WO2019154161A1 - 一种治疗男性疾病的药物组合物及其制备方法和用途 - Google Patents

一种治疗男性疾病的药物组合物及其制备方法和用途 Download PDF

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WO2019154161A1
WO2019154161A1 PCT/CN2019/073552 CN2019073552W WO2019154161A1 WO 2019154161 A1 WO2019154161 A1 WO 2019154161A1 CN 2019073552 W CN2019073552 W CN 2019073552W WO 2019154161 A1 WO2019154161 A1 WO 2019154161A1
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hot water
water extract
parts
pharmaceutical composition
dried
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PCT/CN2019/073552
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French (fr)
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张南
钟荣
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海文健康科技（深圳）有限公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/39—Convolvulaceae (Morning-glory family), e.g. bindweed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/43—Cuscutaceae (Dodder family), e.g. Cuscuta epithymum or greater dodder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Definitions

  • the present application relates to the field of medicine for treating male diseases, and in particular to a pharmaceutical composition for treating male diseases, a preparation method thereof and use thereof.
  • Prostatic hyperplasia is one of the common diseases in middle-aged and elderly men, and it is increasing with the ageing of the global population.
  • the incidence of benign prostatic hyperplasia increases with age, but there are not necessarily clinical symptoms when there is hyperplastic lesions.
  • the incidence of towns is higher than in rural areas, and racial differences also affect the degree of hyperplasia.
  • Prostatic hyperplasia has been hailed as the "four major killers" of older men. Many elderly men have suffered from such diseases.
  • Prostatic hyperplasia seriously endangers the physical and mental health of older men.
  • the occurrence of benign prostatic hyperplasia must have two important conditions: age growth and functional testis.
  • benign prostatic hyperplasia is still unclear, which may be caused by the balance of epithelial and mesenchymal cell proliferation and apoptosis.
  • the incidence of histological prostatic hyperplasia increases with age, usually occurring after 40 years of age, greater than 50% by the age of 60, and as high as 83% by the age of 80. Similar to histological performance, symptoms such as dysuria increase with age. About 50% of men with histological diagnosis of benign prostatic hyperplasia have moderate to severe lower urinary tract symptoms.
  • prostatic hyperplasia The earliest and most common symptoms of prostatic hyperplasia are increased number of nocturia, slow urination, and weakness, and this symptom tends to increase slowly.
  • Complications such as urinary tract infections, bladder stones, inguinal hernia, and hemorrhoids may also occur.
  • Some patients may have symptoms of overactive bladder, a syndrome characterized by urgency, often accompanied by frequent urination and nocturia, with or without urge incontinence, and even with overflowing urine in severe cases incontinence.
  • the treatment of benign prostatic hyperplasia should be based on the patient's symptoms, risk of progression and treatment response, and consider individualized treatment in terms of drug dosage, course of treatment, and combination therapy.
  • combined treatment with ⁇ -blockers + 5 ⁇ -reductase inhibitors for patients with obvious symptoms and high risk of clinical progression is generally long-term medication.
  • the shortcomings of drug treatment of benign prostatic hyperplasia include: side effects are large, and it is easy to produce dependence. After long-term service, it has great harm to the cardiovascular system and immune system. Because Western medicine is not completely clear about the underlying causes and pathogenesis of benign prostatic hyperplasia, western medicine is mainly used to improve and relieve symptoms rather than cure prostate hyperplasia.
  • the present application provides a pharmaceutical composition capable of enhancing immune function, rapidly relieving fatigue, enhancing male vitality, improving fertility, and treating male sexual dysfunction.
  • a pharmaceutical composition for treating a male disease comprising the following components in parts by mass: 10-30 parts of maca hot water extract, 10-30 parts of Tongkat Ali hot water extract, dodder 15-40 parts of hot water extract, 15-40 parts of hot purple squirt hot water extract, and 5-20 parts of American ginseng powder.
  • the pharmaceutical composition comprises, in parts by mass, the following components: 18.75 parts of maca hot water extract, 18.75 parts of Tongkat Ali hot water extract, 25 parts of hot water extract of dodder, and hot purple riveting heat 25 parts of water extract and 12.5 parts of American ginseng powder.
  • the pharmaceutical composition is in the form of an effervescent tablet, a buccal tablet, a granule, a capsule or an oral solution.
  • the present invention also provides a method for preparing a pharmaceutical composition for treating male diseases, characterized in that the pharmaceutical composition comprises, in parts by mass, the following components: maca hot water extract 10-30 parts, east 10-30 parts of hot water extract of Ge'ali, 15-40 parts of hot water extract of Cuscuta, 15-40 parts of hot purple squirt hot water extract, 5-20 parts of American ginseng powder;
  • the preparation method of the pharmaceutical composition includes the following preparation process:
  • the preparation process of the maca hot water extract is: pulverizing the dried maca, adding water to boil and extracting, filtering the dregs, and drying the filtered liquid to obtain a maca hot water extract powder;
  • the preparation process of the hot purple squirt hot water extract is: pulverizing the dried brilliant purple rivet, adding boiling water to extract, filtering the dregs, and drying the filtered liquid to obtain a hot purple squirt hot water extract powder;
  • the preparation process of the Tongkat Ali hot water extract is: pulverizing the dried Tongkat Ali, adding water to boil and extracting, filtering the dregs, and drying the filtered liquid to obtain the Tongkat Ali hot water extract powder;
  • the preparation process of the hot water extract of Cuscuta chinensis is: pulverizing the dried dodder, adding water to boil and extracting, filtering the dregs, and drying the filtered liquid to obtain a hot water extract powder of dodder;
  • the preparation process of the American ginseng powder is: pulverizing dried American ginseng and sieving to obtain American ginseng powder.
  • the preparation process of the maca hot water extract is specifically: pulverizing the dried maca, adding boiling water for 2 h, the mass ratio of maca to water is 1:10, filtering the dregs, and filtering the obtained After the liquid spray is dried, the maca hot water extract powder is obtained.
  • the preparation process of the hot purple squirt hot water extract is specifically: pulverizing the dried brilliant purple rivet, and adding boiling water for 1 hour, the mass ratio of the brilliant purple rivet to the water is 1:10, filtering the dregs, The filtered liquid is spray-dried to obtain a brilliant purple hot water extract powder.
  • the preparation process of the Tongkat Ali hot water extract is specifically: taking the dried Tongkat Ali tree root and pulverizing, adding water and boiling extraction for 2 hours, the mass ratio of Tongkat Ali to water is 1:10, filtering the dregs, The filtered liquid was spray-dried to obtain a Tongkat Ali hot water extract powder.
  • the preparation process of the hot water extract of Cuscuta chinensis is specifically: pulverizing the dried dodder, and extracting by boiling water for 3 hours, the mass ratio of the dodder to the water is 1:10, filtering the dregs, and drying the filtered liquid. After the dodder hot water extract powder.
  • the preparation process of the American ginseng powder is specifically: pulverizing dried American ginseng, passing through a 80 mesh sieve to obtain American ginseng powder.
  • the present application further claims the use of the above pharmaceutical composition for the preparation of a health supplement or medicament for treating a male condition.
  • the present application has the following advantages compared with the prior art: the pharmaceutical composition for treating male diseases of the present application can enhance immune function, quickly relieve fatigue, enhance male vitality, enhance fertility and treat male sex. Dysfunction, can be prepared into related health products or drugs.
  • Example 1 Preparation of a pharmaceutical composition
  • the pharmaceutical composition of the present embodiment is in the form of a capsule (hereinafter referred to as a pharmaceutical capsule), and the pharmaceutical capsule comprises, in parts by mass, the following components: 18.75 parts of maca hot water extract, Tongkat Ali hot water extract 18.75 parts, 25 parts of hot water extract of Cuscuta, 25 parts of hot purple squirt hot water extract, and 12.5 parts of American ginseng powder.
  • the drug capsule in the present embodiment has a weight of 0.4 g per capsule, and contains 0.075 g of hot water extract of maca, 0.075 g of hot water extract of Tongkat Ali, hot water extract of 0.1 g, and hot water of dodder. 0.1 g of extract and 0.05 g of American ginseng powder.
  • the preparation process of maca hot water extract is:
  • 25 kg of dried purple rivet was pulverized, and boiled and extracted with 250 kg of water for 1 h, and the dregs were filtered, and the filtered liquid was spray-dried to obtain 1 kg of hot purple squirt hot water extract powder.
  • the dried 10 kg of dodder was pulverized, and 100 kg of water was added to boil for 3 hours, and the dregs were filtered, and the filtered liquid was spray-dried to obtain 1 kg of dodder hot water extract powder.
  • the maca hot water extract powder, the brilliant purple squirt hot water extract powder, the Tongkat Ali hot water extract powder, the dodder silk hot water extract powder and the American ginseng powder are added in proportion and uniformly mixed, and the mixture is uniformly extinguished by high pressure. After the fungus is sterilized, the capsule can be filled.
  • 1 drug capsule specification: 0.4g / granule; use a physiological saline solution to form a suspension containing 0.4g / mL of the drug, while the concentration of the low-dose group of the drug capsule is 0.4g / mL (normal dose), medium dose The concentration of the group was 0.8g/mL (2 times of the normal dose), and the concentration of the high dose group was 0.12g/mL (3 times of the normal dose);
  • T testosterone (T) assay kit: Beijing North Institute of Biotechnology; estradiol (E2) assay kit: Beijing North Institute of Biotechnology; epidermal growth factor (EGF) kit: Shanghai Senxiong Technology Industrial Co., Ltd.
  • Male Sprague-Dawley rats were bred for 1 week to adapt to the environment, and after normal observation, no abnormalities were observed.
  • Male SD rats were intraperitoneally anesthetized with ketamine hydrochloride injection 100 mg/kg. After anesthesia was successful, the rats were fixed on the operating table. The skin is routinely sterilized, and the bilateral testicles are removed through the scrotum under aseptic conditions, and the stump is ligated to ensure hemostasis and suture the skin. After 1 week of observation, each rat was subcutaneously injected with 3.5 mg/kg propionate propionate once daily for 30 days, resulting in an animal model of benign prostatic hyperplasia.
  • Grouping 60 rats were randomly selected as a blank control group for sham operation; the remaining rats were modeled for prostate hyperplasia. 50 rats randomly divided into 5 groups were randomly divided into 5 groups, each group was 10, as follows: A, model group; B, Shushushu capsule control group; C, drug capsule low dose group; D, drug capsule Dosage group; E, drug capsule high dose group.
  • Group A was administered with normal saline at a dose of 1 mL/100 g body weight.
  • Group B was given a suspension of sputum suspension suspension at a dose of 1 mL/100 g body weight.
  • Groups C, D, and E were given low and medium weights at a dose of 1 mL/100 g.
  • High-concentration drug capsule suspension was intragastrically administered once a day for 30 consecutive days. After 30 days, they were sacrificed together and the prostate tissue was taken for testing.
  • Prostatic wet weight and prostate index 2 hours after the last administration (fasting can not help water for 12h), the rats were weighed separately, the prostate was weighed rapidly, and the prostate index was calculated.
  • Detection of T, E2, EGF level the prostate into two parts, called the left side of the prostate 300mg, add 1mL ice physiological saline, 4 ° C homogenate, centrifuged at 3000rpm for 15min, the prostate tissue homogenate supernatant was determined in the prostate tissue E2, T, EGF levels.
  • the gland density and histomorphology of the prostate were measured.
  • the right prostate tissue was fixed in 10% formalin solution, embedded in paraffin, sectioned, HE stained, and the changes of prostate tissue morphology were observed under light microscope.
  • Determination of glandular density of the prostate using the universal stereometric method, using the test grid analysis method, calculating the percentage of the number of intersections on the gland and the number of intersections in the reference system, the gland density of the prostate, each organ Determined 3 times.
  • the drug capsule of the first embodiment was tested by the method of the second embodiment, and the effects of the drug capsule on the prostate weight, prostate index and gland density of the prostatic hyperplasia model rats were examined.
  • the experimental results are shown in Table 1.
  • the prostate wet weight, prostate index and gland density of the model group were significantly increased (P ⁇ 0.01), indicating that the prostate of the model group was significantly proliferated and the model was successfully replicated.
  • high- and medium-dose drug capsules and Qishushu group can significantly reduce prostate wet weight, prostate index and body mass of prostate gland in rats with benign prostatic hyperplasia (P ⁇ 0.01).
  • the group can significantly reduce the wet weight of the prostate (P ⁇ 0.01), and can significantly reduce the prostate index (P ⁇ 0.05).
  • the drug capsules in the first embodiment were tested by the method in the second embodiment to test the effects of the drug capsules on the T, E2 and EGF in the prostate tissue of the rat model of benign prostatic hyperplasia.
  • the experimental results are shown in Table 2.
  • Table 2 shows that compared with the blank group, the levels of T and EGF in the prostate homogenate of the model group were significantly increased (P ⁇ 0.01). Compared with the model group, high, medium and low dose drug capsules and Qishushu group can significantly reduce the levels of T and EGF in the homogenate of the rat model (P ⁇ 0.01). The effect of the level is not obvious.
  • the glands were arranged closely, and the interstitial space was visible between the glands.
  • the glandular cavity was not dilated, and the glandular epithelium was monolayer columnar.
  • the gland was obviously hyperplasia under the model group.
  • the glandular cavity was cystic dilatation and the size was different.
  • the degree of prostatic gland hyperplasia was improved compared with the model group under the sputum sputum group; the high and medium dose group of the drug capsule was under the microscope See the prostate gland has a certain hyperplasia, a few glandular cavity is cystic dilatation, the local glandular epithelium is papillary to the cavity, which is much better than the model group; the prosthetic gland hyperplasia is seen in the low-dose group of Qianlietongyu capsule.
  • the model group has some improvement.
  • Penile erectile dysfunction syndrome Erectile difficulty
  • Erectile is easy
  • Premature ejac Sex life can be more than 15 minutes
  • the pharmaceutical composition of the present application can significantly reduce prostate wet weight, prostate index and body density of prostate gland in rats with benign prostatic hyperplasia, and significantly reduce T and EGF levels in prostate homogenate of model rats; and informal clinical The study found that the pharmaceutical composition of the present application has a good effect in treating benign prostatic hyperplasia.
  • the pharmaceutical composition of the present application can enhance immune function, rapidly relieve fatigue, enhance male vitality, enhance reproductive function, and treat male sexual dysfunction, and can be prepared into related health care products or drugs.

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Abstract

本申请涉及一种治疗男性疾病的药物组合物，所述药物组合物按质量份数计，包括如下组分：玛卡热水提取物10-30份、东革阿里热水提取物10-30份、菟丝子热水提取物15-40份、艳紫铆热水提取物15-40份、西洋参粉末5-20份。本申请的药物组合物能够显著降低前列腺增生模型大鼠中的前列腺湿重、前列腺指数及前列腺腺体的体密度，以及显著降低模型大鼠前列腺匀浆中T、EGF水平；且经非正式临床研究发现本申请中的药物组合物治疗前列腺增生有很好的效果。本申请的药物组合物能够增强免疫功能、快速缓解疲劳、增强男性活力、增进生殖能力和治疗男性性功能障碍，能够制备成相关保健品或药物。

Description

一种治疗男性疾病的药物组合物及其制备方法和用途
本申请是以申请号为201810118690.9、申请日为2018年2月6日的中国专利申请为基础，并主张其优先权，该申请的全部内容在此作为整体引入本申请中。
技术领域
本申请涉及治疗男性疾病的药物领域，具体涉及一种治疗男性疾病的药物组合物及其制备方法和用途。
背景技术
前列腺增生(BPH)是中老年男性常见疾病之一，随全球人口老年化发病日渐增多。前列腺增生的发病率随年龄递增，但有增生病变时不一定有临床症状。城镇发病率高于乡村，而且种族差异也影响增生程度。前列腺增生被喻为老年男性的“四大杀手”，很多老年男性都患过这样的疾病，前列腺增生严重危害老年男性身心健康。前列腺增生的发生必须具备年龄的增长及有功能的睾丸两个重要条件。但前列腺增生发生的具体机制尚不明确，可能是上皮和间质细胞的增殖和细胞凋亡的平衡性破坏引起的。此外，还有一些相关因素，比如说，雄激素及其与雌激素的相互作用、前列腺间质-腺上皮细胞的相互作用、生长因子、炎症细胞、神经递质及遗传因素等。组织学上前列腺增生的发病率是随年龄的增长而增加，最初通常发生在40岁以后，到60岁时大于50％，80岁时高达83％。与组织学表现相类似，随着年龄的增长，排尿困难等症状也随之增加。大约有50％组织学诊断前列腺增生的男性有中度到重度下尿路症状。
前列增生症最早出现的，也是最主要的症状是夜尿次数增多、排尿缓慢、无力，而且这种症状呈缓慢加重的趋势。患者出现最早的是轻度梗阻，比如尿线细而不畅，然而此时多未引起注意。随着病情发展，就出现尿频、夜尿次数增加、尿费力、尿失控，直到尿潴留(排不出尿来)。可能也会出现尿路感染、膀胱结石、腹股沟疝气、痔疮等并发症。部分患者会出现膀胱过度活动症的表现，这是一种以尿急症状为特征的症候群，常伴有尿频和夜尿症状，可伴或不伴有急迫性尿失禁，严重时甚至出现充溢性尿失禁。
目前，治疗前列腺增生市场上多应用激素类或抗激素类药物、α肾上腺素受体阻滞剂、5α受体还原酶抑制剂、胆固醇抑制剂、植物制剂、中药治疗等。 当然，前列腺增生药物治疗应针对患者的症状、进展风险及治疗反应等因素，在药物剂量、疗程、联合用药等方面考虑个体化治疗。在疗程方面，对于症状明显、临床进展危险较大的患者采用α受体阻滞剂+5α-还原酶抑制剂的联合治疗，一般都是长期用药。药物治疗前列腺增生缺点包括有：副作用大，易产生依赖性，久服之后对心脑血管系统、免疫系统产生较大危害。且由于西医学对于前列腺增生的根本原因和发病机制尚未完全清楚，因而西药在治疗上是以改善和缓解症状为主，而非根治前列腺增生。
申请内容
有鉴于此，为了解决现有技术的问题，本申请提供了一种能够增强免疫功能、快速缓解疲劳、增强男性活力、增进生殖能力和治疗男性性功能障碍的药物组合物。
为了达到上述目的，本申请采取如下技术方案：
一种治疗男性疾病的药物组合物，所述药物组合物按质量份数计，包括如下组分：玛卡热水提取物10-30份、东革阿里热水提取物10-30份、菟丝子热水提取物15-40份、艳紫铆热水提取物15-40份、西洋参粉末5-20份。
优选地，所述药物组合物按质量份数计，包括如下组分：玛卡热水提取物18.75份、东革阿里热水提取物18.75份、菟丝子热水提取物25份、艳紫铆热水提取物25份、西洋参粉末12.5份。
优选地，所述药物组合物的剂型为泡腾片、口含片、颗粒剂、胶囊或口服液。
本申请还提供了一种治疗男性疾病的药物组合物的制备方法，其特征在于，所述药物组合物按质量份数计，包括如下组分：玛卡热水提取物10-30份、东革阿里热水提取物10-30份、菟丝子热水提取物15-40份、艳紫铆热水提取物15-40份、西洋参粉末5-20份；
所述药物组合物的制备方法包括如下制备过程：
所述玛卡热水提取物的制备过程为：将干燥的玛卡粉碎，并加水煮沸萃取，过滤药渣，将过滤得到的液体喷雾干燥后得玛卡热水提取物粉末；
所述艳紫铆热水提取物的制备过程为：将干燥的艳紫铆粉碎，并加水煮沸萃取，过滤药渣，将过滤得到的液体喷雾干燥后得艳紫铆热水提取物粉末；
所述东革阿里热水提取物的制备过程为：将干燥的东革阿里粉碎，加水煮沸萃取，过滤药渣，将过滤得到的液体喷雾干燥后得东革阿里热水提取物粉末；
所述菟丝子热水提取物的制备过程为：将干燥的菟丝子粉碎，并加水煮沸萃取，过滤药渣，将过滤得到的液体喷雾干燥后得菟丝子热水提取物粉末；
所述西洋参粉末的制备过程为：取干燥的西洋参粉碎，过筛，得西洋参粉末。
优选地，所述玛卡热水提取物的制备过程具体为：将干燥的玛卡粉碎，并加水煮沸萃取2h，玛卡与水的质量比为1:10，过滤药渣，将过滤得到的液体喷雾干燥后得玛卡热水提取物粉末。
优选地，所述艳紫铆热水提取物的制备过程具体为：将干燥的艳紫铆粉碎，并加水煮沸萃取1h，艳紫铆与水的质量比为1:10，过滤药渣，将过滤得到的液体喷雾干燥后得艳紫铆热水提取物粉末。
优选地，所述东革阿里热水提取物的制备过程具体为：取干燥的东革阿里树根粉碎，加水煮沸萃取2h，东革阿里与水的质量比为1:10，过滤药渣，将过滤得到的液体喷雾干燥后得东革阿里热水提取物粉末。
优选地，所述菟丝子热水提取物的制备过程具体为：取干燥的菟丝子粉碎，并加水煮沸萃取3h，菟丝子与水的质量比为1:10，过滤药渣，将过滤得到的液体喷雾干燥后得菟丝子热水提取物粉末。
优选地，所述西洋参粉末的制备过程具体为：取干燥的西洋参粉碎，过80目筛，得西洋参粉末。
本申请进一步要求保护上述药物组合物在制备治疗男性疾病的保健品或药物中的用途。
由于以上技术方案的实施，本申请与现有技术相比具有如下优点：本申请的治疗男性疾病的药物组合物，能够增强免疫功能、快速缓解疲劳、增强男性活力、增进生殖能力和治疗男性性功能障碍，能够制备成相关保健品或药物。
具体实施方式
实施例一：药物组合物的制备
1.1药物组合物的组分
本实施例中的药物组合物的剂型为胶囊(以下称为药物胶囊)，且药物胶囊按质量份数计，包括如下组分：玛卡热水提取物18.75份、东革阿里热水提取物18.75份、菟丝子热水提取物25份、艳紫铆热水提取物25份、西洋参粉末12.5份。
具体的，本实施例中的药物胶囊每粒重0.4g，其中含玛卡热水提取物 0.075g、东革阿里热水提取物0.075g、艳紫铆热水提取物0.1g、菟丝子热水提取物0.1g、西洋参粉末0.05g。
1.2药物组合物中各组分的制备方法
以下简述本实施例中药物胶囊中各个组成部分的制备过程：
玛卡热水提取物的制备过程为：
将10kg晒干的玛卡粉碎，并加100kg水煮沸萃取2h，过滤药渣，将过滤得到的液体喷雾干燥后得1kg玛卡热水提取物粉末。
艳紫铆热水提取物的制备过程为：
将25kg晒干的艳紫铆粉碎，并加250kg水煮沸萃取1h，过滤药渣，将过滤得到的液体喷雾干燥后得1kg艳紫铆热水提取物粉末。
东革阿里热水提取物的制备过程为：
取30kg晒干的东革阿里树根粉碎，加300kg水煮沸萃取2h，过滤药渣，将过滤得到的液体喷雾干燥后得1kg东革阿里热水提取物粉末。
菟丝子热水提取物的制备过程为：
取干燥的10kg菟丝子粉碎，并加100kg水煮沸萃取3h，过滤药渣，将过滤得到的液体喷雾干燥后得1kg菟丝子热水提取物粉末。
西洋参粉末的制备过程为：
取10kg晒干的洁净的西洋参粉碎，过80目筛，得9.8kg西洋参粉末。
1.3药物胶囊的制备
将上述制得的玛卡热水提取物粉末、艳紫铆热水提取物粉末、东革阿里热水提取物粉末、菟丝子热水提取物粉末以及西洋参粉末按比例添加并混合均匀，用高压灭菌器灭菌后，装入胶囊即可。
实施例二：实验过程(材料与方法)
2.1动物：雄性SD大鼠60只，清洁级，体重(280±20)g，8月龄，由昆明医科大学实验动物中心提供。
2.2实验药品
①药物胶囊：规格：0.4g/粒；临用时用生理盐水配成含成药0.4g/mL的混悬液，其中药物胶囊低剂量组浓度为含成药0.4g/mL(正常剂量)、中剂量组浓度为含成药0.8g/mL(正常剂量的2倍)、高剂量组浓度为含成药0.12g/mL(正常剂量的3倍)；
②癃闭舒胶囊：规格：0.3g/粒，石家庄科迪药业有限公司生产，批号010601；临用时配成含成药0.03g/mL的混悬液；
③丙酸睾丸酮注射液：规格25mg/1mL，由天津金耀氨基酸有限公司生产；
④睾酮(T)测定试剂盒：北京北方生物技术研究所；雌二醇(E2)测定试剂盒：北京北方生物技术研究所；表皮生长因子(EGF)试剂盒：上海森雄科技实业有限公司。
2.3前列腺增生动物模型制备：(参照卫生部《新药(西药)临床前研究指导原则汇编》造模)
将雄性SD大鼠普通饲养1周以适应环境，并经普通观察无异常后，用盐酸氯胺酮注射液100mg/kg对雄性SD大鼠进行腹腔麻醉，麻醉成功后，将大鼠固定于手术台上，皮肤常规消毒，无菌条件下经阴囊摘除双侧睾丸，结扎残端以确保止血，缝合皮肤。观察1周后，每只大鼠按体重皮下注射丙酸睾丸酮3.5mg/kg，1次/d，连续给药30天，造成前列腺增生动物模型。
2.4分组及给药：
分组：将60只大鼠随机取10只作为空白对照组，做假手术；其余大鼠造前列腺增生模型。将常规造模的50只大鼠随机分为5组，每组l0只，具体如下：A、模型组；B、癃闭舒胶囊对照组；C、药物胶囊低剂量组；D、药物胶囊中剂量组；E、药物胶囊高剂量组。
给药方法：A组按1mL/100g体重给予生理盐水灌胃，B组按lmL/100g体重给予癃闭舒混悬液灌胃，C、D、E组按1mL/100g体重分别给予低、中、高浓度药物胶囊混悬液灌胃，每日1次，连续30天。30天后，一并处死，取前列腺组织待测。
2.5检测指标：
前列腺湿重及前列腺指数：于末次给药后2h(禁食不禁水12h)，大鼠分别称重，迅速取前列腺称其前列腺湿重，计算前列腺指数(前列腺指数＝前列腺湿重g/鼠体重g)。
检测T、E2、EGF：水平将前列腺分成两部分，称前列腺左侧叶300mg，加人1mL冰生理盐水，4℃匀浆，以3000rpm离心15min，取前列腺组织匀浆上清液测定前列腺组织中E2、T、EGF水平。
测定前列腺的腺体密度及组织形态学观察：取右侧前列腺组织固定于10％福尔马林溶液中，石蜡包埋，切片，HE染色，光镜下观察各组前列腺组织形 态变化。
测定前列腺的腺体密度：采用通用立体计量学测定方法，应用测试格点分析法，计算腺体上的交叉点数与参照系中的交叉点数的百分比，为前列腺的腺体密度，每个脏器测定3次。
2.6统计学方法
对实验数据采用SPSS 17.0统计软件包建立数据库，并以
Figure PCTCN2019073552-appb-000001
表示各定量指标的平均值和分散程度。成组设计多个样本均数的比较采用ANOVA(方差分析)检验，多个样本均数间每两个均数比较采用t检验。
实施例三：结果与讨论
3.1对前列腺增生模型大鼠前列腺重、前列腺指数及腺体密度的影响
将实施例一中的药物胶囊采用实施例二中的方法进行实验，并检测药物胶囊对前列腺增生模型大鼠前列腺重、前列腺指数及腺体密度的影响，实验结果见表1。
表1药物胶囊对大鼠前列腺增生模型前列腺湿重、前列腺指数及腺体密度的影响
Figure PCTCN2019073552-appb-000002
Figure PCTCN2019073552-appb-000003
注：与空白组比较， **P<0.01；与模型组比较， △△P<0.01
有表1可知，与空白组相比，模型组大鼠前列腺湿重、前列腺指数及腺体密度都显著增加(P<0.01)，说明模型组大鼠前列腺明显增生，模型复制成功。与模型组相比，高、中剂量药物胶囊组和癃闭舒组均可显著降低前列腺增生模 型大鼠前列腺湿重、前列腺指数及前列腺腺体的体密度(P<0.01)，药物胶囊低剂量组可显著降低大鼠前列腺湿重(P<0.01)，可明显降低前列腺指数(P<0.05)。
3.2对前列腺增生大鼠模型前列腺组织中T、E2及EGF的影响
将实施例一中的药物胶囊采用实施例二中的方法进行实验，检测药物胶囊对前列腺增生大鼠模型前列腺组织中T、E2及EGF的影响，实验结果见表2。
表2药物胶囊对大鼠前列腺增生模型前列腺匀浆中T、E2、EGF水平的影响
Figure PCTCN2019073552-appb-000004
Figure PCTCN2019073552-appb-000005
注：与空白组比较， **P<0.01；与模型组比较， △△P<0.01
表2表明，与空白组比，模型组大鼠前列腺匀浆中T、EGF水平显著升高(P<0.01)。与模型组比，高、中、低剂量药物胶囊组和癃闭舒组均可显著降低模型大鼠前列腺匀浆中T、EGF水平(P<0.01)，实验各组对前列腺组织匀浆中E2水平的影响不明显。
3.3各组前列腺组织形态的观察
空白组镜下见腺体排列紧密，腺体间可见明显的间质，腺腔无扩张，腺上皮单层柱状；模型组镜下见腺体明显增生，腺腔呈囊状扩张，大小不一，多数腺上皮乳头状增生明显突向腔内，间质水肿、瘀血；癃闭舒组镜下见前列腺腺体增生程度较模型组有一定改善；药物胶囊高、中剂量组剂量组镜下见前列腺腺体有一定增生，少数腺腔呈囊状扩张，局部腺上皮呈乳头状向腔内突出，较模型组有很大改善；前列通窍胶囊低剂量组镜下见前列腺腺体增生，较模型组 有一定改善。
实施例四：非正规临床试验
4.1前列腺肥大
100名50-85岁男性前列腺肥大患者，服用实施例一中制备的药物胶囊3个月，每4天一次。有效反应率为80％，服用一次即可缓解相关症状，效果如下：
表3药物胶囊治疗前列腺肥大患者的效果
Figure PCTCN2019073552-appb-000006
4.2改善男性性功能
200名40-60岁男性，服用实施例一中制备的药物胶囊3个月，每5天一次。每次服用20h之后，男性性欲明显提高；5天以内男性晨勃增加；性生活质量大大提高。有效反应率为95％以上，详情如下：
表4药物胶囊改善男性性功能的效果
症状 服用前 服用后(20h后)
阴茎勃起障碍综合症 勃起困难 勃起容易
早泄 早泄 性生活时间可达15分钟以上
4.3治疗男性不育
10名40-50岁男性，在20多岁时有过生育史，在32岁之后无生育，无生育状态持续达10年以上。40岁左右开始进行生育计划，准备2年以上不孕者，服用实施例一中制备的药物胶囊1-2月，成功受孕。反应率为100％。
本申请的药物组合物能够显著降低前列腺增生模型大鼠中的前列腺湿重、前列腺指数及前列腺腺体的体密度，以及显著降低模型大鼠前列腺匀浆中T、EGF水平；且经非正式临床研究发现本申请中的药物组合物治疗前列腺增生有很好的效果。
本申请的药物组合物能够增强免疫功能、快速缓解疲劳、增强男性活力、增进生殖能力功能和治疗男性性功能障碍，能够制备成相关保健品或药物。
上述实施例只为说明本申请的技术构思及特点，其目的在于让熟悉此项技术的人士能够了解本申请的内容并据以实施，并不能以此限制本申请的保护范围，凡根据本申请精神实质所作的等效变化或修饰，都应涵盖在本申请的保护范围之内。

Claims (10)

  1. 一种治疗男性疾病的药物组合物，其特征在于，所述药物组合物按质量份数计，包括如下组分：玛卡热水提取物10-30份、东革阿里热水提取物10-30份、菟丝子热水提取物15-40份、艳紫铆热水提取物15-40份、西洋参粉末5-20份。
  2. 根据权利要求1所述的治疗男性疾病的药物组合物，其特征在于，所述药物组合物按质量份数计，包括如下组分：玛卡热水提取物18.75份、东革阿里热水提取物18.75份、菟丝子热水提取物25份、艳紫铆热水提取物25份、西洋参粉末12.5份。
  3. 根据权利要求1所述的治疗男性疾病的药物组合物，其特征在于，所述药物组合物的剂型为泡腾片、口含片、颗粒剂、胶囊或口服液。
  4. 一种治疗男性疾病的药物组合物的制备方法，其特征在于，所述药物组合物按质量份数计，包括如下组分：玛卡热水提取物10-30份、东革阿里热水提取物10-30份、菟丝子热水提取物15-40份、艳紫铆热水提取物15-40份、西洋参粉末5-20份；
    所述药物组合物的制备方法包括如下制备过程：
    所述玛卡热水提取物的制备过程为：将干燥的玛卡粉碎，并加水煮沸萃取，过滤药渣，将过滤得到的液体喷雾干燥后得玛卡热水提取物粉末；
    所述艳紫铆热水提取物的制备过程为：将干燥的艳紫铆粉碎，并加水煮沸萃取，过滤药渣，将过滤得到的液体喷雾干燥后得艳紫铆热水提取物粉末；
    所述东革阿里热水提取物的制备过程为：将干燥的东革阿里粉碎，加水煮沸萃取，过滤药渣，将过滤得到的液体喷雾干燥后得东革阿里热水提取物粉末；
    所述菟丝子热水提取物的制备过程为：将干燥的菟丝子粉碎，并加水煮沸萃取，过滤药渣，将过滤得到的液体喷雾干燥后得菟丝子热水提取物粉末；
    所述西洋参粉末的制备过程为：取干燥的西洋参粉碎，过筛，得西洋参粉末。
  5. 根据权利要求4所述的治疗男性疾病的药物组合物的制备方法，其特征在于，所述玛卡热水提取物的制备过程具体为：将干燥的玛卡粉碎，并加水煮沸萃取2h，玛卡与水的质量比为1:10，过滤药渣，将过滤得到的液体喷雾干燥后得玛卡热水提取物粉末。
  6. 根据权利要求4所述的治疗男性疾病的药物组合物的制备方法，其特征在于，所述艳紫铆热水提取物的制备过程具体为：将干燥的艳紫铆粉碎，并加 水煮沸萃取1h，艳紫铆与水的质量比为1:10，过滤药渣，将过滤得到的液体喷雾干燥后得艳紫铆热水提取物粉末。
  7. 根据权利要求4所述的治疗男性疾病的药物组合物的制备方法，其特征在于，所述东革阿里热水提取物的制备过程具体为：取干燥的东革阿里树根粉碎，加水煮沸萃取2h，东革阿里与水的质量比为1:10，过滤药渣，将过滤得到的液体喷雾干燥后得东革阿里热水提取物粉末。
  8. 根据权利要求4所述的治疗男性疾病的药物组合物的制备方法，其特征在于，所述菟丝子热水提取物的制备过程具体为：取干燥的菟丝子粉碎，并加水煮沸萃取3h，菟丝子与水的质量比为1:10，过滤药渣，将过滤得到的液体喷雾干燥后得菟丝子热水提取物粉末。
  9. 根据权利要求4所述的治疗男性疾病的药物组合物的制备方法，其特征在于，所述西洋参粉末的制备过程具体为：取干燥的西洋参粉碎，过80目筛，得西洋参粉末。
  10. 权利要求1-3任意一项所述的药物组合物在制备治疗男性疾病的保健品或药物中的用途。
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CN108904777A (zh) * 2018-08-14 2018-11-30 中商国能孵化器集团有限公司 一种治疗前列腺及妇科病的药物组合物及其制备方法
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