No. 1, CT, the kidney invigorating) result after January

Table III: calcium, creatinine and urine calcium creatinine ratio are urinated in treatment before and after January

		Ca	Cr.(mg/％)	Ca/Cr.
		Ca	Cr.(mg/％)	Ca/Cr.	Control	Front and back	1.02±0.64	75.2±25.90	0.014
0.68±0.60	93.75±75.07	0.01					1.02±0.64	75.2±25.90	0.014

CT	Front and back	1.46±0.58	62.38±26.70	0.023
		1.46±0.58	62.38±26.70	0.023	1.15±0.54	81.82±24.24	0.01
		KT	Front and back	1.19±0.88	1.15±0.54	81.82±24.24	0.01	92.53±74.18	0.01
1.55±0.49	98.20±116.69			1.19±0.88	0.02			92.53±74.18	0.01

Discuss

One, erythrocyte sedimentation rate: each organizes the initial survey meansigma methods is that 6.2 ± 5.9-20.75 ± 11.35 are the highest with the kidney invigorating group patient meansigma methods, but its decline is fast than other group also behind the use medicine, possible this group patient is when being examined, the dysequilibrium situation is still arranged in the body, or still has some mild inflammation, but within January, its ESR decline the fastest (20.75 ± 11.35-13.75 ± 2.87) descended about 10mm/1 hour after the use XIANLING GUBAO JIAONANG.This group case performance erythrocyte sedimentation rate is in normal high-level boundary in spinal column paraplegia.CT group erythrocyte sedimentation rate degradation down is little, matched group and little rising arranged.

Two, calcium, phosphorus balance problem: matched group is not owing to use any medicine.Its calcium, phosphorus have balance phenomenon.Often keep balance in vivo because of calcium phosphorus, under nonuser situation, calcium, phosphorus do not have compensation phenomenon.Calcium, phosphorus all have downward trend simultaneously, illustrates that calcium after the paraplegia, phosphorus balance problem it is noted that as additional calcium, phosphorus or give to adjust the Chinese and western drugs of calcium, phosphorus.

CT group blood calcium descends to some extent, and is on the rise but phosphorus does not also descend with calcium, illustrates that CT has part to adjust calcium, the effect of phosphorus homoiostasis.XIANLING GUBAO JIAONANG uses the back blood calcium to descend, and phosphorus also obviously raises, and illustrates that this product has better action at adjusting calcium, phosphorus balance.Basically calcium, the normal ratio of phosphorus have been kept.Further specify XIANLING GUBAO JIAONANG and have the homeostatic effect of adjusting.

Alkali phosphatase changes, and matched group has downward trend, illustrate that in time passing repairs vigor aspect matched group and descend to some extent, no matter and medication group CT group or KT group all rise to some extent, and organize comparatively obvious with CT.Illustrate that CT group increases to bone active, KT group increasing too.

The change of bone X line density: X line bone density meter (QDR-1000USA Hologic) is computer-controlled, and is possessing the standard of each age group normal value, so can accurately calculate the bone density height.Organize a small amount of patient's statistics according to this.This group case density waist three is that 0.857 ± 0.112-0.9, neck of femur are 0.515 ± 0.07-0.69 ± 0.90, femoral shaft 0.37 ± 0.01-1.137 ± 0.253, the waist triple density removes XIANLING GUBAO JIAONANG treatment group slightly raise (0.857 ± 0.112-0.961 ± 0.08), CT does not have change fully, and same neck of femur density KT group also has rising.And the CT group slightly descends.It is all on the rise to waist three and neck of femur density that XIANLING GUBAO JIAONANG is taken the back in a word.

Macroelement such as calcium phosphorus in the XIANLING GUBAO JIAONANG, trace elements zn, Mn content are all high, may provide the source for inorganic salt replenishes.

Brief summary

1, after the paraplegia, calcium phosphorus homoiostasis has detuning phenomena.Calcium, phosphorus all have decline.And losing of medication group phosphorus has improvement.And relatively can improve the level of phosphorus significantly with kidney-reinforcing drug (XIANLING GUBAO JIAONANG).

2, alkali phosphatase: contrasting after the medication has rising, illustrates that medication has the active function that promotes osteocyte.

3, XIANLING GUBAO JIAONANG has the effect that improves bone density or prevent bone density decline.

The XIANLING GUBAO JIAONANG clinical verification is summed up

Observational technique

One, case selection:

1, the age was necessary for more than 50 years old, idiopathic osteoporosis.

2, must have sore waist and aching in the waist and the back or arthralgia symptom person.

3, must possess the report of dual intensity X-bone densitometry, and the bone density at one of them position of waist or wide hip must be lower than 1 or 2 above persons of standard deviation of peak bone mass.

Two, the content of Guan Chaing:

1, pain: divide three of rest pains, movable pain, percussion pain, its degree is divided into, serious (3 minutes), medium (2 minutes), slight (1 minute), painless (0 minute).

2, bone density is measured lumbar vertebra, hip do treatment cross-reference with dual intensity X line, and measuring before and after the treatment must be same machine.

3, toxic reaction, the back of taking medicine is observed not gastrointestinal reaction, anaphylaxis and other pair reaction.

Three, the instructions of taking and the course of treatment:

XIANLING GUBAO JIAONANG (the accurate word (1996) of medicine is defended No. 100019 in the Guizhou Province), specification 0.5g/ grain is oral, every day secondary, each three, three months is a course of treatment, observes two courses of treatment (6 months), does once preliminary brief summary in three months, does summary in six months.

Four, the evaluation of curative effect:

1, individual event curative effect

It is produce effects that symptom pain integration reduces greater than 2/3

It is effective that the pain integration reduces greater than 1/3

Less than 1/3 is invalid.

Bone density increase＞2%BMD is a produce effects

It is effective increasing 0-2%BMD

Be invalid below＜0%

2, total effects

Produce effects: symptom is obviously improved, integration reduce greater than 2/3 or bone density increase＞2%.

Effectively: symptom makes moderate progress, integration reduce greater than 1/3 or bone density increase 0-2%.

Invalid: symptom does not have improvement, and integration reduces deficiency, or bone density reduction person.

Clinical data

One, age and sex

1, the age: this group is observed 90 routine primary osteoporosiies altogether, and the age minimum is 51 years old, is 85 years old to the maximum, and the mean age is 72.8 years old.Wherein: 50-59 year accounts for 5.6%, and 60-69 year accounts for 23.3%, and 70-79 year accounts for and accounts for 7.8%. more than 63.3%, 80 years old

2, sex: in 90 examples, the male accounted for 50% in 45 years old, and women's 45 examples account for 50%, M-F 1: 1.

Two, the situation of bone density

According to the regulation of testing program, select for use dual intensity X bone densitometry report to select to be lower than peak value 1SD or the above person of 2SD in lumbar vertebra or any one position of hip.

1, the distribution of osteoporosis degree

The bone density case is selected situation

BMD	＞1SD	＞2SD	＞2.5SD
BMD	＞1SD	＞2SD	＞2.5SD	Example	22	15	53

Annotate: bone density peak value decline＞1SD is slight osteoporosis;＞2SD is the moderate osteoporosis; 2.5SD be serious osteoporosis.

2, bone density distribution situation: the above person of bone density decline 2SD accounts for the great majority of this group, and what account for each position BMD situation 2SD respectively accounts for 61.1% and 56.7%.

The bone density distribution situation

Lumbar vertebra		Hip
Lumbar vertebra		Hip		＞1SD	＞2SD	＞1SD	＞2SD
Example	19	55	25	＞1SD	＞2SD	＞1SD	＞2SD	51

3, each position BMD situation

Each position BMD situation g/cm ²

Lumbar vertebra

Neck of femur

Ward’s

0.835±0.135

0.690±0.377

0.431±0.160

4, pain situation: this organizes among the 90 routine patients pain based on moderate and severe, is main pain situation with rest pain in rest pain and the movable pain

	Static	Movable pain
	Static	Movable pain	Slightly	0	0
Moderate	41	18	Slightly	0	0
Moderate	41	18	Severe	18	13

The result

One, total effects

Total effects, primary disease is MAIN OUTCOME MEASURES with the changes of bone mineral density, so it is produce effects that total effects improves＞2% with bone density, 2-0% is effective,＜0% is invalid, and the curative effect when this organizes in 90 examples three months is 86.7% of an aggregate efficiency, and obvious effective rate is 55.6%, the curative effect of 73 examples after six months is 90.4% of an aggregate efficiency, and obvious effective rate is 71.2%.

	Total effects
	Total effects					Example	Produce effects	Effectively	Invalid	Total effective rate
Three months six months	90 73	56(62.2％) 52(71.2％)	20(22.2％) 14(19.21％)	14(15.6％) 7(9.6％)	84.4％ 90.4％	Example	Produce effects	Effectively	Invalid	Total effective rate

Learn to handle (Ridit) u=1.111 three months and six months therapeutic outcome no significant difference by statistics.

Two, individual event curative effect

1, pain curative effect

Analgesic effect is comparatively obvious in the 90 example treatments, generally begins to occur effect in 2 weeks, can control or relief of symptoms about 1 month, only has 2 examples to still have pain in the time of three months.Pain relieving second course of treatment is not as main observation item.

Analgesic effect

Produce effects	Effectively	Invalid	Effective percentage
Produce effects	Effectively	Invalid	Effective percentage	59(65.6％)	29(32.3％)	2(2.2％)	97％)

2, changes of bone mineral density

(1), dual intensity X line bone densitometry is general surveys 4 positions, is respectively normotopia L _2-4Hip neck of femur, big thick neck and ward ' s district also have unit to survey 5 positions, add lateral lumber spine L on basis, above-mentioned four positions ₃, sending out in the detection five positions of patient existing increases simultaneously, and what have then is that (seeing Table 8) increased at a position.

Table 8 position bone density increases situation

Example	A position	Two positions	Three positions	Four positions	Five positions
Example	A position	Two positions	Three positions	Four positions	Five positions	Three months 90 6 months 73	36 30	23 12	15 19	5 4	0 1

(2) its density increases the comparison of situation between different observation period, from routine number in the time of three months spinal column to increase ratio higher, hip is then less, in the time of six months relatively hip then be significantly improved.And six months meansigma methods of BMD all increased than three months.

	Normotopia example BMD	Side position example BMD	Neck of femur example BMD	Big thick neck example BMD	Ward example BMD
	Normotopia example BMD	Side position example BMD	Neck of femur example BMD	Big thick neck example BMD	Ward example BMD	Three months with the treatment before than six months with the treatment before than six months with three months the ratio	42/90 0.33 31/73 0.034 33/73 0.035	32/60 0.066 31/53 0.077 20/53 0.054	29/90 0.027 23/73 0.051 40/73 0.032	12/60 0.031 13/60 0.023 29/60 0.025	25/90 0.038 27/73 0.044 44/73 0.041

(3), bone density therapeutic outcome.This group observed result, XIANLING GUBAO has obvious therapeutic action to osteoporosis, and to the influence of bone density, six months result was obviously than three months, but not statistically significant.

The therapeutic outcome of bone density

	n	＞2% produce effects	2-0% is effective	＜0% is invalid
	n	＞2% produce effects	2-0% is effective	＜0% is invalid	Three months six months	90 73	56(62.2％) 52(71.2％)	20(22.2％) 14(19.2％)	14(15.6％) 7(9.6％)

Untoward reaction

Beginning a period of time has individual patients constipation, xerostomia, dry lip phenomenon to occur among the 90 routine patients, can alleviate after anti symptom treatment also and can take medicine in the same old way, observes nothing through long-term prescription above-mentioned symptom is taking place, and no gastrointestinal reaction does not have other untoward reaction.

Brief summary

1) XIANLING GUBAO JIAONANG treatment osteoporosis, through six months therapeutic outcome of these three of us hospital 90 cases, it can improve and alleviate the pain symptom that osteoporosis causes on the one hand, and obviously improved the Leg Cramps phenomenon that causes because of osteoporosis, simultaneously to the bone density effect that also is significantly improved.

2) this medicine taking convenience is convenient to secular taking at every day three times, each two, and nontoxic pair of reaction is worthy to be popularized.

XIANLING GUBAO ZHIJI treat 64 routine osteoporosises, femur necrosis and fracture the clinical treatment brief summary we united six four tame hospitals of unit and observed 64 routine cases from different viewing angle cooperations jointly, the result still has same result with basic research.Now comprehensively be described below:

The cooperation of this group is totally six units, and four tame hospitals are wherein arranged, and observes from different perspectives, acts in accordance with the division of their functions and duties.Detailed programs are looked under each hospital conditions, and respectively from biochemical, radioimmunity, X line bone density, and clinical gross examination of skeletal muscle are though case load is few, all than deeply observing from different directions.

Male 48 people in case 64 examples, women 16 people.The age reckling is 52 years old, the maximum 85 years old, 64.57 years old mean age. hip femur head necrosis 16 examples wherein, intertrochanteric fracture of the femur 6 examples.Vertebral compression fracture 11 examples, fracture of femoral neck 29 examples.Clinical cure rate 86.36%, effective 11.6%, 2 example is not controlled because of other sick section.Effective percentage reaches 97.96%.

One, clinical biochemical detects:

(1) index: erythrocyte sedimentation rate, blood calcium, serium inorganic phosphorus, creatinine, urine calcium, alkaline phosphorus enzyme.

(2) method: case is divided three groups, 1 matched group: 2 calcitonin groups; 3 the kidney invigorating medicines (QLH) group.Promptly carry out detecting the first time above every index after the experiment beginning.The CT group gives to fall calcium 50iu then, and inferior on every Wendesdays, the kidney invigorating group gives three slices/time of pharmacy, three times/day.Repeat once all detections again after 45 days end of term of experiment.

(3) result:

1 paralytic patient uses CT (calcitonin) and No. 1 results of comparison of the kidney invigorating to see Table 1

Table 1. complete paraplegia patient use calcitonin, the kidney invigorating after No. 1 January ESR, blood calcium Ca, P, AKP change:

Project level		ESR(mm/ml)	Ca(mmol/l)	P(mg％)	AKP(Ku)
Project level		ESR(mm/ml)	Ca(mmol/l)	P(mg％)	AKP(Ku)	Matched group	Front and back	7.4±5.54 7.65±7.02	1.23±0.01 0.09±0.05	3.89±0.40 3.58±0.06	76.5±17.8 62.25±8.41
The calcitonin group	Front and back	8.24±5.14 6.24±5.86	1.33±0.07 1.01±0.03	3.65±0.51 3.56±0.26	56.5±5.78 66.24±3.87	Matched group	Front and back	7.4±5.54 7.65±7.02	1.23±0.01 0.09±0.05	3.89±0.40 3.58±0.06	76.5±17.8 62.25±8.41
The calcitonin group	Front and back	8.24±5.14 6.24±5.86	1.33±0.07 1.01±0.03	3.65±0.51 3.56±0.26	56.5±5.78 66.24±3.87	No. 1, the kidney invigorating	Front and back	20.70±10.24 12.67±2.58	1.21±0.064 1.02±0.02	4.01±0.43 4.34±0.60	91.78±14.8 93.13±13.5

Presentation of results: No. 1, the kidney invigorating has certain effect to keeping of bone density.

2 paralytic patients use CT and the kidney invigorating front and back calcium in No. 1 January, phosphorus, creatinine change.

Table 2, bone paralytic patient use calcitonin and the kidney invigorating are urinated calcium, creatinine after No. 1 January, are reached ca/cr ratio fully.

Project level		Urine calcium (mgl%)	Creatinine (mgl%)	Urine calcium/creatinine
Project level		Urine calcium (mgl%)	Creatinine (mgl%)	Urine calcium/creatinine	Matched group	Front and back	1.02±0.64 0.68±0.60	75.2±25.9 93.75±75.07	0.014 0.01
The calcitonin group	Front and back	1.46±0.58 1.15±0.54	62.38±26.70 81.82±24.24	0.023 0.01	Matched group	Front and back	1.02±0.64 0.68±0.60	75.2±25.9 93.75±75.07	0.014 0.01
The calcitonin group	Front and back	1.46±0.58 1.15±0.54	62.38±26.70 81.82±24.24	0.023 0.01	No. 1 group of the kidney invigorating	Front and back	1.19 0.88 1.55±0.49	92.53±74.18 98.20±116.96	0.01 0.02

Data analysis:

1, except that the kidney invigorating group all the other two groups decline is all arranged, the kidney invigorating group urine calcium has increase.

2, three groups of creatinines all have increases and serves as obvious with the CT group.

3, increase morely whether can think that kidney-reinforcing drug strengthens to some extent to the absorption of calcium in the urine calcium/creatinine the kidney invigorating group outside, absorb with drainage direct relation should be arranged, the increase of calcitonin group creatinine is comparatively remarkable, whether can think that this group has certain influence to the metabolism that promotes the creatinine aspect.

Two, penetrate detections such as immunology and cholesterol.

Table 3 radioimmunity IgC, IgALgh reaches triglyceride, cholesterol, and lipoprotein uses No. 1 front and back of the kidney invigorating to become:

The project medication	IgC Mg/ml	IgA mg/ml	IgH mg/ml	Cholesterol mg/dl	Triglyceride mg/dl	B lipoprotein mg/dl
The project medication	IgC Mg/ml	IgA mg/ml	IgH mg/ml	Cholesterol mg/dl	Triglyceride mg/dl	B lipoprotein mg/dl	Before the medication	9.98±0.14	1.97±0.84	0.8±0.37	207.78±28.65	167.78±62.41	416.76±19.82
After the medication	10.42±1.68	1.63±0.68	0.07±0.26	248.40±36.37	153.5±57.10	421.0±98.97	Before the medication	9.98±0.14	1.97±0.84	0.8±0.37	207.78±28.65	167.78±62.41	416.76±19.82

Data analysis:

1.IgC albumen is the part that mainly contains antibody, increases to some extent behind the use kidney-reinforcing drug.

2.IgA globulin antibody is to be present in the slurry property slime body, is positioned at mucomembranous surface, and opposing exotic invasive antibacterial is worked, this group data have decline.

3.IgH increase to some extent after the medication.

4. cholesterol increases, and triglyceride descends and beta Lipoprotein raises.

The result shows that the antibody increase shows that IgC increases after main antibody moiety uses the kidney invigorating medicine, though mucoantibody does not have very influence because of not quite having to descend with the bone relation, the increase of IgH represents that activating complement increases the resistant function of favourable body, the cholesterol increase can be used as the formation that endogenous level prohormone material helps gonadal hormone, and liver oil three fat descend simultaneously has reduction trend to blood vessel scleratheroma.

Three, other radioimmunology is checked.

FSH (follicule-stimulating hormone (FSH)) LH (lutropin) E in the radioimmunology behind the table four use kidney-reinforcing drug ₂(estradiol) T (first gland), T ₃(the former gland original ammonia acid of tetraiodo first gland).

The project medication	PSR(lu/L)	LH(lu/L)	E2(pwol/L)	T(pwol/L)	T3(wg/ml)	T4(wg/dl)
The project medication	PSR(lu/L)	LH(lu/L)	E2(pwol/L)	T(pwol/L)	T3(wg/ml)	T4(wg/dl)	Before the medication	7.8±2.44	8.6±2.1	181.3±33.87	16.58±8.9	2.66±0.96	12.6±3.37
After the medication	10.42±1.63	1.63±0.58	121.48±38.61	19.39±g.9	2.36±0.19	10.05±2.75	Before the medication	7.8±2.44	8.6±2.1	181.3±33.87	16.58±8.9	2.66±0.96	12.6±3.37

Data analysis:

1, the LH/FSH-RH value increases in the gonadal hormone.

2, E2 descends to some extent.

3, T is little has rising and T3T4 decline. and presentation of results gonadal hormone after using kidney-reinforcing drug changes to some extent, E2 descends to some extent, but the LH/FSH-RH value of modulability hormone increases, this can directly act on the secretion that hypophysis increases CANP and promotes sex gland hormones, T3 is that thyroid active part T4 is the basis of forming T3, though the active total thyroxin T level that descends to some extent then slightly raises to some extent.

Discuss:

1, the Chinese medicine XIANLING GUBAO all has the effect of promote repairing in osteoporosis, femur necrosis and fracture to different situations, is challenging from the complete paraplegia patient with the assay of the X-ray bone density of property osteanabrosis particularly.CT group is only kept bone density, though and preparation to the density of bone still can some raising for amount seldom, treatment time, only during one month, medicine time, more permanent its effects were better.

2, kidney-nourishing tcm drug " XIANLING GUBAO " has the inner equilibrium effect of regulating body, is to have the effect that is beneficial to the body regulation and control from the change of thyroid and gonadal hormone.

3, there is tangible effect to show the corresponding raising of AKP to calcium phosphorus.The degree of repairing at any time because of the rising of erythrocyte sedimentation rate behind bone damage descends, and it is that speed promptly illustrates the effect that this favourable sclerotin is repaired that this group experiment kidney-reinforcing drug can make erythrocyte sedimentation rate descend than the CT group.

" XIANLING GUBAO " capsule for treating middle-aged and senile osteoporosis and fracture 119 routine clinical reports

Clinical data

Physical data

This group case 119 examples are divided into three types.

One type (climacteric type): 26 examples.50 years old mean age, average 48 years old menolipsis age; Wherein vertebral fracture 10 examples account for 38.4%; Hip Fracture 10 examples account for 38.4%; Ke Shi 5 examples of fracturing account for 19%, and fracture of calcaneus 1 example accounts for 15%.

Two types (veteran form): 73 examples.Man's 33 examples; Woman's 40 examples, maximum 96 years old age, minimal ages 61 years old, 76.5 years old mean age, intertrochanteric fracture 32 examples wherein, fracture of femoral neck 30 examples; Vertebral fracture 7 examples; Fracture of calcaneus 2 examples; Fracture of the surgical neek of the humerus 3 examples; Hip Fracture accounts for 86%, and vertebral fracture accounts for 9.6%, and fracture of the surgical neek of the humerus 3 examples account for 2.7%.Fracture of femoral neck merges vertebral fracture and Ke Shi 1 example of fracturing.

Three types: 20 examples.54 years old mean age, fracture of femoral neck 5 examples wherein, intertrochanteric fracture 7 examples, Ke Shi 3 examples of fracturing, fracture of calcaneus 3 examples, vertebral fracture 2 examples.

Injured reason: many because of slight external force as jolting by bus, slip and getting injured by a fall due to promptly life damages.Life damage 87 examples account for 73%, and indirect violence 32 examples account for 27%.Fracture kind classification: see Table one.

Table one

The diagnosis of classification of fractures table

The example number

Mean age

The male

The women

Fracture of femoral neck	41	71	15	26
Fracture of femoral neck	41	71	15	26	Intertrochanteric fracture	41	68	23	18
Vertebral fracture	19	59	12	7	Intertrochanteric fracture	41	68	23	18
Vertebral fracture	19	59	12	7	The Ke Shi fracture	9	54	5	4
Fracture of the surgical neek of the humerus	3	72	3	0	The Ke Shi fracture	9	54	5	4
Fracture of the surgical neek of the humerus	3	72	3	0	Fracture of calcaneus	6	55	4	2

Two, therapeutic modality: adopt the combination of Chinese and Western medicine promptly in traction, operation, on the basis of manual reduction external fixation, Chinese medicine for oral administration " XIANLING GUBAO " capsule.

1, fracture of femoral neck: bone draws 20 examples on the condyle of femur, average 56 days pull-in times, traction quality 5-8kg; Skin traction of lower extremity+" fourth " word footwear external fixation 5 examples; Bone traction+internal fixation 11 examples, internal fixation are forcing screw or osseous pin; Femoral head excision 5 examples.

2, intertrochanteric fracture of the femur: bone draws 28 examples on the condyle of femur, average 41 days pull-in times, trailing weight 5-8kg; Bone traction+internal fixation 4 examples, inner fixer are forcing screw; Skin traction+" fourth " word footwear external fixation 9 examples.

3, vertebral fracture: pelvic traction 3 examples, average 30 days pull-in times, weight 12.5-15kg; The lower back bolster, the hardboard bed that crouches, back flesh functional exercise 16 examples.

4, fracture of calcaneus: calcaneal traction 1 example; Manual reduction+plaster slab external fixation 5 examples, 30 days average fixed time.

5, Ke Shi fracture: manual reduction plintlet external fixation 8 examples, improvement colle ' s 1 example of performing the operation.

6, fracture of the surgical neek of the humerus: skin traction therapy 3 examples of swinging one's arm.Follow up a case by regular visits to 76 examples, follow-up rate 63%; The shortest 6 months, the longest 2 years, average 9 months.

Result: see Table two, table three:

Table two: 119 routine osteoporosis biochemistry and erythrocyte sedimentation rate detect tables of data

	Ca	P	AKP	ESR
	Ca	P	AKP	ESR	Front and back	Front and back	Front and back	Front and back
	Fracture of femoral neck	2.30 2.21	1.15 1.40	11.8 12.1	Front and back	Front and back	Front and back	Front and back	68.8 19.8
Intertrochanteric fracture	Fracture of femoral neck	2.30 2.21	1.15 1.40	11.8 12.1	2.28 2.06	1.14 1.44	9.8 11.8	68.4 18.9	68.8 19.8
Intertrochanteric fracture	Vertebral fracture	2.30 2.26	1.15 1.20	9.36 11.08	2.28 2.06	1.14 1.44	9.8 11.8	68.4 18.9	50.3 14.6
Fracture of calcaneus	Vertebral fracture	2.30 2.26	1.15 1.20	9.36 11.08	2.36 2.30	1.18 1.44	9.6 11.5	47.3 16	50.3 14.6
Fracture of calcaneus	The Ke Shi fracture	2.39 2.35	1.19 1.12	7.05 9.16	2.36 2.30	1.18 1.44	9.6 11.5	47.3 16	38.6 13.3
Fracture of the surgical neek of the humerus	The Ke Shi fracture	2.39 2.35	1.19 1.12	7.05 9.16	2.4 2.35	1.08 1.12	8 12	42 10	38.6 13.3

Table three: 119 routine osteoporosis healing times and erythrocyte sedimentation rate average numerical tabular

	The ESR normal time (my god)	The clinical healing time (my god)	Bone healing time (my god)	Average hospital days (my god)	The functional rehabilitation acceptance rate	The common clinical union of bone time (my god)
	The ESR normal time (my god)	The clinical healing time (my god)	Bone healing time (my god)	Average hospital days (my god)	The functional rehabilitation acceptance rate	The common clinical union of bone time (my god)	Fracture of femoral neck	60	72.3	112.9	66.7	87.8％	126
Intertrochanteric fracture	50	52.8	78.5	54.8	92％	58.5	Fracture of femoral neck	60	72.3	112.9	66.7	87.8％	126
Intertrochanteric fracture	50	52.8	78.5	54.8	92％	58.5	Vertebral fracture	42	45	68	45	98％	49 ⁽²⁾
Fracture of calcaneus	24	24.6	3	34	100％	35	Vertebral fracture	42	45	68	45	98％	49 ⁽²⁾
Fracture of calcaneus	24	24.6	3	34	100％	35	The Ke Shi fracture	16	18	35	23	100％	25
Fracture of the surgical neek of the humerus	30	30	45	35	100％	35	The Ke Shi fracture	16	18	35	23	100％	25

Complication and processing: fracture of femoral neck is drawn concurrent decubital ulcer 1 example for a long time, ejects and abandons orthopaedics therapy, through changing dressings, heals after the physical therapy.

Four, analyze and discuss

Osteoporosis is a kind of sclerotin degeneration state, is to lose the sclerotin change that is reduced to feature of bone amount with bone.Osteoporosis then is a series of bone injury illness that cause or print and distribute after becoming with sclerotin, and various types of fracture promptly take place behind microtrauma, brings serious threat for the health of mid-aged population.

Motherland's medical science thinks that osteoporosis belongs to " atrophic debility of bones of suffering from a deficiency of the kidney disease ", ties up in the naturally-aged process of human body, and renal function begins to go down, and bone density reduces, and the bone amount reduces, and the absorption of bone is greater than due to the formation of bone." XIANLING GUBAO " capsule is that prominent domestic bone injury expert reaches the pure Chinese medicinal preparation of professor according to the clinical experience development for many years of " kidney governing bones " theory and combining the time, and it has significant curative effect to osteoporosis (disease) and the multiple orthopaedics illness that the control middle-aged and elderly people produces because of the body naturally-aged.Show from table two to table three: after taking medicine, blood calcium descends, and serium inorganic phosphorus increases, and alkali phosphatase raises, and erythrocyte sedimentation rate descends, and illustrates that " XIANLING GUBAO " capsule has calcium, phosphorus level in the control agent, promotes skeletonization; The bone clinical healing time is carried about the last week than the single method treatment after the medication.

, hemorrhage after the wound because fracture is the surrounding tissue damage, organize machineization, blood PH value descends, and plasma albumin reduces, and newborn globulin increases relatively, and Fibrinogen is hindered the back number and is significantly increased again, so erythrocyte sedimentation rate speeds.With tissue repair, erythrocyte sedimentation rate also descends thereupon later on, treats that fracture reaches before and after the clinical healing, and erythrocyte sedimentation rate is also reduced to normal range.That is illustrate that erythrocyte sedimentation rate drops to normal multilist and shows the clinical healing of fracturing. ⁽⁴⁾

To fracture of the surgical neek of the humerus, clinically see that with middle-aged and elderly people among the 119 routine patients of current sample, fracture of the surgical neek of the humerus 3 examples account for 2.7% more, still also it is listed in osteoporotic fracture.

Modern study shows that kidney-nourishing tcm drug can improve human body to promoting the reaction of gonadal hormone, improves the middle-aged and elderly people level of serum testosterone.The kidney invigorating method or kidney-nourishing tcm drug are adjustable, and complete machine body organ is being organized, and the ANOMALOUS VARIATIONS of biochemistry and ultrastructure aspect makes it to be tending towards normal.To the tissue of body, cell and basic structure composition have general enhancing and protective effect, can delay the old and feeble trend of gonadal tissues such as ovary, uterus, testis.Other has report, and kidney-nourishing tcm drug has a significant effect to osseous tissue, can improve the molten bone phenomenon of neuter.Be used for the clinical osteoporotic development that suppresses, the degeneration of prevention skeleton changes.(4) viewpoint of relevant with modern medicine " gonadal hormone can the directly act on the osteocyte receptor " part that plays the same tune on different musical instruments.

According to observation on Clinical Application, " XIANLING GUBAO " capsule is a kind of safe, effective, pure Chinese medicinal preparation of having no side effect, multiple orthopaedics illness such as osteoporosis that middle-aged and elderly people causes because of the atrophic debility of bones of suffering from a deficiency of the kidney and osteoporosis be can prevent and treat, various osteoarthritis and various old and feeble disease that middle aged and aged women declined and produces because of suffering from a deficiency of the kidney after climacteric also can be delayed.

The present application people has also carried out experiment relatively to the drug effect of the application's medicine and the disclosed medicine of prior art CN1200279A, the result shows the medicine that conventional water extraction process that the application adopts the effect of the resulting medicine of method that part starch and part water carries significantly to be better than prior art obtains, and tests as follows:

The fractures test

Influence to the healing of Os Leporis seu Oryctolagi folding: (1) XIANLING GUBAO obviously shortens the animal bone fracture limb and supports touchdown time; (2) obviously increase animal bone fracture limb X-ray sheet score value; (3) obviously increase animal bone fracture broken ends of fractured bone bony callus area and osteoid area (4) obviously increases animal serum Bone Gla protein, serum levels of ALP, blood-serum P, obviously reduce serum Ca ²⁺

1. trial drug

Title: XIANLING GUBAO.

Compound method:, during experiment XIANLING GUBAO is mixed with the suspension of desired concn with distilled water according to the experimental design needs.

1) XIANLING GUBAO is 1 group: the application's medicine

2) XIANLING GUBAO is 2 groups: the medicine that prior art adopts extraction process by water to obtain

2. EXPERIMENTAL DESIGN

2.1 dosage: every day, dosage was equivalent to 10 times of clinical Coming-of-Age Day consumption

2.2 route of administration: adopt the gastric infusion method.

2.3 date processing: test data carries out t check or X with NDST software ²Check.

3. test method and result

3.1 XIANLING GUBAO is to the influence of Os Leporis seu Oryctolagi folding healing ^[1]: get Japan large ear rabbit, the anesthesia of pentobarbital auricular vein, dorsal position is fixed, left fore unhairing, skin routine disinfection, in left fore oar lateroflexion face longitudinal incision skin 2～3cm, separating muscle is avoided nervus vasculairs, exposes section intersection far away in the radius, with the horizontal sawed-off radius of special hacksaw, form 3mm and cut the complete fracture of damage.The fracture end that will stagger resets, layer-by-layer suture (postoperative wounds unwinding in 7 days), and wound dressing, but unfixing.Postoperative is removed dressing next day, and 18 fracture animals are divided into 2 groups of (9 of every treated animals, male and female dual-purpose, body weight 2.31 ± 0.18kg) at random.The equal gastric infusion of animal, every day 1 time, continuous 28 days.Duration of test carries out the observation of following project:

3.1.1 the fracture limb supports the comparison of touchdown time: after the fracture, animal is for keeping away pain, and suffering from limb dare not land, and sky is lifted the trouble limb.Through over recovery, when the trouble limb dare to be placed on the ground and support body, be the support touchdown time.

The result: XIANLING GUBAO obviously shortens the animal bone fracture limb for 1 group and supports touchdown time, compares according to group with 2 groups.See Table 1.

Table 1 XIANLING GUBAO supports the influence (X ± S) of touchdown time to Os Leporis seu Oryctolagi folding limb

Group	Number of animals (only)	Dosage (g/kg)	The support touchdown time (my god)
Group	Number of animals (only)	Dosage (g/kg)	The support touchdown time (my god)	2 groups of 1 group of XIANLING GUBAO of XIANLING GUBAO	7 7	2.0 2.0	4.29±0.66 5.78±1.86

3.1.2 fracture limb X-ray sheet is marked relatively: the animal bone fracture treatment was got the fracture limb in 28 days and is clapped the X-ray sheet, by the variation of X-ray sheet, marked according to following standard:

1. dislocation: dislocation-free (comprises dislocation＜0.1cm) 1 minute; Dislocation (comprising that the fracture site dislocation slightly becomes the angle above 1/2 or fracture end of its broken ends of fractured bone) 0 minute.

2. external callus: external callus is arranged 1 minute; No external callus 0 minute.

3. internal callus: bone density increases by 1 fen; Bone density does not increase by 0 fen.

4. fracture is stitched: fracture is stitched partly fuzzy or was disappeared 1 fen; Fracture seam 0 minute is arranged.

5. connect: fracture site was connected to an integral body 1 minute; Do not connect 0 fen.

6. healing: not healing (external callus or fracture seam are not still in having) 0 minute; Union of fracture (have inside and outside slight callus to change, the fracture seam shoals or be fuzzy simultaneously) 1 minute.

Result: 1 group of XIANLING GUBAO and 2 groups of apparent in view increase animal bone fracture limb X-ray sheet score values.See Table 2

Table 2 XIANLING GUBAO is to the influence of Os Leporis seu Oryctolagi folding X-ray sheet score value (X ± S)

Group

Number of animals (only)

Dosage (g/kg)

Score value

2 groups of 1 group of XIANLING GUBAO of XIANLING GUBAO

6 6

2.0 2.0

5.78±0.67 3.80±1.66

3.1.3 the union of fracture histological observation relatively ^[1]: the animal bone fracture treatment was put to death after 28 days, got fracture of radius place limb and did 2～3cm, formalin fixed, after the decalcification, cut dehydration along radius major axis median line, paraffin embedding, HE dyeing, om observation is made between the broken ends of fractured bone by image analysis system and to be distinguished, tick this district's osteoid and other heals into the shared scope of branch, calculate bony callus area and osteoid area with electron scanning point.

The result: XIANLING GUBAO compares for 1 group and 2 groups, obviously increases animal bone fracture broken ends of fractured bone bony callus area and osteoid area, the results are shown in Table 3.

Table 3 XIANLING GUBAO is to the fracture influence (X ± S) of end callus of Os Leporis seu Oryctolagi

Group	Number of animals (only)	Dosage (g/kg)	Bony callus area (mm ²)	Osteoid area (mm ²)
Group	Number of animals (only)	Dosage (g/kg)	Bony callus area (mm ²)	Osteoid area (mm ²)	2 groups of 1 group of XIANLING GUBAO of XIANLING GUBAO	4 4	2.0 2.0	4.99±1.84 4.02±1.27	0.30±0.13 0.26±0.26

3.1.4 blood biochemistry index mensuration relatively: the animal bone fracture treatment was got blood in 28 days, and is centrifugal, gets serum, puts with many probes and exempts from instrument survey serum osteocalcin, surveys serum levels of ALP, serum Ca with automatic clinical chemistry analyzer ²⁺, P, and calculate calcium-phosphorus product.

The result: XIANLING GUBAO all obviously increases animal serum Bone Gla protein, serum levels of ALP, blood-serum P for 1,2 groups, obviously reduces serum Ca ²⁺, 1 group effect is better than 2 groups, the results are shown in Table 4.

Table 4 XIANLING GUBAO JIAONANG to the influence of Os Leporis seu Oryctolagi folding blood biochemistry index (X ± S, N=9)

Group Ca ^2-×P	Bone Gla protein (μ g/L)	ALP (u)	Ca ²⁺ (mmol)	P (mmol)
Group Ca ^2-×P	Bone Gla protein (μ g/L)	ALP (u)	Ca ²⁺ (mmol)	P (mmol)	2 groups of 1 group of 6.81 ± 0.88 XIANLING GUBAO of XIANLING GUBAO	2.75±0.70 2.60±0.40	123.70±17.70 112.30±12.10	2.06±0.18 2.04±0.13	3.31±0.30 3.04±0.98

6.42±2.95

4. brief summary

(1) XIANLING GUBAO obviously shortens animal bone fracture limb support touchdown time for 1 group;

(2) XIANLING GUBAO obviously increases animal bone fracture limb X-ray sheet score value for 1 group, at faces such as fracture site dislocation-free, external callus appearance, internal callus appearance, the disappearance of fracture seam, the connection of broken ends of fractured bone bone, union of fracture;

(3) XIANLING GUBAO obviously increases animal bone fracture broken ends of fractured bone bony callus area and osteoid area for 1 group;

(4) XIANLING GUBAO obviously increases animal serum Bone Gla protein, serum levels of ALP, blood-serum P for 1 group, obviously reduces serum Ca ²⁺

From table 1～table 4 as seen: 1 group effect obviously is better than 2 groups the XIANLING GUBAO test group, and promptly the effect of the application's medicine significantly is better than disclosed medicine in the prior art.

The paired observation of XIANLING GUBAO ZHIJI treatment menopausal syndrome (climacteric syndrome)

Refer to middle aged and aged women a period of time before and after menopause on women's climacteric syndrome, because a series of each system's untoward reaction appear in decrease in estrogen.My institute adopts Chinese medicine 185 routine climacteric syndromes, and compares observation with the western medicine primary disease, and the result is reported as follows:

Data and method

1.1 data: my institute carries out the gynaecopathia generaI investigation in the 1-11 month in 1997 to area, Kweiyang 7556 routine female employees, and wherein perimenopausal women 2380 examples have the typical case to enclose exhausted phase syndrome symptom and treat 185 examples, and minimum 37 years old of age, (menolipsis 1 ⁺Year), maximum 55 years old, 46 years old mean age, 185 examples all no estrogen were used contraindication.

1.2 method: 185 examples are divided into two groups, and I organizes (Chinese medicine and western medicine therapeutic alliance group) 185 examples.Use the pure Chinese medicinal preparation XIANLING GUBAO JIAONANG, each 1.5g, every day twice, Western medicine, the nilestriol 5mg/ month, add medroxyprogestetone acetate 10mg/ day decoction being taken at a draught after March, serve on 5 days.II organizes (simple western medicine treatment group) 57 examples, uses the female that of Buddhist nun pure 5mg/ days, adds medroxyprogestetone acetate 10mg/ day decoction being taken at a draught after March, serve on 5 days.

1. criterion of therapeutical effect and result

2.1 criterion of therapeutical effect: 4 weeks were a course of treatment, and check once March, transference cure, and check sign feminine gender be produce effects, the symptom improvement checks that sign is bright to be improved as improvement; It is invalid that treatment back sign does not have significant change.

2.2 result's (seeing Table 1)

Table 1 liang group therapeutic outcome relatively

Group	The example number	Produce effects	％	Take a turn for the better	％	Invalid	％	Total effective rate %
Group	The example number	Produce effects	％	Take a turn for the better	％	Invalid	％	Total effective rate %	The I group	128	115	89.8	12	9.4	1	0.8	99.20
The II group	57	15	26.32	25	43.26	17	29.82	70.18	The I group	128	115	89.8	12	9.4	1	0.8	99.20

P＜0.05, two a group comparing difference is showing

I organizes the course of treatment in the shortest 4 weeks (1 course of treatment), the longest 12 weeks (3 courses of treatment).II organizes the course of treatment in the shortest 12 weeks (5 courses of treatment are many).All mend and give a large amount of vitamin for two groups during the treatment, keep the emotion optimism, remove obstacle at heart, strengthen the confidence of Fighting Disease.

2. discuss

After the women enters climacteric, in the variation that produces in varying degrees on psychology and the health, the people that adaptive capacity is good can tide over smoothly, but having partly, menopausal women then causes many symptoms because of ovarian function decline hormonal readiness descends, disturbed normal live and work, cause the generation of disease, identical symptom appears in not every women, concerning a women, the symptom that occur different periods is also different, because the decline of hormonal readiness, common neurological symptom, hectic fever, night sweat, emotion changes, hypomnesis, insomnia etc.In addition, genitals's atrophy, menoxenia, vulvovaginal atrophy and malnutrition arranged, the sexual life difficulty reaches because the intravaginal environment changes, resistance descends, cause senile vaginitis, frequent micturition, stress incontinence can appear in urinary system, owing to atrophy between flesh at the bottom of the basin of uterus causes uterus and vaginal wall prolapsus, cutis laxa, nonelastic, easy damaged, xerostomia, eye binding film drying etc.Cardiovascular and skeletal system sickness rate such as atherosclerosis, angina pectoris can occur and rise, waist leg joint pain and osteoporosis and cause fracturing that incidence rate increases etc.

The traditional Chinese medical science is that opinion is thought: the climacteric syndrome mainly originates from the spleen nephrasthenia.Unbalanced state appears in body when regulating the equilibrium between yin and yang hypofunction, because the spleen deficiency of kidney-QI dashes a loss, and asthenia of essence and blood, the negative and positive imbalance, and cause visceral dysfunction.The prosperity and decline of clinical manifestation and spleen, kidney has substantial connection, and it is main therefore treating and should nourishing the spleen kidney, and we use its main component Herba Epimedii of XIANLING GUBAO, Radix Dipsaci, Fructus Psoraleae etc.Main effect is that prevention and treatment middle-aged and elderly people are regulated the row symptom that the equilibrium between yin and yang hypofunction occurs because of suffer from a deficiency of the kidney weak caused osteoporosis and body, human body immunity improving power, adjust sexual function, replenish the female that alcohol of Buddhist nun (estriol class medicine), remedy and improve and quicken the Chinese medicine effect than slow defective, make it to shorten the course of treatment, strengthen drug effect, suitably reduce the side effect of Western medicine, owing to strengthen further understanding in recent years, improve the health service quality of perimenopausal women to climacteric; Reduce the symptom development, this paper thinks, takes as far as possible, and life-time service can be avoided the old and feeble excessively of cardiovascular system diseases and prevention body.

The therapeutic test of climacteric syndrome animal model

1. to the influence of castrated rats gonadal hormone ^[7]: after female rats given the pentobarbital intraperitoneal anesthesia, in about under the most last rib, midaxillary line and apart from the about 2cm infall in the spinal column outside, cut skin and dorsal muscles, extract the both sides ovary, the layer-by-layer suture stitching.Postoperative next day, 40 neuters are divided into 4 groups of (10 of every treated animals at random, body weight 216.63 ± 16.38g): XIANLING GUBAO JIAONANG high dose group (give XIANLING GUBAO JIAONANG 3g/kg), low dose group (giving XIANLING GUBAO JIAONANG 1g/kg), positive controls (giving diethylstilbestrol 0.004g/kg), model control group capacity normal saline such as () giving, other gets 10 of female rats, the same incision skin and dorsal muscles, but do not extract ovary, sew up the incision, be made as blank group (give and wait the capacity normal saline).Animal equal every day of gastric infusion 1 time, continuous 28 days.1h after the last administration puts to death animal and gets blood, and is centrifugal, gets serum, puts with many probes and exempts from instrument mensuration serum E2.

The result: XIANLING GUBAO JIAONANG obviously increases castrated rats serum E2 level, compares P＜0.05 with the blank group.See Table 1.

Table 1 XIANLING GUBAO JIAONANG is to the influence of castrated rats gonadal hormone (X ± S)

Group	Number of animals (only)	Dosage (g/kg)	E2 (pg/m1)	The P value
Group	Number of animals (only)	Dosage (g/kg)	E2 (pg/m1)	The P value	Model control group XIANLING GUBAO group XIANLING GUBAO group diethylstilbestrol group blank group	10 10 10 10 10	3.0 1.0 0.004	4.53±2.96# 7.05±2.10 5.46±4.33 7.70±3.02 8.02±3.76	＜0.05 ＞0.05 ＜0.05 ＜0.05

Compare with the blank group: #P＜0.05, ##P＜0.05, ###P＜0.001 (down together)

2. to the influence of model of yang asthenia mice body weight, internal organs coefficient ^[4]: 72 of mices, male and female half and half, be divided into 6 groups at random: XIANLING GUBAO JIAONANG high dose group (give XIANLING GUBAO JIAONANG 4g/kg), middle dosage group (giving XIANLING GUBAO JIAONANG 2.6g/kg), low dose group (giving XIANLING GUBAO JIAONANG 1.3g/kg), positive controls (jenny is given diethylstilbestrol 0.002g/kg, and buck is given methyltestosterone 0.005g/kg), model control group (give and wait the capacity normal saline), blank group (to etc. the capacity normal saline).Except that capacity normal saline such as blank group intramuscular injection, all the other only respectively organize intramuscular injection hydrocortisone 1mg/. day, continuous 7 days, make model of yang asthenia.Simultaneously, animal gastric infusion every day 1 time, continuous 10 days.1h puts to death animal after the last administration, weighs in, and cuts open and get liver, spleen, uterus and ovary, calculates coefficient after weighing.

The result: XIANLING GUBAO JIAONANG can make yang deficiency mouse liver, spleen, seminal vesicle, uterus, ovary and situation about losing weight be improved significantly, with model control group relatively, P＜0.05, P＜0.01, P＜0.001.See Table 2.

Table 2 XIANLING GUBAO JIAONANG to the influence of model of yang asthenia mice internal organs coefficient (X ± S, g/10g.wt, N=12)

Group	Liver	Spleen	Testis	Seminal vesicle	Uterus+ovary
Group	Liver	Spleen	Testis	Seminal vesicle	Uterus+ovary	Model control group XIANLING GUBAO group XIANLING GUBAO group XIANLING GUBAO group positive controls blank group	0.591±0.245 0.649±0.158 0.662±0.061 0.620±0.160 0.650±0.214 0.655±0.088	0.056±0.026# 0.076±0.014* 0.077±0.012* 0.071±0.037 0.075±0.014* 0.081±0.028*	0.071±0.033 0.082±0.041 0.079±0.005 0.080±0.045 0.082±0.015 0.083±0.031	.026±0.007# 0.036±0.013 0.037±0.009* 0.032±0.010 0.037±0.006* 0.039±0.012*	0.025±0.011 0.037±0.005* 0.031±0.005 0.028±0.004 0.032±0.007 0.035±0.010

3. to the influence of model of yang asthenia mice swimming endurance ^[4]: 72 of mices, male and female half and half, be divided into 6 groups at random: XIANLING GUBAO JIAONANG high dose group (giving XIANLING GUBAO JIAONANG 4g/kg), middle dosage group (giving XIANLING GUBAO JIAONANG 2.6g/kg), low dose group (giving XIANLING GUBAO JIAONANG 1.3g/kg), (jenny is given diethylstilbestrol 0.002g/kg to positive controls, buck is given methyltestosterone 0.005g/kg), model control group (give and wait the capacity normal saline), blank group (give and wait the capacity normal saline) is except that capacity normal saline such as blank group intramuscular injection, all the other only respectively organize intramuscular injection hydrocortisone 1mg/. day, continuous 7 days.Simultaneously, animal gastric infusion every day 1 time, continuous 10 days.1h after the last administration loads the load of its body weight 10% with mice, puts into 9 ℃ water, observes its time-to-live.

The result: XIANLING GUBAO JIAONANG obviously improves the mice swimming endurance, compares P＜0.05 with model control group.See Table 3.

Table 3 XIANLING GUBAO JIAONANG is to the influence of model of yang asthenia mice body weight, swimming endurance (X ± S)

Group	Number of animals (only)	Dosage (g/kg)	Body weight (g)	Time-to-live (S)
Group	Number of animals (only)	Dosage (g/kg)	Body weight (g)	Time-to-live (S)	Model control group XIANLING GUBAO group XIANLING GUBAO group XIANLING GUBAO group positive controls blank group	12 12 12 12 12 12	4.0 2.6 1.3	19.33±4.70## 22.83±1.64* 23.67±1.56 24.25±1.48 23.83±2.12 24.92±2.57	204.33±27.73### 250.42±6 8.33* 224.25±55.72 230.00±44.91 262.17±63.13 264.67±35.28*

4. to the influence of deficiency of YIN model mice body weight, internal organs coefficient ^[4]: 72 of mices, male and female half and half are divided into 6 groups at random: XIANLING GUBAO JIAONANG high dose group (give XIANLING GUBAO JIAONANG 4g/kg), middle dosage group (giving XIANLING GUBAO JIAONANG 2.6g/kg), low dose group (giving XIANLING GUBAO JIAONANG 1.3g/kg), positive controls (giving FUFANG SHENGDI JIANYE 20g/kg), model control group (give and wait the capacity normal saline), blank group (to etc. the capacity normal saline).Irritate stomach except that the blank group and give the normal saline such as the capacity of grade, all the other each treated animals are with thyroid tablet 3mg, reserpine injection 0.02mg/. day gastric infusion, continuous 7 days, make deficiency of YIN model.Simultaneously, animal gastric infusion every day 1 time, continuous 10 days.1h puts to death animal after the last administration, weighs in, and cuts open and get liver, spleen, uterus and ovary, calculates coefficient after weighing.

The result: XIANLING GUBAO JIAONANG can make deficiency of YIN mouse liver, spleen, seminal vesicle, uterus, ovary and situation about losing weight be improved significantly, with model control group relatively, P＜0.05.See Table 4.

Table 4 XIANLING GUBAO JIAONANG to the influence of deficiency of YIN model mice internal organs coefficient (X ± S, g/10g.wt, N=12)

Group	Liver	Spleen	Testis	Seminal vesicle	Uterus+ovary
Group	Liver	Spleen	Testis	Seminal vesicle	Uterus+ovary	Model control group XIANLING GUBAO group XIANLING GUBAO group XIANLING GUBAO group positive controls blank group	0.428±0.071## 0.560±0.074* 0.557±0.096 0.495±0.108 0.519±0.156 0.513±0.058**	0.037±0.009## 0.047±0.007** 0.046±0.007* 0.042±0.010 0.043±0.012 0.061±0.008***	0.071±0.009 0.073±0.013 0.070±0.009 0.076±0.007 0.084±0.021 0.076±0.008	0.016±0.010# 0.027±0.006* 0.017±0.007 0.023±0.008 0.020±0.006 0.028±0.005*	0.021±0.004### 0.029±0.006* 0.035±0.006* 0.023±0.004 0.035±0.010 0.034±0.005***

5. deficiency of YIN model mice is turned round the body analgesic test ^[8]: 72 of mices, male and female half and half are divided into 6 groups at random: XIANLING GUBAO JIAONANG high dose group (give XIANLING GUBAO JIAONANG 4g/kg), middle dosage group (giving XIANLING GUBAO JIAONANG 2.6g/kg), low dose group (giving XIANLING GUBAO JIAONANG 1.3g/kg), positive controls (giving pethidine 0.025g/kg), model control group (give and wait the capacity normal saline), blank group (to etc. the capacity normal saline).Irritate stomach except that the blank group and give the normal saline such as the capacity of grade, all the other are respectively organized with thyroid tablet 3mg, 0.02mg/ .d gastric infusion of reserpine injection, continuous 7 days, make deficiency of YIN model.Simultaneously, except that positive control treated animal 30min only the intraperitoneal injection 1 time before observing writhing response, all the other each treated animal gastric infusions every day 1 time, continuous 10 days.30min after the last administration, every Mus lumbar injection 0.6% acetic acid 0.2ml observes mouse writhing number of times in the 10min immediately.

The result: the XIANLING GUBAO JIAONANG Dichlorodiphenyl Acetate causes the pain mice obvious analgesic activity, can obviously reduce the mouse writhing number of times, compares P＜0.05 with model control group.See Table 5.

Table 5 XIANLING GUBAO JIAONANG is to the influence of deficiency of YIN model mice body weight, writhing response (X ± S)

Group	Number of animals (only)	Dosage g/kg)	Body weight (g)	Turn round the body number of times
Group	Number of animals (only)	Dosage g/kg)	Body weight (g)	Turn round the body number of times	Model control group XIANLING GUBAO group XIANLING GUBAO group XIANLING GUBAO group positive controls blank group	12 12 12 12 12 12	4.0 2.6 1.3 0.025	18.17±3.19### 22.33±3.14** 21.00±2.86* 21.17±3.21* 22.50±4.64* 23.83±1.80***	28.83±8.82# 17.33±8.12* 21.58±7.60 19.50±13.35 11.75±10.86*** 22.42±6.16*

6. deficiency of YIN model mice hot plate analgesic test: filter out 60 of the normergic male and female mices of pain with 55 ℃ of hot plates, body weight 18～22g is divided into 6 groups at random: XIANLING GUBAO JIAONANG high dose group (give XIANLING GUBAO JIAONANG 4g/kg), middle dosage group (giving XIANLING GUBAO JIAONANG 2.6g/kg), low dose group (giving XIANLING GUBAO JIAONANG 1.3g/kg), positive controls (giving pethidine 0.025g/kg), model control group (give and wait the capacity normal saline), blank group (to etc. the capacity normal saline).Irritate stomach except that the blank group and give the normal saline such as the capacity of grade, all the other respectively with thyroid tablet 3mg, reserpine injection 0.02mg/ are only organized. day gastric infusion, continuous 7 days, manufacturing deficiency of YIN model.Simultaneously, except that positive control treated animal 30min only the intraperitoneal injection 1 time before observing writhing response, all the other each treated animal gastric infusions every day 1 time, continuous 10 days.After the last administration, respectively at behind the medicine 30,60,90,120min, mice is placed on 55 ℃ of hot plates, measure every Mus and react latent time bitterly.

The result: XIANLING GUBAO JIAONANG causes the pain mice to hot plate does not have obvious analgesic activity, compares P＞0.05 with model control group.See Table 6.

Table 6 XIANLING GUBAO JIAONANG to deficiency of YIN model mice react bitterly latent time influence (X ± S, N=10)

Group	Pain is reacted latent time (S)
	Pain is reacted latent time (S)					Before the medicine	0.5h behind the medicine	1h	1.5h	2h
	Model control group XIANLING GUBAO group XIANLING GUBAO group	20.70±5.44 22.50±4.88 21.40±4.55	17.00±7.69 21.90±5.07 21.30±7.56	18.60±4.70 23.00±7.33 22.30±8.76	19.70±6.46 24.90±6.30 23.30±6.60	Before the medicine	0.5h behind the medicine	1h	1.5h	2h	18.50±5.48 21.60±5.68 22.60±12.63

XIANLING GUBAO group positive controls blank group

20.40±6.02 20.80±3.88 21.70±6.77

22.60±8.26 50.50±5.06*** 20.10±4.51

23.50±6.72 46.00±8.25*** 21.40±5.60

24.30±7.27 48.30±11.42*** 23.10±4.72

22.30±6.31 45.80±5.67*** 21.70±3.89

7. to the influence of spontaneous activity in mice ^[3]: 60 of mices, 18～22g, male and female half and half are divided into 5 groups at random: XIANLING GUBAO JIAONANG high dose group (give XIANLING GUBAO JIAONANG 4g/kg), middle dosage group (giving XIANLING GUBAO JIAONANG 2.6g/kg), low dose group (giving XIANLING GUBAO JIAONANG 1.3g/kg), positive controls (giving pentobarbital sodium 0.02g/kg), blank group capacity normal saline such as () giving.Except that positive controls 30min only the intraperitoneal injection 1 time before observing spontaneous activity in mice, the equal gastric infusion of all the other each treated animals, every day 1 time, continuous 7 days.30min after the last administration observes the number of times of lifting two forelimbs in the mice 2min.

The result: XIANLING GUBAO JIAONANG does not have obvious influence to spontaneous activity in mice, compares P＞0.05 with the blank group.See Table 7.

Table 7 XIANLING GUBAO JIAONANG is to the influence of spontaneous activity in mice (X ± S)

Group	Number of animals (only)	Dosage (g/kg)	Lift the forelimb number of times	The P value
Group	Number of animals (only)	Dosage (g/kg)	Lift the forelimb number of times	The P value	Blank group XIANLING GUBAO group XIANLING GUBAO group XIANLING GUBAO group positive controls	12 12 12 12 12	4.0 2.6 1.3 0.02	16.42±3.60 15.75±6.05 16.83±6.78 16.17±4.37 8.50±5.21	＞0.05 ＞0.05 ＞0.05 ＜0.001

8. to the influence of mice subliminal hypnosis dosage ^[4]: 72 of mices, 18～22g, male and female half and half.Be divided into 5 groups at random: XIANLING GUBAO JIAONANG high dose group (give XIANLING GUBAO JIAONANG 4g/kg), middle dosage group (giving XIANLING GUBAO JIAONANG 2.6g/kg), low dose group (giving XIANLING GUBAO JIAONANG 1.3g/kg), positive controls (giving pentobarbital sodium 0.02g/kg), blank group capacity normal saline such as () giving.Except that positive controls 30min only the intraperitoneal injection 1 time before observing mice hypnosis reaction, the equal gastric infusion of all the other each treated animals.Every day 1 time, continuous 7 days.30min after the last administration.The equal lumbar injection pentobarbital sodium of all the other each treated animals 0.02g/kg observes the interior mice righting reflex loss of 15min immediately and reaches the above number of 1min.

The result: XIANLING GUBAO JIAONANG does not have obvious influence to mice subliminal hypnosis dosage, compares P＞0.05 with the blank group.See Table 8.

Table 8 XIANLING GUBAO JIAONANG is to the influence of mice subliminal hypnosis (X ± S)

Group	Number of animals (only)	Dosage (g/kg)	The righting reflex loss number of elements	％	The P value
Group	Number of animals (only)	Dosage (g/kg)	The righting reflex loss number of elements	％	The P value	Blank group XIANLING GUBAO group XIANLING GUBAO group XIANLING GUBAO group positive controls	12 12 12 12 12	4.0 2.6 1.3 0.02	1 3 2 3 9	8 25 17 25 92	＞0.05 ＞0.05 ＞0.05 ＜0.001

Brief summary

1, XIANLING GUBAO JIAONANG compares significance to obvious increase castrated rats serum E2 level with the blank group;

2, XIANLING GUBAO JIAONANG can make yang deficiency mouse liver, spleen, seminal vesicle, uterus, ovary and situation about losing weight be improved significantly, with the blank group relatively, significance;

3, XIANLING GUBAO JIAONANG obviously improves the mice swimming endurance, compares significance with the blank group;

4, XIANLING GUBAO JIAONANG can make deficiency of YIN mouse spleen, seminal vesicle, uterus, ovary and situation about losing weight be improved significantly, with the matched group of sky relatively, significance;

5, the XIANLING GUBAO JIAONANG Dichlorodiphenyl Acetate causes the pain mice obvious analgesic activity, can obviously reduce the mouse writhing number of times, compares significance with the blank group;

6, XIANLING GUBAO JIAONANG causes the pain mice to hot plate does not have obvious analgesic activity, compares nonsignificance with the blank group;

7, XIANLING GUBAO JIAONANG does not have obvious influence to spontaneous activity in mice, compares nonsignificance with the blank group;

8, XIANLING GUBAO JIAONANG does not have obvious influence to mice subliminal hypnosis dosage, compares nonsignificance with the blank group.The zoopery results suggest: XIANLING GUBAO JIAONANG has function that promotes union of fracture, anti-inflammation detumescence and the effect that improves climacteric syndrome.

The test of XIANLING GUBAO treatment osteoarthritis

1. Chinese People's Anti-Japanese Military and Political College Mus adjuvant arthritis test ^[4]: 40 of rats, body weight 189.43 ± 20.35, male, be divided into 4 groups at random: XIANLING GUBAO JIAONANG high dose group (give XIANLING GUBAO JIAONANG 3g/kg), low dose group (giving XIANLING GUBAO JIAONANG 1g/kg), positive controls (giving prednisone 0.006g/kg), blank group capacity normal saline such as () giving.The equal gastric infusion of animal, every day 1 time, continuous 24 days.Measure every Mus left and right sides hind leg ankle joint girth before the medicine earlier, test 30min behind the 1st day medicine, the left back sufficient plantar subcutaneous injection Freund's complete adjuvant 0.1ml of every Mus, the next day measure every Mus left and right sides hind leg ankle joint girth, with two ankle girth differences before the medicine as the swelling degree.

The result:

A. XIANLING GUBAO JIAONANG has the obvious suppression effect to the rat joint constitutional inflammation due to the 6th, 8,20,22 day Freund's complete adjuvant, with the blank group relatively, P＜0.05.See Table 1, Fig. 3.

B. XIANLING GUBAO JIAONANG has the obvious suppression effect to the rat joint secondary inflammation due to the 12nd, 14,16,18,20,22,24 day Freund's complete adjuvant, with the blank group relatively, P＜0.05, P＜0.01, P＜0.001.See Table 2, Fig. 4.

Table 1 XIANLING GUBAO JIAONANG to the influence of rat assist agent arthritis primary lesion (X ± S, N=10)

Group	Swelling degree (mm)
	Swelling degree (mm)					2 days	4 days	6 days	8 days
	Blank group XIANLING GUBAO group XIANLING GUBAO group prednisone group	5.00±1.27 4.90±1.22 5.25±2.19 5.40±1.54	9.95±1.23 9.70±2.00 10.05±1.95 7.85±2.25*	15.45±2.31 12.80±3.04* 15.15±3.36 12.55±2.35*		2 days	4 days	6 days	8 days	15.85±3.21 13.90±3.31* 15.35±3.75 13.35±2.88*
Group		5.00±1.27 4.90±1.22 5.25±2.19 5.40±1.54	9.95±1.23 9.70±2.00 10.05±1.95 7.85±2.25*	15.45±2.31 12.80±3.04* 15.15±3.36 12.55±2.35*		Swelling degree (mm)				15.85±3.21 13.90±3.31* 15.35±3.75 13.35±2.88*
	10 days	12 days		14 days	16 days	Swelling degree (mm)
	10 days	12 days		14 days	16 days	Blank group XIANLING GUBAO group XIANLING GUBAO group prednisone group	15.30±3.57 13.35±2.81 15.15±3.77 12.20±2.29*	17.65±4.50 14.25±2.99 15.10±4.14 12.20±2.39**	19.85±5.84 16.55±4.39 18.40±5.22 13.75±3.58*	24.15±6.70 20.00±6.22 22.70±6.43 17.85±4.24*
	Swelling degree (mm)						15.30±3.57 13.35±2.81 15.15±3.77 12.20±2.29*	17.65±4.50 14.25±2.99 15.10±4.14 12.20±2.39**	19.85±5.84 16.55±4.39 18.40±5.22 13.75±3.58*	24.15±6.70 20.00±6.22 22.70±6.43 17.85±4.24*

Group
					18 days	20 days	22 days	24 days
	Blank group XIANLING GUBAO group XIANLING GUBAO group prednisone group	23.10±6.99 20.15±5.23 22.95±5.97 17.25±3.80*	19.90±4.32 16.40±2.90* 19.25±4.32 16.15±2.93*	18.55±3.63 15.40±2.65* 18.55±3.56 14.00±1.89**	18 days	20 days	22 days	24 days	14.95±2.96 14.15±2.27 14.65±5.13 13.35±1.60

Table 2 XIANLING GUBAO JIAONANG to the influence of rat assist agent arthritis secondary lesion (X ± S, N=10)

Group	Swelling degree (mm)
	Swelling degree (mm)					2 days	4 days	6 days	8 days
	Blank group XIANLING GUBAO group XIANLING GUBAO group prednisone group	1.00±0.13 0.99±0.12 1.03±0.22 1.04±0.15	1.50±0.12 1.47±0.20 1.51±0.20 1.29±0.22*	1.52±0.70 1.50±0.55 1.47±0.71 1.23±0.37	1.79±0.48 1.54±0.57 1.56±0.62 1.37±0.50		4 days	6 days	8 days
Group		1.00±0.13 0.99±0.12 1.03±0.22 1.04±0.15	1.50±0.12 1.47±0.20 1.51±0.20 1.29±0.22*	1.52±0.70 1.50±0.55 1.47±0.71 1.23±0.37	1.79±0.48 1.54±0.57 1.56±0.62 1.37±0.50		Expansibility (mm) expands
	10 days	12 days	14 days		16 days		Expansibility (mm) expands
	10 days	12 days	14 days		16 days	Blank group XIANLING GUBAO group XIANLING GUBAO group prednisone group	2.99±0.69 2.50±0.62 3.00±0.33 1.97±0.65**	6.08±0.59 5.00±0.67 6.07±0.71 3.80±1.14*	10.10±1.29 7.80±1.14* 9.00±1.39 5.15±1.06*		11.20±1.23 9.00±0.67* 10.29±1.21 6.15±1.00*
Group	Swelling degree (mm)						2.99±0.69 2.50±0.62 3.00±0.33 1.97±0.65**	6.08±0.59 5.00±0.67 6.07±0.71 3.80±1.14*	10.10±1.29 7.80±1.14* 9.00±1.39 5.15±1.06*		11.20±1.23 9.00±0.67* 10.29±1.21 6.15±1.00*
	Swelling degree (mm)					18 days	20 days	22 days		24 days
	Blank group XIANLING GUBAO group XIANLING GUBAO group prednisone group	11.25±1.89 8.80±1.06 9.95±0.90 5.05±0.90*	9.70±2.50 7.95±1.52* 9.55±1.57 4.10±1.33**	9.05±1.95 7.05±1.59* 8.80±1.25 3.40±0.74**		18 days	20 days	22 days		24 days	7.55±1.91 6.10±0.94* 8.00±1.97 3.55±0.90**

2. the swollen test of Chinese People's Anti-Japanese Military and Political College Mus chemical foot ^[5]: 40 of rats, body weight 209.63 ± 15.09g, male and female half and half are divided into 4 groups at random: XIANLING GUBAO JIAONANG high dose group (give XIANLING GUBAO JIAONANG 3g/kg), low dose group (are given XIANLING GUBAO JIAONANG 1g sheet/kg), positive controls (giving prednisone 0.006g/kg), blank group capacity normal saline such as () giving.The equal gastric infusion of animal, every day 1 time, continuous 7 days.Behind the last administration 30min, in left back whole plantar subcutaneous injection 1% carrageenin 0.1ml, immediately behind the

injection carrageenin

1,2,4,6h measures about every Mus the whole sole of the foot girth in back, with two sufficient girth differences as the swelling degree.

The result: foot swelling has the obvious suppression effect to XIANLING GUBAO JIAONANG to the rat chemical, compares P＜0.05 with the blank group.See Table 3.

Table 3 XIANLING GUBAO JIAONANG to the bullate influence of rat chemical foot (X ± S, N=10)

Group	Swelling degree (cm)
	Swelling degree (cm)				1h	2h	4h	6h
	Blank group XIANLING GUBAO group XIANLING GUBAO group prednisone group	1.22±0.25 1.13±0.26 1.20±0.48 0.88±0.29*	1.73±0.33 1.43±0.28* 1.67±0.30 1.29±0.23**	2.34±0.35 2.00±0.26* 2.20±0.42 1.44±0.24***	1h	2h	4h	6h	1.81±0.40 1.72±0.47 1.84±0.30 1.41±0.29*

3. the swollen test of the damaging foot of Chinese People's Anti-Japanese Military and Political College Mus ^[5]: in 3.1.2 " XIANLING GUBAO JIAONANG is to the influence of fracture healing in rats " experiment, in fact the manufacturing of fracture model has caused damage to animal, and inflammatory reaction is arranged, and can cause that fracture limb foot is swollen.Respectively at measuring every Mus left and right sides metapedes ankle joint girth in 2,4,6 days behind the animal bone fracture, with two ankle girth differences as the swelling degree.

The result: XIANLING GUBAO JIAONANG swells to the damaging foot of rat the obvious suppression effect, compares P＜0.05 with the blank group.See Table 4.

Table 4 XIANLING GUBAO JIAONANG is to the bullate influence of the damaging foot of rat (X ± S)

Group	Number of animals (only)	Dosage (g/kg)	Swelling degree (cm)
			Swelling degree (cm)			Second day	The 4th day	The 6th day
			Blank group XIANLING GUBAO group XIANLING GUBAO group bone setting tablet group	12 12 12 12	3.0 1.0 3	Second day	The 4th day	The 6th day	1.35±0.41 1.25±0.40 1.31±0.32 1.32±0.32	1.59±0.40 1.25±0.40* 1.37±0.47 1.21±0.26**	1.50±0.30 1.21±0.33* 1.29±0.50 1.21±0.26*

The inflammation test of 4 anti-mice ears ^[6]: 60 of mices, body weight 18～22g, male and female half and half, be divided into 5 groups at random: the XIANLING GUBAO JIAONANG high dose group (is given XIANLING GUBAO JIAONANG 4g/kg, clinical Coming-of-Age Day 20 times of consumption), middle dosage group (is given XIANLING GUBAO JIAONANG 2.6g/kg, clinical Coming-of-Age Day 13 times of consumption), low dose group (giving XIANLING GUBAO JIAONANG 1.3g/kg, clinical Coming-of-Age Day 6.5 times of consumption), positive controls (giving prednisone 0.005g/kg), blank group capacity normal saline such as () giving.Each treated animal gastric infusion every day 1 time, for three days on end.30min after the last administration drips 100% dimethylbenzene 0.02ml and causes inflammation before and after every Mus auris dextra, cause scorching back 4h, cuts left and right sides ear, gets auricle with the 8mm card punch at same position, and auricle is weighed, and is the swelling degree with left and right sides auricle weight difference.

The result: XIANLING GUBAO JIAONANG xylol induced mice ear inflammation has the obvious suppression effect, compares P＜0.05 with the blank group.See Table 5.

Table 5 XIANLING GUBAO JIAONANG is to the influence of mice ear inflammation (X ± S)

Group	Number of animals (only)	Dosage (g/kg)	Swelling degree (mg)	The P value
Group	Number of animals (only)	Dosage (g/kg)	Swelling degree (mg)	The P value	Blank group XIANLING GUBAO group XIANLING GUBAO group XIANLING GUBAO group prednisone group	12 12 12 12 12	4.0 2.6 1.3 0.005	8.09±1.51 7.12±0.54 7.26±0.43 7.86±0.51 5.86±0.82	＜0.05 ＞0.05 ＞0.05 ＜0.001

5. anti-mouse peritoneal capillary permeability test ^[4]: 60 of mices, body weight 18～22g, male and female half and half are divided into 5 groups at random: XIANLING GUBAO JIAONANG high dose group (give XIANLING GUBAO JIAONANG 4g/kg), middle dosage group (giving XIANLING GUBAO JIAONANG 2.6g/kg), low dose group (giving XIANLING GUBAO JIAONANG 1.3g/kg), positive controls (giving prednisone 0.005g/kg), blank group capacity normal saline such as () giving.The equal gastric infusion of animal, every day 1 time, for three days on end.30min after the last administration, every caudal vein is injected 0.5% azovan blue 0.1ml/10g, and lumbar injection 0.6% acetic acid 0.2m1/ immediately, put to death animal behind the 20min, cut off the abdominal cavity, use normal saline flushing, collect the abdominal cavity washing liquid, get supernatant in 721 type spectrophotometer 590nm places mensuration optical density (0D) after centrifugal.

The result: XIANLING GUBAO JIAONANG obviously reduces the mouse peritoneal capillary permeability, compares p＜0.05 with the blank group.See Table 6.

Table 6 XIANLING GUBAO JIAONANG is to the influence of mouse peritoneal capillary permeability (X ± S)

Group	Number of animals (only)	Dosage (g/kg)	OD	The P value
Group	Number of animals (only)	Dosage (g/kg)	OD	The P value	Blank group XIANLING GUBAO group XIANLING GUBAO group XIANLING GUBAO group prednisone group	12 12 12 12 12	4.0 2.6 1.3 0.005	0.31±0.06 0.27±0.02 0.28±0.06 0.30±0.04 0.18±0.05	＜0.05 ＞0.05 ＞0.05 ＜0.001

6. the bullate test of Chinese People's Anti-Japanese Military and Political College's rat meat bud ^[6]: 40 of rats, body weight 163.15 ± 16.32g, male, be divided into 4 groups at random: XIANLING GUBAO JIAONANG high dose group (give XIANLING GUBAO JIAONANG 3g/kg), low dose group (giving XIANLING GUBAO JIAONANG 1g/kg), positive controls (giving prednisone 0.006g/kg), blank group capacity normal saline such as () giving.The anesthesia of animal lumbar injection pentobarbital sodium is faced upward the position and is fixed, the abdominal part unhairing, and routine disinfection, it is subcutaneous behind the incision skin aseptic cotton balls to be implanted left and right sides axillary fossa, 1 of every side.Postoperative began gastric infusion, every day 1 time, continuous 7 days the same day.Drug withdrawal day is put to death animal, peels off the cotton balls that wraps up granulation tissue, weighs after 50 ℃ of oven dry, deducts cotton balls weight, and promptly granuloma is heavy, calculates the granuloma net weight by mg/100g.wt.

The result: XIANLING GUBAO JIAONANG can alleviate the rat granuloma and form, but compares P＞0.05 with the blank group.See Table 7.

Table 7 XIANLING GUBAO JIAONANG is to the granulomatous influence of rat (X ± S)

Group

Number of animals

Dosage

The granuloma net weight

The P value

	(only)	(g/kg)	(mg/100g.wt)
	(only)	(g/kg)	(mg/100g.wt)		Blank group XIANLING GUBAO group XIANLING GUBAO group prednisone group	10 10 10 10	3.0 1.0 0.006	36.09±15.22 25.54±7.11 31.00±8.62 21.91±8.24	＞0.05 ＞0.05 ＜0.05

Brief summary

1, XIANLING GUBAO JIAONANG has the obvious suppression effect to the rat joint constitutional inflammation due to the 6th, 8,20, the 22 day Freund's complete adjuvant of injection Freund's complete adjuvant, compares significance with the blank group; Rat joint secondary inflammation due to the 12nd, 14,16,18,20,22, the 24 day Freund's complete adjuvant of injection Freund's complete adjuvant there is the obvious suppression effect, compares significance with the blank group;

2, foot swelling has the obvious suppression effect to XIANLING GUBAO JIAONANG to the rat chemical, compares significance with the blank group;

3, XIANLING GUBAO JIAONANG swells to the damaging foot of rat the obvious suppression effect, compares significance with the blank group;

4, XIANLING GUBAO JIAONANG xylol induced mice ear inflammation has the obvious suppression effect, compares significance with the blank group;

5, XIANLING GUBAO JIAONANG obviously reduces the mouse peritoneal capillary permeability, compares significance with the blank group;

6, XIANLING GUBAO JIAONANG can alleviate the formation of rat granuloma, but compares nonsignificance with the blank group.

Embodiment

Embodiment 1

Herba Epimedii 1500 gram Radix Dipsacis 800 gram Radix Salviae Miltiorrhizaes 100 grams

The Rhizoma Anemarrhenae 100 gram Fructus Psoraleaes 100 gram Radix Rehmanniae 100 grams

Take by weighing each flavor by prescription, Radix Salviae Miltiorrhizae, Radix Dipsaci and Fructus Psoraleae are pulverized, cross 200 mesh sieves, make impalpable powder; With the surplus stock fragmentation, extracting in water 3 times adds 30 times in water at every turn, extracts successively 3,2,1 hours, and filtration or centrifugal gets the water extract; Above-mentioned water extract is concentrated into the thick paste that relative density is 1.35-1.38 (30 degree); The dextrin and the lactose that add 3 times; Add above-mentioned Radix Salviae Miltiorrhizae, Radix Dipsaci and Fructus Psoraleae powder again, mixing is made granule, and drying promptly gets the application's capsule.

Embodiment 2

Herba Epimedii 1167 gram Radix Dipsacis 167 gram Radix Salviae Miltiorrhizaes 83 grams

The Rhizoma Anemarrhenae 83 gram Fructus Psoraleaes 83 gram Radix Rehmanniae 83 grams

Take by weighing each flavor by prescription, Radix Salviae Miltiorrhizae is pulverized, cross 80 mesh sieves, make fine powder; With the surplus stock fragmentation, extracting in water 2 times adds 20 times in water at every turn, extracts 3 hours at every turn, and filtration or centrifugal gets the water extract; Above-mentioned water extract is concentrated into the clear paste that relative density is 1.20 (50 degree); Add above-mentioned Radix Salviae Miltiorrhizae powder again, mixing is made granule, and drying promptly gets the application's tablet.

Embodiment 3

Herba Epimedii 1200 gram Radix Dipsacis 200 gram Radix Salviae Miltiorrhizaes 500 grams

The Rhizoma Anemarrhenae 500 gram Fructus Psoraleaes 500 gram Radix Rehmanniae 500 grams

Take by weighing each flavor by prescription, Radix Salviae Miltiorrhizae is pulverized, and crosses 100 mesh sieves, makes impalpable powder; With the surplus stock fragmentation, extracting in water 3 times adds 20 times in water at every turn, extracts 2 hours at every turn, and filtration or centrifugal gets the water extract; Above-mentioned water extract is concentrated; Drying is ground into 100 purpose impalpable powders; The dextrin and the lactose that add 2 times;

Add above-mentioned Radix Salviae Miltiorrhizae powder again, mixing is granulated, drying, and granulate obtains the application's granule.

Embodiment 4

Take by weighing each flavor by prescription, Radix Salviae Miltiorrhizae and Radix Dipsaci are pulverized, cross 200 mesh sieves, make impalpable powder; With the surplus stock fragmentation, extracting in water 2 times adds 30 times in water at every turn, extracts 2 hours at every turn, and filtration or centrifugal gets the water extract; Above-mentioned water extract is concentrated; Drying is ground into 150 purpose impalpable powders; The dextrin or the lactose that add 5 times; Add above-mentioned Radix Salviae Miltiorrhizae and Radix Dipsaci powder again, mixing is granulated, drying, and granulate obtains the application's granule.

Embodiment 5

Take by weighing each flavor by prescription, Radix Salviae Miltiorrhizae, Radix Dipsaci and Fructus Psoraleae are pulverized, cross 80 mesh sieves, make fine powder; With the surplus stock fragmentation, extracting in water 2 times adds 20 times in water at every turn, extracts 3 hours at every turn, and filtration or centrifugal gets the water extract; Above-mentioned water extract is concentrated; Drying is ground into 300 purpose impalpable powders; Add 5 times the dextrin and the mixture of Icing Sugar; Add above-mentioned Radix Salviae Miltiorrhizae, Radix Dipsaci and Fructus Psoraleae powder again, mixing is granulated, drying, and granulate obtains the application's granule.

Embodiment 6

Take by weighing each flavor by prescription, Radix Salviae Miltiorrhizae is pulverized, and crosses 100 mesh sieves, makes impalpable powder; With the surplus stock fragmentation, extracting in water 3 times adds 20 times in water at every turn, extracts 2 hours at every turn, and filtration or centrifugal gets the water extract; Above-mentioned water extract is concentrated; The dextrin that adds 2 times; Add above-mentioned Radix Salviae Miltiorrhizae powder again, mixing adds sweeting agent, perfusion, and gland is sterilized, and obtains the application's oral liquid.

Embodiment 7

Take by weighing each flavor by prescription, Radix Salviae Miltiorrhizae and Radix Dipsaci are pulverized, cross 200 mesh sieves, make impalpable powder; With the surplus stock fragmentation, extracting in water 2 times adds 30 times in water at every turn, extracts 2 hours at every turn, and filtration or centrifugal gets the water extract; Above-mentioned water extract is concentrated; The dextrin or the lactose that add 5 times; Add above-mentioned Radix Salviae Miltiorrhizae and Radix Dipsaci powder again, mixing adds sweeting agent, perfusion, and gland is sterilized, and obtains the application's oral liquid.

Embodiment 8

Take by weighing each flavor by prescription, Radix Salviae Miltiorrhizae, Radix Dipsaci and Fructus Psoraleae are pulverized, cross 300 mesh sieves, make impalpable powder; With surplus stock

Fragmentation, extracting in water 2 times adds 20 times in water at every turn, extracts 3 hours at every turn, and filtration or centrifugal gets the water extract; Above-mentioned water extract is concentrated; The mixture that adds 5 times dextrin, lactose and Icing Sugar; Add above-mentioned Radix Salviae Miltiorrhizae, Radix Dipsaci and Fructus Psoraleae powder again, mixing adds sweeting agent, perfusion, and gland is sterilized, and obtains the application's oral liquid.

Embodiment 9

Take by weighing each flavor by prescription, Radix Salviae Miltiorrhizae and Radix Dipsaci are pulverized, cross 100 mesh sieves, make impalpable powder; With the surplus stock fragmentation, extracting in water 2 times adds 30 times in water at every turn, extracts 2 hours at every turn, and filtration or centrifugal gets the water extract; Above-mentioned water extract is concentrated; The dextrin or the lactose that add 5 times; Add above-mentioned Radix Salviae Miltiorrhizae and Radix Dipsaci powder again, mixing concentrates, and adds sweeting agent, antiseptic, perfusion, and gland is sterilized, and obtains the application's mixture.

Embodiment 10

Take by weighing each flavor by prescription, Radix Salviae Miltiorrhizae is pulverized, cross 80 mesh sieves, make fine powder; With the surplus stock fragmentation, extracting in water 2 times adds 10 times in water at every turn, extracts 3 hours at every turn, and filtration or centrifugal gets the water extract; Above-mentioned water extract is concentrated; The mixture that adds 5 times dextrin, lactose and Icing Sugar; Add above-mentioned Radix Salviae Miltiorrhizae powder again, mixing concentrates, and drying is pulverized, and adds a certain proportion of citric acid and sodium bicarbonate, granulates, and tabletting obtains the application's effervescent tablet.

Embodiment 11

Fragmentation, extracting in water 2 times adds 20 times in water at every turn, extracts 2 hours at every turn, and filtration or centrifugal gets the water extract; Above-mentioned water extract is concentrated; Drying is ground into 100 fine powders, adds Radix Dipsaci and Fructus Psoraleae powder again, adds 5 times dextrin; Mixing, pill, drying obtains the application's XIANLING GUBAO micropill.

Embodiment 12

Take by weighing each flavor by prescription, Radix Salviae Miltiorrhizae and Radix Dipsaci are pulverized, cross 200 mesh sieves, make impalpable powder; With the surplus stock fragmentation, extracting in water 2 times adds 30 times in water at every turn, extracts 2 hours at every turn, and filtration or centrifugal gets the water extract; Above-mentioned water extract is concentrated; The dextrin and the lactose that add 3 times; Add above-mentioned Radix Salviae Miltiorrhizae and Radix Dipsaci powder again, mixing concentrates, and drying is ground into fine powder, with an amount of vegetable oil mixing, makes the application's soft capsule.

Description of drawings:

Fig. 1 XIANLING GUBAO is to the om observation result of the morphologic influence of ovariectomized rat osseous tissue

Fig. 2 XIANLING GUBAO is to the scanning electron microscopic observation result of the morphologic influence of ovariectomized rat osseous tissue

Fig. 3 XIANLING GUBAO JIAONANG is to the influence of rat assist agent arthritis primary lesion

Fig. 4 XIANLING GUBAO JIAONANG is to the influence of rat assist agent arthritis secondary lesion

Claims

1, the application of a kind of Chinese medicine composition in the medicine of preparation treatment osteoarthritis is characterized in that this Chinese medicine composition made by being prepared as follows technology by following raw medicaments in portion by weight: Herba Epimedii 12-20 part Radix Dipsaci 2-8 part Radix Salviae Miltiorrhizae 1-5 part Rhizoma Anemarrhenae 1-5 part Fructus Psoraleae 1-5 part Radix Rehmanniae 1-5 part

1) takes by weighing the raw material of Chinese medicine of respectively distinguishing the flavor of by proportioning,, cross 80-300 order or 300 orders, make fine powder or impalpable powder with top sieve with Radix Salviae Miltiorrhizae or Radix Salviae Miltiorrhizae and Radix Dipsaci or Radix Salviae Miltiorrhizae, Radix Dipsaci and Fructus Psoraleae pulverizing;

3) above-mentioned water extract is concentrated;

5) add in 0.3 to 5 times dextrin, lactose or the Icing Sugar one or more;

2, application according to claim 1 is characterized in that the weight proportion of crude drug wherein is:

3, application according to claim 1 is characterized in that the weight proportion of crude drug wherein is:

4, application according to claim 1 is characterized in that the weight proportion of crude drug wherein is:

5, application according to claim 1 is characterized in that the weight proportion of crude drug wherein is:

6, application according to claim 1 is characterized in that the weight proportion of crude drug wherein is:

7, application according to claim 1 is characterized in that the weight proportion of crude drug wherein is: