Traditional Chinese medicine composition for treating ischemic femoral head necrosis, preparation and application

Abstract

The invention belongs to the field of traditional Chinese medicine treatment, and particularly relates to a traditional Chinese medicine composition for treating femoral head necrosis. The composition is prepared from the following raw materials: prepared rehmannia root, parasitic loranthus, teasel root, Chinese angelica, vinegar-processed musk, vinegar-processed myrrh, cinnamon, ligusticum wallichii, leech, corydalis tuber, white paeony root, coix seed, pulp of dogwood fruit, medlar, hot drynaria rhizome, dried tangerine or orange peel, peach kernel, safflower and liquorice. The traditional Chinese medicine composition is rigorous in compatibility, has the effects of tonifying liver and kidney and promoting blood circulation to remove meridian obstruction, and pharmacological tests prove that the traditional Chinese medicine composition can obviously reduce the level of alkaline phosphatase (ALP) in serum of a traumatic femoral head avascular necrosis model rat, increase the level of calcium (Ca) and phosphorus (P), optimize the hemorheological characteristics of the rat, improve the empty bone fossa rate of the femoral head of the model rat, and improve the curative effect of the traumatic femoral head avascular necrosis. Meanwhile, the safety is high, the toxic and side effects are small, the clinical medication selection of patients can be increased, and the popularization and application value is relatively high.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicines, and specifically relates to a new traditional Chinese medicine composition, a preparation and a use thereof, and specifically relates to a traditional Chinese medicine composition, a preparation and a use thereof for treating ischemic femoral head necrosis. Background Art

[0002] Ischemic femoral head necrosis is a disease that causes hip pain and dysfunction due to damage to the blood supply to the femoral head due to trauma or disease, and the death of bone marrow and bone cells, which leads to the collapse of the femoral head. If not treated in time, joint movement may be limited and pain may be obvious. It often occurs in young and middle-aged people and is a common and intractable bone disease. In recent years, the prevalence has gradually increased among young and middle-aged people aged 20 to 40.

[0003] According to the cause of the disease, ischemic femoral head necrosis can be divided into two types: traumatic and non-traumatic. Among them, non-traumatic femoral head necrosis may be caused by long-term use of glucocorticoids, long-term excessive drinking, ischemia and other factors, as well as idiopathic femoral head necrosis combined with diabetes, hyperlipidemia, and unknown causes.

[0004] Western medicine treatment methods vary according to the severity of the disease. Conservative treatments include more rest or taking painkillers, anti-inflammatory drugs, bone protection drugs, etc. In severe cases, joint replacement surgery is required. However, clinical treatment has found that medication can relieve pain in the short term, but the effect is limited, it cannot be cured and is prone to recurrence. Surgical treatment has satisfactory results, but it is usually not used for young people, and postoperative exercise is limited.

[0005] Compared with Western medicine, TCM treatment has more obvious advantages. TCM has unique theories and experience in the treatment of ischemic femoral head necrosis. In ancient literature, femoral head disease presents as bone arthritis and bone erosion of the hip. According to the "Guidelines for the Diagnosis and Treatment of Non-Traumatic Femoral Head Necrosis by Integrated Traditional Chinese and Western Medicine", TCM treatment methods play a very important role in the clinical treatment of non-traumatic femoral head necrosis (NONFH). The principles of TCM treatment are to promote blood circulation and remove blood stasis, nourish the liver and kidney, regulate qi and relieve pain. It can significantly reduce hip pain, improve blood supply to the femoral head, reduce the risk of femoral head collapse, promote improvement of hip joint function, delay the progression of femoral head necrosis, and significantly improve the hip preservation rate.

[0006] Therefore, it is of great significance to seek traditional Chinese medicine to treat ischemic femoral head necrosis. Summary of the invention

[0007] In order to enrich the medication options for clinical patients, the purpose of the present invention is to provide a new Chinese medicine composition, preparation and use for treating ischemic femoral head necrosis.

[0008] The first purpose of the present invention is to provide a Chinese medicine composition for treating ischemic femoral head necrosis. The inventor, in a scientific and prudent attitude, has confirmed through pharmacological experiments that the Chinese medicine composition can effectively improve the clinical symptoms of rats with femoral head necrosis.

[0009] Specifically, the Chinese medicine composition includes the following components in parts by weight:

[0010] 5-15 weight parts of Rehmannia glutinosa 5-15 weight parts of Radix Dipsaci 10-20 weight parts

[0011] 10-20 parts by weight of Angelica sinensis 5-15 parts by weight of Rhizoma Cibotii 5-15 parts by weight of Myrrh

[0012] 10-20 parts by weight of cinnamon bark 10-20 parts by weight of chuanxiong 10-20 parts by weight of leech 1-5 parts by weight

[0013] 5-15 parts by weight of Corydalis yanhusuo 10-20 parts by weight of white peony root 10-20 parts by weight of coix seed 10-20 parts by weight

[0014] 5-15 parts by weight of cornus fruit 5-15 parts by weight of wolfberry 10-20 parts by weight of drynaria

[0015] Tangerine peel 1-10 parts by weight Peach kernel 1-10 parts by weight Safflower 1-10 parts by weight

[0016] Licorice 1-10 parts by weight.

[0017] Furthermore, in the traditional Chinese medicine composition, the rehmannia root is cooked rehmannia root, the leech is scalded leech, the rhizoma strychni is vinegar rhizoma strychni, the myrrh is vinegar myrrh, the corydalis yanhusuo is vinegar corydalis yanhusuo, the drynaria root is scalded drynaria root, and the peach kernel is fried peach kernel.

[0018] In the embodiment, when the Chinese medicine composition is the following weight parts, the effect is better:

[0019] 10-15 weight parts of Radix Rehmanniae Preparata 10-15 weight parts of Radix Dipsaci 12-18 weight parts

[0020] 12-18 parts by weight of Chinese Angelica sinensis 8-12 parts by weight of Vinegar Myrrh 8-12 parts by weight of

[0021] 10-15 weight parts of cinnamon bark 12-18 weight parts of chuanxiong 1-5 weight parts of scalded leeches

[0022] 10-15 parts by weight of vinegar Corydalis 12-18 parts by weight of white peony root 12-18 parts by weight of coix seed 12-18 parts by weight

[0023] 5-15 weight parts of cornus fruit 5-15 weight parts of wolfberry 12-18 weight parts of scalded bone drynaria

[0024] 2-8 parts by weight of dried orange peel 2-8 parts by weight of stir-fried peach kernel 2-8 parts by weight of safflower 2-8 parts by weight

[0025] 2-8 parts by weight of liquorice.

[0026] Further, in a preferred embodiment, the Chinese medicine composition is the following parts by weight:

[0027] 12 weight parts of Radix Rehmanniae Preparata 12 weight parts of Radix Dipsaci 15 weight parts

[0028] 15 parts by weight of Chinese Angelica sinensis 9 parts by weight of Vinegar Myrrh 9 parts by weight

[0029] 12 parts by weight of cinnamon bark 15 parts by weight of chuanxiong scalded leech 3 parts by weight

[0030] 12 parts by weight of vinegar Corydalis 15 parts by weight of white peony root Coix seed 15 parts by weight

[0031] 9 parts by weight of cornus fruit 12 parts by weight of wolfberry 15 parts by weight of boiled drynaria rhizome

[0032] 6 parts by weight of dried orange peel 6 parts by weight of stir-fried peach kernel 6 parts by weight of safflower 6 parts by weight

[0033] 6 parts by weight of liquorice.

[0034] The second object of the present invention is to provide a use of a Chinese medicine composition in the preparation of a medicine for treating and reducing hip joint pain, improving femoral head blood supply, reducing the risk of femoral head collapse, and promoting improvement of hip joint function.

[0035] Specifically, the use is the use of the Chinese medicine composition in the preparation of a drug for treating ischemic femoral head necrosis. Pharmacological experiments have confirmed that the Chinese medicine composition of the present invention has better efficacy when used in the preparation of a drug for treating ischemic femoral head necrosis.

[0036] The third object of the present invention is to provide a method for preparing the Chinese medicine composition:

[0037] (1) Scald leeches, stir-fried peach kernels, and half the weight of Rehmannia root and Fructus Corni are ground into fine powder for later use;

[0038] (2) decocting and extracting angelica, safflower, cinnamon bark, dried orange peel, ligusticum chuanxiong, white peony root and liquorice with ethanol water, filtering, saving the residue separately and using the filtrate for later use;

[0039] (3) taking the residue from step (2) and combining it with other Chinese medicinal materials, boiling it with water, filtering it, and setting aside the filtrate;

[0040] (4) combining the drug solutions of step (2) and (3), concentrating under reduced pressure to a drug solution density of 1.20-1.25 mg / ml, and setting aside;

[0041] (5) Add the Chinese medicine powder from step (1), stir evenly, and add conventional pharmaceutical excipients to prepare a conventional preparation.

[0042] Preferably, the decoction in step (2) is performed using 3-4 times the mass of 60-85% ethanol water, and the decoction is performed 2-3 times.

[0043] The decoction in step (3) is 8-10 times the mass of water, first boiled with high heat, then boiled with low heat, each time boiling for 0.25-3 hours, and boiled 2-3 times.

[0044] The vacuum degree of the reduced pressure concentration in step (4) is -0.08-0.1Mpa, and the temperature is 60-70°C.

[0045] In a preferred embodiment, the preparation method of the Chinese medicine composition is:

[0046] (1) Scald leeches, stir-fried peach kernels, and half the weight of Rehmannia root and Fructus Corni are ground into fine powder for later use;

[0047] (2) taking angelica, safflower, cinnamon bark, tangerine peel, chuanxiong, white peony root, and liquorice with 3-4 times the mass of 70-85% ethanol water, decocting 2-3 times for decoction extraction, filtering, storing the residue separately, and using the filtrate for later use;

[0048] (3) Take the residue from step (2) and combine it with other Chinese medicinal materials, add 8-10 times the weight of water, boil it with high heat first, then boil it with low heat, boil it for 0.25-3 hours each time, boil it 2-3 times, filter it, and set aside the filtrate;

[0049] (4) The drug solutions of step (2) and (3) are combined, concentrated under reduced pressure at a vacuum degree of -0.08-0.1 MPa and a temperature of 60-70° C. to a drug solution density of 1.20-1.25 mg / ml, and set aside;

[0050] (5) Add the Chinese medicine powder from step (1), stir evenly, and add conventional pharmaceutical excipients to prepare a conventional preparation.

[0051] The fourth object of the present invention is to provide a dosage form of the Chinese medicine composition, specifically an oral preparation, more preferably a decoction, granules, tablets or pills.

[0052] The Chinese medicine composition of the present invention has achieved remarkable progress:

[0053] (1) The Chinese medicine composition of the present invention has been scientifically and rigorously designed in terms of compatibility, and has also incorporated the research results of modern pharmacology to ensure the scientificity and reliability of the therapeutic effect.

[0054] (2) The Chinese medicine composition of the present invention targets the mechanism of ischemic femoral head necrosis and uses a variety of Chinese herbal medicines in combination to significantly improve local blood circulation and promote the regeneration and repair of bone tissue, providing clinicians with a new treatment option, especially for patients who do not respond well to traditional treatments.

[0055] (3) The preparation method of the Chinese medicine composition of the present invention is simple, it directly hits the affected part of the femoral head, eliminates pathogenic factors, has the effects of nourishing the liver and kidney, promoting blood circulation and unblocking collaterals, and can significantly improve the blood supply to the femoral head, especially for the treatment of ischemic femoral head necrosis, with significant therapeutic effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Figure 1 The effect of the Chinese medicine composition of the present invention on the hollow bone pit rate of the femoral head in rats with steroid-induced femoral head avascular necrosis (compared with the normal control group: P < 0.01 ** Compared with the model control group, P<0.01 was used ## express);

[0057] Figure 2 The effect of the Chinese medicine composition of the present invention on the trabecular area ratio of rats with steroid-induced avascular necrosis of the femoral head (compared with the normal control group: P < 0.01 ** Compared with the model control group, P<0.01 was used ## express);

[0058] Figure 3 The effect of the Chinese medicine composition of the present invention on the density ratio of the rat model of steroid-induced femoral head avascular necrosis (compared with the normal control group: P < 0.01 ** Compared with the model control group, P<0.01 was used ## express). DETAILED DESCRIPTION

[0059] The above contents of the present invention are further described in detail below through specific implementation methods in the form of embodiments. However, this should not be understood as the scope of the above subject matter of the present invention being limited to the following examples. All technologies realized based on the above contents of the present invention belong to the scope of the present invention.

[0060] Similar modifications, replacements or changes made to the technical solution of the present invention based on the routine selection and industry experience of those skilled in the art are all within the protection scope of the present invention.

[0061] Example 1 Preparation of granules

[0062] Formula:

[0063]

[0064] The preparation method is:

[0065] (1) Scald leeches, stir-fried peach kernels, and half the weight of Rehmannia root and Fructus Corni are ground into fine powder for later use;

[0066] (2) Take angelica, safflower, cinnamon bark, dried orange peel, chuanxiong, white peony root, and liquorice and boil them three times with 85% ethanol water, filter, save the residue and use the filtrate for later use;

[0067] (3) Take the residue from step (2) and combine it with other Chinese medicinal materials, add 8 times the weight of water, boil it with high heat first, then boil it with low heat, boil it for 3 hours each time, boil it 3 times, filter it, and set aside the filtrate;

[0068] (4) The drug solutions from step (2) and (3) are combined, concentrated under reduced pressure at a vacuum degree of -0.08-0.1 MPa and a temperature of 70° C. to a drug solution density of 1.20 mg / ml, and set aside;

[0069] (5) Add the Chinese medicine powder from step (1), stir evenly, and add conventional pharmaceutical excipients to prepare granules.

[0070] Example 2 Preparation of granules

[0071] Formula:

[0072]

[0073] The preparation method is:

[0074] (1) Scald leeches, stir-fried peach kernels, and half the weight of Rehmannia root and Fructus Corni are ground into fine powder for later use;

[0075] (2) Take angelica, safflower, cinnamon bark, dried orange peel, chuanxiong, white peony root, and liquorice and boil them twice with 70% ethanol water, filter, save the residue and use the filtrate for later use;

[0076] (3) Take the residue from step (2) and combine it with other Chinese medicinal materials, add 10 times the weight of water, boil it with high heat first, then boil it with low heat, boil it for 2 hours each time, boil it twice, filter it, and set aside the filtrate;

[0077] (4) The drug solutions from step (2) and (3) are combined, concentrated under reduced pressure at a vacuum degree of -0.08-0.1 MPa and a temperature of 60° C. to a drug solution density of 1.22 mg / ml, and set aside;

[0078] (5) Add the Chinese medicine powder from step (1), stir evenly, and add conventional pharmaceutical excipients to prepare granules.

[0079] Example 3 Preparation of granules

[0080] Formula:

[0081]

[0082]

[0083] The preparation method is the same as Example 1.

[0084] Example 4 Preparation of granules

[0085] Formula:

[0086]

[0087] The preparation method is the same as Example 1.

[0088] Example 5 Preparation of granules

[0089] Formula:

[0090]

[0091] The preparation method is the same as Example 1.

[0092] Example 6 Preparation of granules

[0093] Formula:

[0094]

[0095]

[0096] The preparation method is the same as Example 1.

[0097] Example 7 Preparation of granules

[0098] Formula:

[0099]

[0100] The preparation method is the same as Example 1.

[0101] Preparation of Comparative Example 1 Granules

[0102] Formula:

[0103]

[0104] (1) Take all the Chinese medicinal materials, add 10 times the weight of water, boil them with high heat first, then boil them with low heat, boil them for 3 hours each time, boil them 3 times, combine and filter, and concentrate the filtrate under reduced pressure at a vacuum degree of -0.08-0.1Mpa and a temperature of 60°C to a liquid density of 1.25mg / ml for later use;

[0105] (2) Add the Chinese medicine powder from step (1), stir evenly, and add conventional pharmaceutical excipients to prepare granules.

[0106] Preparation of Comparative Example 2 Granules

[0107] Formula:

[0108]

[0109] The preparation method is the same as Example 1.

[0110] Preparation of Comparative Example 3 Granules

[0111] Formula:

[0112]

[0113] The preparation method is the same as Example 1.

[0114] Preparation of Comparative Example 4 Granules

[0115] Formula:

[0116]

[0117]

[0118] The preparation method is the same as Example 1.

[0119] Preparation of Comparative Example 5 Granules

[0120] Formula:

[0121]

[0122] The preparation method is the same as Example 1.

[0123] Preparation of Comparative Example 6 Granules

[0124] Formula:

[0125]

[0126] The preparation method is the same as Example 1.

[0127] Experimental Example 1 Study on the effect of the Chinese medicine composition of the present invention on rats with traumatic femoral head avascular necrosis model

[0128] 1 Materials and Methods

[0129] 1.1 Experimental animals and feeding

[0130] Healthy male SPF SD rats, 6-8 weeks old, weight: 200±20g. Provided by Lunan Pharmaceutical Group Co., Ltd., experimental animal license number: SYXK(Lu)2018-0008.

[0131] The experiment began after the animals were acclimatized to the laboratory for 1 week.

[0132] 1.2 Modeling method

[0133] Healthy rats were anesthetized by intraperitoneal injection of 3% sodium pentobarbital, the skin, myofascia and muscles were cut, the round ligament at the femoral trochanter was cut, the hip joint was exposed and dislocated, the capsule fibers were removed, and the femoral neck periosteum was scraped, then repositioned and sutured layer by layer. Penicillin was injected intramuscularly for anti-inflammatory treatment for 3 days after surgery, and clear necrosis and subchondral fracture under imaging CT were used as the standard for successful modeling.

[0134] 1.3 Administration

[0135] The rats with successful modeling were divided into 7 groups, namely, model group, positive control group, low-dose group of Example 1 (referred to as "experimental low-dose group"), high-dose group of Example 1 (referred to as "experimental high-dose group"), Example 2 group, comparative example 2 group, and comparative example 6 groups, with 10 rats in each group. At the same time, 10 healthy rats were taken as the normal control group.

[0136] The low-dose group of Example 1 and the high-dose group of Example 1 were orally administered with the Chinese medicine preparation obtained in Example 1, with a total raw drug content of 9 g / kg / d and 36 g / kg / d, respectively; the Example 2 group, the Comparative Example 2 group, and the Comparative Example 6 group were respectively administered with the pharmaceutical preparations prepared in the corresponding examples, with a total raw drug content of 9 g / kg / d; the positive control group was orally administered with 9 mg / kg / d of alendronate sodium, and the normal control group and the model group were orally administered with an equal volume of physiological saline, once a day, for 4 consecutive weeks.

[0137] 2. Detection indicators and methods

[0138] 2.1 Daily observation of animals:

[0139] Observe and record the animal's behavior, fur condition, excretion, and death, etc. If an animal is found dead or abnormal, perform an autopsy in time and draw blood for examination as much as possible.

[0140] 2.2 Blood biochemistry examination:

[0141] 24 hours after the last administration, blood was collected from the abdominal aorta of the rats and centrifuged at 3000r / min for 10min to obtain the upper serum, and the levels of calcium (Ca), phosphorus (P), and alkaline phosphatase (ALP) in the serum were analyzed and determined.

[0142] 2.3 Blood rheology examination:

[0143] 24 hours after the last administration, blood was collected from the abdominal aorta and the whole blood viscosity was measured with EDTA anticoagulation.

[0144] 2.4 Detection of VEGF165, BMP-2 and iNOS expression.

[0145] 24 hours after the first administration, blood was collected from the abdominal aorta of the rats and centrifuged at 3000 r / min for 10 min to obtain the upper serum, and the expressions of VEGF165, BMP-2 and iNOS in the serum were detected.

[0146] 2.5 Statistical analysis

[0147] SPSS 22.0 software was used for statistical analysis, and the experimental data were expressed as “mean ± standard deviation”. ” is expressed in the form of .

[0148] 3 Experimental results

[0149] 3.1 Daily observation of animals

[0150] Compared with the normal control group, the rats in each example group had significantly less food intake and sleep, dull hair, and curled up. After administration, the condition of the rats improved to varying degrees, among which the rats in the high-dose group of Example 1 recovered the best.

[0151] 3.2 Blood biochemistry test results

[0152] The results are shown in Table 1. Compared with the blank control group, the ALP level of rats in the model control group was significantly increased (P<0.01). Compared with the model group, the ALP level of rats in the positive control group, the embodiment group, and the positive control group was significantly reduced (P<0.01), and the Ca and P levels were significantly increased (P<0.01); there was no significant difference in the comparative embodiment group (P>0.05).

[0153] Table 1 ALP, Ca, and P levels

[0154]

[0155] Note: Compared with the normal control group: P < 0.01 ** Compared with the model control group, P<0.01 was used ## express.

[0156] 3.3 Results of blood rheology examination

[0157] As shown in the results of Table 2, compared with the blank control group, the low, medium and high shear rates of the rats in the model group increased significantly (P<0.05). Compared with the model group, the low, medium and high shear rates of the rats in the positive control group and each embodiment group decreased significantly (P<0.01), among which, the low, medium and high shear rates of the rats in the high-dose group of Example 1 decreased significantly (P<0.01), and there was no significant difference in the comparative embodiment group.

[0158] Table 2 Low, medium and high shear rates

[0159]

[0160]

[0161] Note: Compared with the normal control group: P < 0.01 ** Compared with the model control group, P<0.01 was used ## 3.4 Results of VEGF165, BMP-2 and iNOS level determination

[0162] As can be seen from the results in Table 3, compared with the blank control group, the low, medium and high shear rates of the rats in the model group increased significantly (P<0.05). Compared with the model group, the low, medium and high shear rates of the rats in the positive control group and each embodiment group decreased significantly (P<0.01), among which the low, medium and high shear rates of the rats in the high-dose group of Example 1 decreased significantly (P<0.01), and there was no significant difference in the comparative embodiment group.

[0163] Table 3 VEGF165, BMP-2, and iNOS levels

[0164]

[0165] Note: Compared with the normal control group: P < 0.01 ** Compared with the model control group, P<0.01 was used ## express.

[0166] Experimental Example 2 Study on the effect of the Chinese medicine composition of the present invention on the model rats of steroid-induced femoral head avascular necrosis

[0167] 1 Materials and Methods

[0168] 1.1 Experimental animals and feeding

[0169] Healthy SPF SD rats, 6-8 weeks old, half male and half female, weight: 200±20g. Provided by Lunan Pharmaceutical Group Co., Ltd., experimental animal license number: SYXK(Lu)2018-0008.

[0170] The experiment began after the animals were acclimatized to the laboratory for 1 week.

[0171] 1.2 Modeling method

[0172] The rats were injected with 40 μg / kg / d lipopolysaccharide solution through the tail vein for 3 consecutive days. 24 hours after the last injection, 40 mg / kg / d methylprednisolone sodium succinate was injected into the gluteal muscle. The first three weeks were injected three times with an interval of 48 hours per week, and the fourth to sixth weeks were injected twice with an interval of 72 hours. After administration, each group was injected once a week to maintain the model. The blank control group was replaced with sterile water for injection. All rats were injected with penicillin (160,000 units / ml, 0.1 ml / rat) twice a week in the gluteal muscle. After 6 weeks, the modeling results were observed and detected by HE staining.

[0173] 1.3 Administration

[0174] The rats with successful modeling were divided into 6 groups, namely, model group, positive control group, Example 1 group, Example 2 group, Comparative Example 3 group, and Comparative Example 4 group, with 10 rats in each group. Meanwhile, 10 healthy rats were taken as normal control group.

[0175] Among them, Example 1 group, Example 2 group, Comparative Example 3 group, and Comparative Example 4 group were all gavaged with the Chinese medicine preparations prepared in the corresponding examples in sequence, with a total raw drug content of 9 g / kg / d. The positive control group was gavaged with 0.12 g / kg / d of commercially available Xuezhikang, and the normal control group and the model group were gavaged with an equal volume of physiological saline, once a day, for 4 consecutive weeks.

[0176] 2. Detection indicators and methods

[0177] 2.1 Results of changes in the hollow bone pit rate and trabecular bone area ratio in rat femoral heads

[0178] (1) After the experiment, the rats were killed and the femoral heads of both sides were taken. A small piece of the left femoral head was taken for HE staining and the empty bone pit rate was calculated:

[0179] Empty bone pit rate = number of empty bone pits / total number of bone pits;

[0180] (2) Image pro-plus 6.0 software was used to detect and calculate the trabecular bone ratio, where the trabecular bone ratio was the percentage of the total trabecular bone area to the total field of view area.

[0181] 2.2 Bone density measurement results

[0182] The femoral density of the right femoral head of the rat was measured using an X-ray bone densitometer.

[0183] 3 Experimental results

[0184] 3.1 Results of the hollow bone pit rate in the femoral head of rats in each group

[0185] from Figure 1From the data change trend, it can be seen that after modeling, the empty bone pit rate of the femoral head of the rats in the model group was significantly higher than that in the normal control group, and the difference was statistically significant (P < 0.01). After drug administration, the empty bone pit rate of the femoral head of the rats in each drug administration group decreased compared with the model group, especially the decrease in Example 1 group, Example 2 group and the positive drug control group was significant (P < 0.01), among which the decrease value of the empty bone pit rate of the femoral head in Example 1 group was the best.

[0186] 3.2 Results of femoral head trabecular area ratio of rats in each group

[0187] from Figure 2 The results show that after femoral head necrosis occurs, the femoral head trabecular area ratio of the model group rats is significantly lower than that of the normal control group (P < 0.01), indicating that the embodiment of steroid-induced femoral head avascular necrosis modeling is successful. After administration, the femoral head trabecular area ratio of the rats in each administration group is significantly higher than that of the model group (P < 0.01), indicating that the drugs used have a good improvement effect on femoral head necrosis in rats. Specifically, the femoral head trabecular area ratio of the rats in Example 1 is higher than that of other administration groups, indicating that the Chinese medicine treatment effect of the present invention is the best.

[0188] 3.3 Comparison of femoral head bone density in each group of rats

[0189] from Figure 3 The results show that compared with the normal control group, the femoral bone density of the model group rats decreased significantly (P < 0.01). After administration, the femoral bone density values ​​of the rats in each group increased to varying degrees, among which the differences between Example 1, Example 2, and the positive control group were also statistically significant (P < 0.01), while there was no significant difference between Examples 3 and 4 (P > 0.05). It can be seen that after the Chinese medicine composition of the present invention was used to treat rats, the femoral bone density was higher than that of other administration groups, indicating that the Chinese medicine composition of the present invention has a good therapeutic effect.

[0190] The Chinese medicine compound involved in the present invention is carefully matched, and pharmacological experiments have verified that it can effectively improve the clinical symptoms of rats with femoral head necrosis. Experimental results show that the Chinese medicine compound can reduce the level of alkaline phosphatase (ALP) in the serum of rats with traumatic femoral head avascular necrosis model, increase the levels of calcium (Ca) and phosphorus (P), optimize the blood rheological properties of rats, increase the empty bone pit rate of the femoral head of the model rats, and regulate bone density. These results show that the Chinese medicine compound of the present invention has a significant therapeutic effect on the rat model of femoral head necrosis.

Claims

1. A Chinese medicine composition for treating ischemic necrosis of the femoral head, characterized in that: The Chinese medicine composition comprises the following components in parts by weight: 5-15 weight parts of Rehmannia glutinosa 5-15 weight parts of Radix Dipsaci 10-20 weight parts 10-20 parts by weight of Angelica sinensis 5-15 parts by weight of Rhizoma Cibotii 5-15 parts by weight of Myrrh 10-20 parts by weight of cinnamon bark 10-20 parts by weight of chuanxiong 10-20 parts by weight of leech 1-5 parts by weight 5-15 parts by weight of Corydalis yanhusuo 10-20 parts by weight of white peony root 10-20 parts by weight of coix seed 10-20 parts by weight 5-15 parts by weight of cornus fruit 5-15 parts by weight of wolfberry 10-20 parts by weight of drynaria Tangerine peel 1-10 weight parts Peach kernel 5-15 weight parts Safflower 5-15 weight parts Licorice 5-15 parts by weight.

2. The Chinese medicine composition according to claim 1, characterized in that In the traditional Chinese medicine composition, the rehmannia root is cooked rehmannia root, the leech is scalded leech, the cyperus rotundus is vinegar cyperus rotundus, the myrrh is vinegar myrrh, the corydalis root is vinegar corydalis root, the drynaria root is scalded drynaria root, and the peach kernel is stir-fried peach kernel.

3. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition comprises the following components by weight: 10-15 parts by weight of Radix Rehmanniae Preparata, 10-15 parts by weight of Radix Glehniae, 12-18 parts by weight of Radix Dipsaci 12-18 parts by weight of Chinese Angelica sinensis 8-12 parts by weight of Vinegar Myrrh 8-12 parts by weight of 10-15 weight parts of cinnamon bark 12-18 weight parts of chuanxiong 1-5 weight parts of scalded leeches 10-15 parts by weight of vinegar Corydalis 12-18 parts by weight of white peony root 12-18 parts by weight of coix seed 12-18 parts by weight 5-15 weight parts of cornus fruit 5-15 weight parts of wolfberry 12-18 weight parts of scalded bone drynaria 2-8 parts by weight of dried orange peel 8-12 parts by weight of stir-fried peach kernel 8-12 parts by weight of safflower Licorice 10-15 parts by weight.

4. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition can be prepared into a conventional preparation, preferably one of the oral preparations, specifically one of the decoction, granules, tablets or pills.

5. The Chinese medicine composition according to claim 4, characterized in that: The preparation method of the Chinese medicine composition is as follows: (1) Scald leeches, stir-fried peach kernels, and half the weight of Rehmannia root and Fructus Corni are ground into fine powder for later use; (2) decocting and extracting angelica, safflower, cinnamon bark, dried orange peel, ligusticum chuanxiong, white peony root and liquorice with ethanol water, filtering, saving the residue separately and using the filtrate for later use; (3) taking the residue from step (2) and combining it with other Chinese medicinal materials, boiling it with water, filtering it, and setting aside the filtrate; (4) combining the drug solutions of step (2) and (3), concentrating under reduced pressure to a drug solution density of 1.20-1.25 mg / ml, and setting aside; (5) Add the Chinese medicine powder from step (1), stir evenly, and add conventional pharmaceutical excipients to prepare a conventional preparation.

6. The Chinese medicine composition according to claim 5, characterized in that: In the step (2), 3-4 times the mass of 60-85% ethanol water is used for decoction, and the decoction is performed 2-3 times.

7. The Chinese medicine composition according to claim 5, characterized in that: The decoction in step (3) is 8-10 times the mass of water, first boiled with high heat, then boiled with low heat, each time boiling for 0.25-3 hours, and boiled 2-3 times.

8. The Chinese medicine composition according to claim 5, characterized in that: The vacuum degree of the reduced pressure concentration in step (4) is -0.08-0.1Mpa, and the temperature is 60-70°C.

9. Use of the Chinese medicine composition as described in any one of claims 1 to 8 in the preparation of a medicine for reducing hip joint pain, improving femoral head blood supply, reducing the risk of femoral head collapse, and promoting improvement of hip joint function.

10. The use according to claim 9, characterized in that: The application of the traditional Chinese medicine composition in preparing medicine for treating ischemic femoral head necrosis.

Images