CN1062136C - Medicine for treatment of osteoporosis - Google Patents

Abstract

The present invention discloses a medicine for treating osteoporosis, which belongs to medicine preparation products with natural Chinese medicinal plants as raw materials. After three traditional Chinese medicines of human placenta, chicken's gizzard-membrane and donkey-hide gelatin are dried, pulverized and sieved, and the sieved powder is uniformly mixed and filled into medicinal capsules to prepare the medicine. The present invention has the advantages of less medicine flavor and low cost. Because the medicine is prepared from natural medicines, the medicine has the advantages of no side effect when taken for a long term, obvious treatment effect and stable treatment effect.

Description

The medicine of treatment osteoporosis

The present invention relates to a kind of medicine for the treatment of osteoporosis, belonging to the natural Chinese medicine is the pharmaceutical product of raw material.

Osteoporosis is that a kind of general bone amount relevant with endocrine function reduces and bone structure changes, with bone fragility and easily cause the disease of fracturing.Often life is made troubles and is painful to middle-aged and elderly people, even because of the fracture loss of life, has increased family and burden on society.Along with social senilization, oneself becomes the important medical scientific research task prevention and treatment osteoporosis.

The treatment osteoporosis adopts calcium preparation or hormone medicine usually both at home and abroad, and the latter has certain curative effect to postmenopausal osteoporosis, and the former therapeutic effect is had different opinions.The theory of traditional Chinese medical science basis " kidney governing bones " " the kidney invigorating and essence nourishing " is to this disease determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs.40 pages of " Journal of Traditional Chinese Medicine " 1986 the 6th phases have been published " clinical observation of osteoporosis is treated in the kidney invigorating and essence nourishing ruling by law ", and it is oral that the kidney invigorating and essence nourishing side that selects for use is Fructus Ligustri Lucidi, Semen Cuscutae, Fructus Lycii, Rhizoma Dioscoreae, Fructus Psoraleae, the Radix Astragali, Poria, Radix Achyranthis Bidentatae is fried in shallow oil soup.22 (8) 20 pages of " new the traditional Chinese medical science " nineteen nineties have been published " osteoporosis is controlled and tested " literary composition, and adopting from intending a dragon two celestial three yellow stuff is that plus-minuss such as Os Draconis, Herba Epimedii, Rhizoma Curculiginis, the Radix Astragali, Cortex Phellodendri, Radix Et Rhizoma Rhei are controlled and tested 2 examples.

Chinese patent 1076088 discloses a kind of compound method of functional food of protect against osteoporosis, is the food that adopts Fructus Lycii, Poria, Semen Euryales, Semen Nelumbinis, Rhizomadioscoreae, calcium gluconate, milk powder, vitamin C D etc. to make.

Chinese patent 1080537A discloses a kind of " goods of protect against osteoporosis and method for making thereof ", is the fruit extract that contains in the Fructus Cnidii of Umbelliferae Cnidium Cusson plant is made medicine or health product.

The objective of the invention is to combine by natural Chinese medicine, contain the effect of parahormone sample, promote the intestinal calcium absorption, improve the medicine of the protect against osteoporosis of calcium balance in the body in order to provide a kind of.

Medicine of the present invention is with the Therapeutic Principle of the traditional Chinese medical science " the smart marrow of giving birth to of kidney-replenishing blood-nourishing benefit ", selects to include multiple steroid hormone estradiol, progesterone, testosterone ... and the medicine of promoting sexual gland hormone etc., improve the regulating action of related hormones to bone metabolism; Select for use and include ossein, gelatin former to be to produce medicines such as lysine, glycine after the Main Ingredients and Appearance of bone and connective tissue and the hydrolysis,, to increase calcium absorption and the effect of retention in vivo to improve calcium balance in the body; Select for use to include the stomach kinases, pepsin, the medicine of amylase and 17 seed amino acids strengthens the gastro-intestinal digestion absorbability, with promotion intestinal calcium absorption function, thereby promotes bone formation, and it is heavy to increase bone, delays bone loss, improves the bone density homogenizing.

The present invention is that the drug regimen of following row weight portion forms.

Placenta Hominis 80-150 part Colla Corii Asini 15-30 part Endothelium Corneum Gigeriae Galli 8-15 part

Preparing the ideal weight portion proportioning of pharmaceutical formulation of the present invention is:

10 parts of 20 parts of Endothelium Corneum Gigeriae Galli of 100 parts of Colla Corii Asini of Placenta Hominis

The method that above-mentioned each component is made medicament capsule preparation of the present invention is:

Placenta Hominis, Endothelium Corneum Gigeriae Galli select through peach, go to go mouldy, and 140 ℃ of mechanical activation comminution after oven dry in 45 minutes are crossed 100 mesh sieves and become powder in the rearmounted far infrared baking oven of clear water rinsing; Colla Corii Asini is smashed and is put 60 ℃ of oven dry in the baking oven, pulverizes 100 mesh sieves and becomes powder, and above medicated powder uniform mixing is the yellowish-brown fine powder, incapsulates, and every capsules contains medicine 0.4 gram of the present invention approximately.

Drug administration method of the present invention: oral capsule every day 3 times, each 3-4 grain was taken in 30 minutes after meal.

Clinical research:,, select primary osteoporosis patient 242 examples clinically according to Chinese and western medicine dual diagnosis standard for showing the curative effect of medicine of the present invention, wherein use medicine 162 examples of the present invention, matched group uses estrogen 30 examples, uses calcium preparation 30 examples, and medicine of the present invention is represented with TPF.Male TPF group treatment back Tes level obviously rises as can be seen from Table 1, and the PTH secretion obviously descends front and back difference highly significant P＜0.05, P＜0.01.Significantly rise before the treatment in the secretion treatment back of CT, but P＜0.1.The secretion of FSH LH treatment back descends before the treatment to some extent, but change not obvious, P＜0.1, P＞0.05.Women T.P.F group is treated back E as can be seen from Table 2 ₂Level obviously raises, and the P.T.H secretion significantly descends, and front and back difference highly significant, P are all＜0.001.F.S.H treatment back secretion also obviously descends front and back obvious difference P＜0.05.Also descend but P＞0.05 before the treatment after the LH secretion treatment.Change not obvious P＞0.5 before and after the CT secretion treatment.

The T.P.F group is treated back 24 hours Ca as can be seen from Table 3 ⁺⁺Output, significantly descend, and the AKP secretion obviously raises, and front and back difference highly significant P all＜0.05.

Bone density average P＜0.05 that significantly raises after the medication of T.P.F group as can be seen from Table 4.The bone density average has downward trend to reduce 0.064g/Cm after the medication of contrast calcium preparation group ², but the not obvious P of front and back difference＞0.5.

Bone density value obviously rises front and back difference highly significant P＜0.05 after the medication of T.P.F group as can be seen from Table 5.And bone density value does not have significant change P＞0.5 after the medication of contrast estrogen group.The group of not taking medicine is observed the back than bone density value decline 0.130g/Cm before observing ², but P＞0.05.

The total effective rate of T.P.F group is 88.9% as can be seen from Table 6, and wherein obvious effective rate is 50%; Estrogen group total effective rate is 50%, and wherein obvious effective rate is 17%; Calcium preparation group total effective rate is 26.7%, and wherein obvious effective rate is 6%; Through X ²Check T.P.F group effective percentage is higher than matched group, compares P＜0.05 with the estrogen group, compares P＜0.01 with the calcium preparation group.

Clinical observation shows: curative effect of medication 1. of the present invention is good, and not only clinical symptoms is developed and improved to delaying osteoporosis disease, and treatment back bone density average increases to some extent.2. natural drug is taken without any side effects for a long time.3. flavour of a drug are few, and cost is low, and preparation method is simple.

Experimentation: the 1. osteoporosis model of the excision 12 months old rats bilateral ovaries used of this research, model group and matched group all are what there were significant differences on every index, thereby are consistent with external research.

2. it is effectively (to show 7-11) that medicine of the present invention is used for protect against osteoporosis, is the best with 2g/kg dosage wherein, and the rat bone cortical thickness of castration is increased, and calcium level improves, and no matter the chemical analysis of bone is dry weight.Still ashes weight and Ca, P content all increase, and histological examination also shows the pathological change that mitigating osteoporosis disease is arranged, and is applicable to the control postmenopausal osteoporosis.

3. medicine of the present invention is said by theory of Chinese medical science can mend " kidney ", the prosperity and decline and the skeletal growth of " kidney governing bones " kidney essense have substantial connection, modern pharmacology studies show that the ovarian hormone that Placenta Hominis is contained, the effect that Alfasone has prevention of osteoporosis to lose, estrogen indirectly can be by increasing the secretion of calcitonin, suppress bone absorption, increase small intestinal to the heavily absorption of the absorption of Ca and renal tubules to Ca, Colla Corii Asini contains ossein, can get gelatin after the hydrolysis, protein and several amino acids, lysine wherein, glycine all helps absorbing of Ca, experiment shows that also Colla Corii Asini has the effect of antagonism hydrocortisone (immunosuppressant), is beneficial to the treatment osteoporosis; Endothelium Corneum Gigeriae Galli contains gastric hormone, can promote the gastric gland secretion, increases digestive function, promotes absorbing of this medicine.

Embodiment: take by weighing select in the Placenta Hominis 100kg that goes mouldy, the rearmounted far infrared baking oven of Endothelium Corneum Gigeriae Galli 10kg rinsing 140 ℃ 45 minutes, mechanical activation comminution is crossed 100 mesh sieves and is become powder; Colla Corii Asini 20kg smashes and puts 60 ℃ in baking oven, dries 100 mesh sieves and becomes powder, and above-mentioned medicated powder uniform mixing is the yellowish-brown fine powder, the oral capsule of packing into, and every contains 0.4 gram approximately, and it is standby to bottle.

Serum hormone is measured relatively before and after the treatment of table 1 male T.P.F group $(\stackrel{\_\_}{X}\±\mathrm{SD})$

Serum hormone is measured relatively before and after the treatment of table 2 women T.P.F group $(\stackrel{\_\_}{X}\±\mathrm{SD})$

The variation of biochemical indicator before and after the treatment of table 3 men and women T.P.F group $(\stackrel{\_\_}{X}﹠PlusMinus;\mathrm{SD})$

The T.P.F group	Twenty-four-hour urine calcium Ca ++mmol/L	Blood alkali phosphatase A K P IU/ml
			Treatment back n t D before the treatment	3.69±1.67 2.1±0.88 36 2.55 ＜0.05	42.244±24.17 71.67±22.g 36 2.72 ＜0.05

Two groups of variations of observing front and back bone density average of table 4 male

Group	((the g/Cm of X ± SD) before the medication 2)	((the g/Cm of X ± SD) after the medication 2)	n	t	p
						T.P.F group calcium preparation group	0.539±0.092 0.724±0.107	0.734±0.088 0.660±0.11	60 30	2.67 1.35	＜0.05 ＞0.05

Three groups of variations of observing front and back bone density average of table 5 women:

Group	((the g/Cm of X ± SD) before the medication 2)	((the g/Cm of X ± SD) after the medication 2)	n	t	p
						The T.P.F group estrogen group group of not taking medicine	0.419±0.089 0.641±0.083 0.642±0.127	0.604±0.09 0.648±0.077 0.512±0.102	102 30 20	2.82 0.50 0.719	＜0.05 ＞0.5 ＞0.05

Table 6 is respectively organized the clinical efficacy relative analysis:

Group	The example number	Produce effects example number %	Effective routine number %	Invalid routine number %	Total effective rate example number %
						T.P.F group estrogen group calcium preparation group	162 30 30	81 50 5 17 2 6	63 39 10 33 6 30	18 11.1 15 50.0 22 73.3	144 88.9 15 50.0 8 26.7

Table 7 T.P.F is to the influence of rat blood serum Ca, P $(\stackrel{\_\_}{X}\±\mathrm{SD})$

* with M group contrast P＜0.01

Table 8 T.P.F is to the influence of rat femur cortex thickness of bone $(\stackrel{\_\_}{X}\±\mathrm{SD})$

* compare P＜0.01 with the M group

Table 9 T.P.F is to the influence of rat dry weight $(\stackrel{\_\_}{X}\±\mathrm{SD})$

* compare P＜0.01 with the M group

Table 10 T.P.F is to the influence of rat ash weight $(\stackrel{\_\_}{X}\±\mathrm{SD})$

* compare P＜0.05 with the M group

Table 11 T.P.F is to the influence of rat femur bone Ca, P content $(\stackrel{\_\_}{X}﹠PlusMinus;\mathrm{SD})$

Group	Dosage g/kg	Femur number (individual)	Ca			P
									Content mg/100g.bw		Loss Rate %	Content mg/100g.bw		Loss Rate %
			C M C 2 T 1 T 2 T 3	0.2mg/kg 2.0 1.0 0.5	14 12 14 15 18 18	0.079±0.012 0.067±0.009 0.08l±0.008* 0.077±0.009* 0.072±0.009 0.074±0.009		---- 15.2 -2.5 2.5 8.9 6.3									0.043+0.005 0.036±0.005 0.042±0.005 0.040±0.004* 0.037±0.005 0.039±0.006		--- 16.3 2.3 7.0 14.0 9.3

Claims (2)

1 one kinds of medicines for the treatment of osteoporosis is characterized in that this medicine is that drug regimen by following weight parts forms: Placenta Hominis 80-150 part, Colla Corii Asini 15-30 part, Endothelium Corneum Gigeriae Galli 8-15 part.

The medicine of 2 treatment osteoporosis according to claim 1 is characterized in that the weight portion proportioning of this medicine is: 100 parts of Placenta Hominiss, 20 parts in Colla Corii Asini, 10 parts of Endothelium Corneum Gigeriae Galli.