CN100594918C - Compound Chinese medicinal oral preparation for treating osteoporosis and preparation method thererof - Google Patents
Compound Chinese medicinal oral preparation for treating osteoporosis and preparation method thererof Download PDFInfo
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Abstract
Disclosed is a Chinese medicinal compound oral preparation for treating osteoporosis and bone fracture, which is prepared from raw materials including drynaria, prepared rhizome of rehmannia, dipsacusroot, cortex acanthopanacis, root of herbaceous peony, Chinese angelica root, safflower, notoginseng, rhubarb horsetails, licorice root, and can be prepared into capsules, tablets, granules and otherconventional oral administration preparations.
Description
[technical field]
The present invention relates to the osteoporotic Chinese medicine compound oral formulations of a kind of treatment, is one group of oral formulations forming of feedstock production and preparation method thereof with Rhizoma Drynariae, Radix Dipsaci, Cortex Acanthopancis, Radix Rehmanniae Preparata, Radix Angelicae Sinensis, Radix Notoginseng, Flos Carthami, Radix Et Rhizoma Rhei, Radix Glycyrrhizae, the Radix Paeoniae Alba particularly.
[technical background]
Osteoporosis is a kind of relevant with the age, and the disease of non-specific dysostosis mainly occurs in spongioplasm bone parts in the skeleton.The people is very fine and close at skeleton at an early age, but after the age increase, the fracture that can attenuate of part bone trabecula, it is big that the bone trabecula gap becomes, and osteoporosis to be exactly hole in the skeleton become big becomes many, that is to say that the bone trabecula amount reduces, the cortical bone attenuation, promptly skeleton density diminishes, and quality reduces.This means that the contained content of mineral substances of unit volume skeleton reduces,, just cause fracture even spontaneous fracture easily when skeleton density drops to marginal value when following.Because the osteoporosis course of disease slowly and often is left in the basket, up to fracturing.It is introduced will have 80% to disable after the patients with osteoporosis fracture, wherein 5%～50% will be dead in 1 year.The main cause of suffering from osteoporosis has following:
Woman climacteric estrogen secretion deficiency: the women of artificial or natural cause menopause because endogenous estrogen hyposecretion causes bone metabolism to lose the support of hormone, is destroyed the adjusting of bone and skeletonization.Meanwhile, estrogenic minimizing also suppresses the pth secretion parathyroid hormone, suppresses vitamin D to hepatic and/or renal hydroxylation function, causes many-sided bone metabolism disturbance.
Nutrient imbalance: calcium and phosphorus metabolism disorder is osteoporotic major reason, nutrients such as other trace element and protein also influence the metabolism of calcium, bad living habit influences the absorption of human body to calcium equally as drinking, drink aspects such as a large amount of coffees, smoking, and the loss of calcium in the body is speeded up.
Hypomotility: modern study confirms, lacks motion, and especially adolescence lacks motion, will cause the deposit wretched insufficiency of bone density and bone mineral content.
Osteoporosis is that a kind of gradual osseous tissue degenerative change is main general metabolism skeletal diseases.Development takes place and usually is potentiality in it, and it is slight not have any symptom or symptom in early days, and middle and late stage then tangible symptom can occur.As osteodynia, osteoarthrosis dysfunction, even bow-backed and fracture etc., have a strong impact on quality of life.Its clinical symptoms shows as: sore waist and aching in the waist and the back, tic, numb hand and foot twinge, easy fracture, odontoseisis, myasthenia of limbs etc.And with multiple complications such as hypertension, arteriosclerosis, diabetes.
It is varied to be used for the treatment of osteoporotic medicine in the prior art, and Western medicine is as hormones such as estrogen etc., and the diphosphonic acid salt is as according to for phosphoric acid and Alendronic Acid salt etc.; Calcitonin; Vitamin D; Novel vitamin D analogues and metabolite thereof; Calcium; Sodium fluoride; According to general pyrite; The synthetic steroid thing of protein stimulatory such as nandrolone, stanozolol and testosterone etc.Herbal species mainly contains: according to safe; More health bone; Cause health; " three-flower " bone-knitting powder; The Gold Testudinis bone looses; Bone is dredged spirit; The bone health that heals; GUSHUKANG; Bone is dredged treasured etc.Though above-mentioned Chinese and western drugs respectively has characteristics, deficiency is also arranged, bigger as the side effect of hormone method, often with short-term untoward reaction such as vaginal hemorrhage, tenderness of breasts; The digestive tract discomfort may appear in diphosphate, albuminuria, heating, bone mineralising obstacle etc.And part Chinese medicine, for example Radix Notoginseng Tabellae, GUSHUKANG etc. then are partial to synthetism or traumatic injury.
2005.9.21 day disclosed No. 200410073077.8 Chinese invention patents are our company's Chinese medicine preparation that belong to identical category in first to file, this medicine can overcome above-mentioned defective, and indication is more comprehensive, and side effect is also less.It is complicated that but this medicine also exists prescription, the deficiency that taking dose is bigger.
[summary of the invention]
The objective of the invention is to replenish the deficiency of prior art, a kind of blood circulation promoting and blood stasis dispelling that has is provided, reducing swelling and alleviating pain, the bone and muscle strengthening effect is used for the treatment of the Chinese medicine compound oral formulations that osteoporosis and other reason cause fracture.Oral formulations involved in the present invention, with Rhizoma Drynariae, Radix Dipsaci is monarch drug, Cortex Acanthopancis, Radix Rehmanniae Preparata, Radix Angelicae Sinensis, the Radix Paeoniae Alba are share and are ministerial drug, Radix Notoginseng, Flos Carthami, Radix Et Rhizoma Rhei share and are assistant, and Radix Glycyrrhizae, the Radix Paeoniae Alba are combined into mutually and make, and can play cooperative compensating, the effect for the treatment of both the principal and secondary aspects of a disease, it is simple also to have prescription simultaneously, low cost, the advantage that taking dose is little.
Can make Chinese medicine compound oral formulations involved in the present invention according to following method:
(1), gets 13 parts of Rhizoma Drynariae, 11 parts of Radix Dipsaci in weight portion; 10～12 parts of Cortex Acanthopanciss, 12～14 parts in Radix Rehmanniae Preparata, each 7～9 parts of the Radix Paeoniae Alba, Radix Angelicae Sinensis; 7～9 parts on Flos Carthami, each 3～5 parts of Radix Notoginseng, Radix Et Rhizoma Rhei; 3～5 parts in Radix Glycyrrhizae;
(2) above ten flavors are got Radix Notoginseng, and 80 ℃ of oven dry are ground into fine powder, and are after the sterilization, standby;
(3) get Radix Angelicae Sinensis and extracted volatile oil 6 hours, separate volatile oil with steam distillation, standby; Water liquid filters, and medicinal liquid device is in addition collected, and is standby;
(4) all the other eight flavors with extract Radix Angelicae Sinensis volatile oil after medicinal residues mix, add 5～10 times of water gagings decoctions three times, each 1 hour, three decoction liquor and above-mentioned Radix Angelicae Sinensis medicinal liquid merge, and are evaporated to relative density and are 1.20 clear paste, add the Radix Notoginseng fine powder, mix homogeneously, through granulating oven dry, granulate, spray into Radix Angelicae Sinensis volatile oil, put hermetic container interior vexed 2 hours, and adopted the aluminium plastic packaging bag packing or incapsulate or insert the tablet machine tabletting, can make granule, capsule or tablet respectively.
Based on above-mentioned Chinese medicine extraction preparation method, with reference to preparation method of the prior art, also can be made into different oral formulations such as drop pill and oral liquid.
[beneficial effect]
Osteoporosis is that a kind of gradual osseous tissue degenerative change is main general metabolism skeletal diseases.Development takes place and usually is potentiality in it, and it is slight not have any symptom or symptom in early days, and middle and late stage then tangible symptom can occur.As osteodynia, osteoarthrosis dysfunction, even bow-backed and fracture etc., have a strong impact on quality of life.Its clinical symptoms shows as: sore waist and aching in the waist and the back, tic, numb hand and foot twinge, easy fracture, odontoseisis, myasthenia of limbs etc.And with multiple complications such as hypertension, arteriosclerosis, diabetes.
It is varied to be used for the treatment of osteoporotic medicine in the prior art, though characteristics are respectively arranged, deficiency is arranged also, bigger as the side effect of hormone method, often with short-term untoward reaction such as vaginal hemorrhage, tenderness of breasts; The digestive tract discomfort may appear in diphosphate, albuminuria, heating, bone mineralising obstacle etc.And part Chinese medicine then is partial to synthetism or traumatic injury as Radix Notoginseng Tabellae, GUSHUKANG etc.
2005.9.21 day disclosed No. 200410073077.8 Chinese invention patents are our company's Chinese medicine preparation that belong to identical category in first to file, this medicine can overcome above-mentioned defective, and indication is more comprehensive, and side effect is also less.It is complicated that but this medicine also exists prescription, the deficiency that taking dose is bigger.
Pure Chinese medicine compound oral formulations involved in the present invention, with Rhizoma Drynariae, river continuous section nourishing the liver and kidney, bone and muscle strengthening, promoting blood circulation and stopping pain is a monarch drug.Cortex Acanthopancis, Radix Rehmanniae Preparata, Radix Angelicae Sinensis, the Radix Paeoniae Alba are share with nourishing YIN and supplementing blood, and marrow is given birth in replenishing essence, and auxiliary group medicine bone and muscle strengthening is so be ministerial drug.Radix Notoginseng, Flos Carthami, Radix Et Rhizoma Rhei share, assistant principal drug assistance blood circulation promoting and blood stasis dispelling, and removing obstruction in the collateral to relieve pain, but Radix Notoginseng benefiting vital QI and blood still, the Radix Et Rhizoma Rhei bitter cold can be helped the product of make all temperature compensations again, in order to avoid dry strong impairment of YIN is the usefulness that assistant helps the system of assistant, so be adjuvant drug.Source of generating QI and blood is opened in the Radix Glycyrrhizae invigorating the spleen and replenishing QI, is harmonious with the Radix Paeoniae Alba, the cloudy flourish muscle pain relieving of sweet acidify, and can be in harmonious proportion the property of medicine, and make it out of question, play liver and kidney tonifying altogether, bone and muscle strengthening, the merit of stasis-dispelling and pain-killing is so be messenger drug.
Compare with other Chinese medicine compound oral formulations that is used for the treatment of osteoporosis in the prior art, oral formulations involved in the present invention, with the traditional Chinese medical science " kidney tonifying, essence replenishing; give birth to the marrow bone strengthening ", principles such as " nourshing blood and promoting blood circulation, blood stasis dispersing and deswellings; pain relieving " is the basis, dialectical executing controlled, and comprehensive control improves total quality emphatically, has blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, effects such as bone and muscle strengthening are used for the treatment of the fracture that osteoporosis and other reason cause, good effect, instant effect can effectively promote the precipitation of calcium in skeleton, has the dual function of treatment and prevention simultaneously.It is simple also to have prescription simultaneously, low cost, the advantage that taking dose is little.
Be the clinical data of pure oral preparation of Chinese traditional medicinal involved in the present invention below, as proof data to beneficial effect.
1. the second stage of clinical research proof bone return the former lumbar and back pain that osteoporosis is occurred, aching and limp unable, walk with difficulty, symptoms such as cramp, the vertigo, Hiccough and deaf have the obvious treatment effect, improve these symptoms even reached the purpose of clinic control, total effective rate is 94.44%, wherein clinic control 12.96%, produce effects 19.44%, progressive 62.04%; Bone density is also improved.Regulation according to scheme: than greater than 2% be produce effects, bone density is constant and be effective less than 2% before the bone density after the treatment and the treatment, and total effective rate is that produce effects adds effectively: the total effective rate of lumbar vertebra L2-L4 is 71.74%; The total effective rate of neck of femur is 69.39%; The total effective rate of Ward triangle is 67.21%; The total effective rate of greater trochanter is 79.01%.
The contrast medicine is a GUSHUKANG KELIJI, its new drug for having gone on the market.This bone is returned former capsule and its relatively, in the control of traditional Chinese medical science disease and on improving all with to contrast medicine similar, on statistics, all there is not statistical significance, but investigational agent slightly is better than contrasting medicine (traditional Chinese medical science disease investigational agent and contrast medicine total effective rate is respectively 94.44% and 89.42%, and bone density lumbar vertebra L2-4 total effective rate is respectively 71.74% and 49.06% on actual efficacy; Ward triangle total effective rate is respectively 67.21% and 66.1%), and the bone density matched group of neck of femur and greater trochanter slightly is better than treatment group (its total effective rate is respectively 75% and 69.39% and 81.58% and 79.01%) from total effective rate.
This medicine is obvious to the effect of main symptoms such as aching pain in waist and back, two groups widely different during first month, test group obviously is better than matched group, but As time goes on, its difference is more and more littler, compares its P value between two groups and is respectively 0.0073,0.1708,0.5220,0.4295,0.9508,0.7813.
Light-headedness last the first month, second month and June two groups P value be respectively 0.0296,0.0283,0.0269, test group is better than matched group.Be respectively 0.0395,0.0214,0.0157 from the increasing P value of difference between two groups of April aspect walking with difficulty, test group obviously is better than matched group.
It is less that drug-induced untoward reaction is observed in this clinical trial, and not observing trial drug has anomalous effects to the heart, liver, renal function, blood system.Prove that by II phase clinical research bone returns former capsule that osteoporosis is had clinical efficacy, and have the safety of medication.
2.III clinical research goes into to organize case totally 436 examples, enters patient's bone that safety analysis crowd and ITT analyze the crowd and returns former group, GUSHUKANG group to be respectively 329 examples, 107 examples, 413 examples enter PP crowd, and two groups is respectively 312 examples, 101 examples.The result thinks:
2.1 tcm syndrome primary symptom ITT crowd when treatment finished in 6 months, bone return former group, GUSHUKANG group tcm syndrome primary symptom score dropped to 2.89 fens from 8.14 minutes, 8.13 minutes respectively, 3.32 minutes, on average descended 5.26 minutes, 4.81 minutes.Analyze by statistics, the result thinks that two groups of differences have statistical significance (p＜0.05), and bone returns former group to be better than the GUSHUKANG group.Think and treatment grouping and center non-interaction action show each center unanimity as a result through investigating the conforming covariance analysis of each center result.PP crowd is similar to ITT crowd result.
2.2 tcm syndrome time disease ITT crowd is when treatment finished in 6 months, bone return former group, GUSHUKANG group tcm syndrome time disease score dropped to 2.25 fens from 7.79 minutes, 7.54 minutes respectively, 2.31 minutes, average decline 5.54 minutes, 5.23 minutes, analyze by statistics, the result shows two groups of difference not statistically significants (p＜0.05).Investigate the conforming covariance analysis of each center result and think and treatment grouping and center non-interaction action show each center unanimity as a result that PP crowd is similar to ITT crowd result.
2.3 bone density scoring, bone density measurement value, that bone density value accounts for two groups of peak value percentage ratios is all close, difference not statistically significant (p＞0.05).The bone density curative effect at each unusual position is all close, take all factors into consideration under the situation of each unusual position effect, bone returns former group of obvious effective rate, effective percentage to be respectively 26.40%, 59.94%, GUSHUKANG group obvious effective rate, effective percentage are respectively 20.95%, 60.00%, and the CMH assay shows two groups of difference not statistically significants (p＞0.05).
2.4 clinical symptoms (tcm syndrome) curative effect: bone returns former group of clinic control rate, obvious effective rate to be respectively 9.82%, 30.06%, GUSHUKANG group clinical efficacy clinic control rate, obvious effective rate are respectively 3.74%, 18.69%, the CMH assay shows that two groups of differences have statistical significance (p＜0.05), and bone returns former group of tcm syndrome curative effect to be better than the GUSHUKANG group.But the individual event tcm symptom is analyzed, and the difference of soreness of the waist and knees, two symptom variation of walking with difficulty has statistical significance (p＜0.05), and other symptom difference does not all detect significant difference.
Return former group to be 6.69% 2.5 this observes whole adverse events incidence rate bones, the GUSHUKANG group is 2.80%.The adverse events incidence rate relevant with trial drug is 1.82%, all shows gastronintestinal system, mainly contains diarrhoea, vomiting, feels sick, abdominal distention, gastrointestinal hemorrhage and stomach discomfort, and degree all shows as gently, moderate.
2.6 observe trial drug the heart, liver, renal function, blood system there is not anomalous effects.
Prove that by III phase clinical research bone returns former capsule that osteoporosis is had tangible clinical efficacy, and have the safety of medication.
[specific embodiment]
One group of specific embodiment is provided below, can the preparation method of pure oral preparation of Chinese traditional medicinal involved in the present invention be described further.With g or kg is unit, respectively based on following three prescriptions, can be prepared into the capsule and the tablet of three kinds of heterogeneity proportionings:
(1) prescription one Rhizoma Drynariae 130g, Radix Dipsaci 110g, Cortex Acanthopancis 100g, Radix Rehmanniae Preparata 120g, the Radix Paeoniae Alba, Radix Angelicae Sinensis, each 70g of Flos Carthami, Radix Notoginseng, Radix Et Rhizoma Rhei, each 30g of Radix Glycyrrhizae;
(2) prescription two Rhizoma Drynariae 130g, Radix Dipsaci 110g, Cortex Acanthopancis 110g, Radix Rehmanniae Preparata 130g, the Radix Paeoniae Alba, Radix Angelicae Sinensis, each 80g of Flos Carthami, Radix Notoginseng, Radix Et Rhizoma Rhei, each 40g of Radix Glycyrrhizae;
(3) prescription three Rhizoma Drynariae 130g, Radix Dipsaci 110g, Cortex Acanthopancis 120g, Radix Rehmanniae Preparata 140g, the Radix Paeoniae Alba, Radix Angelicae Sinensis, each 90g of Flos Carthami, Radix Notoginseng, Radix Et Rhizoma Rhei, each 50g of Radix Glycyrrhizae;
(4) preparation takes by weighing the Chinese medicine of respectively distinguishing the flavor of respectively according to the ratio of above-mentioned prescription, can obtain three groups of different combinations, gets Radix Notoginseng and dries 2 hours down in 80 ℃, pulverizes, and crosses 100 mesh sieves, and the X60 irradiation sterilization is standby; Radix Angelicae Sinensis extracted volatile oil 6 hours with steam distillation, separated volatile oil (volatile oil is dissolved in the ether), and is standby; Water liquid filters, and medicinal liquid device is in addition collected, and is standby; All the other eight flavors mix with the medicinal residues of extraction behind the Radix Angelicae Sinensis volatile oil, decoct with water three times, add 8 times of amounts of water at every turn, decocted 1 hour, three decoction liquor and Radix Angelicae Sinensis water liquid merge, it is the clear paste of 1.20 (50 ℃) that concentrating under reduced pressure becomes relative density, again with Radix Notoginseng fine powder mixing granulation, and oven dry, granulate, spray was put hermetic container interior vexed 2 hours with Radix Angelicae Sinensis volatile oil, made the Chinese medicine composition composition granule of three kinds of different proportionings respectively;
(5) above-mentioned granule is incapsulated, promptly make capsule involved in the present invention;
(6) above-mentioned granule is adopted the aluminium plastic packaging bag packing, promptly make granule involved in the present invention, can take after mixing it with water;
(7) above-mentioned granule is inserted the tablet machine tabletting, promptly make tablet involved in the present invention.
Claims (1)
1. a Chinese medicine compound oral formulations that is used for the treatment of osteoporosis is that feedstock production forms with 10 flavor Chinese medicines, and its preparation process is as follows:
(1), gets 13 parts of Rhizoma Drynariae, 11 parts of Radix Dipsaci in weight portion; 10～12 parts of Cortex Acanthopanciss, 12～14 parts in Radix Rehmanniae Preparata, each 7～9 parts of the Radix Paeoniae Alba, Radix Angelicae Sinensis; 7～9 parts on Flos Carthami, each 3～5 parts of Radix Notoginseng, Radix Et Rhizoma Rhei; 3～5 parts in Radix Glycyrrhizae;
(2) above ten flavors are got Radix Notoginseng, and 80 ℃ of oven dry are ground into fine powder, and are after the sterilization, standby;
(3) get Radix Angelicae Sinensis and extracted volatile oil 6 hours, separate volatile oil with steam distillation, standby; Water liquid filters, and medicinal liquid device is in addition collected, and is standby;
(4) all the other eight flavors with extract Radix Angelicae Sinensis volatile oil after medicinal residues mix, add 5～10 times of water gagings decoctions three times, each 1 hour, three decoction liquor and above-mentioned Radix Angelicae Sinensis medicinal liquid merge, and are evaporated to relative density and are 1.20 clear paste, add the Radix Notoginseng fine powder, mix homogeneously, through granulating oven dry, granulate, spray into Radix Angelicae Sinensis volatile oil, put hermetic container interior vexed 2 hours, and took out, standby;
(5) above-mentioned granule branch is packed into capsule or adopt the aluminium plastic packaging bag packing or insert the tablet machine tabletting can obtain capsule, granule or the tablet of described compound Chinese medicinal preparation respectively.
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| EP3903798A1 (en) * | 2020-04-27 | 2021-11-03 | Lulin Wang | Bone-strengthening pill (bsp) as a dietary supplement to improve blood circulation and strengthen bone and muscle |
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| CN105616548A (en) * | 2014-10-31 | 2016-06-01 | 镇江泰飞尔医药有限公司 | Traditional Chinese medicinal granules for treating osteoporosis and preparation method of traditional Chinese medicinal granules |
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| 中医药治疗原发性骨质疏松的研究进展. 陈韶坤等.河南中医，第25卷第2期. 2005 |
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| EP3903798A1 (en) * | 2020-04-27 | 2021-11-03 | Lulin Wang | Bone-strengthening pill (bsp) as a dietary supplement to improve blood circulation and strengthen bone and muscle |
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