Methods and compositions for treating diabetes
A composition, a technology for type 2 diabetes, applied in drug combinations, metabolic diseases, pharmaceutical formulations, etc.
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Embodiment 1
[0140] Example 1: Identification of Effective Emulsifiers for Homogeneous Therapeutic Protein / Fish Oil Formulations
[0141] Previous formulations of insulin in fish oil were found to precipitate over time; therefore, they were inconvenient for large-scale preparation of pharmaceutical dosage forms. The new formulation contained 3.375 g of SBTI per 22.5 g of fish oil and contained the following emulsifiers to be tested: lecithin (test sequence 1), polysorbate 80 (Tween-80) (sequence 2) or (Sequence 3), alone or in combination with each other or with glyceryl monostearate (GMS) ( figure 1 ). Subsequently, the most promising formulations (indicated by asterisks) were melted by (which is a waxy solid at room temperature), which is then regenerated by adding it to fish oil. After cooling the mixture, the solid components are added in powder form in the following order: EDTA, SBTI, aprotinin and insulin; and the resulting liquid is mixed and homogenized in a roller mill.
Embodiment 2
[0142] Example 2: In vivo testing of various emulsifier formulations
[0143] Materials and Experimental Methods
[0144] preparation
[0145] The formulations tested in Experiments 2A and 2B are shown in Table 1. The percentage of emulsifier is expressed as a weight / weight ratio relative to the weight of liquid present.
[0146] Table 1
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[0149] feed
[0150] Animal Health: Only clinically veterinary-certified healthy pigs were used for research. Residence: When with CVC, live alone, other times, live in groups. Cushion: concrete + wood chips. Lighting: 12-12h photoperiod. Temperature: 19-25°C
[0151] identification
[0152] Uniquely identify each animal by ear tag.
[0153] experimental design
[0154] Animals were fasted for 24-36 hours prior to testing. Drink water freely.
[0155] Animals were anesthetized with 20 mg / kg Ketamine + 2 mg / kg Xylazine. Fasted and anesthetized pigs were placed in left lateral recumbency, after which the liq...
Embodiment 3
[0163] Example 3: Oral insulin / oral exenatide combination significantly reduces blood sugar levels and prevents postprandial blood sugar fluctuations
[0164] Materials and Experimental Methods
[0165] animal
[0166] Healthy 25-30 kg, 3-4 month old pigs were used.
[0167] experimental design
[0168] Pigs were fasted for 24-36 hours before the start of the study. Replace the CVC every five days (unless circumstances warrant an earlier replacement). After being connected to endotracheal tube and respirator (2 L O per minute) 2 , when needed, 3-5% isoflurane), the animal was anesthetized by face mask administration of isoflurane, then placed in left lateral recumbency, and under endoscopic guidance, the capsule was administered directly into ten duodenum. When both oral insulin and oral exenatide are administered, the oral exenatide is delivered first, followed by the oral insulin within 2-10 minutes. The pigs were returned to the pen to fully recover from the anesthes...
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