This invention relates to compositions useful in combating

Transcription

1 This invenion relaes o composiions useful in combaing sympoms of faigue, paricularly sympoms occurring in cases suffering from exhausion caused by physical srain, delayed convalescence afer infecious diseases and surgical inervenions, malnuriion and anemic condiions, including pregnancy anemia. I have found ha in he reamen of he above sympoms, composiions in which he viamin B-complex is combined wih cerain specific amino acids described hereinafer, have a effec "r.[air" which canno be obained by he use of he here described amino acids alone or he B-complex alone, or by he use of oher mixures or combi.naions of said amino acids of B-complex, res5recive- 1y. In addiion o he objecive clinical improvemens, almos immediae effecs are noed in he relief from nervous ension, increase of abiliy of coordinaed acion and hinking, increased appeie, and relief from insomnia. lfhe problem of achieving an evaluaion was solved by checking he subjecive improvemens simulaneously wrlh a series of blood couns. The resuls of hese blood couns invariably subsaniaed he subjecive claims by showing an increase of hemoglobin and red blood ce1ls, ofen afer he firs injecion. The improvemens obained have proved o be permanen. In order o es he response of a nerve accessible o objecive clinical observaion, paiens wih hearing disorders, as well as persons of normal hearing, were reaed wih he above menioned' composiions and subjeced o clinical obsqrvaion by means of he audiomeer. InaaLl cases an increase in hearing acuiy was observed upon such reamen. In normal persons, his effec appeared as hyperacousis. :fhe improved hearing was evidenced for he mos par in he higher ocaves. fre specific amino acids used in he before menioned composiions are: beane, gluamic acid, glycine, hisidine, mehionine,

2 yrosine and cyseine. One single acid or a mixure of several amino acids may be used. Cyseine mus be preferably used eiher in combinaion wih beaine or wih choline, and i is preferable o use x^ro or more amino acids in mixure wih he viamin B-comp1ex. As menioned above, he viamin B-complex is used in combinaion wih one or more specific amino acids of he group here described in order o obain he above described effecs. In addiion o he viamin e-compex and he amino acids, cerain oher ingrediens of he beneficial effec may be used in my composiions, as described hereinafer. I has been found ha he composiions of he here described ype have he disadvanage ha hey are no sufficienly sable and undergo cerain undesired chemical changes upon sorage in solid or dissolved condiion. have norrv found ha his disadvanage.i can be overcome by adding o he eomposiions a small amoun, O.O5%, of p-hydroxybenzoic mehyl eser or p-hydroxybenzoic ejryl eser. Derivaives of hese compounds in which Jle hydroxy group is convered ino he -ONa group may also be used. Amouns of abou 0.01 o O.O2% by weigh based on he oal weigh of he ingrediens in undissolved condiion proved o be sufficien o obain a saisfacory sabilizing effec and hese arnouns of 0.01 o 0.02% are preferabj.y used. The sabilizing effec is essenial as i permis he preparaion of sable composiions having uniforp properies and being free_ from undesired changes during he necessary sorage period. The composiions according o his invenion may be used hy oral or by pareneral adminisraion. Example I Capsules o be used.by oral adminisraion consis of Viamin Viamin A D (Fish l;iver Oil) 4,ooo usp unis (Irladiaed Ergoserol) 400 USP unis \ -2-

3 viamin B, (Thiamine ncl, 666 usp unis) Viamin 82 (Riboflavin) Viamin 86 (nyridoxine HCL) viamin C (ascorbic acid, 750 USp unis) 2 ng 2 mg 0.1 mg 37.5 m9 Niacin amid,e Calcium panohenae Cyseine hydr:ochloride Urea Tyrosine Choline cluamic acid Liver Conc. 1:20 Yeas-dried USp LO.Q mg 1 mg I mg ZS mg G0 mg 30 mg 6O ng 25 mg 50 mg p-hydroxybenzoic mehyl eser O.Ol5% of he oal weigh of undi ssolved ingrediens. Example 2 A 2 cc soluion for inrarnuscular injecion i.s prepared by dissolving in disilled waer viamin B, Viamin B., I z viamin B- b NiacinAmide urea r{isidine rrcl Sodium gluamae Choline cirae Mehionine 20 mg 5 mg 10 mg 50 mg 2oo mg 40 mg 100 mg 20 mg 40 mg p-hydroxybenzoic mehyl eser O.ois% of he oal weigh of undi ssolve& inqrediens. Benzyl aleohol ChlorobuanoL Propylene glycol 2 % of he olal weigh O.4 % of he oal weigh 25 % of he oal weigh -J-

4 Example 3 A 2 cc soluion for inramuscular injecion is prepared by ilissolving in serile disilled waer 80 mg hisidine hydrochloride 5 mg viamin B, 5 mg viamin B, '0.5im9 viamin Ba mg nicoine amide and 2.0 mg calcium panohenae p-hydroxybenzoie ehyl eser A.O2% of he oal weigh of undi ssolved ingredigrns. Examplp 4 A composiion is prepared by mixing 100 mg eyseine hydrochloride 300 mg gluamic acid hydrochloride 5 mg viamin a, 5 mg viamin B, 40 mg viamin C 30 mg choline L70 mg viamin B filrae facor of lirzer 170 mg rice polish 170 mg yeas p-hydroxybenzoic ehyl- eser o.ot/" of he oal weigh of fhe mixure is adminisered in he form of capsules, for example hree imes a day. ExampLe 5 A composiion is prepared by mixing 100 m9 eyseine 300 mg mehionine 5 mg viamin a, 5 mg viamin B, 40 mg viamin C -4-

5 30 mg choline 1-70 m9 vi,amin e filrae facor of liver 170 mg yeas 170 mg rice polish p-hydroxybenzoic mehyleser O. OL3% of he oal weigh of undissolved ingrediens, Examr:le 6 A 2 ee soluion for inramuscular injecion is prepared by dissolving in serile, disilled waer 80,ngl mehionine 20 mg viamin a, 5 mg viamin e, 10 mg viamin au 30 mg nicoinamide 2 ng calcium panohenae p-hydroxybenzoic mehyleser 0. OI% of he oal weigh of und,issolved ingrediens. Example 7 prepared, by dissolving in waer A 2cc soluion for inramuscular injecion is ' 80 nrg hisidine hydrochloride 5-10 mq viamin B- -T 5 mg viamin B, mg viamin eu 2O-30.0 mg niacin amide 2.0 mg calcium pan-ohenae mg urea O mg propyleneglycol 6.0 ms mg chlorobuanol 0.71 m9 nipagin p-hydroxybenzoic ehyleser O.O2% of he oal weigh of undissolved ingrediens. -5-

6 r will be undersood ha he invenion is no limied o he proporions, ingrediens or oher deails described above and permis of various modificaions wihou deparing from he spiri hereof wihin he seope of he appended claims. I is o be undersood ha he erm "amino acid" is used in he presen specifieaion and claims o include he free amino acids as well as sals of he ""iu". Reference is made o my co-pend.ing appli.caion der.o. 581,945 filed March 9, L945, of which his is a eoninuaion-in-par. he p-hydroxybenzoic mehyleser menioned above has he ' formula HO-C5II4-COO.C% _ and he p-hydroxybenzoie ehyleser has he formula HO-CaE.-COO. CZH'. \

7 Wha f claim is: 1) A herapeuically combinaion compound,s of he acive composiion which comprises in viamin B-complex and a leas one sex hormone. 2) A herapeuically acive composiion which comprises in combinaion compounds of he viamin B-complex, a leas one sex hormone, and a leas one amino acid seleced from Lhe group consising of beaine, gluamic 'acid, glycine, hisidine, mehionine, yrosine and cyseine. 3) A herapeuically acive composiion which comprises in combinaion compounds of he viamin B-complex, a leas one sex hormone, choline, and a leas one amino acid, seleced, from he group. consising of beaine, gluamic acid,, glycine, hisidine, mehionine, yrosine and cyseine. 4) A composiion as claimed in claim 2, in which he amino acids presen are cyseine, yrosine and gluamic acid,. 5) A composiion as claimed in claim 2, ir/,unicn he amino acids presen are hisidine, gluamic acid and mehionine. 5) A composiion as claimed in claim 2, in which he amino acid presen is hisidine 7) A herapeuically acive composiion which comprises in combinaion compound.s of he viamin B-complex, a leas one sex hormone, a leas one amino acid seleced from rhe g.roup consising of beaine, gluamic acid, glycine,_ hisidine, mehionine, yrosine and cyseine and a sma1l amoun of a sabii-zer seleced, from he group of p-hydroxybenzoic mehyl eser and p-hydroxy- 8) A herapeuieally acive composiion which comprises in combinaion compound,s of he viamin B-comp1ex, a leas one sex hormone, choline, a leas one amino, acid seleced from he group consising of beaine, gluamic acid., glycine, hisidine, mehionine, yrosine and cyseine and a small amoun of a sabilizer seleced from he grolp of p-hydroxybenzoic mehyl eser and p-hydroxybenzoic ehyl eser.