JPH0552815B2 - - Google Patents

Description

[Detailed description of the invention]

The present invention relates to preventive and therapeutic agents for human rotavirus diarrhea. More specifically, the present invention relates to preventive and therapeutic agents for human diarrhea caused by human rotavirus that proliferates in the digestive tract. Although remarkable progress has been made in the treatment of bacterial infections with the advent of antibiotics, the current situation is that no effective antiviral agent has yet appeared in the case of viral diseases. For example, rotavirus is the most important pathogenic virus among diarrheal diseases (particularly infantile diarrhea), and despite the development of preventive and therapeutic methods worldwide, the development of a vaccine has not yet been implemented. It has not yet come to fruition. As a result of repeated studies on preventive and therapeutic methods for diarrhea caused by rotavirus, the present inventor found that milk or its milk components collected from dairy animals immunized with human rotavirus. It was discovered for the first time that the method was effective, and the present invention was completed. The prophylactic and therapeutic agent of the present invention is produced, for example, as follows. That is, 7 to 9 months of pregnancy in dairy animals.
Immunization is performed by subcutaneously or intramuscularly inoculating human rotavirus or human rotavirus vaccine 3 to 6 times every 14 days. The amount of inoculation is not particularly limited, but its upper limit is determined by the side effects caused by inoculation. Preferably, the prophylactic and therapeutic agent of the present invention can be obtained by collecting colostrum 1 to 3 days after birth. The milk of dairy animals of the present invention, which has the effect of preventing diarrhea caused by human rotavirus or alleviating or curing the disease state, can be administered by any method, including oral administration that allows for enteral absorption. Administration is preferred. That is, milk as it is or its milk components, such as powdered milk obtained by dehydrating milk or dehydrating and skimming milk, is orally administered. The dosage is determined according to the patient's age, health condition, weight, degree of disease, type of concurrent treatment, if any, frequency of treatment, nature of desired effect, etc. Generally the daily dose as milk is 0.1−20
ml/Kg body weight, usually about 1-10ml/Kg body weight, 1
Administered twice or more. When the active ingredient of the milk of the present invention is orally administered, it is used in the form of tablets, capsules, powders, liquids, elixirs, and the like. When used in such forms, solid or liquid non-toxic pharmaceutical carriers can be included in the composition. As an example of a solid carrier, conventional gelatin type capsules are used. The active ingredient may also be packaged as a tablet or powder, with or without adjuvants. Next, an example will be given and explained. Example 1 Holstein cows at 8 months of pregnancy are subcutaneously immunized with human rotavirus Wa strain ¹⁰⁹ mice/ml five times every 10 days. Collect colostrum on the 1st, 2nd, and 3rd day after birth. The obtained colostrum (10) is centrifuged at 7000 rpm for 30 minutes three times to remove bacteria and fat, and the supernatant skimmed milk is collected. The anti-human rotavirus neutralizing antibody titers of the colostrum obtained on the first and second days are as shown in Table 1.

[Table] Example 2 Colostrum on day 1 obtained in the same manner as Example 1 20
ml of skim milk was freeze-dried, dissolved in 20 ml of distilled water immediately before administration, and administered to 8 patients with infant diarrhea.
The drug was administered once a day for 3 days. As a result, in the control group that was not administered rotavirus colostrum, diarrhea continued for an average of 4 days, whereas in the rotavirus colostrum administration group, the diarrhea subsided within 3 days. Furthermore, when rotavirus in stool was confirmed using an electron microscope, rotavirus excretion continued for an average of 6 days in the control group, whereas rotavirus excretion stopped within 4 days in the rotavirus colostrum administration group. In some cases, excretion of rotavirus stopped within one day, confirming the effectiveness.Furthermore, no side effects were observed in the rotavirus colostrum administration group. Example 3 Human rotavirus MO strain ¹⁰⁶ /50μ was injected into 5-day-old BAL B/C suckling mice with an outer diameter of 1.5
The infection was carried out orally via a mm Teflon tube. When the mice were observed to develop diarrhea after infection, the peak was observed 48 hours after infection. The results are shown in Table 2.

【table】

[Table] Example 4 Human rotavirus Wa strain immunized bovine colostrum and human rotavirus obtained in the same manner as in Example 1
KUN strain immunized cow colostrum was added to 5-day-old BAL B/
C was administered to suckling mice in an amount of 50μ, and 1 hour later, they were orally infected with human rotavirus MO strain in the same manner as in Example 3. As a control, experiments were conducted in which bovine colostrum was administered without immunization with human rotavirus, and in which bovine colostrum was not administered at all. The results are shown in Table 3.

【table】

[Table] As is clear from the results in Table 3, diarrhea occurred when bovine colostrum without immunization was administered and when bovine colostrum was not administered; No onset of diarrhea was observed in those administered bovine colostrum. Therefore,
It was confirmed that the rotavirus-immunized colostrum of the present invention has a preventive effect against rotavirus diarrhea.

Claims (1)

[Claims] 1. A disease caused by human rotavirus that is characterized by containing milk or milk components collected from a dairy animal immunized with human rotavirus that proliferates in the human digestive tract. A prophylactic and therapeutic drug for human diarrhea. 2. The prophylactic and therapeutic agent according to claim 1, wherein the diarrheal disease is infantile diarrhea. 3. The prophylactic and therapeutic agent according to any one of claims 1 to 2, characterized in that a human rotavirus vaccine is used as the human rotavirus. 4. The prophylactic and therapeutic agent according to any one of claims 1 to 3, characterized in that pregnant dairy animals are immunized with human rotavirus or human rotavirus vaccine. 5. The prophylactic and therapeutic agent according to claim 4, wherein the milk is colostrum. 6. The prophylactic and therapeutic drug according to any one of claims 1 to 5, which is a dairy animal or a cow.