Sildenafil Citrate Raw Material

This is the most famous medication commonly used to treat erectile dysfunction. It works by relaxing muscles and increasing blood flow, usually taken 30 minutes to 1 hour before sexual activity.

The commonly used clinical dosage form is film coated tablets, with commonly used specifications of 25mg, 50mg, and 100mg; In recent years, new dosage forms have emerged continuously, including orally disintegrating tablets, oral suspensions, sustained-release agents, and orally disintegrating films.

Sildenafil citrate is a selective type 5 phosphodiesterase (PDE5) inhibitor that increases cGMP levels in tissues by inhibiting the breakdown of cGMP by PDE5, thereby relaxing smooth muscles and increasing tissue blood flow. PDE5 is mainly distributed in the corpus cavernosum of the penis and has extremely low effects on tissues such as myocardium and skeletal muscle, making it highly selective. The therapeutic effect of this product on erectile dysfunction needs to be effective under sexual stimulation: when sexual stimulation is present, the corpus cavernosum of the penis releases nitric oxide (NO), which activates guanylate cyclase to produce cGMP; Sildenafil inhibits PDE5, reduces cGMP degradation, enhances the NO cGMP pathway, leading to relaxation of smooth muscle in the corpus cavernosum and massive blood flow into the penis, resulting in natural erection. After oral administration, the absorption is rapid, reaching the peak of blood medication within 30-120 minutes (average of 27 minutes), and the efficacy lasts for about 4 hours (with the strongest effect at 2 hours). Erectile response increases with dose (25mg, 50mg, 100mg), but there is no significant improvement in efficacy beyond 100mg.
Other potential pharmacological effects
In recent years, research has found that the PDE5 inhibition, antioxidant, anti-inflammatory, and neuroplasticity properties of sildenafil have potential application value in multiple fields (currently mostly in the research stage):
1. Promote wound healing: local application of sildenafil preparations (such as gel and cream) can accelerate wound closure, increase angiogenesis, promote collagen regeneration, and synergize with platelet rich plasma (PRP) to enhance the effect;
2. Improve lead induced hypertension and endothelial dysfunction: reduce reactive oxygen species (ROS) formation through antioxidant effects, increase NO metabolite levels, improve endothelial function, and reduce lead induced hypertension;
3. Antidepressant potential: Through its neuroplasticity, anti-inflammatory, and antioxidant properties, it has become a potential candidate drug for severe depression (MDD) and treatment resistant depression (TRD);
4. Liver protection and antioxidant effects: By increasing the synthesis of endogenous hydrogen sulfide (H ₂ S) in the liver, enhancing antioxidant capacity, and regulating the Keap1/Nrf2 pathway

1. Suitable for adult males who are unable to achieve or maintain sufficient penile erection to achieve satisfactory sexual activity due to psychological (such as anxiety, stress), physiological (such as vascular disease, neurogenic disease, endocrine disorders), or mixed factors. Clinical data shows that most patients take effect within 30 minutes to 1 hour, with an effective rate of about 70% -80%.
2. Suitable for WHO Group 1 pulmonary arterial hypertension patients (such as idiopathic pulmonary arterial hypertension, connective tissue disease-related pulmonary arterial hypertension, etc.), by dilating pulmonary artery blood vessels to reduce pulmonary artery pressure and improve exercise tolerance.
3. Suitable for individuals who are about to enter high-altitude areas (≥ 3000 meters) and have a history of acute mountain sickness. By dilating pulmonary blood vessels to increase oxygen exchange efficiency, acute mountain sickness can be prevented.

Initial dose: The recommended starting dose for adults is 50mg, taken as needed;
Dose adjustment: Adjust to 25mg (insufficient efficacy or significant adverse reactions) or 100mg (poor efficacy and good tolerance) based on efficacy and tolerability;
Administration time: Take about 1 hour before sexual activity (within 0.5-4 hours), ineffective when there is no sexual stimulation; Medication should not be taken more than once within 24 hours.
Dose adjustment for special populations

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