CN101007117A - Application of 'Gu Kang' medicine in preparation of formulations for treating osteoarthritis and osteoporosis - Google Patents
Application of 'Gu Kang' medicine in preparation of formulations for treating osteoarthritis and osteoporosis Download PDFInfo
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Abstract
The present invention discloses the novel use of bone-care medicament, wherein banana tree root, creeping oxalis, psoralea fruit and dipsacus root are used as raw material, conventional processes are employed to obtain various extracts, auxiliary materials are charged to produce dosage forms of oral administration and injection suitable for clinical applications. The medicament can be used for treating osteoarthritis and osteoporosis.
Description
Technical field
The present invention relates to the novel clinical use of 'Gu Kang ' medicine, particularly 'Gu Kang ' medicine and belong to the application in the deficiency of the liver and kindey preparation in preparation treatment osteoarthritis, osteoporosis.Belong to technical field of medicaments.
Technical background
Osteoarthritis (be called for short OA) be a kind of be the chronic joint disease of feature with focal articular cartilage degeneration, bone loss, the hyperosteogeny formation of edge, joint and joint deformity and the densification of subchondral bone matter, claim osteoarthritis, degenerative osteoarthritis again, hypertrophiarthritis is modal chronic, a progressivity rheumatism after the middle age.Find according to the generaI investigation of X line: up to 80%, wherein have symptom and moving obstacle person to account for 1/8 greater than 55 years old age group incidence rate.Present western medical treatment OA is still based on symptomatic treatment such as anti-inflammation analgesia medicine and non-steroid medicines, but side effect is big, and more contraindication is arranged, and patient is difficult to take for a long time and tolerate.Chinese medicine is accumulating rich experience aspect the treatment OA, and safe.
Osteoporosis is to reduce and osseous tissue microstructure degenerative change is a kind of general metabolic osteopathy of feature bone fragility increase with the bone amount, because of its sickness rate raises day by day, become and have a strong impact on the healthy disease of old people, the present patients with osteoporosis of China reaches 9,000 ten thousand more than.At present also there is not to cure fully the medicine of osteoporosis, domestic and international some medicines such as calcium preparation, vitamin D and derivant, the gonadal hormone etc. that use, though certain curative effect is arranged, because of it has side effect, contraindication is many, patient is difficult to take for a long time.Chinese medicine is accumulating rich experience aspect the treatment OA, and safe.
'Gu Kang ' medicine is meant by " national drug standards (trying) " (version in 2002) " in the medicine of the raw materials used medicine of bone recovering capsule preparation.'Gu Kang ' medicine is used for treatment of fractures clinically.'Gu Kang ' medicine is used for the treatment that osteoarthritis and osteoporosis belong to deficiency of the liver and kindey, has had not yet to see report.
Summary of the invention
The objective of the invention is to, the application of 'Gu Kang ' medicine in preparation treatment osteoarthritis, osteoporosis preparation is provided.The present invention has obtained beyond thought therapeutic effect for 'Gu Kang ' medicine provides new purposes.
Technical scheme of the present invention.Comprise application and 'Gu Kang ' medicine the application in preparation treatment osteoporosis preparation of 'Gu Kang ' medicine in preparation treatment osteoarthritis preparation.
The application of 'Gu Kang ' medicine in preparation treatment osteoarthritis preparation is that 'Gu Kang ' medicine is made clinical acceptable forms in order to the treatment osteoarthritis.
The application of above-mentioned 'Gu Kang ' medicine in preparation treatment osteoarthritis preparation, described preparation can be the dosage form of various clinical practices such as pill, capsule, powder, tablet, granule, microcapsule, drop pill, injection, syrup, soft capsule, dispersible tablet, oral solution, gel.
The application of 'Gu Kang ' medicine in preparation treatment osteoporosis preparation is that 'Gu Kang ' medicine is made clinical acceptable forms in order to the treatment osteoporosis.
The application of above-mentioned 'Gu Kang ' medicine in preparation treatment osteoporosis preparation, the dosage form of various clinical practices such as the pill that described preparation can prepare for the preparation process according to routine, capsule, powder, tablet, granule, microcapsule, drop pill, injection, syrup, soft capsule, dispersible tablet, oral solution, gel.
'Gu Kang ' medicine among the present invention is the pharmaceutical composition of being made by the primary raw material of following weight parts proportioning:
Radix Musae 100-1000 Herba Oxalidis Corniculatae 100-800 Fructus Psoraleae 100-1000
Radix Dipsaci 100-600 Radix Notoginseng 50-300.
'Gu Kang ' medicine is more preferably the pharmaceutical composition of being made by the primary raw material of following weight parts proportioning:
Radix Musae 400-800 Herba Oxalidis Corniculatae 300-600 Fructus Psoraleae 400-800
Radix Dipsaci 200-400 Radix Notoginseng 100-200.
What 'Gu Kang ' medicine was best is the pharmaceutical composition of being made by the primary raw material of following weight parts proportioning:
Radix Musae 600 Herba Oxalidis Corniculataes 400 Fructus Psoraleaes 600
Radix Dipsaci 300 Radix Notoginseng 150.
Preparation of the present invention can Radix Musae, Herba Oxalidis Corniculatae, Fructus Psoraleae, Radix Dipsaci are raw material, technology obtains various extracts routinely, add adjuvant again and make any oral and injectable dosage forms that is suitable for using clinically, as pill, capsule, powder, tablet, granule, drop pill, injection, soft capsule, dispersible tablet, oral solution, gel etc.Described adjuvant comprises excipient substances such as conventional solvent, disintegrating agent, correctives, antiseptic, coloring agent, binding agent, lubricant, lubricant, wetting agent, thickening agent, solubilizing agent, substrate.
Because the present invention discloses the effect that 'Gu Kang ' medicine treatment osteoarthritis, osteoporosis belong to deficiency of the liver and kindey first, therefore so long as with 'Gu Kang ' medicine be used for the treatment of osteoarthritis, osteoporosis belongs to deficiency of the liver and kindey and all belongs to protection scope of the present invention.With the preparation of 'Gu Kang ' medicine preparation pack or description on or on other any type of propaganda material, as long as indicate or point out it to have the effect that treatment osteoarthritis, osteoporosis belong to deficiency of the liver and kindey, also fall into protection scope of the present invention.
As everyone knows, determining a kind of constituent of Chinese medicine composition, a kind of new Chinese medicine composition promptly is provided, is the work that will pay many creative works.Equally, providing a kind of novel clinical use of known Chinese medicine composition, also is the work that will pay many creative works.The present invention is exactly the achievement that the applicant obtains on the basis of testing repeatedly, contrast, conclude, summing up.'Gu Kang ' medicine is used for preparing the preparation that treatment osteoarthritis, osteoporosis belong to deficiency of the liver and kindey, has obtained beyond thought therapeutic effect.Both, also, Chinese traditional treatment osteoarthritis, osteoporosis provided a kind of novel drugs for belonging to deficiency of the liver and kindey for 'Gu Kang ' medicine provides new clinical application.
Following clinical verification can further specify therapeutic effect of the present invention.
Clinical experiment example 1: capsule of the present invention is to the effect of treatment osteoarthritis
The clinical experiment preparation method of capsule of the present invention:
Get Radix Musae 600g, Herba Oxalidis Corniculatae 400g, Fructus Psoraleae 600g, Radix Dipsaci 300g, Radix Notoginseng 150g, the above five tastes are got Radix Musae 30g and are become fine powder with the Radix Notoginseng pulverize separately, three flavors such as residue Radix Musae and all the other Fructus Psoraleaes decoct with water three times, and each 1 hour, collecting decoction, filtrate is concentrated into the thick paste of relative density 1.31-1.35 (60 ℃), adds above-mentioned fine powder, mixing, dry, be ground into fine powder, mixing, the capsule of packing into No. 1, every dress 0.4g promptly gets the clinical experiment capsule.
1, materials and methods
1.1 physical data
The 240 routine out-patients 1.1.1 case is originated, treatment group (capsule of the present invention) 160 examples, wherein male 56 examples, women 104 examples; Matched group (ZHUANGGU GUANJIE WAN) 80 examples, wherein male 26 examples, women 54 examples.
1.2 verification method
1.2.1 the checking group is oral, each 3-4 grain, and 3 times on the one, 1 month is a course of treatment;
1.2.2 matched group is oral, one time 6 gram, and 2 times on the one, 1 month is a course of treatment;
1.2.3 auxiliary treatment all advises the patient suitably to carry out functional exercise during treating for two groups, with muscle strength reinforcing, blood circulation promoting, prevent overworked, local voluntarily tumbling, be affectedly bashful, press, therapy such as hot compress, to dredge local QI and blood.Two groups all forbid in other, therapy such as Western medicine and physical therapy.
1.3 diagnostic criteria
1.3.1 from the beginning of seeing that waist lower limb, spinal column, knee joint etc. have a dull ache, bend and stretch more, pitching, change one's position unfavorablely, light activity is alleviated slightly, climate change increases the weight of, and does not touchingly repeatedly heal.
1.3.2 insidious onset, morbidity slowly is more common in person in middle and old age.
1.3.3 but local joint mild swelling, closing when movable often has noise made in coughing or vomiting thorn sound or friction sound.The visible amyotrophy of severe patient, joint deformity, the curved back of the body camel of waist.
1.3.4 the X line is taken the photograph the sheet inspection: show osteoporosis, articular surface is irregular, and articular surface is irregular, and the joint space is narrow, the sclerosis of subchondral bone matter, and edge lip sample changes hyperosteogeny formation.
Heavy 1.3.5 have a blood test, anti-" O ", mucin, rheumatoid factor etc. are differentiated mutually with rheumatism numbness, numbness.
1.4 case choice criteria
1.4.1 doctor trained in Western medicine standard: person in middle and old age, heavy burden joint dull pain, movable or tired postemphasis alleviates after the rest, and then constant pain, ankylosis, limitation of activity has deformity; The X ray examination is degenerative osteoarthritis.
1.4.2 tcm diagnosis standard: arthralgia, the soft knee joint acid of shin, the joint enlargement, walking or movable unfavorable, tongue fur is red partially, thin or thin greasy, rolling pulse or string.
1.4.3 case exclusion standard:
Do not meet the osteoarthritis diagnostic criteria.
Age is at under-18s or over-65s, gestation or women breast-feeding their children, allergic constitution or to drug allergy person.
Take other relevant medicine for a long time, person immediately can not stop using.
Late deformity, maimed person, disability person.
Merge serious primary disease such as liver, kidney, hemopoietic system, hormonal system, the psychotic.
Sb.'s sickness becomes critical, is difficult to definite estimator is done in the effectiveness and the safety of new drug.
Do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect, or data is not congruent affects the treatment or safe judgement person.
1.5 observation index
1.5.1 safety observation: situations such as attention breathing, the rhythm of the heart, hepatic and renal function, the observation of neural poison reaction, 2 weeks write down 1 time, finish the back comprehensive review 1 course of treatment, unusually then check 1 time as finding to have, the person does not participate in efficacy analysis because of the side reaction stopped treatment, but participates in during the side reaction statistical analysis.
1.5.2 observed content: observe the forward and backward arthralgia degree of treatment, arthroncus degree and number, articular pain degree, joint function disturbance degree and number, stiff time in morning, grip, joint creeping chill, pain increase in intensity under coldness, the variation of tongue arteries and veins etc., routine blood test, liver, renal function.
1.5.3 curative effect determinate standard: " traditional Chinese medical science disease diagnosis criterion of therapeutical effect " rheumatism involving the bone efficacy assessment standard of issuing according to State Administration of Traditional Chinese Medicine: (1) cures: arthralgia, swelling disappear, and it is normal that movable function recovers, and lab testing is normal.(2) take a turn for the better: arthroncus, pain relief, movable function take a turn for the better.(3) do not heal: arthralgia and swelling no change.
1.6 Clinical results checking group and matched group totally 240 routine patient treatments were evaluated by above-mentioned curative effect determinate standard after January, the results are shown in Table 1,2,3.As known from Table 1, two groups of curative effects are relatively learned by statistics and are handled, and the treatment group is cured curative effect and obviously is better than matched group, and statistical significance (P＜0.05=is arranged; As known from Table 2, two groups of different parts curative effects compare, and treatment group curative effect obviously is better than matched group, and statistical significance (P＜0.05 or P＜0.01=are arranged.From the medication process, the treatment group has no adverse reaction, and side reactions such as the flatulence that occurs feeling sick after matched group has 2 examples to take medicine disappear after the drug withdrawal.
Table 1 liang group patient curative effect is (n) relatively
| Group | The example number | Therapeutic outcome | Cure rate | Total effective rate | ||
| Cure | Take a turn for the better | Do not heal | ||||
| The treatment group | 160 | 73 | 72 | 15 | 45.6％ | 90.6％ |
| Matched group | 80 | 25 | 41 | 14 | 31.25％ | 82.5％ |
Table 2 liang group patient's site of pathological change and curative effect be (n) relatively
| Site of pathological change | The treatment group | Matched group | ||||||||
| n | Pool more | Take a turn for the better | Do not heal | Cure rate | n | Cure | Take a turn for the better | Do not heal | Cure rate | |
| Knee joint | 85 | 43 | 39 | 3 | 50.6％ | 39 | 14 | 21 | 6 | 35.90％ |
| Lumbar vertebra | 37 | 17 | 15 | 5 | 45.9％ | 21 | 6 | 10 | 5 | 28.57％ |
| Cervical vertebra | 22 | 7 | 11 | 4 | 31.8％ | 11 | 3 | 6 | 2 | 27.27％ |
| Elbow joint | 16 | 6 | 7 | 3 | 37.5％ | 8 | 2 | 5 | 1 | 25.00％ |
Table 3 a liang group is cured patient's pain disappearing time relatively
| Group | n | Pain disappearing time | |||
| In 7 days | 14 days | 21 days | 30 days | ||
| The treatment group | 132 | 29 | 58 | 38 | 7 |
| Matched group | 49 | 5 | 19 | 17 | 13 |
2, clinical verification is summed up
Osteoarthritis be a kind of be the chronic joint disease of feature with focal articular cartilage degeneration, bone loss, the hyperosteogeny formation of edge, joint and joint deformity and the densification of subchondral bone matter, claim osteoarthritis, degenerative osteoarthritis again, hypertrophiarthritis is modal chronic, a progressivity rheumatism after the middle age.Osteoarthritis belongs to traditional Chinese medical science rheumatism involving the bone category, be commonly considered as at present because the influence of machinery and the comprehensive functions such as change of enzyme cause, because the mechanical movement in joint, cause the wearing and tearing of articular surface cartilage, and then influence its metabolism, and causing that finally fray edge Dens Elephatis becomes and thickens, ligament adheres to the place in the cartilage edge, form hyperosteogeny, thereby influence joint motion.The traditional Chinese medical science is thought major lesions at bone, so claim " rheumatism involving the bone ".Primary disease is many by worn with age, and is congenital or the day after tomorrow is not enough and intemperate sexual intercourse and cause the bone of suffering from a deficiency of the kidney and become homeless foster; Or the wound blood stasis, joint stays the stasis of blood, and wind and cold pyretic toxicity heresy is invaded and the skeleton joint in an opponent's defence.Exopathogen and blood stasis impatency skeleton joint finally form rheumatism involving the bone.Sick this of primary disease is being suffered from a deficiency of the kidney, and disease is marked on the wind and cold impatency, belongs to the disease of deficiency in origin and excess in superficiality.Therefore treat suitable treating both the principal and secondary aspects of a disease, the kidney invigorating bone strengthening is to consolidate it, and promoting blood circulation to remove obstruction in the collateral is to control its mark.Preparation of the present invention is made up of Radix Musae, Herba Oxalidis Corniculatae, Fructus Psoraleae, Radix Dipsaci, Radix Notoginseng etc., and all medicines share, and play the kidney invigorating bone strengthening altogether, channels sootheing and network vessel quickening, and pain relieving is invigorated blood circulation.Show that through clinical verification preparation of the present invention (capsule) truly has curative effect to osteoarthritis, has no adverse reaction and toxic and side effects, and is safe and convenient to use.
Clinical experiment example 2: capsule of the present invention belongs to the effect of deficiency of the liver and kindey to the treatment osteoporosis
Capsule is by the preparation of the preparation method in the clinical experiment 1.
Physical data
1.1 checking group (capsule of the present invention) is totally 150 examples
Sex: male 55 examples, women 95 examples;
Age: minimum 42 years old, maximum 65 years old, average 59.4 years old;
The cause of disease: senile osteoporosis 132 examples, women's osteosporosis after menopause 79 examples;
The state of an illness: severe 56 examples, moderate 80 examples, slight 14 examples.
1.2 matched group (XIANLING GUBAO PIAN) is totally 50 examples
(1) sex: male 17 examples, women 33 examples;
(2) age: minimum 43 years old, maximum 65 years old, average 60.2 years old;
(3) cause of disease: senile osteoporosis 42 examples, women's osteosporosis after menopause 28 examples;
(4) state of an illness: severe 17 examples, moderate 27 examples, slight 6 examples.
2, verification method
2.1 usage, consumption and the course of treatment
The checking group, oral, each 3-4 grain on the one, 3 times on the one, 3 months is a course of treatment;
Matched group, oral, one time 6 gram, 2 times on the one, 3 months is a course of treatment.
2.2 observed content: with lumbago and backache, cramp, symptom such as weak, bone density, blood alkali phosphatase (ALP), blood calcium, serium inorganic phosphorus etc. make to detect index, relatively change before and after the treatment, and take statistics to learn and handle.Have a blood test, routine urinalysis, liver, renal function detect, and observe the untoward reaction after the medication.
3, diagnostic criteria
3.1 tcm diagnosis, dialectical standard
Select deficiency of the liver and kindey disease: with lumbar vertebrae pain, aching and limp unable be primary symptom, also can show as dizzyly, body of the tongue is red partially or light; The taste deficient syndrome is with lumbar vertebrae pain, and muscle is withered becomes thin, and spiritlessness and weakness is a primary symptom, also shows as the limbs weakness, and appetite descends, pale complexion, palpitation and insomnia, pale tongue, thready pulse.
3.2 Western medicine diagnose standard
General weakness serves as obviously with spinal column portion pain, increases the weight of gradually, and microtrauma can cause fracture.
Vertebra has kyphosis deformity.
X line performance: sclerotin is generally sparse, and obvious with vertebra, basin bone, proximal femur, fish tail sample double concave appears in vertebral body, and intervertebral space broadening has the S tuberosity, and thoracic vertebra is wedge and becomes, and the vertebral body pilosity of getting involved, is dispersed in.
3.3 case exclusion standard
(1) do not meet the diagnosing osteoporosis standard.
(2) age is at under-18s or over-65s, gestation or women breast-feeding their children, allergic constitution or to drug allergy person.
(3) take other relevant medicine for a long time, person immediately can not stop using.
(4) late deformity, maimed person, disability person.
(5) merge serious primary disease such as liver, kidney, hemopoietic system, hormonal system, psychotic.
Sb.'s sickness becomes critical, is difficult to definite estimator is done in the effectiveness and the safety of new drug.
Do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect, or data is not congruent affects the treatment or safe judgement person.
4, checking result
4.1 curative effect determinate standard
Produce effects: pain obviously alleviates or disappears; Weak disappearance, vertebral body tenderness and purt pain obviously alleviate or disappear; Bone density increases, and blood calcium, serium inorganic phosphorus, AKP are normal; Hepatic and renal function is normal; Bone densitometry is not descending or is increasing.
Effectively: pain relief; Vertebral body tenderness and purt pain obviously alleviate; Blood calcium, serium inorganic phosphorus, AKP are normal; Bone densitometry is not descending or is increasing.
Invalid: all clinical symptoms, sign, biochemical analysis and bone densitometry are all preceding identical with medication.
Make parameters for observation on effect with the ultrasonic speed of bone (SOS), blood calcium, serium inorganic phosphorus and serum alkaline phosphatase, observe blood, routine urinalysis, check liver, renal function, the untoward reaction of checking group and matched group is observed in the detection of having an electro-cardiogram.
4.2 Clinical results
4.2.1 the clinical verification curative effect relatively
The curative effect statistical table of table 1 checking group and matched group
| Group | The example number | Produce effects | Effectively | Invalid | Effective percentage |
| The checking group | 150 | 73 | 61 | 16 | 89.3 |
| Matched group | 50 | 21 | 22 | 7 | 86 |
4.2.2 quantitative ultrasound method (SOS) is measured tibial bone mineral content result
| Grouping | The example number | Before the treatment (X ± S) | The treatment back (X ± S) |
| The checking group | 150 | 3677.67±162.10 | 3814.48±230.60 |
| Matched group | 50 | 3609.75±224.98 | 3733.70±225.11 |
Annotate: * and matched group compare, P＞0.05, and △ and preceding relatively P＜0.05 of treatment compare P＜0.01 (down together) before △ △ and the treatment.
4.2.3 the right calcaneus bone density measurement of checking group and matched group result
The right calcaneus bone density of 200 routine sufferers of osteoporosis face (surface of bone amasss ratio, and BAR) (%, X ± S)
The result shows that checking group and matched group all can significantly improve the bone density of sufferers of osteoporosis face (P＜0.01).
4.2.4 checking group and matched group results of biochemical
| The mensuration project | The checking group | Matched group | ||
| Before the treatment | After the treatment | Before the treatment | After the treatment | |
| Blood calcium (mmol/L) | 2.49±2.06 * | 2.17±0.23 * | 2.47±0.30 | 2.38±0.28 |
| Serium inorganic phosphorus (mmol/L) | 1.22±0.15 * | 1.33±0.18 * | 1.25±0.18 | 1.38±0.19 |
| AKP(lu/L) | 102.6±26.4 * | 90.4±21.2 * | 105.9±25.1 | 92.4±22.9 |
The result shows that checking group blood calcium has appreciable impact (P＜0.01), and matched group does not make significant difference; But two groups of all can raise serium inorganic phosphorus (P＜0.01) and reduction alkali phosphatases (P＜0.05), the checking group is identical with the matched group effect.
4.2.5 analysis of adverse reactions
Through the medication of a course of treatment, its blood, routine urinalysis and liver, the cardiac electrical inspection of renal function there is no ANOMALOUS VARIATIONS, and the patient does not see discomfort yet, shows through the treatment of a course of treatment not see tangible untoward reaction.
5, clinical verification conclusion
Alcium and phosphor metabolization imbalance in the sufferers of osteoporosis face body, the bone recovering capsule can obviously reduce blood calcium, and the rising serium inorganic phosphorus shows that it has the effect of regulating alcium and phosphor metabolization, is of value to the treatment of osteoporosis; Sufferers of osteoporosis face reverses losing of bone, so can eliminate or alleviate patient's symptoms such as pain because bone loss often has symptoms such as aching pain in waist and back, and the bone recovering capsule can increase bone density.Testing result through bone ultrasonic velocity and biochemical indicator shows that after patients with osteoporosis was taken the bone recovering capsule, bone resorption was suppressed, and the bone amount is preserved, and obvious adverse reaction does not take place during the medication.Because onset is rapid, stable curative effect has no side effect, one of the active drug of treat osteoporosis of can yet be regarded as, worth further developmental research and applying.
The specific embodiment
Embodiment 1: capsule
Get Radix Musae 600g, Herba Oxalidis Corniculatae 400g, Fructus Psoraleae 600g, Radix Dipsaci 300g, Radix Notoginseng 150g, the above five tastes are got Radix Musae 30g and are become fine powder with the Radix Notoginseng pulverize separately, three flavors such as residue Radix Musae and all the other Fructus Psoraleaes decoct with water three times, and each 1 hour, collecting decoction, filtrate is concentrated into the thick paste of relative density 1.31-1.35 (60 ℃), adds above-mentioned fine powder, mixing, drying is ground into fine powder, mixing, the capsule of packing into No. 1 is made 1000, every dress 0.4g, each 3-4 grain, three times on the one.Be a course of treatment January.
Embodiment 2: tablet
Get Radix Musae 500g, Herba Oxalidis Corniculatae 500g, Fructus Psoraleae 550g, Radix Dipsaci 350g, Radix Notoginseng 100g, Cornu Cervi Pantotrichum 50g, the above five tastes, get Cornu Cervi Pantotrichum and become fine powder with the Radix Notoginseng pulverize separately, all the other four flavors decoct with water three times, and each 1 hour, collecting decoction, filtrate is concentrated into the thick paste of relative density 1.20-1.35 (60 ℃), add above-mentioned fine powder, add appropriate amount of auxiliary materials starch, dextrin, ethanol, make 1000 in tablet, each 3-4 sheet, three times on the one.Be a course of treatment January.
Embodiment 3: granule
Get Radix Musae 200g, Herba Oxalidis Corniculatae 150g, Fructus Psoraleae 350g, Radix Dipsaci 100g, Herba Epimedii 150g, Radix Notoginseng 50g, the above five tastes, decoct with water three times, each 1 hour, collecting decoction, filtrate is concentrated into the thick paste of relative density 1.20-1.35 (60 ℃), dry, add sucrose: dextrin=4: 1 is made granule 400g, each 6g, three times on the one as excipient.Be a course of treatment January.
Embodiment 4: granule
Get the ethanol extract 87g of five kinds of medical materials such as Radix Musae 900g, Herba Oxalidis Corniculatae 500g, Fructus Psoraleae 800g, Radix Dipsaci 450g, Radix Notoginseng 250g, make granule 600g, each 6g, three times on the one.Be a course of treatment January.
Embodiment 5: powder
Get Radix Musae 800g Herba Oxalidis Corniculatae 700g Fructus Psoraleae 500g Radix Dipsaci 300g Radix Notoginseng 150g, preparation technology makes 540g powder routinely, each 9g, three times on the one.Be a course of treatment January.
Embodiment 6: injection
Get Radix Musae 1000g Herba Oxalidis Corniculatae 600g Fructus Psoraleae 700g Radix Dipsaci 400g Radix Notoginseng 200g, preparation technology makes injection 300ml routinely, per injection 5ml, twice on the one.Be a course of treatment January.
Embodiment 7: microcapsule
Get Radix Musae 400g Herba Oxalidis Corniculatae 300g Fructus Psoraleae 800g Radix Dipsaci 400g Radix Notoginseng 150g, preparation technology makes microcapsule 300ml routinely, each oral 20ml, twice on the one.Be a course of treatment January.
Embodiment 8: syrup
Get Radix Musae 700g Herba Oxalidis Corniculatae 400g Fructus Psoraleae 600g Radix Dipsaci 200g Radix Notoginseng 300g, preparation technology makes syrup 1000ml routinely, each oral 20ml, three times on the one.Be a course of treatment January.
Embodiment 9: dispersible tablet
Get Radix Musae 900g Herba Oxalidis Corniculatae 500g Fructus Psoraleae 800g Radix Dipsaci 200g Radix Notoginseng 300g, preparation technology makes 500 dispersible tablets routinely, and each 4, three times on the one.Be a course of treatment January.
Embodiment 10: oral liquid
Get Radix Musae 600g Herba Oxalidis Corniculatae 500g Fructus Psoraleae 700g Radix Dipsaci 600g Radix Notoginseng 200g, preparation technology makes oral liquid 1000ml routinely, each 20ml, three times on the one.Be a course of treatment January.
Embodiment 11: injectable powder
Get Radix Musae 300g Herba Oxalidis Corniculatae 600g Fructus Psoraleae 700g Radix Dipsaci 400g Radix Notoginseng 200g, preparation technology makes injectable powder 35g routinely, each 0.5g, twice on the one.Be a course of treatment January.
Embodiment 12: gel
Get Radix Musae 800g Herba Oxalidis Corniculatae 500g Fructus Psoraleae 900g Radix Dipsaci 300g Radix Notoginseng 100g, preparation technology makes gel g routinely, the heavy 0.2g of every ball, each 10 balls, three times on the one.Be a course of treatment January.
Embodiment 13: drop pill
Get Fructus Psoraleae 650g, Radix Notoginseng 200g is crushed to 80 orders, extracts twice with 70% alcohol heating reflux, measures ethanol extractions 2 hours with 6 times for the first time, measure ethanol extractions 1 hour with 4 times for the second time, filter merging filtrate, concentrate and reclaim ethanol, be concentrated into relative density 1.2 (60 ℃).Other gets Radix Musae 800g, Herba Oxalidis Corniculatae 300g and Radix Dipsaci 400g, boils twice with decocting, adds 8 times of water gagings for the first time and decocts 1.5 hours, add for the second time 6 times of water gagings and decocted 1 hour, merge and boil liquid, filter, be concentrated into relative density 1.31-1.35 (60 ℃), drying and crushing to 200 order.With above two kinds of extractum in 1: 1 ratio mixing.Appropriate amount of PEG-6000 is added (90 ℃) fusion in the water-bath, press medicated powder: PEG-6000=1: 0.7 abundant stirring and evenly mixing, preserve under 80 ℃ of conditions.The medicinal liquid for preparing is gone into drop pill mechanism be equipped with drop pill, water dropper bore 30-40 millimeter, water dropper is to 10-20 centimetre of liquid coolant height, drip system with the per minute 30-40 speed of dripping, add liquid coolant paraffin oil or methyl-silicone oil, chilling temperature is 10-12 ℃, the heavy 0.03g of every ball, each 10, three times on the one.Be a course of treatment January.
Embodiment 14: soft capsule
Get Radix Musae 200g, Herba Oxalidis Corniculatae 400g, Radix Dipsaci 350g, above three herbal medicines are pulverized supercritical CO
2Extraction adds 40% medical material amount, 95% ethanol and makes entrainer, extracting pressure 30Mpa, 40 ℃ of temperature, the mixing supercritical extract 8.5g of Radix Musae, Herba Oxalidis Corniculatae and Radix Dipsaci; Get Fructus Psoraleae 800g, Radix Notoginseng 100g two flavor medical materials, Radix Notoginseng powder is broken into coarse powder, adds 60% alcohol reflux 2 times, each 1 hour, extracting solution reclaimed ethanol, is concentrated into relative density 1.2, centrifugal, supernatant is crossed macroporous resin column, and water lotion is abandoned in washing, 60% ethanol elution, reclaim ethanol, concentrate drying gets Fructus Psoraleae, Radix Notoginseng ethanol extract 17g.Preparation gelatin solution (gelatin: glycerol: water=10: 5: 9), get suspending agent paraffin oil thermosol in soybean oil, slowly add mixing medicaments, use milling treatment of colloid, medicinal liquid and gelatin solution are pressed into the soft capsule of predetermined weight by pellet press, through the drying of finalizing the design, wash ball, packing and promptly get 1000 of soft capsules, every 0.5 gram.An oral 1-2 grain, three times on the one.Be a course of treatment January.
Claims (10)
1. the application of 'Gu Kang ' medicine in preparation treatment osteoarthritis preparation.
2. the application of 'Gu Kang ' medicine according to claim 1 in preparation treatment osteoarthritis preparation, it is characterized in that: 'Gu Kang ' medicine is the pharmaceutical composition of being made by the primary raw material of following weight parts proportioning,
Radix Musae 100-1000 Herba Oxalidis Corniculatae 100-800 Fructus Psoraleae 100-1000
Radix Dipsaci 100-600 Radix Notoginseng 50-300.
3. the application of 'Gu Kang ' medicine according to claim 2 in preparation treatment osteoarthritis preparation, it is characterized in that: 'Gu Kang ' medicine is the pharmaceutical composition of being made by the primary raw material of following weight parts proportioning,
Radix Musae 400-800 Herba Oxalidis Corniculatae 300-600 Fructus Psoraleae 400-800
Radix Dipsaci 200-400 Radix Notoginseng 100-200.
4. the application of 'Gu Kang ' medicine according to claim 3 in preparation treatment osteoarthritis preparation, it is characterized in that: 'Gu Kang ' medicine is the pharmaceutical composition of being made by the primary raw material of following weight parts proportioning,
Radix Musae 600 Herba Oxalidis Corniculataes 400 Fructus Psoraleaes 600
Radix Dipsaci 300 Radix Notoginseng 150.
5. according to the application of the described 'Gu Kang ' medicine of arbitrary claim in the claim 1 to 4 in preparation treatment osteoarthritis preparation, it is characterized in that: described preparation is pill, capsule, powder, tablet, granule, microcapsule, drop pill, injection, syrup, soft capsule, dispersible tablet, oral solution, gel according to the conventional formulation prepared.
6. the application of 'Gu Kang ' medicine in preparation treatment osteoporosis preparation.
7. the application of 'Gu Kang ' medicine according to claim 6 in preparation treatment osteoporosis preparation, it is characterized in that: 'Gu Kang ' medicine is the pharmaceutical composition of being made by the primary raw material of following weight parts proportioning,
Radix Musae 100-1000 Herba Oxalidis Corniculatae 100-800 Fructus Psoraleae 100-1000
Radix Dipsaci 100-600 Radix Notoginseng 50-300.
8. the application of 'Gu Kang ' medicine according to claim 7 in preparation treatment osteoporosis preparation, it is characterized in that: 'Gu Kang ' medicine is the pharmaceutical composition of being made by the primary raw material of following weight parts proportioning,
Radix Musae 400-800 Herba Oxalidis Corniculatae 300-600 Fructus Psoraleae 400-800
Radix Dipsaci 200-400 Radix Notoginseng 100-200.
9. the application of 'Gu Kang ' medicine according to claim 8 in preparation treatment osteoporosis preparation, it is characterized in that: 'Gu Kang ' medicine is the pharmaceutical composition of being made by the primary raw material of following weight parts proportioning,
Radix Musae 600 Herba Oxalidis Corniculataes 400 Fructus Psoraleaes 600
Radix Dipsaci 300 Radix Notoginseng 150.
10. according to the application of the described 'Gu Kang ' medicine of arbitrary claim in the claim 5 to 9 in preparation treatment osteoporosis preparation, it is characterized in that: described preparation is pill, capsule, powder, tablet, granule, microcapsule, drop pill, injection, syrup, soft capsule, dispersible tablet, oral solution, gel.
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| CNB2006102000904A CN100546612C (en) | 2006-01-27 | 2006-01-27 | The application of 'Gu Kang ' medicine in preparation treatment osteoarthritis, osteoporosis preparation |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103417761A (en) * | 2013-08-21 | 2013-12-04 | 贵州维康药业有限公司 | Medicinal liquor for treatment of fracture and osteoporosis |
| CN103520433A (en) * | 2013-10-08 | 2014-01-22 | 广州加原医药科技有限公司 | Traditional Chinese medicine composition for treatment of osteoporosis and preparation method thereof |
| CN115814004A (en) * | 2023-01-06 | 2023-03-21 | 北京朕荣国际生物科技有限公司 | Medicine composition for treating bone disease |
-
2006
- 2006-01-27 CN CNB2006102000904A patent/CN100546612C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103417761A (en) * | 2013-08-21 | 2013-12-04 | 贵州维康药业有限公司 | Medicinal liquor for treatment of fracture and osteoporosis |
| CN103520433A (en) * | 2013-10-08 | 2014-01-22 | 广州加原医药科技有限公司 | Traditional Chinese medicine composition for treatment of osteoporosis and preparation method thereof |
| CN115814004A (en) * | 2023-01-06 | 2023-03-21 | 北京朕荣国际生物科技有限公司 | Medicine composition for treating bone disease |
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| Publication number | Publication date |
|---|---|
| CN100546612C (en) | 2009-10-07 |
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