Study on formulation and preparation technology of the composite cellulose-based enteric capsule shells.

OBJECTIVE: To study the new formulation and technology of composite cellulose-based enteric capsule shell with one-time dipping molding without organic solvent. METHODS: Hydroxypropyl methylcellulose phthalate-55S (Hp55S) was used as the main film-forming material, agar as gelling agent, and hydroxypropyl methylcellulose (HPMC) as disintegrating regulator. The preparation technology was as follows: ① Hp55S was dissolved in dilute ammonia solution with pH of 10 ∼ 11 at room temperature to obtain transparent Hp55S solution. ② The mixture of HPMC, KCl, and Tween-80 was fully dispersed in the agar solution at 90 ∼ 100 °C and cooled to 50 ∼ 55 °C under continuous stirring to obtain a transparent agar/HPMC solution. ③The Hp55S solution was heated to 50 ∼ 55 °C and poured into the agar/HPMC solution and stirred evenly to obtain the composite cellulose solution, which was kept at 50 ∼ 55 °C for standby. ④The composite cellulose-based enteric capsule shells were prepared by dipping, spinning, drying, stripping and trimming, and joining. RESULTS: The composite cellulose-based enteric capsule shell prepared according to this formula and process met the quality requirements of 'enterosoluble vacant capsules' in Chinese Pharmacopeia. CONCLUSION: Compared with the traditional formula and preparation technology of enteric capsule shell, the product is a plant type enteric capsule shell, no organic solvent is used in the formula, and the forming steps of multiple dipping solution is not used in the process. The advantages of this study are that the production steps are simplified, the production process is environmentally friendly, and the production cost is reduced.

[Endometrial carcinoma in patients below 45 years of age: clinical analysis of 53 cases].

OBJECTIVE: To investigate the clinical characteristics of endometrial carcinoma in patients below 45 years of age. METHODS: The clinical data were collected from 53 patients with endometrial carcinoma below 45 years of age, who were divided into less than 40 year group (group A, 28 cases) and 40 to 45 year group (group B, 25 cases) and their clinical data were compared. RESULTS: A rate of 57.1% (16/28) of the patients in group A were infertile, and 78.5% (22/28) reported irregular menstruation. In group B, the infertility rate was 28.0% (7/25), and 48% (12/25) of the patients were obese, 56% (14/25) had abnormal vaginal bleeding, and 32% (8/25) had diabetes and hypertension. The two groups differed significantly in the infertility rate, number of pregnancies and deliveries and the incidences of obesity, hypertension and diabetes. The pathological classification, grade of differentiation, pathological staging, depth of myometrial invasion, and cervical infiltration status were comparable between the two groups (P>0.05). All the 53 patients received surgical interventions and follow. up for two years, during which 1 patients in group B had relapse. CONCLUSION: Patients with endometrial carcinoma at 40 years of age or below often have infertility, and those over 40 years are exposed to such high-risk factors as obesity, diabetes, and hypertension. Its major clinical symptom of endometrial carcinoma is menstrual disorders. The differentiation, pathological staging, pathological classification of the malignancy are not associated with age in patients below 45 years of age. Early diagnosis often warrants more favorable prognosis.