Pharmaceutical composition for preventing esophageal stenosis

Abstract

The invention discloses a pharmaceutical composition for preventing esophageal stenosis. The pharmaceutical composition consists of glucocorticoid and sesame oil, the glucocorticoid is triamcinolone acetonide or dexamethasone. The pharmaceutical composition provided by the invention is prepared from 1-5 parts by weight of triamcinolone acetonide and 10-15 parts by weight of sesame oil; or 5-10 parts by weight of dexamethasone and 100 parts by weight of sesame oil. The medicine composition is simple, raw materials are low in price, and mass production and use are facilitated. Practical research finds that the pharmaceutical composition provided by the invention can be used for preventing esophageal stenosis caused by disease reasons, such as esophageal stenosis after large-area endoscopic submucosal dissection (the dissection area is 2 / 3 or above) of esophageal premature cancer, esophageal restenosis after benign esophageal stenosis dilation treatment and the like.

Description

Technical Field

[0001] The present invention relates to a pharmaceutical composition, in particular to a pharmaceutical composition for preventing esophageal stenosis. Background Art

[0002] Esophageal cancer has a poor prognosis due to the difficulty in early detection. Emerging optical imaging technologies are helping to detect esophageal precancerous lesions and early cancer. ESD has been recognized as an effective treatment for esophageal cancer. ESD enables en bloc resection, facilitates accurate histological assessment, and reduces the risk of esophageal cancer recurrence. Furthermore, the long-term efficacy of ESD is comparable to that of surgery, while offering advantages such as less trauma and fewer complications.

[0003] However, esophageal strictures are prone to develop after ESD, especially when the circumference of the lesion is resected to more than three-quarters. Endoscopists usually assess patients at high risk for esophageal strictures based on the circumference and depth of invasion of the lesion and use hormones or stents early to prevent the development of esophageal strictures. Summary of the Invention

[0004] In order to prevent the formation of esophageal stenosis after a large-area ESD surgery, the present invention provides a pharmaceutical composition for preventing esophageal stenosis, characterized in that it consists of a glucocorticoid and sesame oil; the glucocorticoid is triamcinolone acetonide or dexamethasone.

[0005] Furthermore, it is a unit preparation.

[0006] Furthermore, the unit preparation is an oral preparation.

[0007] Furthermore, the amount of triamcinolone acetonide is 1 to 5 parts by weight, and the amount of sesame oil is 10 to 15 parts by weight.

[0008] Furthermore, the amount of dexamethasone is 5 to 10 parts by weight, and the amount of sesame oil is 100 parts by weight.

[0009] In summary, the present invention has the following beneficial effects compared to the prior art:

[0010] The pharmaceutical composition provided by the present invention comprises 1 to 5 parts by weight of triamcinolone acetonide and 10 to 15 parts by weight of sesame oil; or 5 to 10 parts by weight of dexamethasone and 100 parts by weight of sesame oil. The pharmaceutical composition has simple ingredients and inexpensive raw materials, which is conducive to mass production and use.

[0011] Through actual research, it was found that the drug combination provided by the present invention can be used to prevent esophageal stenosis caused by disease, such as preventing esophageal stenosis after large-area endoscopic submucosal resection of early esophageal cancer (resection area of ​​2 / 3 circumference or more), and esophageal restenosis after dilation treatment of benign esophageal stenosis. DETAILED DESCRIPTION

[0012] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present invention. As used herein, unless the context clearly indicates otherwise, the singular form can also include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, they indicate the presence of features, steps, operations, devices, components and / or combinations thereof.

[0013] The invention provides a pharmaceutical composition for preventing esophageal stenosis, which is characterized in that the pharmaceutical composition consists of glucocorticoid and sesame oil; the glucocorticoid is triamcinolone acetonide or dexamethasone.

[0014] As a preference, it is a unit dosage form.

[0015] As a preference, the unit dosage form is an oral dosage form.

[0016] As a preferred embodiment, the amount of triamcinolone acetonide is 1 to 5 parts by weight, and the amount of sesame oil is 10 to 15 parts by weight.

[0017] As a preference, the amount of dexamethasone is 5 to 10 parts by weight, and the amount of sesame oil is 100 parts by weight.

[0018] (1) Scientific basis

[0019] Studies have shown that local glucocorticoids (such as triamcinolone acetonide injection) can reduce the stenosis rate after ESD (from 30% to 70% to 10% to 20%).

[0020] The anti-inflammatory and pro-healing properties of sesame oil may synergistically enhance the effects.

[0021] 1. Triamcinolone acetonide

[0022] Concentration: 0.1% to 0.5% (i.e. 1 to 5 mg / mL sesame oil)

[0023] Long-acting glucocorticoids have strong local anti-inflammatory and anti-fibrotic effects and a long half-life (several weeks), making them suitable for reducing the frequency of administration.

[0024] Existing studies have shown that local injection of triamcinolone acetonide (concentration 10-40 mg / mL) can effectively inhibit esophageal stenosis, but oral topical application requires a lower concentration to avoid the risk of mucosal atrophy.

[0025] Sesame oil can enhance drug adhesion and prolong local retention time.

[0026] 2. Dexamethasone

[0027] Concentration: 0.01% to 0.1% (i.e. 0.1 to 1 mg / mL sesame oil)

[0028] Dexamethasone has a potent anti-inflammatory effect, but its short half-life (36–72 hours) requires more frequent dosing. Even at low concentrations, it can inhibit inflammatory cell infiltration and collagen deposition, reducing the risk of systemic absorption.

[0029] Suitable for short-term high-frequency use (such as within 1 to 2 weeks after surgery).

[0030] (2) Sesame oil and hormone ratio

[0031] Basic recipe:

[0032] Triamcinolone acetonide: 0.3% (3 mg / mL) suspension in sesame oil.

[0033] Dexamethasone: 0.05% (0.5 mg / mL) solution in sesame oil.

[0034] Excipients recommendations:

[0035] Adhesive ingredients (such as carbomer or hypromellose) can be added to prolong the residence time of the drug in the esophageal wound.

[0036] Sesame oil needs to be sterilized to avoid microbial contamination.

[0037] (3) Dosage regimen

[0038] 1. Timing: Start use within 24 hours after surgery and continue for 2 to 4 weeks (adjust according to wound healing).

[0039] 2. Methods:

[0040] After oral administration, the patient should remain in supine position for 5 to 10 minutes to allow the medicine to evenly cover the wound.

[0041] 2 to 3 times a day, 5 to 10 mL each time (the hormone dosage needs to be adjusted according to the concentration).

[0042] 3. Notes:

[0043] Avoid taking with food or water, and do not eat within 30 minutes after administration.

[0044] Monitor for local adverse effects (e.g., mucosal ulcers, Candida infections).

[0045] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

Claims

1. A pharmaceutical composition for preventing esophageal stenosis, characterized in that: The invention is composed of glucocorticoid and sesame oil; the glucocorticoid is triamcinolone acetonide or dexamethasone.

2. The pharmaceutical composition for preventing esophageal stenosis according to claim 1, characterized in that It is a unit preparation.

3. The pharmaceutical composition for preventing esophageal stenosis according to claim 2, characterized in that: The unit preparation is an oral preparation.

4. The pharmaceutical composition for preventing esophageal stenosis according to claim 2 or 3, characterized in that The triamcinolone acetonide is present in an amount of 1 to 5 parts by weight, and the sesame oil is present in an amount of 10 to 15 parts by weight.

5. The pharmaceutical composition for preventing esophageal stenosis according to claim 2 or 3, characterized in that: The dexamethasone is in an amount of 5 to 10 parts by weight, and the sesame oil is in an amount of 100 parts by weight.