Method for treating herpes virus infection
A herpes virus infection and herpes virus technology, applied in antiviral agents, pharmaceutical formulas, medical preparations of non-active ingredients, etc., can solve problems such as low solubility and difficult realization of diclofenac aqueous injection solutions
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Embodiment 1
[0032] Embodiment 1. Preparation of emulsion formula
[0033] The emulsion carrier ± [active ingredient] is prepared by the following steps:
[0034] 1. Preparation of the oil phase: Immerse the mixing vessel in a hot water bath (80±2°C). [Acyclovir, 50g] methylparaben (1g), propylparaben (1g), cetyl alcohol (60g), sorbitan monostearate 60 (12g), hard Fatty acid (steric acid) (20g), synthetic spermaceti (50g), dimethyl polysiloxane (30g), and triglyceride caprylic-capric acid ester (miglyol) 812 (70g) add this mixing vessel and stir to Mix well. The mixture was filtered once through a 150 mesh screen to remove particulates.
[0035] 2. Preparation of the aqueous phase: Immerse another mixing vessel in a hot water bath (80±2°C). [Diclofenac sodium salt, 50g] [Diclofenac lidocaine salt, 10g, 30g, or 50g] polysorbate 60 (36g), propylene glycol (160g), sodium citrate (10g), and sufficient to make the total weight reach 1000 g of pure water was added to the mixing vessel and s...
Embodiment 2
[0038] Example 2. Testing different compounds on animals
[0039] Target:
[0040] Test (1) ADO-1, ADO-2, ADO-3, and ADO-4 on herpes animal model; (2) 1% VDO99 emulsion, 3% VDO99 emulsion, 5% VDO99 emulsion and their placebo; ( 3) Effect of VGO99 emulsion (diclofenac sodium, 50 mg (RA009)), VDO99 emulsion (diclofenac, lidocaine salt 50 mg (RA052)), VAO99 emulsion (lidocaine, 50 mg (RA001)) and their placebo emulsions. The emulsion formulation ± active ingredient was prepared according to Example 1.
[0041] Test compound:
[0042] Group I
[0043] ADO-1: 5% acyclovir (50mg / g) plus 5% diclofenac lidocaine salt (Lidofenac50mg / g)
[0044] ADO-2: 5% acyclovir (50mg / g)
[0045] ADO-3: 5% diclofenac lidocaine salt (Lidofenac 50mg / g)
[0046] ADO-4: Vector.
[0047] Group II
[0048] 1% VDO99 emulsion: diclofenac, lidocaine salt (Lidofenac 10mg / g, RA032);
[0049] VDO99 placebo emulsion (RA035 placebo);
[0050] 3% VDO99 emulsion: diclofenac, lidocaine salt (Lidofenac 30mg / ...
Embodiment 3
[0122] Example 3. Clinical research protocol
[0123] Target:
[0124] To evaluate the effectiveness of VGO99 (5% diclofenac sodium emulsion) in patients with herpes zoster. The efficacy is judged by intensity ratings of pain and lesions.
[0125] study endpoint
[0126] Evaluate the following endpoints
[0127] · The primary efficacy endpoint was the time to complete cessation of shingles-related pain. Subjects were defined as achieving complete cessation of pain if they were pain-free for at least 7 days (pain reported as 0 on a numerical scale of 0-100).
[0128] Time to cessation of acute phase pain (pain experienced until all crusts fall off)
[0129] • A rough rate of subjects achieving complete cessation of shingles-related pain at the end of the follow-up period.
[0130] • Rough rate of subjects free of blisters, ulcers and crusts at the end of the treatment period and follow-up period.
[0131] • Percent reduction in VAS pain scores at specific clinical visits...
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