阅读说明：本技术 一种药物组合物 (A pharmaceutical composition ) 是由 陈启仪 于 2021-01-19 设计创作，主要内容包括：本发明公开了一种药物组合物,按重量份数比制成此药物组合物的药效原料为：西牛黄60～65份；冰片90～100份；珍珠90～95份；人指甲150～155份；象牙屑900～1000份；青黛1800～1850份；壁钱20000～21000份；地塞米松5～8份；甲硝唑500～550份；果胶5000～5100份；长型双歧杆菌、嗜酸乳杆菌和粪肠球菌共210～220份。本发明的药物组合物能够显著治疗溃疡性结直肠炎、疗射性直肠损伤和直肠吻合口溃疡,放射性直肠损伤有效率达63.32％,溃疡性结直肠炎有效率52.6％。吻合口溃疡有效率42.83％；而传统治疗方法的有效率低于20％。(The invention discloses a pharmaceutical composition, which is prepared from the following pharmacodynamic raw materials in parts by weight: 60-65 parts of bezoar; 90-100 parts of borneol; 90-95 parts of pearls; 150-155 parts of human nails; 900-1000 parts of ivory bits; 1800-1850 parts of indigo naturalis; 20000-21000 parts of walleye; 5-8 parts of dexamethasone; 500-550 parts of metronidazole; 5000-5100 parts of pectin; 210-220 parts of bifidobacterium longum, lactobacillus acidophilus and enterococcus faecalis. The pharmaceutical composition can be used for remarkably treating ulcerative colitis, rectal injury caused by radiation and rectal anastomotic ulcer, the effective rate of the rectal injury caused by radiation reaches 63.32%, and the effective rate of the ulcerative colitis reaches 52.6%. The effective rate of anastomotic ulcer is 42.83%; the effective rate of the traditional treatment method is lower than 20%.)

1. The pharmaceutical composition is characterized in that the pharmaceutical raw materials for preparing the pharmaceutical composition according to the parts by weight are as follows: 60-65 parts of bezoar; 90-100 parts of borneol; 90-95 parts of pearls; 150-155 parts of human nails; 900-1000 parts of ivory bits; 1800-1850 parts of indigo naturalis; 20000-21000 parts of walleye; 5-8 parts of dexamethasone; 500-550 parts of metronidazole; 5000-5100 parts of pectin; 210-220 parts of bifidobacterium longum, lactobacillus acidophilus and enterococcus faecalis.

2. The pharmaceutical composition according to claim 1, wherein the pharmaceutical raw materials for preparing the pharmaceutical composition in parts by weight are: 60 parts of bezoar; 90 parts of borneol; 90 parts of pearl; 150 parts of human nail; 900 parts of ivory bits; 1800 parts of indigo naturalis; 20000 parts of wall money; 5 parts of dexamethasone; 500 parts of metronidazole; 5000 parts of pectin; 210 parts of bifidobacterium longum, lactobacillus acidophilus and enterococcus faecalis.

3. The pharmaceutical composition according to claim 1, wherein the pharmaceutical raw materials for preparing the pharmaceutical composition in parts by weight are: the pharmaceutical composition is prepared from the following pharmacodynamic raw materials in parts by weight: 65 parts of bezoar; 100 parts of borneol; 95 parts of pearl; 155 parts of human nail; 1000 parts of ivory bits; 1850 parts of indigo naturalis; 21000 shares of walleye; 8 parts of dexamethasone; 550 parts of metronidazole; 5100 parts of pectin; 220 parts of bifidobacterium longum, lactobacillus acidophilus and enterococcus faecalis.

4. The pharmaceutical composition of claim 1, wherein the viable count of Bifidobacterium longum, Lactobacillus acidophilus and enterococcus faecalis is not less than 1.0 x 10⁷CFU。

5. The pharmaceutical composition of claim 1, wherein said wallpapers are collected from wall tiles.

6. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is prepared by a process comprising the steps of: mixing calculus bovis, Borneolum Syntheticum, Margarita, human nail, dens Elephatis, indigo naturalis and semen Strychni mixed powder, dexamethasone, metronidazole, and Bifidobacterium longum, Lactobacillus acidophilus and enterococcus faecalis mixed powder in parts by weight; mixing in 2.5X 10⁵And (4) adding parts of physiological saline to form a suspension.

7. The pharmaceutical composition of claim 6, wherein the pharmaceutical composition is used in suspension with physiological saline.

Technical Field

The invention relates to the technical field of medicines, in particular to a pharmaceutical composition.

Background

Chronic ulcerative colitis is a chronic inflammatory disease of unknown cause characterized by the mucosa and submucosa of the large intestine (mainly the rectum and colon). Bloody diarrhea is the most common early symptom. Other symptoms are abdominal pain, hematochezia, weight loss, tenesmus, vomiting, etc. in turn. The disease was first described in 1875 and was initially referred to as simple ulcerative colitis and later as nonspecific colitis.

Ulcerative colitis, the current traditional treatment is basically the treatment of taking medicines and injections and the treatment of surgical resection of the whole colon. At present, the drug therapy mostly adopts similar salicylic acid drugs and glucocorticoids, and the like, such as: sulfasalazine, 5-aminosalicylic acid, azathioprine, 6-mercaptopurine (6-MP), cyclosporine and other medicines and preparations. Among these drugs, sulfapyridine has a great side effect on the liver and cannot be used together with antibiotics or for a long time. The surgical treatment is to remove the whole colon, but the surgical complications are more, so the life quality of the postoperative patient is seriously affected. Therefore, safe and effective treatment measures for the disease are sought at home and abroad.

Radiation Proctitis (RP) refers to the radiation injury of the rectum caused by radiation therapy of patients with pelvic malignant tumors such as cervical cancer, endometrial cancer, ovarian cancer, prostate cancer, rectal cancer, bladder cancer, etc. According to the onset time and the course of disease, Acute Radiation Proctitis (ARP) and Chronic Radiation Proctitis (CRP) can be classified. More than 75% of patients receiving pelvic radiotherapy will develop ARP and 5% -20% will develop CRP. The radioactive rectal injury is mainly manifested as hematochezia. The radioactive proctitis is accompanied by hemorrhage, has no specific medicine, mainly needs invasive operations such as endoscope and local injection, and has poor curative effect.

The incidence rate of anastomotic ulcer, particularly rectal low anastomotic ulcer, is high, patients can feel hematochezia and anus retrogression swelling, life treatment and life crisis are seriously affected, but no specific treatment means exists at first, and the medicine for relieving edema is mainly used locally.

Therefore, there is a need to find a pharmaceutical composition that can significantly treat ulcerative colitis, therapeutic rectal lesions and anastomotic rectal ulcers.

Disclosure of Invention

The invention aims to overcome the defects in the prior art, and provides a pharmaceutical composition which can be used for remarkably treating ulcerative colitis, rectal injury caused by injection and rectal anastomotic ulcer.

In order to achieve the purpose, the invention adopts the technical scheme that:

the pharmaceutical composition is prepared from the following pharmacodynamic raw materials in parts by weight: 60-65 parts of bezoar; 90-100 parts of borneol; 90-95 parts of pearls; 150-155 parts of human nails; 900-1000 parts of ivory bits; 1800-1850 parts of indigo naturalis; 20000-21000 parts of walleye; 5-8 parts of dexamethasone; 500-550 parts of metronidazole; 5000-5100 parts of pectin; 210-220 parts of bifidobacterium longum, lactobacillus acidophilus and enterococcus faecalis.

Further, the pharmacodynamic raw materials for preparing the pharmaceutical composition according to the weight portion ratio are as follows: 60 parts of bezoar; 90 parts of borneol; 90 parts of pearl; 150 parts of human nail; 900 parts of ivory bits; 1800 parts of indigo naturalis; 20000 parts of wall money; 5 parts of dexamethasone; 500 parts of metronidazole; 5000 parts of pectin; 210 parts of bifidobacterium longum, lactobacillus acidophilus and enterococcus faecalis.

Further, the pharmacodynamic raw materials for preparing the pharmaceutical composition according to the weight portion ratio are as follows: the drug effect raw materials for preparing the drug composition according to the weight portion ratio are as follows: 65 parts of bezoar; 100 parts of borneol; 95 parts of pearl; 155 parts of human nail; 1000 parts of ivory bits; 1850 parts of indigo naturalis; 21000 shares of walleye; 8 parts of dexamethasone; 550 parts of metronidazole; 5100 parts of pectin; 220 parts of bifidobacterium longum, lactobacillus acidophilus and enterococcus faecalis.

Further, the viable bacteria amount of the bifidobacterium longum, the lactobacillus acidophilus and the enterococcus faecalis is more than or equal to 1.0 multiplied by 10⁷CFU。

Further, the wallpapers are collected from the wall bricks.

Further, the preparation method of the pharmaceutical composition comprises the following steps: mixing calculus bovis, Borneolum Syntheticum, Margarita, human nail, dens Elephatis, indigo naturalis and semen Strychni mixed powder, dexamethasone, metronidazole, and Bifidobacterium longum, Lactobacillus acidophilus and enterococcus faecalis mixed powder in parts by weight; mixing in 2.5X 10⁵And (4) adding parts of physiological saline to form a suspension.

Further, the pharmaceutical composition is used in a suspension with physiological saline.

By adopting the technical scheme, compared with the prior art, the invention has the following technical effects:

the pharmaceutical composition can be used for remarkably treating ulcerative colitis, rectal injury caused by radiation and rectal anastomotic ulcer, the effective rate of the rectal injury caused by radiation reaches 63.32%, and the effective rate of the ulcerative colitis reaches 52.6%. The effective rate of anastomotic ulcer is 42.83%; the effective rate of the traditional treatment method is lower than 20%.

The pharmaceutical composition of the invention is composed of plant Chinese herbal medicines and western medicines, the traditional Chinese medicine formula has the functions of clearing away heat and toxic materials, astringing, removing necrotic tissue and promoting granulation, dexamethasone can reduce local immune inflammatory reaction, metronidazole can locally resist infection, reduce inflammatory reaction of bleeding parts, repair wound surfaces, and relieve or cure bleeding.

Detailed Description

The following specific examples further illustrate the invention but are not to be construed as limiting the invention. It should be noted that the embodiments and features of the embodiments may be combined with each other without conflict.

Example 1

The pharmaceutical composition comprises: 0.06g of bezoar bovis; 0.09g of borneol; 0.09g of pearl; 0.15g of human nail; ivory bits 0.9g (baked); indigo naturalis 1.8g (removing foot ash, cleaning); 20g of walleye (can be used on baked earth wall bricks and can not be used on wood boards); 5mg of dexamethasone; 0.5g of metronidazole; 5g of pectin; bifidobacterium longum, Lactobacillus acidophilus and enterococcus faecalis 210mg, wherein the amount of viable bacteria is 1.0 × 107 CFU.

The pharmaceutical composition is mixed into 250ml of normal saline to form a suspension, and the suspension is used as a suspension for treating ulcerative colitis, rectal injury and rectal anastomotic ulcer.

Example 2

The pharmaceutical composition comprises: 0.065g of bezoar bovis; 0.10g of borneol; 0.095g of pearl; 0.155g of human nail; ivory bits 1.0g (baked); indigo naturalis 1.85g (removing foot ash, cleaning); wall coin 21g (available for baking on wall brick, unavailable on wood board); dexamethasone (8 mg); 0.55g of metronidazole; 5.1g of pectin; bifidobacterium longum, Lactobacillus acidophilus and enterococcus faecalis 220mg in total, wherein the amount of viable bacteria is 1.0 × 107CFU or more.

The pharmaceutical composition is mixed into 250ml of normal saline to form a suspension, and the suspension is used as a suspension for treating ulcerative colitis, rectal injury and rectal anastomotic ulcer.

Experimental example:

clinical research results show that clinical symptoms such as diarrhea, bloody purulent stool, abdominal pain and the like of patients with ulcerative colitis can be quickly eliminated by using the medicinal composition enema, the pathological changes of intestinal mucosa can be obviously improved, inflammation mediums are eliminated, ulcer healing is promoted, and therefore a good treatment effect is achieved. Meanwhile, safety indexes show that after enema treatment, the patient has no abnormal changes in liver and kidney functions, X-ray chest radiographs, electrocardiograms, hematuria and other routine examinations, and no adverse reaction and toxic or side effect are found. The results of the clinical study are as follows:

1. results of clinical studies on radiation-induced intestinal injury: 653 patients with radioactive intestinal injury and bloody stool are treated by the center, after 6-day continuous retention enema, the average bleeding stopping time stops 72 hours after the enema, and the effective number of 412 patients has the effective rate of 63.09%.

2. Results of clinical studies on ulcerative colitis: 386 patients with ulcerative colitis and bloody stool are treated by the center, the average bleeding stopping time stops 48 hours after the enema after continuous retention enema for 12 days, and the effective number of 201 patients has the effective rate of 52.07%.

3. Clinical results of stomal ulcer study: 163 patients with anastomotic ulcer with bloody stool are treated by the center, the average bleeding stopping time stops 48 hours after the enema after 9 days of continuous retention enema, 83 effective patients have the effective rate of 50.92 percent.

The above effective is cured and improved, and the cure is as follows: clinical symptoms disappear, and intestinal mucosa pathological changes are detected to be recovered to normal by enteroscopy and the like; improvement: the clinical symptoms are relieved, the pathological changes of intestinal mucosa are improved by enteroscopy and the like, and a small amount of red and white blood cells are normally found in the excrement; and (4) invalidation: before and after treatment, clinical symptoms and enteroscopy and the like do not improve or obviously improve.

While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention.