Traditional Chinese medicine composition with efficacy of treating osteoporosis

Abstract

The invention belongs to the field of effects of traditional Chinese medicines in treatment of osteoporosis. The pathological change of osteoporosis is mainly bone microstructure injury, and comprises cortical bone thinning and porosity increase, bone trabecular connectivity loss, quantity reduction and gap increase, and bone reconstruction imbalance is the main reason of bone microstructure injury of osteoporosis patients. Adjustment of unbalanced bone metabolism and improvement of bone microstructure are key points in treatment. According to the technical scheme, the traditional Chinese medicine composition is preferably prepared from the following components in parts by weight: 1500 to 2500 parts of radix astragali seu hedysari, 300 to 600 parts of fructus schisandrae chinensis, 800 to 1200 parts of fructus lycii, 800 to 1200 parts of radix trichosanthis, 800 to 1200 parts of rhizoma anemarrhenae, 800 to 1200 parts of radix puerariae, 800 to 1200 parts of bulbus allii macrostemi, 500 to 700 parts of rhizoma acori graminei, 800 to 1200 parts of radix angelicae sinensis and 800 to 1200 parts of radix salviae miltiorrhizae. The traditional Chinese medicine composition disclosed by the invention can also be prepared into different dosage forms of medicines such as tablets, capsules, granules, oral liquid or injection together with pharmaceutically acceptable auxiliary materials.

Description

Technical Field

[0001] The invention belongs to the field of the effect of traditional Chinese medicine in treating osteoporosis. Background Art

[0002] Osteoporosis (OP) has become a major disease that endangers the health of the elderly. With the aging of the population in my country, the prevalence of osteoporosis has risen rapidly and has become an important public health issue. Its pathological changes are mainly bone microstructure damage, including thinning of cortical bone and increased porosity, loss of trabecular connectivity, decreased number and increased gaps, all of which lead to decreased bone strength, combined with decreased bone mass and increased fracture risk. Unbalanced bone remodeling is the main cause of bone microstructure damage in osteoporotic patients. Therefore, regulating unbalanced bone metabolism and improving bone microstructure are the key to treating osteoporosis. Summary of the invention

[0003] Purpose of the Invention The aim of the present invention is to find a Chinese medicine composition for treating osteoporosis in the treasure house of traditional Chinese medicine.

[0004] Technical solutions adopted A Chinese medicine composition with the efficacy of treating osteoporosis, comprising the following ingredients in parts by weight: 500-4000 parts of astragalus, 100-1000 parts of schisandra, 500-3000 parts of wolfberry, 500-3000 parts of trichosanthes, 500-3000 parts of anemarrhena, 500-3000 parts of kudzu root, 500-3000 parts of allium macrostemon, 200-900 parts of calamus, 500-3000 parts of angelica, and 500-3000 parts of salvia miltiorrhiza.

[0005] Furthermore, the ratio is: 1500-2500 parts of Astragalus, 300-600 parts of Schisandra, 800-1200 parts of Lycium barbarum, 800-1200 parts of Radix Trichosanthis, 800-1200 parts of Anemarrhena, 800-1200 parts of Pueraria, 800-1200 parts of Allium macrostemon, 500-700 parts of Acorus calamus, 800-1200 parts of Angelica sinensis, and 800-1200 parts of Salvia miltiorrhiza.

[0006] Furthermore, the Chinese medicine composition of the present invention can be prepared into medicines in different dosage forms such as tablets, capsules, granules, oral liquids or injections with pharmaceutically acceptable excipients. Beneficial Effects

[0007] In the process of osteoporosis, bone microstructure damage is the main pathological change of osteoporosis, and bone remodeling imbalance is the main factor of bone microstructure damage. Regulating unbalanced bone metabolism and improving bone microstructure damage can delay the progression of osteoporosis. The Chinese medicine composition of the present invention improves bone microstructure, reduces bone loss, and increases bone density, thereby delaying the progression of osteoporosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 The effect of the composition on calcium and phosphorus metabolism in osteoporotic mice, wherein: BMD: bone mineral density; BV / TV: bone volume fraction; BS / BV: bone surface area to bone volume ratio; BS / TV: bone surface area to tissue volume ratio; Tb.Pf: trabecular pattern factor; Tb.N: trabecular number # - Represents the comparison between the sham group (Sham) and the model group (OVX), p ≤ 0.05( # ); p ≤0.01( ## ); p ≤ 0.0001( ### ) * -Comparison between the representative model group (OVX) and the drug-treated groups (EV, QDL, QDH), p ≤0.05( * ); p ≤ 0.01( ** ); p ≤ 0.0001( *** ).

[0009] Figure 2 The invention relates to the effect of the composition on the bone microstructure of osteoporosis patients. DETAILED DESCRIPTION

[0010] In the examples listed in this specification, a specific ratio of 20g of Astragalus, 6g of Angelica, 10g of Rehmannia, 9g of White Peony, 10g of Drynaria, 10g of Psoralea corylifolia, 9g of Eucommia, 10g of Polygonatum, 10g of Millennium Jian, and 10g of Antler Tablets is used. Experimental data are used to show the effect of the Chinese medicine composition of the present invention on preventing and treating osteoporosis in vivo.

[0011] 1. Drug under test Weigh 7 days’ worth of crude drug in proportion, add 10 times the amount of distilled water to extract 3 times, 1.5 hours each time. Filter, combine the extracts, and concentrate until each milliliter is equivalent to 1g of crude drug.

[0012] 2. Experimental Animals 2.1 The experimental animals were healthy SPF-grade C57BL / 6 female mice, which were subjected to ovariectomy intervention surgery after two weeks of adaptive feeding. All surgical instruments were sterilized before the experiment. 61 8-week-old mice were ear-tagged, weighed, and anesthetized with isoflurane. 43 mice except the sham group (Sham group) underwent OVX modeling surgery: After checking to make sure that the mice were in an anesthetized state, the mice were fixed on the operating board in a prone position, the hair at the surgical site on the back was shaved, and after disinfection with iodine, a 0.5 cm small incision was made on both sides of the back, the skin and subcutaneous tissue were cut open in sequence, the fat was bluntly separated to find the ovaries and ligated at the proximal fallopian tube, the ovaries were removed, and sutured layer by layer in sequence; after the wound was opened in the Sham group, only a small amount of fat around the ovaries was removed and sutured layer by layer in sequence. After the operation, the mice were placed in a warm and comfortable environment to observe their condition. After they woke up, they were put back into the cage. After the sham operation or OVX operation, the mice were fed routinely, had normal drinking water and food intake, and observed the appearance of each mouse (whether the wound was healed or delaminated), activity status, etc. Sick mice with poor mobility, crooked head, etc. were removed in time, and the weight of the mice was recorded.

[0013] 2.2 Grouped Dosing After 4 weeks of conventional feeding, mice with completed modeling and normal status were selected and randomly divided into model group (OVX group) (11 mice), estradiol valerate group (EV group, 0.13 mg / kg) (11 mice), low-dose group of the Chinese medicine composition of the present invention (QDL, 6.9 g crude drug / kg) (11 mice), and high-dose group of the Chinese medicine composition of the present invention (QDH, 13.8 g crude drug / kg) (10 mice) after 4 weeks of conventional feeding. The mice were intragastrically administered once a day, 6 times a week, and continued to be administered for 12 weeks. The sham operation group and the model group were intragastrically administered with pure water (0.1 ml / 10 g). During the feeding period, they drank water and ate normally. The activity and appearance of each mouse were observed, and the body weight was recorded.

[0014] 2.3 Detection indicators Sampling: After 3 months of drug administration, the mice were killed after fasting, and the skin and muscles of both lower limbs were peeled off in turn. The complete femurs on both sides of the mice were obtained as much as possible, fixed with 4% paraformaldehyde, and stored in a -80℃ refrigerator.

[0015] Micro CT detection of mouse bone tissue: The mouse femur samples were taken out of 4% paraformaldehyde, rinsed with PBS solution, and then the surface liquid was dried with filter paper, and then fixed along the long axis in a circular mold made of foam, and scanned with Micro-CT SkyScan 1176. The scanning conditions were: source voltage: 50kV, source current: 455μA; exposure time: 265ms; resolution: 18μm, filter thickness: 0.5mm aluminum sheet. The data obtained by Micro-CT scanning were imported into CTAn and CTvol, and the bone tissue was quantitatively analyzed to obtain the bone density and various bone parameters in a specific area.

[0016] 3. Experimental results 3.1 General situation.

[0017] The mice in the normal control group grew rapidly, gained weight gradually, had shiny fur, and ate normally. After the model was successfully established, the animals in the model group became listless, slow in movement, had yellow fur that lost its luster, became emaciated, had severe hunched backs, had increased urine output, ate less, and had loose stools.

[0018] 3.2 Effects on biochemical indicators in serum.

[0019] After modeling, serum calcium and phosphorus in the serum of the ovariectomized mice group were significantly decreased (P<0.01), and the ALP level was increased (P<0.01), indicating that the model animals had abnormal calcium and phosphorus metabolism; compared with the model group, the blood calcium in the serum of the low-dose animals of the Chinese medicine composition of the present invention was increased, and the ALP level was decreased, and the P values ​​were all <0.01. The high-dose group of the Chinese medicine composition of the present invention showed a significant increase in blood calcium and phosphorus levels, and a significant decrease in ALP, and the P values ​​were all <0.01. In addition, compared with the low-dose group of the Chinese medicine composition of the present invention, the serum phosphorus in the high-dose group of the Chinese medicine composition of the present invention was significantly increased (P<0.01), and the ALP was decreased (P<0.05); the results indicate that the Chinese medicine composition of the present invention can significantly improve the calcium and phosphorus metabolism disorders in osteoporotic mice. The results are shown in Table 1, i.e., the effects of the Chinese medicine composition of the present invention on calcium and phosphorus in osteoporotic mice. The results are compared with the model group. P <0.01( △△ ); Compared with the low-dose group of the Chinese medicine composition of the present invention, P <0.05( * ), P <0.01( ** ).

[0020] Table 1 Effect of the Chinese medicine composition of the present invention on calcium and phosphorus metabolism in mice (x±s)

[0021] Note: Compared with the model group, △△ P<0.01; compared with QDL, * P <0.05, ** P <0.01 3.3 Effects on mouse bone microstructure.

[0022] In OVX mice, it was observed that BMD, BV / TV, BS / TV, and Tb.N decreased significantly, and BS / BV and Tb.Pf increased significantly (P<0.05), indicating that the model group was successfully established compared with the sham operation group. Further, compared with the OVX group, the femoral bone density of mice in the positive drug group (EV group) increased significantly (P<0.05), and the femoral bone density of mice in the groups administered with the Chinese medicine composition of the present invention (QDL group and QDH group) showed an upward trend; the BV / TV, BS / TV, and Tb.N of the femur of mice in the OVX group were significantly lower than those in the Sham group. After administration of the QDH group, BV / TV, BS / TV, and Tb.N increased significantly (P<0.005). Compared with the OVX group, the BS / BV of the QDH group decreased significantly (P<0.005), and Tb.Pf also decreased significantly (P<0.01). The above results show that after administration of the Chinese medicine composition of the present invention, the bone surface area to bone volume ratio (BS / BV) and trabecular bone pattern factor (Tb.Pf) were significantly reduced, and the other bone parameters (except bone density) were significantly increased, indicating that the administration of the Chinese medicine composition of the present invention can significantly reduce bone loss in mice and improve bone microstructure. The QDH group has the best therapeutic effect. Figure 1 , that is, the effect of the Chinese medicine composition of the present invention on the bone microstructure of osteoporotic mice. The results are compared between the sham group (Sham) and the model group (OVX). p ≤ 0.05( # ); p ≤ 0.01( ## ); p ≤ 0.0001( ### ); Comparison between the model group (OVX) and the drug-treated groups (EV, QDL, QDH) p ≤ 0.05( * ); p ≤ 0.01( ** ); p ≤ 0.0001( *** ).

[0023] Discussion: In the occurrence and development of osteoporosis, bone microstructure damage is the main pathological change of osteoporosis, and bone remodeling imbalance is the main factor of bone microstructure damage. Regulating unbalanced bone metabolism and improving bone microstructure damage can delay the progression of osteoporosis. The experimental results show that the Chinese medicine composition of the present invention intervenes in the process of osteoporosis by improving calcium and phosphorus metabolism, reducing bone loss, and repairing bone microstructure.

[0024] Osteoporotic fractures are the main cause of death and disability caused by osteoporosis. Inhibiting the imbalance of bone metabolism and delaying bone microstructural damage are important ways to intervene in the process of osteoporosis. The comprehensive prevention and treatment of traditional Chinese and Western medicine can not only improve the clinical symptoms of patients and improve their quality of life, but also prevent the development of osteoporosis and the occurrence of osteoporotic fractures. The Chinese medicine composition of the present invention is a Chinese medicine compound with clinical efficacy and clear mechanism of action, and has broad clinical application prospects.

[0025] Summarize: Animal experiments show that the composition of the present invention can intervene in the process of osteoporosis by improving calcium and phosphorus metabolism, reducing bone loss, and repairing bone microstructure. The composition of the present invention can be further prepared into medicines in different dosage forms such as tablets, capsules, granules, oral liquids or injections with pharmaceutically acceptable excipients.

Claims

1. A Chinese medicine composition for treating osteoporosis, comprising the following components in parts by weight: 500-4000 parts of astragalus, 100-1000 parts of schisandra, 500-3000 parts of wolfberry, 500-3000 parts of trichosanthes, 500-3000 parts of anemarrhena, 500-3000 parts of kudzu root, 500-3000 parts of allium macrostemon, 200-900 parts of calamus, 500-3000 parts of angelica, and 500-3000 parts of salvia.

2. A Chinese medicine composition for treating osteoporosis according to claim 1, characterized in that: 1500-2500 parts of astragalus, 300-600 parts of schisandra, 800-1200 parts of wolfberry, 800-1200 parts of trichosanthes, 800-1200 parts of anemarrhena, 800-1200 parts of kudzu root, 800-1200 parts of allium macrostemon, 500-700 parts of calamus, 800-1200 parts of angelica, and 800-1200 parts of salvia miltiorrhiza.

3. A Chinese medicine composition for treating osteoporosis according to claim 1 or 2, characterized in that: It is made into medicines in different dosage forms such as tablets, capsules, granules, oral liquids or injections with pharmaceutically acceptable excipients.

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