Tribulus terrestris Preparations Comparative Investigation

D. Obreshkova Ph.D., T. Pangarova, S. Milkov and D. Dinchev Publication in Pharmacia, vol. XLV, bk. 2/1998, 11. Sopharma Ltd.

Summary: A comparative investigation in respect to qualitative and quantitative composition of raw materials from Tribulus terrestris L. and a variety of preparations from different origin have been performed. The results obtained concerning furostanol saponins indicate that most of the raw materials are either impurified products derived from Tribulus terrestris or from the powdered plant itself. The content of protodioscin and protogracillin in the preparations except for Bulgarian Tribestan film tablets (Sopharma) are in insignificant amount.

Tribulus terrestris L. Zigophyllaceae has long been quite popular in the folk medicine of the Oriental countries and Bulgaria as a medicinal plant in the treatment of sexual deficiency. Based on that information an original non-hormonal natural product Tribestan has been developed in Chemical Pharmaceutical Research Institute [13, 16, 17, 20] and is in production by Sopharma Joint Stock Co., Bulgaria.

The active components of Tribestan are steroid saponins of furostanol type [3, 12, 14, 15]. The two dominating furostanol bisglycosides have been identified as protodioscin and protogracillin [18] and have been tested biologically as pure substances [24].

As far as Tribestan is non-hormonal phytochemical preparation, the drug has an effect on the hormonal balance in the body [1, 8, 9, 12]. Simultaneously with emphasis upon sexual system, Tribestan has shown a general stimulating action such as motor activity, muscle tone, restorative tonic for vigor, vitality and stamina. For that reason Tribestan is suitable and successfully applied in bodybuilding and in force sports.

Toxicological studies [11], teratogenic [5] and carcinogenic [2] investigations, clinical check ups [7, 10, 23] show that Tribestan has a very good tolerance and no undesired side effects.

It may be remarked that a number of containing Tribulus terrestris are on sale in the U.S.A., with a claim of a high stimulating action. Tribulus terrestris L. is still a plant of high interest nowadays [21].

The purpose of our study is to determine furostanol saponins [4, 5, 6] in a number of raw materials of different origin as a lot of American preparations in comparison with Bulgarian Tribestan substance and filmtablets produced by Sopharma.

Materials and Methods

The analytical method used for quantitative determination of furostanol saponins [4] has been accepted by registration of Tribestan in the United States.

Results and Discussion

The results obtained are shown in Table 1 for raw materials from Tribulus terrestris and in Table 2 for Tribulus terrestris preparations.

It is obvious that most of the raw materials and preparations contain different amount of furostanol saponins, much less than those in the Bulgarian preparation. They vary in dependence on their origin.

Table 1

Source Tribulus terrestris raw materials Principle furostanol saponin Conternt of Furostanol saponins calculated with reference to Protodioscin per cent
Sopharma Tribestan    
- Lot No. 01196 Protodioscin, Protogracillin 51.6
- Lot No. 21296 Protodioscin, Protogracillin 52.6
- Lot No 10197 Protodioscin, Protogracillin 53.0
- Lot No 20297 Protodioscin, Protogracillin 57.0
Dabur, India VI-1006 Unknown 0.1
Kaiser Pharmaceuticals Taiwan - Product # 856 Lot # 18204 Protogracillin 0.2
Pharmabul, USA - Lot # 9610819, 3-7-97, 40 mesh Protodioscin, Protogracillin 1.5
Technical Sourcing International Inc. (TSI) lot # SM971016 Saponin 90%, Furostanol 15% Protogracillin 20.0
Hackettstown 07840
- Batch # TTR-9705
-Batch # TTR-9801

Protogracillin
Protogracillin

3.5
4.5
China origin
-No 8745/5/20/98
-No 5424CB/5/20/98

Protogracillin
Unknown

3.2
less than 0.1


Table 2

Source Tribulus terrestris preparations Principle furostanol saponin Conternt of Furostanol saponins calculated with reference to Protodioscin per cent in grams per tablet/capsule
Sopharma Tribestan
- Lot No. 120798 Protodioscin, Protogracillin 0.1050
- Lot No. 70298 Protodioscin, Protogracillin 0.1144
- Lot No 70498 Protodioscin, Protogracillin 0.1189
LifeTime Sports Nutrition's MALE POWER II Protodioscin, Protogracillin 0.0080
Gero Vita International GemiX Protodioscin, Protogracillin 0.0051
Biotest Laboratories TRIBEX 500 Protogracillin 0.0216
SciFi's 19-NOR TRIBUSTENE Protogracillin 0.0083
Prolab's CHRYSIN ANDROSTEN Unknown 0.0003
Optimum Nutrition's ANDRO STACK 850 Protogracillin 0.0040
AST Research's ANDRO PLEX 700 Protodioscin, Protogracillin 0.0047
Muscletech's ANOTESTEN Protodioscin, Protogracillin 0.0159
Twinlab's TRIBULUS FUEL Protogracillin 0.0051
Twinlab's TESTOSTERONE FUEL BOOSTER Protogracillin 0.0030
Klein Laboratories/Sports One ANDRO-XS Protogracillin 0.0047
Universal Laboratories ANDRO STACK Unknown 0.0005
Natural Balance/Per Products ANDRO MAX Protodioscin, Protogracillin 0.0049
Bodyonic's TRIBESTROL PINNACLE Protodioscin, Protogracillin 0.0080
Engineered & Applied Science ANDRO 6 Protodioscin, Protogracillin 0.0091
Pharmabul's TRIBESTAN Protodioscin, Protogracillin 0.0053
Nuntritional Technologies, Inc. TRIBULUS TERRESTRIS Protogracillin 0.0029
ASN's PHYTOBUL Protogracillin 0.0051
Golden's TETRAGEN Protodioscin, Protogracilllin 0.0092

References

  1. Dikova, N et V. Ognyanova. Pharmacokinetic studies on Tribestan - Anniversary scientific session '35 Years Chemical Pharmaceutical Research Institute, Sofia, 1983.
  2. Gendjev, Z. Studies on Tribestan carcinogenicity. Scientific-Technical Report, 1983.
  3. Gyulemetova, R. - Diploma thesis, 1973
  4. Gyulemetova, R., et al. On Tribestan standardization - Pharmazie, 37, 1982, 4.
  5. Ilieva, Z. Embriotoxic and teratological studies on Tribestan, Scientific-Technical report, 1981.
  6. Kiosava Shu et M. Hatoh - Chem. Pharm. Bull., 16, 1968, No. 6, 1162.
  7. Koumanov, F. et al. Clinical trial of Tribestan - Exper. Med. 1982, No. 2.
  8. Milanov, S. et al. Tribestan effect on the concentration of some hormones in the serum of healthy subjects.
  9. Nicolov, R. Neuropharmacological study on Tribestan. Scientific-Technical Report, 1981.
  10. Protich, M. et al. Clinical trial on Tribestan on infertile males. Scientific-Technical report, 1981.
  11. Tanev, G. and S. Zarkova: Toxicological studies on Tribestan. Scientific-Technical report, 1981.
  12. Tomova, M. et D.Panova - Pharmacia (Sofia), 4, 211.
  13. Tomova, M., D. Panova, S. Zarkova et V., Dikov license (II) 11450, 30 1/02 A 61 K/1966.
  14. Tomova, M, et al. - Planta medica, 3, 1974, 213.
  15. Tomova, M. et al. - Planta medica, 3, 1974, 233.
  16. Tomova, M., R. Gyulemetova et S. Zarkova - aut. lic. (11) 27584 a 61 K 35/1978.
  17. Tomova, M., et R. Gyulemetova - aut. license (11) 2, 2(51) A 1K 35/1978.
  18. Tomova, M. et R. Gyulemetova - Planta Medica, 2, 188.
  19. Tomova, M. et al. Steroidal saponins from Tribulus terrestris L., Varna, 1981.
  20. Tomova, M. et al. - License 68478/18.01.1985
  21. Yan Wang et al. Steroidal saponins from fruits of Tribulus terrestris. - Phytochemistry, 45, 1996, No. 4, 1996.
  22. Vankov, S. On Tribestan pharmacology. Scientific-Technical Report, 1980.
  23. Viktorov, L et al. Clinical trial of Tribestan - 1 Med., 2, 1982.
  24. Zarkova, S. - Dissertation, 1978.

D. Obreshkova, Central Laboratory, Sopharma Ltd.

16 Iliensko Chaussee St., Sofia, Bulgaria 1220

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