Bone benefiting granule and preparation method thereof

Abstract

The invention discloses bone benefiting granules and a preparation method thereof. The invention relates to bone-tonifying granules, which are prepared from the following components in parts by weight: 200 to 280 parts of salted fructus psoraleae, 320 to 400 parts of rhizoma drynariae, 320 to 400 parts of radix rehmanniae recen, 320 to 400 parts of herba epimedii, 680 to 760 parts of radix salviae miltiorrhizae and 320 to 400 parts of rhizoma dioscoreae. The preparation method comprises the following steps: a) weighing medicines and decocting: weighing salted fructus psoraleae, rhizoma drynariae, radix rehmanniae recen, herba epimedii, radix salviae miltiorrhizae and rhizoma dioscoreae, adding water and decocting twice to obtain bone tonifying soup; and b) post-treatment: preparing the bone benefiting soup into granules to obtain a finished product. The bone tonifying granules prepared by the invention have the curative effect of taking deficiency and blood stasis into consideration, and can be mainly used for treating middle-aged and old people with osteoporosis symptoms caused by deficiency of liver and kidney and blood stasis and patients with symptoms such as waist and back pain, soreness and weakness of feet and knees and the like.

Description

[Technical field]

[0001] The invention relates to the technical field of Chinese medicine granules, in particular to the technical field of Chinese medicine granules capable of treating osteoporosis. [Background technology]

[0002] With the increasing aging of society, the incidence of osteoporosis has jumped to the seventh place among various common diseases in the world, and is recognized as a serious social public health problem. Osteoporosis is a systemic bone disease characterized by low bone mass and damage to bone microstructure. The occurrence and development of osteoporosis is usually attributed to the imbalance between bone absorption and bone formation, while lower bone resistance leads to increased pain, functional limitations and increased risk of fractures caused by osteoporosis. The reasons for this are nothing more than hormone changes, bone unloading and accumulation of senescent cells, which mediate the aging bone changes of osteoporosis.

[0003] Common osteoporosis treatment drugs in clinical practice are nothing more than achieving treatment by reducing bone resorption, promoting bone formation and promoting bone mineralization. This usually only increases bone density, but does not improve bone quality and bone strength, cannot effectively reduce the incidence of fractures, and long-term use has considerable side effects. At present, the most widely used osteoporosis treatment drugs in clinical practice are bisphosphonates such as alendronate sodium and zoledronic acid. From the existing clinical results, such drugs can indeed effectively increase the patient's bone density, but some patients will experience adverse reactions such as fever and muscle aches after use. In addition, there are reports that such drugs may cause problems such as mandibular necrosis and femoral head necrosis. In recent years, the popular denosumab has a good clinical efficacy, but there is a problem that the patient's bone density decreases again after stopping the drug, and it is often easily accompanied by adverse reactions including hypocalcemia, gingival swelling and pain, periodontal infection and deep infection. Although some studies on targeted drugs for the pathogenesis of osteoporosis have been carried out, a series of problems such as safety and effective dosage have not been fully resolved. Therefore, it is urgent to find an effective, inexpensive, and low-toxic treatment, and it is necessary to give full play to the advantages and characteristics of traditional Chinese medicine.

[0004] Existing traditional Chinese medicines for osteoporosis include Xianling Gubao Capsules, Jintiange Capsules, Qianggu Capsules, Gushukang Capsules and Gubi Tablets. These capsules often cause difficulty in swallowing for older patients. In addition, these traditional Chinese medicines are mostly formulated with liver and kidney tonifying and greasy ingredients, which may increase the burden on the spleen and stomach function of elderly patients, leading to digestive tract reactions such as indigestion, nausea and vomiting in elderly patients. [Summary of the invention]

[0005] The purpose of the present invention is to solve the problems in the prior art and to provide a kind of bone-benefiting granules and a preparation method thereof. The prepared bone-benefiting granules have the therapeutic effects of taking both deficiency and blood stasis into consideration, and can be used to treat the symptoms of osteoporosis in the middle-aged and elderly people caused by liver and kidney deficiency and blood stasis, as well as those accompanied by symptoms such as low back pain and soreness of the feet and knees.

[0006] To achieve the above object, the present invention is implemented through the following technical solutions:

[0007] A bone-benefiting granule comprises 200-280 parts of salt psoralea corylifolia, 320-400 parts of drynaria rhizome, 320-400 parts of raw rehmannia root, 320-400 parts of celery root, 680-760 parts of salvia miltiorrhiza and 320-400 parts of yam in a weight ratio.

[0008] Preferably, the composition comprises 220-260 parts by weight of Psoralea corylifolia, 340-380 parts by weight of Drynaria fortunei, 340-380 parts by weight of Rehmannia root, 340-380 parts by weight of Epimedium, 700-740 parts by weight of Salvia miltiorrhiza and 340-380 parts by weight of Dioscorea opposita.

[0009] Preferably, the composition comprises 220 parts of salt psoralea corylifolia, 340 parts of drynaria rhizome, 340 parts of raw rehmannia root, 340 parts of celery root, 700 parts of salvia miltiorrhiza and 340 parts of yam in a weight ratio.

[0010] Preferably, the composition comprises 238 parts of salt psoralea corylifolia, 357 parts of drynaria rhizome, 357 parts of raw rehmannia root, 357 parts of celery root, 714 parts of salvia miltiorrhiza and 357 parts of yam in a weight ratio.

[0011] Preferably, the composition comprises 260 parts of salt psoralea corylifolia, 380 parts of drynaria rhizome, 380 parts of raw rehmannia root, 380 parts of celery root, 740 parts of salvia miltiorrhiza and 380 parts of yam in a weight ratio.

[0012] A method for preparing bone-benefiting granules comprises the following steps:

[0013] a) weighing and decocting: weighing salt psoralea corylifolia, drynariae rhizoma, raw rehmannia root, epimedium, salvia miltiorrhiza and yam, adding water and decocting twice to obtain Yigu decoction;

[0014] b) Post-processing: the bone-benefiting soup is made into granules to obtain a finished product.

[0015] Preferably, in step a), 10 to 14 times of water is added during the first decoction and the mixture is boiled for 40 to 80 minutes after the water boils, and 8 to 12 times of water is added during the second decoction and the mixture is boiled for 15 to 45 minutes after the water boils.

[0016] Preferably, in the step a), filtering treatment is performed after the two decoctions respectively, and the bone-benefiting soup is obtained by mixing the filtrates filtered out from the two decoctions respectively.

[0017] Preferably, in the step b), a thickener is first added to the concentrated bone-benefiting soup, and then the thickener is added to the soup after drying, crushing and sieving in sequence, and the mixture is mixed and granulated.

[0018] Preferably, the thickener is maltodextrin.

[0019] Beneficial effects of the present invention:

[0020] Osteoporosis belongs to the category of "bone atrophy" and "bone arthritis", and is based on kidney essence deficiency and marked by blood stasis blocking the meridians. In the elderly with renal failure, the kidney essence is insufficient, and there is no marrow to nourish the bones, which leads to bone atrophy and weakness. In addition, the qi deficiency of the elderly cannot promote the normal circulation of blood, which will cause blood stasis over time, blocking the meridians. Pain and functional disorders will occur when the meridians are blocked. Blood stasis can also cause qi and blood circulation disorders, and nutrients cannot nourish the internal organs, causing liver, spleen and kidney deficiency and aggravating the symptoms of osteoporosis. The present invention adopts 6 herbs, namely, psoralea corylifolia, drynaria fortunei, epimedium, raw rehmannia root, salvia miltiorrhiza and Chinese yam, to decoct the bone-benefiting soup and nourish the kidney and activate blood circulation (i.e. nourish the kidney qi, activate blood circulation and remove blood stasis), so as to achieve the therapeutic effect of taking both deficiency and blood stasis into consideration. The present invention can be mainly used to treat osteoporosis symptoms in middle-aged and elderly people caused by liver and kidney deficiency and blood stasis, as well as those accompanied by symptoms such as low back pain and sore feet and knees.

[0021] Kidney is the foundation of innate constitution, responsible for bone and marrow production, so Psoralea corylifolia and Drynaria fortunei are used as monarch drugs in the prescription to warm the kidney and assist yang, nourish the kidney and strengthen bones; Xianlingpi nourishes the kidney essence, relieves numbness and relieves pain, strengthens tendons and bones, and is the minister drug; spleen is the source of acquired constitution, responsible for the muscles of the limbs, and Chinese yam is used as the minister drug to nourish acquired constitution. Due to long-term illness causing blood stasis, blood stasis is not smooth, and pain gradually occurs. This prescription is supplemented with Rehmannia glutinosa and Salvia miltiorrhiza to promote blood circulation and remove blood stasis to relieve pain; Xianlingpi and Chinese yam are combined, yin and yang are harmonious, and yin qi is not hurt. The whole prescription nourishes the spleen and kidney, promotes blood circulation and relieves pain. From the perspective of drug composition, monarch, minister, assistant and envoy, Yigutang can not only replenish the yin and yang qi in the kidney, but also replenish the acquired spleen and stomach, while promoting blood circulation and removing blood stasis, relieving numbness and relieving pain. That is to say, compared with products on the market such as Xianling Gubao Capsules, Jintiange Capsules, Qianggu Capsules, Gusukang Capsules and Gubi Tablets, the present invention adds spleen invigoration on the basis of tonifying the liver and kidneys and activating blood circulation. Therefore, it is more suitable for the actual situation of middle-aged and elderly people. It can tonify the liver and kidneys, strengthen the spleen, activate blood circulation and prevent and treat osteoporosis, and it is not easy to increase the burden on the spleen and stomach function of elderly patients.

[0022] The present invention is also based on the original Chinese medicine formula. By first adding maltodextrin to the concentrated Yi Gu Tang, and then adding maltodextrin after drying, crushing and sieving in sequence and mixing and granulating, the Yi Gu Tang is made into granules, which is not only easy to carry but also more convenient for patients to take than capsules. [Specific implementation method]

[0023] Embodiment 1:

[0024] First, weigh 220 parts of salt psoralea, 340 parts of drynaria, 340 parts of raw rehmannia, 340 parts of xianlingpi, 700 parts of danshen and 340 parts of yam in a weight ratio, add water and boil twice to obtain Yigutang. In the first decoction, add 12 times of water and boil for 60 minutes after the water boils, and add 10 times of water and boil for 30 minutes after the water boils in the second decoction; filter the two decoctions respectively, and the Yigutang is obtained by mixing the filtrates filtered out of the two decoctions. Next, add maltodextrin to the Yigutang after the concentration treatment, and then add maltodextrin after drying, crushing and sieving in sequence, mix and granulate, make 1000 parts, package, and obtain the finished product.

[0025] Embodiment 2:

[0026] Weigh 238 parts of salt psoralea, 357 parts of drynaria, 357 parts of raw rehmannia, 357 parts of epimedium, 714 parts of salvia miltiorrhiza and 357 parts of yam in a weight ratio. Other parts are the same as in Example 1.

[0027] Embodiment three:

[0028] Weigh 260 parts of salt psoralea, 380 parts of drynaria, 380 parts of raw rehmannia, 380 parts of celery, 740 parts of salvia miltiorrhiza and 380 parts of yam in a weight ratio. Other parts are the same as in Example 1.

[0029] Embodiment 4:

[0030] The clinical efficacy and safety of the Yigu granules prepared in Example 2 were tested using a randomized controlled clinical design. 214 patients with osteoporosis were selected and randomly divided into a treatment group and a control group according to the treatment plan. The baselines of the two groups of patients were comparable. Among them, there were 105 cases in the control group (43 males, 62 females, aged (77.1 ± 6.6) years old); 109 cases in the treatment group (52 males, 57 females, aged (76.5 ± 7.1) years old). The treatment plan of the treatment group was more than that of the control group. The treatment course of both groups of patients was 3 months, and the follow-up period was controlled for 6 months. After treatment, the visual analog scale (VAS), lumbar bone density (BMD), fracture risk assessment (FRAX), TCM syndrome score, and bone metabolism indicators alkaline phosphatase (ALP) and plasma tartrate-resistant acid phosphatase (TRAP5b) were used to evaluate the clinical efficacy of the two groups.

[0031] Results A total of 214 patients were followed up. After treatment, the VAS score, BMD, FRAX, TCM syndrome score and bone metabolism indexes (ALP, TRAP5b) of the patients were significantly improved compared with those before treatment, and the difference was statistically significant (P < 0.05). After treatment, the improvement degree of the treatment group was more obvious than that of the control group, and the difference in VAS score and TCM syndrome score was statistically significant (P < 0.01). The total effective rate of the observation group was 82.6%, which was higher than the total effective rate of 68.6% in the control group, and the difference was statistically significant (P < 0.05). This shows that oral administration of traditional Chinese medicine Yigu granules at the same time as conventional anti-osteoporosis treatment can effectively improve the bone density of patients and promote bone formation in patients. In terms of relieving the pain degree and comprehensive activity function of patients, the advantages are more obvious, and it has good clinical efficacy and safety. In addition, no obvious adverse reactions were found during our follow-up. Therefore, the clinical efficacy of Yigu granules can be confirmed.

[0032] The above embodiments are intended to illustrate the present invention, not to limit the present invention. Any solution that is a simple transformation of the present invention belongs to the protection scope of the present invention.

Claims

1. A bone-benefiting granule, characterized in that: The invention comprises 200-280 parts of salt psoralea corylifolia, 320-400 parts of drynaria rhizome, 320-400 parts of raw rehmannia root, 320-400 parts of celery root, 680-760 parts of salvia miltiorrhiza and 320-400 parts of yam in a weight proportion.

2. The bone-benefiting granules according to claim 1, characterized in that: The invention comprises 220-260 parts of salt psoralea corylifolia, 340-380 parts of drynaria rhizome, 340-380 parts of raw rehmannia root, 340-380 parts of celery root, 700-740 parts of salvia miltiorrhiza and 340-380 parts of yam in a weight proportion.

3. The bone-benefiting granules according to claim 2, characterized in that: The invention comprises 220 parts of salt psoralea corylifolia, 340 parts of drynaria rhizome, 340 parts of raw rehmannia root, 340 parts of celery root, 700 parts of salvia miltiorrhiza and 340 parts of yam in a weight proportion.

4. The bone-benefiting granules according to claim 2, characterized in that: The invention comprises 238 parts of salt psoralea corylifolia, 357 parts of drynaria rhizome, 357 parts of raw rehmannia root, 357 parts of celery root, 714 parts of salvia miltiorrhiza and 357 parts of yam in a weight proportion.

5. The bone-benefiting granules according to claim 2, characterized in that: The invention comprises 260 parts of salt psoralea corylifolia, 380 parts of drynaria rhizome, 380 parts of raw rehmannia root, 380 parts of celery root, 740 parts of salvia miltiorrhiza and 380 parts of yam in a weight proportion.

6. A method for preparing bone-benefiting granules according to any one of claims 1 to 5, characterized in that: The steps include: a) weighing and decocting: weighing salt psoralea corylifolia, drynariae rhizoma, raw rehmannia root, epimedium, salvia miltiorrhiza and yam, adding water and decocting twice to obtain Yigu decoction; b) Post-processing: the bone-benefiting soup is made into granules to obtain a finished product.

7. The method for preparing the bone-benefiting granules according to claim 6, characterized in that: In the step a), 10 to 14 times of water is added during the first decoction and the mixture is boiled for 40 to 80 minutes after the water boils, and 8 to 12 times of water is added during the second decoction and the mixture is boiled for 15 to 45 minutes after the water boils.

8. The method for preparing the bone-benefiting granules according to claim 6, characterized in that: In the step a), filtering treatment is performed after the two decoctions respectively, and the bone-benefiting soup is obtained by mixing the filtrates filtered out from the two decoctions respectively.

9. The method for preparing bone-benefiting granules according to claim 6, characterized in that: In the step b), a thickener is first added to the concentrated bone-benefiting soup, and then the thickener is added to the soup after drying, crushing and sieving in sequence, and the mixture is mixed and granulated.

10. The method for preparing bone-benefiting granules according to claim 9, characterized in that: The thickener is maltodextrin.