阅读说明：本技术 药物组合物及其制备方法与在肩周炎治疗中的应用 (Pharmaceutical composition, preparation method thereof and application thereof in scapulohumeral periarthritis treatment ) 是由 江玉娟 刘杰 许敏 高超 潘瑞雪 王莉 张亚欣 陈克欣 郝红慧 于 2020-07-28 设计创作，主要内容包括：本公开涉及用于治疗肩周炎的药物组合物,具体提供药物组合物及其制备方法与在肩周炎治疗中的应用。一方面提供一种药物组合物在制备治疗肩周炎药物中的应用,所述药物组合物为：三七1-15份、川芎3-20份、延胡索2-15份、白芍3-20份、威灵仙4-25份、葛根3-20份、羌活4-25份。另一方面提供一种用于治疗肩周炎的药物组合物,所述药物组合物为：三七15-45份、川芎8-30份、延胡索2-7份、白芍3-7份、威灵仙5-11份、葛根5-9份、羌活4-25份。经实验发现,现有技术中治疗颈椎病的明仁颈痛片对于肩周炎的治疗有疗效,但对于糖尿病型肩周炎,其效果不如更改配比后的新药物组合物。(The disclosure relates to a pharmaceutical composition for treating scapulohumeral periarthritis, and particularly provides a pharmaceutical composition, a preparation method thereof and application thereof in scapulohumeral periarthritis treatment. On the one hand, the application of a pharmaceutical composition in preparing a medicine for treating scapulohumeral periarthritis is provided, and the pharmaceutical composition is as follows: 1-15 parts of pseudo-ginseng, 3-20 parts of ligusticum wallichii, 2-15 parts of corydalis tuber, 3-20 parts of radix paeoniae alba, 4-25 parts of radix clematidis, 3-20 parts of radix puerariae and 4-25 parts of notopterygium root. In another aspect, a pharmaceutical composition for treating scapulohumeral periarthritis is provided, wherein the pharmaceutical composition comprises: 15-45 parts of pseudo-ginseng, 8-30 parts of ligusticum wallichii, 2-7 parts of corydalis tuber, 3-7 parts of white paeony root, 5-11 parts of clematis root, 5-9 parts of kudzu root and 4-25 parts of notopterygium root. Experiments show that the Mingren Jingtongtian tablets for treating cervical spondylosis in the prior art have the curative effect on the treatment of scapulohumeral periarthritis, but have the effect on the diabetic scapulohumeral periarthritis inferior to that of a new pharmaceutical composition with the changed proportion.)

1. The application of a pharmaceutical composition in preparing a medicine for treating scapulohumeral periarthritis is characterized in that the pharmaceutical composition is as follows: 1-15 parts of pseudo-ginseng, 3-20 parts of ligusticum wallichii, 2-15 parts of corydalis tuber, 3-20 parts of radix paeoniae alba, 4-25 parts of radix clematidis, 3-20 parts of radix puerariae and 4-25 parts of notopterygium root;

or 2-10 parts of pseudo-ginseng, 5-15 parts of ligusticum wallichii, 3-10 parts of corydalis tuber, 5-15 parts of radix paeoniae alba, 8-20 parts of radix clematidis, 5-15 parts of radix puerariae and 8-20 parts of notopterygium root;

or 2-3 parts of pseudo-ginseng, 7-8 parts of ligusticum wallichii, 5-6 parts of corydalis tuber, 7-8 parts of radix paeoniae alba, 10-11 parts of radix clematidis, 7-8 parts of radix puerariae and 10-11 parts of notopterygium root;

or 2.3 parts of pseudo-ginseng, 7.6 parts of ligusticum wallichii, 5.4 parts of corydalis tuber, 7.6 parts of white paeony root, 10.5 parts of clematis root, 7.6 parts of kudzu root and 10.5 parts of notopterygium root.

2. The use of the pharmaceutical composition of claim 1 in the preparation of a medicament for the treatment of scapulohumeral periarthritis, wherein the preparation method of the pharmaceutical composition comprises:

(1) firstly, the pseudo-ginseng is crushed into 100-mesh and 120-mesh fine powder;

(2) extracting volatile oil from Notopterygii rhizoma and radix Clematidis, collecting the distilled water solution in another container, decocting the residue with water for 1 hr, and filtering to obtain filtrate;

(3) decocting radix Puerariae and radix Paeoniae alba with water twice (2 hr for the first time and 1 hr for the second time), mixing the filtrate with the above two water solutions, concentrating, precipitating with ethanol, recovering ethanol, and concentrating to obtain fluid extract with relative density of 1.25-1.30 at 50 deg.C;

(4) reflux-extracting rhizoma Ligustici Chuanxiong and rhizoma corydalis with ethanol, removing residue, recovering ethanol from the extractive solution, and concentrating to obtain fluid extract with relative density of 1.25-1.30 at 50 deg.C;

(5) mixing the above two fluid extracts, adding Notoginseng radix powder, mixing, drying, pulverizing into fine powder, adding appropriate amount of rhizoma Peucedani, mixing, and spraying the volatile oil of Notopterygii rhizoma and radix Clematidis.

3. The pharmaceutical composition for treating scapulohumeral periarthritis is characterized by comprising the following components in parts by weight: 15-45 parts of pseudo-ginseng, 8-30 parts of ligusticum wallichii, 2-7 parts of corydalis tuber, 3-7 parts of white paeony root, 5-11 parts of clematis root, 5-9 parts of kudzu root and 4-25 parts of notopterygium root.

4. The pharmaceutical composition for treating scapulohumeral periarthritis is characterized by comprising the following components in parts by weight: 20-40 parts of pseudo-ginseng, 10-20 parts of ligusticum wallichii, 3-5 parts of corydalis tuber, 5-7 parts of radix paeoniae alba, 9-10 parts of radix clematidis, 5-7 parts of radix puerariae and 4-17 parts of notopterygium root.

5. The pharmaceutical composition for treating scapulohumeral periarthritis is characterized by comprising the following components in parts by weight: 25-35 parts of pseudo-ginseng, 10-15 parts of ligusticum wallichii, 4 parts of corydalis tuber, 6-7 parts of radix paeoniae alba, 9 parts of radix clematidis, 6-7 parts of radix puerariae and 9-10 parts of notopterygium root.

6. The pharmaceutical composition for treating scapulohumeral periarthritis is characterized by comprising the following components in parts by weight: 30 parts of pseudo-ginseng, 15 parts of ligusticum wallichii, 4 parts of corydalis tuber, 6 parts of white paeony root, 9 parts of clematis root, 6.3 parts of kudzu root and 9.7 parts of notopterygium root.

7. A method for preparing a medicinal composition for treating scapulohumeral periarthritis is characterized by comprising the following steps: the method comprises the following steps:

(1) grinding Notoginseng radix and rhizoma Ligustici Chuanxiong together;

(2) extracting volatile oil from Notopterygii rhizoma and radix Clematidis, and collecting the distilled water solution in another container;

(3) decocting the white paeony root with the water solution distilled in the step (2), and collecting and concentrating filtrate for later use;

(4) extracting radix Puerariae and rhizoma corydalis with water, and removing residue;

(5) mixing the filtrate and the extraction product obtained in the steps (3) and (4), concentrating, and precipitating with ethanol;

(6) and (3) uniformly mixing the fine powder in the step (1) with the clear paste in the step (5), and spraying the volatile oil of the notopterygium root and the clematis root extracted in the step (2) to obtain the traditional Chinese medicine.

8. The method for preparing a pharmaceutical composition for the treatment of scapulohumeral periarthritis according to claim 7, wherein: in the step (1), the pseudo-ginseng and the szechuan lovage rhizome are crushed into 100-mesh 120-mesh fine powder.

9. The method for preparing a pharmaceutical composition for the treatment of scapulohumeral periarthritis according to claim 7, wherein: in the step (3), the white paeony root is cut into small blocks and decocted for 4-4.5 hours.

10. The method for preparing a pharmaceutical composition for the treatment of scapulohumeral periarthritis according to claim 7, wherein: in the step (5), the concentrated solution is made into clear paste with the relative density of 1.50-1.55 at 50 ℃.

Technical Field

The disclosure relates to a pharmaceutical composition for treating scapulohumeral periarthritis, and particularly provides a pharmaceutical composition, a preparation method thereof and application thereof in scapulohumeral periarthritis treatment.

Background

The statements herein merely provide background information related to the present disclosure and may not necessarily constitute prior art.

Scapulohumeral periarthritis, commonly called congealing shoulder and fifty shoulder. The pain of the shoulder is gradually produced, the pain is gradually increased at night, the activity function of the shoulder joint is limited and gradually increased, and the pain is gradually relieved after reaching a certain degree until the shoulder joint is completely restored to be the chronic specific inflammation of the shoulder joint capsule and the surrounding ligaments, tendons and bursa. Periarthritis of shoulder is a common disease with pain and difficulty in movement of shoulder joints as main symptoms.

Disclosure of Invention

The traditional Chinese medicine composition aims at solving the problem that the prior art generally adopts blood circulation promoting and stasis removing medicines to treat scapulohumeral periarthritis, has a certain curative effect, but has a poor general effect on diabetic scapulohumeral periarthritis.

In one or more embodiments of the present disclosure, there is provided a use of a pharmaceutical composition for preparing a medicament for treating scapulohumeral periarthritis, the pharmaceutical composition comprising: 1-15 parts of pseudo-ginseng, 3-20 parts of ligusticum wallichii, 2-15 parts of corydalis tuber, 3-20 parts of radix paeoniae alba, 4-25 parts of radix clematidis, 3-20 parts of radix puerariae and 4-25 parts of notopterygium root;

or 2-10 parts of pseudo-ginseng, 5-15 parts of ligusticum wallichii, 3-10 parts of corydalis tuber, 5-15 parts of radix paeoniae alba, 8-20 parts of radix clematidis, 5-15 parts of radix puerariae and 8-20 parts of notopterygium root;

or 2-3 parts of pseudo-ginseng, 7-8 parts of ligusticum wallichii, 5-6 parts of corydalis tuber, 7-8 parts of radix paeoniae alba, 10-11 parts of radix clematidis, 7-8 parts of radix puerariae and 10-11 parts of notopterygium root;

or 2.3 parts of pseudo-ginseng, 7.6 parts of ligusticum wallichii, 5.4 parts of corydalis tuber, 7.6 parts of white paeony root, 10.5 parts of clematis root, 7.6 parts of kudzu root and 10.5 parts of notopterygium root.

In one or more embodiments of the present disclosure, there is provided a pharmaceutical composition for treating scapulohumeral periarthritis, the pharmaceutical composition comprising: 15-45 parts of pseudo-ginseng, 8-30 parts of ligusticum wallichii, 2-7 parts of corydalis tuber, 3-7 parts of white paeony root, 5-11 parts of clematis root, 5-9 parts of kudzu root and 4-25 parts of notopterygium root.

In one or more embodiments of the present disclosure, there is provided a pharmaceutical composition for treating scapulohumeral periarthritis, the pharmaceutical composition comprising: 20-40 parts of pseudo-ginseng, 10-20 parts of ligusticum wallichii, 3-5 parts of corydalis tuber, 5-7 parts of radix paeoniae alba, 9-10 parts of radix clematidis, 5-7 parts of radix puerariae and 4-17 parts of notopterygium root.

In one or more embodiments of the present disclosure, there is provided a pharmaceutical composition for treating scapulohumeral periarthritis, the pharmaceutical composition comprising: 25-35 parts of pseudo-ginseng, 10-15 parts of ligusticum wallichii, 4 parts of corydalis tuber, 6-7 parts of radix paeoniae alba, 9 parts of radix clematidis, 6-7 parts of radix puerariae and 9-10 parts of notopterygium root.

In one or more embodiments of the present disclosure, there is provided a pharmaceutical composition for treating scapulohumeral periarthritis, the pharmaceutical composition comprising: 30 parts of pseudo-ginseng, 15 parts of ligusticum wallichii, 4 parts of corydalis tuber, 6 parts of white paeony root, 9 parts of clematis root, 6.3 parts of kudzu root and 9.7 parts of notopterygium root.

In one or more embodiments of the present disclosure, there is provided a method for preparing a pharmaceutical composition for treating scapulohumeral periarthritis, comprising the steps of:

(1) grinding Notoginseng radix and rhizoma Ligustici Chuanxiong together;

(2) extracting volatile oil from Notopterygii rhizoma and radix Clematidis, and collecting the distilled water solution in another container;

(3) decocting the white paeony root with the water solution distilled in the step (2), and collecting and concentrating filtrate for later use;

(4) extracting radix Puerariae and rhizoma corydalis with water, and removing residue;

(5) mixing the filtrate and the extraction product obtained in the steps (3) and (4), concentrating, and precipitating with ethanol;

(6) and (3) uniformly mixing the fine powder in the step (1) with the clear paste in the step (5), and spraying the volatile oil of the notopterygium root and the clematis root extracted in the step (2) to obtain the traditional Chinese medicine.

One of the above technical solutions has the following advantages or beneficial effects:

1) according to the first aspect of the disclosure, the application of the Mingren Jingtong tablet in the aspect of scapulohumeral periarthritis treatment is researched, as can be seen from fig. 1, in wind-cold-dampness scapulohumeral periarthritis, the Mingren Jingtong tablet and the medicine with the improved formula thereof have better treatment effects, are similar to those of Wantong muscle and bone patches in the prior art, and develop the application of the Mingren Jingtong tablet.

2) The inventor discovers that the blood circulation promoting and blood stasis removing medicines are generally adopted to treat the scapulohumeral periarthritis in the prior art in the actual treatment process of the scapulohumeral periarthritis, and the problem of poor effect generally exists for the diabetic scapulohumeral periarthritis although the medicine has a certain curative effect. Therefore, the inventor tries to explore the application of the Mingren Jingtong tablet in the scapulohumeral periarthritis and finds that the Mingren Jingtong tablet has better effect than Wantong muscle and bone paste in the treatment of the diabetes type scapulohumeral periarthritis. In the second aspect of the disclosure, the formula and the formulation of the Mingren Jingtong tablet are optimized, namely, the proportion of pseudo-ginseng and rhizoma ligustici wallichii is improved in the formula aspect, the oral medicine is changed into the external medicine in the formulation aspect, and as can be seen from fig. 2, the effect of the pharmaceutical composition in the experiment 1 group is far better than that of other groups in the treatment of the diabetes type scapulohumeral periarthritis. Obviously, for the diabetes type scapulohumeral periarthritis, the mingren neck pain tablets and the Wantong muscle and bone paste have the old effect on the treatment of the scapulohumeral periarthritis, but are far inferior to the pharmaceutical composition described in the experiment 1 group. Therefore, the novel medicinal composition with the improved formula plays a greater role in the treatment of the diabetic scapulohumeral periarthritis, and therefore, the medicament with the improved formula can meet the treatment requirement of the diabetic scapulohumeral periarthritis.

3) The third aspect of the disclosure provides a preparation method of a medicament with an optimized formulation, and as can be seen from fig. 1-2, the effect of the pharmaceutical composition described in example 1 is better than that of the pharmaceutical compositions described in examples 3 and 4, it can be seen that the grinding of notoginseng and chuanxiong rhizome together has a matching relationship, and possibly the grinding of notoginseng and chuanxiong rhizome promotes the separation of components of each other, which is beneficial for the medicament to act. And the inventor thinks that the effect of the white paeony root is possibly conflicted in the process of matching the cold medicament and the warm medicament, and the white paeony root is decocted by the extraction waste water of the notopterygium root and the clematis root, so that the cold property of the white paeony root is slightly neutralized, and the absorption of the medicaments by a patient is facilitated.

4) The performance of the medicine is tested by taking the New Zealand rabbits as an animal model, the mode is generally accepted in the field of scapulohumeral periarthritis treatment, the New Zealand rabbits are treated by ice compress, wind-cold-dampness scapulohumeral periarthritis is simulated, and obviously, the medicine composition is mainly applied to rheumatoid scapulohumeral periarthritis.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate embodiments of the disclosure and, together with the description, serve to explain the disclosure and not to limit the disclosure.

FIG. 1 shows the results of measurement of the content of 5-HT, IL-1. beta. and IL-10 in serum homogenate 2 weeks after the administration to New Zealand rabbits as described in example 5.

FIG. 2 shows the measurement results of the levels of 5-HT, IL-1. beta. and IL-10 in the serum homogenate 2 weeks after the SD rat described in example 6.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments of the present invention without making any creative effort, shall fall within the protection scope of the present invention.

The diagnosis standard of the wind-cold-dampness scapulohumeral periarthritis disclosed by the invention is as follows: symptoms are: the pain stage is characterized by gradual reduction of shoulder joint activity, including outward rotation, inward rotation and outward expansion of the shoulder, which is most obvious in outward expansion function limitation, and the typical shoulder carrying phenomenon appears, even the shoulder serum atrophy appears in the shoulder, the symptoms above the remission stage are gradually relieved, and the shoulder joint activity is gradually recovered.

Laboratory examination, x-ray examination is negative, and osteoporosis is visible in patients with chronic diseases. The frozen shoulder is proved by the Lishi broadside shoulder line examination (from the inner edge of the humeral shaft to the upper edge of the scapula body along the humeral neck, head and through the scapula pelvis) when the line is not continuous, especially the axillary side edge of the glenohumeral joint and the humeral head move upwards, namely when the humeral shoulder line is positive.

The diagnosis standard of the diabetic scapulohumeral periarthritis disclosed by the disclosure is formulated by referring to the traditional Chinese medicine industry standard, traditional Chinese medicine disease diagnosis and treatment effect standard of the people's republic of China and the pain diagnosis and treatment science, and specifically, the diabetic scapulohumeral periarthritis has (1) the age of more than 50 years and the history of more than 6 years. (2) The history of symmetric pain in the shoulder joints is accompanied by limited movement for about 3 months. (3) There is no disease of heart, brain and kidney. (4) The fasting blood sugar of two groups of patients is less than or equal to 7.0mmol/L (126mg/dL), and the glycosylated hemoglobin is less than or equal to 8.0%.

The traditional Chinese medicine composition aims at solving the problem that the prior art generally adopts blood circulation promoting and stasis removing medicines to treat scapulohumeral periarthritis, has a certain curative effect, but has a poor general effect on diabetic scapulohumeral periarthritis.

In one or more embodiments of the present disclosure, there is provided a use of a pharmaceutical composition for preparing a medicament for treating scapulohumeral periarthritis, the pharmaceutical composition comprising: 1-15 parts of pseudo-ginseng, 3-20 parts of ligusticum wallichii, 2-15 parts of corydalis tuber, 3-20 parts of radix paeoniae alba, 4-25 parts of radix clematidis, 3-20 parts of radix puerariae and 4-25 parts of notopterygium root;

or 2-10 parts of pseudo-ginseng, 5-15 parts of ligusticum wallichii, 3-10 parts of corydalis tuber, 5-15 parts of radix paeoniae alba, 8-20 parts of radix clematidis, 5-15 parts of radix puerariae and 8-20 parts of notopterygium root;

or 2-3 parts of pseudo-ginseng, 7-8 parts of ligusticum wallichii, 5-6 parts of corydalis tuber, 7-8 parts of radix paeoniae alba, 10-11 parts of radix clematidis, 7-8 parts of radix puerariae and 10-11 parts of notopterygium root;

or 2.3 parts of pseudo-ginseng, 7.6 parts of ligusticum wallichii, 5.4 parts of corydalis tuber, 7.6 parts of white paeony root, 10.5 parts of clematis root, 7.6 parts of kudzu root and 10.5 parts of notopterygium root.

Further, the preparation method of the pharmaceutical composition comprises the following steps:

(1) firstly, the pseudo-ginseng is crushed into 100-mesh and 120-mesh fine powder;

(2) extracting volatile oil from Notopterygii rhizoma and radix Clematidis, collecting the distilled water solution in another container, decocting the residue with water for 1 hr, and filtering to obtain filtrate;

(3) decocting radix Puerariae and radix Paeoniae alba with water twice (2 hr for the first time and 1 hr for the second time), mixing the filtrate with the above two water solutions, concentrating, precipitating with ethanol, recovering ethanol, and concentrating to obtain fluid extract with relative density of 1.25-1.30 at 50 deg.C;

(4) reflux-extracting rhizoma Ligustici Chuanxiong and rhizoma corydalis with ethanol, removing residue, recovering ethanol from the extractive solution, and concentrating to obtain fluid extract with relative density of 1.25-1.30 at 50 deg.C;

(5) mixing the above two fluid extracts, adding Notoginseng radix powder, mixing, drying, pulverizing into fine powder, adding appropriate amount of rhizoma Peucedani, mixing, and spraying the volatile oil of Notopterygii rhizoma and radix Clematidis.

In one or more embodiments of the present disclosure, there is provided a pharmaceutical composition for treating scapulohumeral periarthritis, the pharmaceutical composition comprising: 15-45 parts of pseudo-ginseng, 8-30 parts of ligusticum wallichii, 2-7 parts of corydalis tuber, 3-7 parts of white paeony root, 5-11 parts of clematis root, 5-9 parts of kudzu root and 4-25 parts of notopterygium root.

In one or more embodiments of the present disclosure, there is provided a pharmaceutical composition for treating scapulohumeral periarthritis, the pharmaceutical composition comprising: 20-40 parts of pseudo-ginseng, 10-20 parts of ligusticum wallichii, 3-5 parts of corydalis tuber, 5-7 parts of radix paeoniae alba, 9-10 parts of radix clematidis, 5-7 parts of radix puerariae and 4-17 parts of notopterygium root.

In one or more embodiments of the present disclosure, there is provided a pharmaceutical composition for treating scapulohumeral periarthritis, the pharmaceutical composition comprising: 25-35 parts of pseudo-ginseng, 10-15 parts of ligusticum wallichii, 4 parts of corydalis tuber, 6-7 parts of radix paeoniae alba, 9 parts of radix clematidis, 6-7 parts of radix puerariae and 9-10 parts of notopterygium root.

In one or more embodiments of the present disclosure, there is provided a pharmaceutical composition for treating scapulohumeral periarthritis, the pharmaceutical composition comprising: 30 parts of pseudo-ginseng, 15 parts of ligusticum wallichii, 4 parts of corydalis tuber, 6 parts of white paeony root, 9 parts of clematis root, 6.3 parts of kudzu root and 9.7 parts of notopterygium root.

In one or more embodiments of the present disclosure, there is provided a method for preparing a pharmaceutical composition for treating scapulohumeral periarthritis, comprising the steps of:

(1) grinding Notoginseng radix and rhizoma Ligustici Chuanxiong together;

(2) extracting volatile oil from Notopterygii rhizoma and radix Clematidis, and collecting the distilled water solution in another container;

(3) decocting the white paeony root with the water solution distilled in the step (2), and collecting and concentrating filtrate for later use;

(4) extracting radix Puerariae and rhizoma corydalis with water, and removing residue;

(5) mixing the filtrate and the extraction product obtained in the steps (3) and (4), concentrating, and precipitating with ethanol;

(6) and (3) uniformly mixing the fine powder in the step (1) with the clear paste in the step (5), and spraying the volatile oil of the notopterygium root and the clematis root extracted in the step (2) to obtain the traditional Chinese medicine.

Further, in the step (1), the pseudo-ginseng and the ligusticum wallichii are crushed into 100-120-mesh fine powder.

Further, in the step (3), the white paeony root is cut into small blocks and decocted for 4-4.5 hours.

Further, in the step (5), the concentrated extract is clear paste with the relative density of 1.50-1.55 at 50 ℃.