CN118319985A - External pharmaceutical composition for treating erectile dysfunction and preparation method and application thereof - Google Patents
External pharmaceutical composition for treating erectile dysfunction and preparation method and application thereof Download PDFInfo
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The invention provides an external pharmaceutical composition for treating erectile dysfunction, which is prepared from sildenafil and a composition A in the following weight proportions: 0.1 to 40 parts of sildenafil and 1.5 to 6 parts of composition A, wherein the composition A consists of icariine, cistanche ethanol extract, propidium bromide, diacetyl choline phosphate and 0.2 percent nitroglycerin. The invention also provides a preparation method and application of the external pharmaceutical composition. According to the invention, the icariin, the cistanche ethanol extract and the sildenafil are combined, so that the hardness and the frequency of penile erection of a patient at night can be effectively improved, and the occurrence rate of adverse reactions is reduced. The external pharmaceutical composition for treating erectile dysfunction has good curative effect, exerts the synergistic effect by combining the raw materials, has no side effect, is safe in clinical use, and has the advantages of simple, quick and efficient preparation method, easy operation and convenient carrying.
Description
Technical Field
The invention relates to an external pharmaceutical composition for treating erectile dysfunction, belonging to the field of medicines.
Background
Erectile dysfunction (Erectile Dysfunction, ED) refers to repeated or continuous occurrence of an insufficient erection or a sustained erection in a male patient. The predominant drug for the treatment of Erectile Dysfunction (ED) is the phosphodiesterase type 5 inhibitor (PDE 5 i), and the representative drug is sildenafil. Such drugs are available only through the prescription of the physician and are typically administered orally 30 to 60 minutes prior to the performance of the sexual act. While PDE5 inhibitors are widely used to treat ED for many years and are safe for most people, there may be some side effects. The literature shows that sildenafil has systemic vasodilation and therefore patients sensitive to blood pressure changes should be cautious, for example patients with left ventricular outflow tract obstruction. Meanwhile, sildenafil administration may increase the incidence of non-arteritic anterior ischemic optic neuropathy (NAION) in men over 50 years of age. How to reduce adverse reactions caused by sildenafil has important significance for improving clinical treatment effect of sildenafil and improving life quality and acceptance of patients.
Application No. 201710553825.X, title of invention: a pharmaceutical composition for external use containing sildenafil citrate is provided, which can be further prepared into external ointment, is smeared on penis before the start of sexual behavior, is rapidly absorbed and acts, and does not need to wait for 1 hour of drug acting time compared with oral preparations. However, sildenafil disclosed in the patent is a single component, and can not exert the efficacy of the drug better than sildenafil citrate for oral administration.
In recent years, the incidence of erectile dysfunction has increased dramatically worldwide and continues to show a trend toward rejuvenation. Although many domestic and foreign researches show that the western medicines have higher effective rate for treating erectile dysfunction, the western medicines have limitations, the western medicines cannot achieve long-term treatment effect, and the safety problems are relatively high. Traditional Chinese medicines gradually show good development prospects. The traditional Chinese medicine has long history of preventing and treating erectile dysfunction, and the traditional Chinese medicine with the functions of tonifying kidney and strengthening yang is used for treating the erectile dysfunction, so that the traditional Chinese medicine is a common method of ancestral medicine. Four plant extracts of cistanche salsa, epimedium herb, cynomorium songaricum and medlar have a promoting effect on rat erection (Yu Fan, research on the effect of the four plant extracts on rat erection function, university of Yangzhou, 2020 Shuoshi paper) are reported in literature, but the drugs are mainly orally taken and are required to be metabolized through liver to play a role. Application number: 200910132502.9, name of invention: a traditional Chinese medicine for curing male sexual dysfunction relates to a traditional Chinese medicine for curing male sexual dysfunction and depression, which relates to the field of traditional Chinese medicine natural pharmaceutical preparations, and the raw materials of the preparation of the invention are: cistanche, epimedium, ginseng, rhizoma polygonati and radix bupleuri. The preparation has the effects on the penis erection latency of the castrated male animals, the weight of the sexual organs and the index of the viscera, can obviously shorten the penis erection latency of the castrated male animals, increase the weight of the sexual organs of the castrated mice, and obviously improve the symptoms of body temperature reduction, weight reduction, stress capacity reduction and activity reduction of the yang-deficient mice. The prescription disclosed in this patent is also administered orally. Zhang Shigeng, observation of the curative effect of the icariin complex in the external coating treatment of premature ejaculation, journal 2010 of the Chinese men science, volume 24, 3, reports that the icariin complex (containing 3% of peppermint oil, 30% of icariin and the balance of beta-cyclodextrin coated peppermint oil) is used for treating premature ejaculation. Because the factors influencing absorption are more when the medicine is externally used, the medicine effect achieved by the existing external preparation is not ideal, and the clinical requirement cannot be met.
Disclosure of Invention
The invention aims to provide a medicament for improving sildenafil adverse reaction and improving erectile function. A topical pharmaceutical composition for treating erectile dysfunction, and its preparation method and application are provided.
The invention provides an external pharmaceutical composition for treating erectile dysfunction, which is prepared from sildenafil and a composition A in the following weight proportions:
0.1 to 40 parts of sildenafil and 1.5 to 6 parts of composition A,
Wherein the composition A comprises icariin, cistanche ethanol extract, propidium bromide, and diacetyl choline phosphate, and 0.2% nitroglycerin.
Further preferably, the feed additive is prepared from the following raw materials in parts by weight:
1.5 to 3 parts of sildenafil, 1.5 to 4.5 parts of icariin, 1.5 to 3 parts of cistanche ethanol extract (calculated by the amount of cistanche raw materials), 0.6 part of propidium bromide, 0.6 part of diacetyl choline phosphate and 0.2 percent of nitroglycerin.
Still more preferably, the feed additive is prepared from the following raw materials in parts by weight:
3 parts of sildenafil, 3 parts of icariin, 3 parts of cistanche ethanol extract (calculated by cistanche raw drugs), 0.6 part of propidium bromide, 0.6 part of diacetyl choline phosphate and 0.6 part of 0.2% nitroglycerin.
The external pharmaceutical composition is prepared from sildenafil, icariin, cistanche ethanol extract, propidium bromide, diacetyl choline phosphate and 0.2% nitroglycerin serving as active ingredients, and pharmaceutically acceptable auxiliary materials or auxiliary ingredients.
Wherein the external preparation is gel, spray, liniment, ointment, cream and solution.
Wherein, the matrix of the gel is carbomer and the cosolvent is Tween-80; the humectant comprises the following components: glycerol, propylene glycol; the penetration enhancer and antiseptic is ethanol and the acid-base regulator is triethanolamine.
The invention also provides a preparation method of the external pharmaceutical composition for treating erectile dysfunction, which comprises the following steps:
a. Weighing herba cistanches, drying at 60deg.C, pulverizing into fine powder, extracting with 50-85% ethanol solution under heating, concentrating extractive solution, crystallizing, and drying to obtain herba cistanches ethanol extract;
b. Weighing the raw materials in weight ratio, mixing with the cistanche ethanol extract prepared in the step a, and adding pharmaceutically acceptable auxiliary materials or auxiliary components to prepare the external preparation commonly used in pharmacy.
The invention provides application of the external pharmaceutical composition in preparing medicines for treating erectile dysfunction.
Wherein the medicine is used for improving the erection hardness and frequency of the penis of the patient at night and treating impotence.
The beneficial effects of the invention are as follows:
According to the invention, the icariin, the cistanche ethanol extract and the sildenafil are combined, so that the hardness and the frequency of penile erection of a patient at night can be effectively improved, and the occurrence rate of adverse reactions is reduced. The external pharmaceutical composition for treating erectile dysfunction has good curative effect, exerts the synergistic effect by combining the raw materials, has no side effect, is safe in clinical use, and has the advantages of simple, quick and efficient preparation method, easy operation and convenient carrying.
Detailed Description
EXAMPLE 1 preparation of the gel of the invention
Oven drying herba cistanches at 60deg.C, pulverizing into fine powder, extracting with 50-85% ethanol solution, reflux extracting, concentrating, crystallizing, and drying to obtain ethanol extract of herba cistanches;
Pulverizing herba Epimedii, reflux extracting with ethanol under heating, and concentrating the extractive solution. Then extracting with n-butanol, and further separating and purifying icariin. The icariin can also be directly used as a commercial product.
Under the high-speed rotation of a magnetic stirrer, 0.8gCP parts of the mixture are added into a beaker containing 100mL of deionized water to form a suspension, the suspension is taken overnight, after the suspension is fully swelled, auxiliary materials such as glycerol, propylene glycol and the like, sildenafil, icariine, cistanche ethanol extract, propidium amine, diacetyl choline phosphate and 0.2 percent of nitroglycerin are slowly added according to the proportion of table 1, then triethanolamine is used for adjusting the pH value to 6.0-8.0, and the mixture is transferred into a centrifuge to be centrifuged for 20 minutes at 2500r/min to prepare gel with uniform texture.
The beneficial effects of the invention are demonstrated by clinical trials below.
Test example 1 clinical trials of the drug of the present invention.
1. Erectile dysfunction tester
1.1 Criteria for enrollment
(1) Age: 18-45 years old; (2) there is a fixed sex partner and regular life; (3) Meets the diagnostic criteria for ED, an International erectile function index score (IIEF-5) <22 points; (4) no similar drug treatment was used 1 month prior to treatment; (5) No drugs affecting sexual function are taken during treatment; (6) patients were informed and agreed to participate in the study.
1.2 Exclusion criteria
(1) Congenital genital organ deformity and dysplasia; (2) severe reproductive system infections; (3) ED which occurs after genitourinary surgery and lower abdominal surgery; (4) severe cardiac, hepatic, renal dysfunction; (5) Severe hypertension, diabetes, hematopathy are not controlled; (6) severe psychological disorders.
2. Final enrolled tester
90 Patients diagnosed as erectile dysfunction in combination with hospitals in the Sichuan province from month 1 of 2023 to month 12 of 2023 have the ages of 18 to 45 years and average 28.5 years, and have no serious diseases such as heart, brain, liver, kidney, hematopoietic system and the like.
3. Random method
The study was a random control study, and random assigned codes were generated by expert statistics using SAS software. The PROCPLAN statement in SAS software is written, and the existing SEED number SEED is specified as 90. Random numbers are mixed according to the ratio of 1:1: proportion of 1 subjects enrolled in the study were equally assigned to the observations group (drug prepared according to the method of example 1, prescription 1), control group 1, control group 2, control group 3, control group 4 and control group 5, 15 cases each, totaling 90 cases. The grouping situation and the intervention scheme are recorded in detail by the card and are hidden by the envelope seal. The envelope number and the serial number of the card are corresponded, and the envelope is stored by an unknowing responsible person.
3. Treatment regimen
The observation group adopts a prescription one treatment, the control group 1, the control group 2, the control group 3, the control group 4 and the control group 5 respectively adopt a prescription two, a prescription three, a prescription four, a prescription five and a prescription six treatment, and the topical gel is smeared on the penis every day, and the proportion of the prescription is shown in the table 1.
TABLE 1 formulation ratio of the inventive composition
| Raw and auxiliary materials | Prescription one | Prescription two | Prescription III | Prescription IV | Prescription five | Prescription six |
| Sildenafil citrate, calculated as sildenafil | 25mg | 25mg | 25mg | 5mg | 5mg | 5mg |
| Icariin | 25mg | 50mg | 0mg | 35mg | 70mg | 0mg |
| Cistanche extract (calculated by cistanche raw drug) | 25mg | 0mg | 50mg | 35mg | 0mg | 70mg |
| Propidium amine | 5mg | 5mg | 5mg | 5mg | 5mg | 5mg |
| Phosphodiacetylcholines | 5mg | 5mg | 5mg | 5mg | 5mg | 5mg |
| 0.2% Nitroglycerin | 5mg | 5mg | 5mg | 5mg | 5mg | 5mg |
4. Observation index
4.1 Intravaginal Ejaculation Latency Time (IELT): the 6 groups of patients were compared for IELT before treatment and 28 days after treatment.
4.2 Satisfaction of sexual intercourse: the satisfaction of both sex partners with sex life before and after treatment was compared for 6 groups of patients. Intercourse satisfaction evaluation criteria: satisfaction: both sex partners indicate satisfaction; basically satisfied: a sex partner means satisfactory, another unsatisfactory or substantially satisfactory; dissatisfaction, both sex partners indicate dissatisfaction.
5. Statistical method
Using SPSS19.0 statistical software, the count data is expressed in percent (%), the inter-group comparison is tested by x2, the inter-group comparison is tested by t, and P <0.05 is statistically significant.
6. Test results
Table 16 group of patients were compared with IELT before and after treatment
Note that: p < 0.05 compared to the control groups 1-5
Table 1 shows that the comparative differences in IELT for 6 groups of patients before treatment were statistically significant (P > 0.05). 28 days after treatment, the observed group had a significantly higher IELT than the 5 control groups, and the differences between the two groups were statistically significant (P < 0.05).
Table 26 comparison of clinical efficacy of patients (n/%)
Note that: p < 0.05 compared to the control groups 1-5
The sexual satisfaction of the observed group and the 5 control groups are 86.67%, 46.67%, 40.00%, 46.67% and 33.33%, respectively, the curative effect of the observed group is obviously better than that of the 5 control groups, and the comparison difference of the 6 groups has statistical significance (P is less than 0.05).
No significant side effects were seen in the observation group and 5 control groups, none of the 6 patients had been withdrawn from treatment. The clinical control test results prove that the novel topical gel can obviously prolong male ejaculation time and improve sexual satisfaction.
Claims (9)
1. A topical pharmaceutical composition for the treatment of erectile dysfunction, characterized in that: the composition is prepared from sildenafil and a composition A in the following weight ratio:
0.1 to 40 parts of sildenafil and 1.5 to 6 parts of composition A,
Wherein the composition A comprises icariin, cistanche ethanol extract, propidium bromide, and diacetyl choline phosphate, and 0.2% nitroglycerin.
2. The pharmaceutical composition for external use for treating erectile dysfunction according to claim 1, wherein: the composite material is prepared from the following raw materials in parts by weight:
1.5 to 3 parts of sildenafil, 1.5 to 4.5 parts of icariin, 1.5 to 3 parts of cistanche ethanol extract (calculated by the amount of cistanche raw materials), 0.6 part of propidium bromide, 0.6 part of diacetyl choline phosphate and 0.2 percent of nitroglycerin.
3. The pharmaceutical composition for external use for treating erectile dysfunction according to claim 2, wherein: the composite material is prepared from the following raw materials in parts by weight:
3 parts of sildenafil, 3 parts of icariin, 3 parts of cistanche ethanol extract (calculated by cistanche raw drugs), 0.6 part of propidium bromide, 0.6 part of diacetyl choline phosphate and 0.6 part of 0.2% nitroglycerin.
4. A pharmaceutical composition for external use for treating erectile dysfunction according to any of claims 1-3, characterized in that: the external preparation is prepared from sildenafil, icariin, cistanche ethanol extract, propidium bromide, diacetyl choline phosphate and 0.2% nitroglycerin serving as active ingredients, and pharmaceutically acceptable auxiliary materials or auxiliary components.
5. The pharmaceutical composition for external use for treating erectile dysfunction according to claim 4, wherein: the external preparation is gel, spray, liniment, ointment, cream and solution.
6. The pharmaceutical composition for external use for treating erectile dysfunction according to claim 5, wherein: the matrix of the gel is carbomer, and the cosolvent is Tween-80; the humectant comprises the following components: glycerol, propylene glycol; the penetration enhancer and antiseptic is ethanol and the acid-base regulator is triethanolamine.
7. A method for preparing a pharmaceutical composition for external use for treating erectile dysfunction according to any one of claims 1 to 6, characterized in that: it comprises the following steps:
a. Weighing herba cistanches, drying at 60deg.C, pulverizing into fine powder, extracting with 50-85% ethanol solution under heating, concentrating extractive solution, crystallizing, and drying to obtain herba cistanches ethanol extract;
b. Weighing the raw materials in weight ratio, mixing with the cistanche ethanol extract prepared in the step a, and adding pharmaceutically acceptable auxiliary materials or auxiliary components to prepare the external preparation commonly used in pharmacy.
8. Use of the pharmaceutical composition for external use according to any one of claims 1 to 6 for the preparation of a medicament for the treatment of erectile dysfunction.
9. Use according to claim 9, characterized in that: the medicine is used for improving the erection hardness and frequency of the penis at night and treating impotence.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202410443483.6A CN118319985A (en) | 2024-04-12 | 2024-04-12 | External pharmaceutical composition for treating erectile dysfunction and preparation method and application thereof |
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| CN202410443483.6A CN118319985A (en) | 2024-04-12 | 2024-04-12 | External pharmaceutical composition for treating erectile dysfunction and preparation method and application thereof |
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