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Pollixol™ Studies

ROPEX® is 100% natural and completely safe, made from organically grown Secalecereale, Phleumpratence and Zeamays pure botanical seed extract using our patented extraction method.

ROPEX® is manufactured under strict pharmaceutical ISO 9002 standards to assure quality and potency. ROPEX's® principal ingredient Pollixol™ has been extensively researched for its health benefits including those of the reproductive system:



Study 1:   Effect of Pollixol™ pollen-extract on the Sex-hormone-induced Nonbacterial Prostatitis in Rats

Mitsue Hanamoto, Min Liao, Hajime Suzuki, Mitsuoki Ohba, Masato Honma, Akiko Nagashima, Syouhei Namikata, Shigeru Satoh, Makoto Ishii, Fumio Kimura and Etsuji Higaki Ome Research Laboratories, Tobishi Pharmaceutical Co., Ltd., 7-1, 1-chome, Suehiro-cho, Ome-shi, Tokyo 198-0025, Japan

Pollixol™ pollen-extract is a preparation made from eight kinds of pollen. The active components are water-soluble (PolliAq) and fat-soluble (PolliLip) fractions. Pollixol™ (ref. CN-009) has been used for the treatment of chronic prostatitis in Europe and Japan. To study the action of CN-009 on the prostatitis, we examined the effect of CN-009 on the sex-hormone-induced nonbacterial prostatitis in rats.

Aged Wistar rats (10 months old) were castrated and then injected 17ß-estradiol (0.25 mg/kg, s.c.) for 30 days. These treatments reduced the weight of prostate and induced the inflammation and epithelial cell dysfunction of the lateral prostate lobe in the rats. Testosterone (2.5 mg/kg, s.c.) injected for the last 14 days of the treatment of 17ß-estradiol to the rats restored markedly the estradiol-induced prostatitis. Those changes were similar to the findings reported by others. CN-009 was administered orally for the last 14 days of the treatment of 17ß-estradiol to the rats. The administration of 378 mg/kg of CN-009 did not change in the prostatic histopathological findings, while 1260 mg/kg of CN-009 increased the number of intracellular secretory granules of epithelial cells and diminished weakly the invasion of inflammatory cells into the lumen or the stroma in the prostatic gland.

These results suggest that CN-009 may recover the prostatic epithelial cell dysfunction and have the mild anti-inflammatory properties.
Study 2:   Efficacy of Pollixol™ administration for infertile males associated with asymptomatic pyospermia

Tetsuya Arai, Shin Horiuchi, Kenichiro Yoshida
Department of Urology, Dokkyo University School of Medicine

Introduction
The cases, that white blood cell is significantly higher in semen, accounts for 16 ~ 17% of male infertility patients. Interestingly, it was common that no bacterial finding is presented in these cases, using standardized bacterial test, PCR methods for Chlamydia trachomatis (C. trachomatis), and semi-quantitative analysis for Urea plasma urealyticum (U. urealyticum). Although these cases are classified in nonbacterial chronic prostatitis, it has been generally recognized to be associated with male infertility. In present study, we reported that administration of Pollixol™ reduce PMN-elastase activity and to improve seminal findings in semen for 17 male infertility patients with no bacterial finding in semen.

Material and Methods
17 male infertility patients associated with nonbacterial asymptomatic pyospermia were treated with Pollixol™ 6 tablets daily over 12 weeks, then sperm density, progressively motile sperm ratio, sperm motility and PMN-elastase activity in semen were measured.

Results
In all patients, progressively motile sperm ratio, sperm motility and PMN-elastase activity in seminal fluid were improved.

Conclusion
Administration of Pollixol™ is seemed to be effective in the treatment of infertile males associated with nonbacterial asymptomatic pyospermia.
Study 3:   Effect of Pollixol™ Pollen-Extract on Experimental Nonbacterial Prostatitis in Rats

Toshiyuki Kamijo,1* Shiegeru Sato2, and Tadaichi Kitamura1
Department of Urology, Faculty of Medicine, University of Tokyo, Japan
Ohme Research Laboratories, Tobishi Pharmaceutical Co., Ltd., Tokyo, Japan

Background
The treatment for chronic nonbacterial prostatitis (NBP) has not been established. Pollixol™ pollen extract (ref. CN-009) is reported to have therapeutic effects for NBP. The effects and mechanisms of CN-009 were investigated. Pollixol consists of a water soluble fraction (PolliAQ) and fat-soluble fraction (PolliLIP).

Methods
Ten-month-old rats were used with administration of estradiol after castration, which were similar to human NBP histologically. Since CN-009 consists of PolliAq and PolliLip, these extracts were administered, respectively. The prostate was evaluated histopathologically including glandular damage (epithelial score), stromal ratio and immunohistochemical assays for epithelial function (PAP), stromal evaluation (Vimentin), cell proliferation (PCNA) and apoptosis (deoxyuridine triphosphate biotin nick end-labeling (TUNEL)

Results

Controls revealed severe acinar gland atrophy and stromal proliferation. CN-009 showed diminished these damages. Epithelial score was better (P<0.01) and PAP positive materials were more abundant in CN-009 and PolliLip than in Controls. The stromal ratio was lower in CN-009 (P<0.01) and PolliAq (P<0.05). There was no difference for PCNA positive cells in the epithelium and stroma, and TUNEL positive cells in the epithelium. While, the number of TUNEL positive cells in the stroma of CN-009 and PolliAQ increased (P<0.01)

Conclusion

These findings suggest that CN-009 protects acinar epithelial cells mainly by POLLILIP and also inhibits stromal proliferation in association with enhanced apoptosis mainly by PolliAq. Prostate 49: 122-131, 2001. © 2001 Wiley-Liss, Inc. KEY WORDS: Pollixol pollen-extract; apoptosis; chronic prostatitis; sex-hormone-induced prostatitis.

Introductions
Three chronic prostatitis syndromes have been recognized; chronic bacterial prostatitis (CBP), chronic nonbacterial prostatitis (NBP) and prostatodynia. NBP is the most frequent disorder of 64% in these three diseases [1]. The etiology of NBP is unknown. A number of organisms or other factors have been reported to be the possible causes for NBP. They are Trichomonas vaginalis, Chlamydia trachomatis, genital mycoplasmas, staphylococci, coryneforms, genital viruses [2], biofilms [3], stagnation of prostatic secretion, autoimmune disease, allergy, disorder of sex hormone and psychological effects [4, 5]. For the treatment of CBP or NBP, antibiotics of new-quinolone or tetracycline have been administered. However, many cases resist these treatments [6].

Cn-009 is a pollen extract, which contains 20:1 ratio of powdered aqueous and organic extract. It is essentially a microbial digest of a standardized mixture of eight plant species grown at the Scania area in southern Sweden. The active ingredients consist of water-soluble (PolliAQ) and fat-soluble (PolliLIP) fractions [7, 8]. It was reported that CN-009 showed urine discharge action [9.10], anti-prostatic hypertrophic action [7] and anti-inflammatory effects to the prostate [11] in a preliminary study. Since Ask-Upmark [12] Reported CN-009 showed an efficacy to prostatitis, it has been used for the treatment of chronic prostatitis with high therapeutic effects. However, the mechanisms for these effects remain unknown. To assess the mechanisms of the anti-prostatitis effect by CN-009, the present study was performed using a nonbacterial prostatitis rat model [13, 14] induced by 17b -estradiol administrations and castration.

Materials and Methods
Sex Hormone-Induced Nonbacterial Prostatitis Model Ten-month-old Wistar aged male rats were purchased from Japan Slc Co. (Tokyo, Japan). The rats were housed in a climatised environment with a 12-hr light/dark cycle, 40-70% humidity. Food and water were supplied ad libitum. The rats were castrated under ether anesthesia, and then 17b-estradiol (Sigma, MI) 0.25 mg/ 2ml/kg diluted by sesame oil, as an inducer for prostatitis, was subcutaneously injected into the back of rats for 30 days from 1 day after castration [13,14].

Experimental Structure and Schedule
CN-009was suspended for 630 or 1,260 mg/5ml with 1% HCO-60 (Japan Surfactant, Tokyo, Japan). PolliAQ and PolliLIP were similarly prepared for 1,200 and 60-mg/5 ml, respectively. Testosterone (TS) (Wako Chemicals, Tokyo, Japan), as a positive control, was diluted for 2.5-mg/2 ml with corn oil (Yuro Chemical, Tokyo, Japan). The experimental structure is shown in Table I and the experimental schedule is illustrated in Figure 1. The rats were divided into seven groups consisting of Sham-operation (Sham-ope), Control, CN-009 630, CN-009 1260, PolliAQ, PolliLIP and TS with five or six animals in each group.In the Sham-ope group, the rats were treated with only Sham-castration and without any drugs. In the Control group, the rats were injected subcutaneously environment with a 12-hr light/dark cycle, 40-70% humidity. Food and water were supplied ad libitum. The rats were castrated under ether anesthesia, and then 17b-estradiol (Sigma, MI) 0.25 mg/ 2ml/kg diluted by sesame oil, as an inducer for prostatitis, was subcutaneously injected into the back of rats for 30 days from 1 day after castration [13,14].

Experimental Structure and Schedule
CN-009 was suspended for 630 or 1,260 mg/5ml with 1% HCO-60 (Japan Surfactant, Tokyo, Japan). PolliAQ and PolliLIP were similarly prepared for 1,200 and 60-mg/5 ml.,


Table 1. The
structure of the
Experiment
     
Group No. of animals Inflammatory agent Drug treatment
Sham-ope.
Control
CN-009 630
CN-009 1260
PolliAQ
PolliLIP
TS
5
6
5
6
5
6
5
No-treatment
17 b-estradiol 0.25 mg/kg (s.c.)
17 b-estradiol 0.25 mg/kg (s.c.)
17 b-estradiol 0.25 mg/kg (s.c.)
17 b-estradiol 0.25 mg/kg (s.c.)
17 b-estradiol 0.25 mg/kg (s.c.)
17 b-estradiol 0.25 mg/kg (s.c.)
No-treatment
1% HCO-60 (p.o.)
CN-009 630 mg/kg (p.o.)
CN-009 1260 mg/kg (p.o.)
PolliAQ 1200 mg/kg (p.o.)
PolliLIP 60 mg/kg (p.o.)
Testosterone 2.5 mg/kg (s.c)
Each parenthesis represents the route of administration. s.c, subcutaneous injection; p.o., oral administration

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