Dihydrotestosterone in situ gel spray and preparation method thereof

Abstract

The invention relates to a dihydrotestosterone in situ gel spray and a preparation method thereof. The dihydrotestosterone in-situ gel spray of the present invention is prepared from the following raw materials in mass percentage: 25.00% to 75.00% of dihydrotestosterone ethosome, 10.00% to 40.00% of temperature-sensitive gel auxiliary materials, and 0.50% of transdermal accelerator ~10.00%, moisturizing agent 0.50~10.00%, viscosity regulator 0~5.00%, pH regulator 0~5.00%, preservative 0~5.00% and water 5.00~40.00%; the dihydrotestosterone ethosome consists of the following It is prepared from raw materials in mass percentage: 0.10-20.00% of dihydrotestosterone, 5.00-30.00% of phospholipid, 0-5.00% of cholesterol, 20.00-50.00% of absolute ethanol and 30.00-60.00% of water. The dihydrotestosterone in-situ gel spray has good pharmacokinetic and pharmacodynamic properties, is convenient to use, is evenly coated, and has controllable dosage.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a dihydrotestosterone in-situ gel spray and a preparation method thereof. Background technique [0002] Micropenis is not uncommon in pediatric clinical practice. It is the most common sign of virilization and is caused by insufficient androgen production. It is often accompanied by other external genital dysplasia such as small testes, cryptorchidism, and small scrotum. According to epidemiological surveys, between 1985 and 2006, the incidence of micropenis in American children was about 2.6%. In recent years, with people's emphasis on children's reproductive development and the application of early diagnosis technology using small puberty hormone level changes, the demand for children's micropenis treatment drugs is becoming increasingly urgent. [0003] The development of the penis mainly depends on the androgen-testosterone secreted by the Leydig cells of the testi...

AI Technical Summary

Problems solved by technology

There are also some deficiencies: ①The method of use is unhygienic and inconvenient

When using Andractim gel, squeeze the gel on the genitals, and use tools or fingers to apply it on the root of the penis and the surface of the scrotum. When using tools or fingers, the gel drug may be contaminated and the operation is inconvenient; ②Andractim gel is not evenly applied , not conducive to the full absorption of the drug

Andractim gel coating is based on personal habits and experience. It is difficult to ensure uniform coating, and there are many folds in the scrotum. The gel is semi-solid and difficult to apply on the surface of the folds. In fact, the folds of the scrotum have a large surface area, which is a double Hydrotestosterone absorbs the main part through the genitals, which will greatly affect the absorption of drugs through the skin of the genitals, and will limit the drug content and speed of drug percutaneous penetration, which is not conducive to the full absorption of drugs and the speed of onset of action; ③The dosage of Andractim gel is arbitrary, which is not conducive to Play the best effect

The dosage of Andractim gel, according to personal habits and experience, the amount of extruded gel is more random, there is no clear dosage definition, and it is impossible to accurately control the dosage, which is not only detrimental to the efficacy of the drug, but also may lead to drug waste; ④ Andractim gel price Higher, increasing the economic burden of patients, it is not easy for most patients to take long-term medication

Andractim gel is not approved for import in my country, and can only be obtained through overseas purchases or purchasing agents. The overseas price is equivalent to more than RMB 1,500 per piece. The price is high, and long-term medication is required. The families of ordinary patients cannot afford such high treatment costs.

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