JP5578646B2 - Orally administered composition for pharyngitis and influenza prevention / treatment - Google Patents

Description

  The present invention belongs to the technical field of orally administered compositions such as throats for pharyngitis and influenza prevention / treatment.

Conventionally, as a sore throat for pharyngitis, a sore throat for pharyngitis or a cough throat containing an extract of Minami Tenjin has been provided as, for example, Patent Document 1 and the like.
Melia azedarach is a species of the family Muclididae and the family Sendanidae. It is a deciduous tree that grows naturally in the tropical and subtropical regions of Asia, including western Japan. However, the fruit and bark of this sendan are designated as medicines in Japan. In fact, it is used as an external medicine for cracks, red peppers, and mosquitoes as a herbal remedy, and the bark is used as a traditional Chinese herbal medicine. As an anthelmintic, decoction is used as an internal medicine.
By the way, the agony is known as a herbal medicine having an astringent action. This astringent substance has effects such as hemostasis, analgesia, sterilization, and antiseptic, and is used as a cosmetic or pharmaceutical product. In addition, it is used for mucous membrane and skin inflammation for the purpose of suppressing inflammation, and in particular, as an anti-intestinal agent in order to relieve irritation of a stomatitis anti-inflammatory agent and inflamed intestinal mucosa.
However, the fruit and bark of Sendang are medicinal parts, but the leaves are not used and are not used for food. This Sendan leaf extract is also disclosed in Patent Document 2 and the like as having influenza preventive and therapeutic effects.
Further, the present inventors have disclosed in Patent Document 3 and the like that ganoderma charcoal is useful for improving capillaries such as mucous membranes.

JP 2004-269513 A JP 2007-254319 A JP 2001-131019 A

  An object of the present invention is to provide an orally administered composition that uses an unused resource of sendan leaf as a raw material for throat and further enhances the analgesic action of pharyngitis and is also effective in preventing and treating influenza. It is in.

In order to solve the above-mentioned problems, the invention of claim 1 is an orally administered composition for pharyngitis and influenza prevention / treatment, wherein the extract of Sendan leaves and ganoderma is extracted with hot water, Contains as an active ingredient Sendai leaf extract powder and Ganoderma extract powder that are dried and powdered extract, and Ganoderma blackyaki powder that is steamed and grilled from Ganoderma, and contains syrup, brown sugar, and granulated sugar as a base material. The Sendan leaf extract powder is 0.15 wt% or more and 2.50 wt% or less, Ganoderma extract powder is 1.40 wt% or more and 1.57 wt% or less, and Ganoderma black baked powder is 0.25 wt%. % Or more and 0.4% by weight or less.
The invention of claim 2 is characterized in that, in the composition for oral administration for pharyngitis and influenza prevention / treatment according to claim 1, the fragrance is selected from cinnamon, rahan fruit, theanine, licorice and bellflower.

According to the composition for oral administration for pharyngitis and influenza prevention / treatment of the present invention, Sendan leaf extract contains active ingredients such as polyphenol, tannin, triterpene, nimbolin A, B, gedunin, It acts as an anti-inflammatory, analgesic, astringent, bactericidal, immune-improving, and is effective for pharyngitis and influenza prevention / treatment.
Furthermore, it is useful for environmental conservation by using the leaves of Sendang that are not normally used.

Examples of the composition for oral administration of the present invention are throat lozenges, which contain Sendan leaf extract, Ganoderma biloba extract, Ganoderma black powder, as necessary active ingredients, and if necessary, black rice pigment, cassis pigment, blueberry extract, Rakan fruit extract, sesamin, starch syrup, brown sugar, granulated sugar, honey, vitamin C, peppermint, etc. are blended to provide an effect for pharyngitis and influenza prevention / treatment.
Among the above-mentioned compositions, Sendan leaf extract has anti-inflammatory, analgesic, astringent, bactericidal, immune improvement, and particularly has influenza preventive / therapeutic action as disclosed in Patent Document 2. Ganoderma extract and Ganoderma black baked powder have effects such as improvement of microcirculatory blood flow in the skin and mucous membranes, anti-inflammatory, sedation, and supply of trace elements, and particularly Ganoderma black baked powder has a mucosal protective action.

In addition, black rice pigment, cassis pigment, blueberry extract, etc. are added as necessary, but these pigments have mucosal protection by antioxidants of multiple types of anthocyanins and act as natural colorants. It acts as a sweetener (ultra-low calorie), such as cough, anti-inflammation, antipyretic, etc., and starch syrup, brown sugar, granulated sugar, honey, vitamin C, peppermint, etc. are basic materials often used in throat candy.
Further, as perfumes and herbs, cinnamon, rahan fruit, theanine, licorice, bellflower, cinnamon oil and the like may be appropriately selected and used.

Composition of [Example 1] Total amount 200 kg, of which
(1) As a substrate,
Minamata: 38.22 wt%, Brown sugar: 25.47 wt%, Granulated sugar: 31.85 wt%
Honey: 2.23% by weight, Vitamin C: 0.03% by weight,
(2) Cinnamon as a fragrance: 0.29% by weight
(3) As the main component
Sendan leaf extract powder 0.19% by weight
Ganoderma essence powder ... 1.43% by weight
Reishi black baked powder ... 0.29% by weight

Sendan leaf extract powder is about 100 g (10%) of powder per kg of Sendan leaf obtained by pressurized hot water extraction method. Sendan leaf is extracted with pressurized hot water and the extract is extracted. The powder is obtained by drying. Similarly, Ganoderma essence extract powder is about 50 g (about 5%) of powder per kg of Ganoderma by the pressurized hot water extraction method. The extract powder is obtained by drying. In addition, Ganoderma black baked powder is obtained by steaming ganoderma.
By the way, if the extract powder of Sendan leaves is not more than 0.15% by weight, the effect is not obtained, and if it is more than 2.50% by weight, other main components must be reduced, preferably 2.0% by weight. %. In addition, the effect of Ganoderma extract powder is not obtained unless it is 1.40% by weight or more, and when it is 1.57% by weight or more, other main components must be reduced, preferably 1.5% by weight. It is a neighborhood. In addition, the effect of the ganoderma black baked powder is not obtained unless it is 0.25% by weight or more, and when it is 0.4% by weight or more, the other main components must be reduced, preferably 0.3% by weight. It is a neighborhood.
The production method of the throat koji was as follows: (1) The base material was mixed, (2) the fragrance and herbs were blended, and (3) the main component was kneaded to produce 4 g / grain.

Composition of [Comparative Example 1] One commercially available throat koji from Company A Minami Tenshi dried extract 500mg / 9 tablets Additives: Brown sugar, white sugar, starch syrup, l-menthol, gum arabic, white beeswax, talc, carnaubaau, red No. 3, blue No. 1, yellow No. 5, fragrance.

[Comparative experiment for sore throat]
A comparative experiment was conducted on the effect on sore throat using the throat candy of Example 1 and the commercially available throat candy of Comparative Example 1.
Oral diseases such as acute / chronic sore throat, acute / chronic tonsillitis, stomatitis, and periodontal disease are multiple illnesses that occur in ages ranging from children to the elderly. The purpose of this experiment is to observe the subjective symptoms before and after the administration of Sendan leaf throat and the response to drugs of pathogenic bacteria, and to confirm the effect of healing of throat throat on Sendan leaf throat compared with Nanten throat.

(1) Material and method (1) -1. Selection of patients: 132 patients were selected according to the diagnostic criteria of “New Otolaryngology” (switched by Ichiro Imura, edited by Shinya Nomura, Nanzan-do, 2004).
Randomly divided into the Sendan leaf throat cocoon group of Example 1 (hereinafter referred to as “Sendan group”) and the commercially available Minami Tenmi throat cocoon control group (hereinafter referred to as “Control group”) of Comparative Example 1. Sendan group 102, 37 men, 65 women, 20-60 years old (90, 88.2%). Control group 30 men 14 men 16 women age 20-60 (25 people, 83.3%)

(1) -2. Disease type:
The Sendang group of Example 1 was: 41 acute pharyngitis, 57 chronic pharyngitis, 2 chronic tonsillitis, 2 acute tonsillitis.
The control group of Comparative Example 1 was: 15 acute pharyngitis, 14 chronic pharyngitis, 1 acute tonsillitis.

(1) -3. Administration and observation method Administration and observation methods are as follows.
(a) Administration: Example 1 (Sendan leaf throat): Example product of the present invention, 4 g / grain.
Comparative example 1 (Minami Tenmi throat lozenge): Commercial product of company A Example 1 (Sendan group): 1 tablet / 3 hours, 4 tablets / day, taken for 3 days continuously.
Comparative Example 1 (control group): 3 tablets / dose, 3 times / day, taken for 3 consecutive days.

(b) Observation method:
The patient's subjective symptoms were surveyed. The ranking is as follows.
[A: Remarkable]: Subjective symptoms (sore throat, dryness, foreign body sensation, cough, etc.) are almost alleviated, local hyperemia and swelling disappear, mucosal ulcer heals, and white blood cell count of blood test becomes normal.
[B: Effective]: Subjective symptoms are improved, local hyperemia and swelling are reduced, mucosal ulcers are reduced, and white blood cell counts in blood tests are likely to be normal.
[C: Invalid]: Subjective symptoms and signs are the same as 3 days ago.

(2) Experimental Results Experimental results obtained by the above observation method are shown in Table 1 of Example 1 and Table 2 of Comparative Example 2.

As shown in [Table 1] (Example 1) and [Table 2] (Comparative Example 1) above, the subjective symptoms and signs of the Sendan leaf group (102 people) in Example 1 were the control group (30 people). It is clear that the situation has improved.
That is, the effective rate of use of Comparative Example 1 is 40%, while the effective rate of acute pharyngitis when using Example 1 is 40%, and the effective rate of chronic pharyngitis when using Example 1 is 92.7% On the other hand, the effective rate of using Comparative Example 1 is 28.6%, and even in the total of these, the effective rate of using Comparative Example 1 is 36.6%, compared with the effective rate of 94.1% when using Example 1; As a result of comparing the pairs, there was a significant difference (P <0.01). The therapeutic effect of Sendang leaf throat candy in Example 1 is overwhelmingly dominant. During the administration, no side effects were observed in the two sets of Example 1 and Comparative Example 1.

(3) Conclusion In Example 1 (Sendan leaf throat lozenge) used in the experiment, extracts such as Sendan leaf extract powder , Ganoderma extract powder , Ganoderma black powder (Ganoderma charcoal) are mixed, respectively. It has anti-inflammatory, analgesic, astringent, bactericidal, immune improvement, cough, and antipyretic effects.When administered to patients with acute and chronic pharyngitis for 3 consecutive days, a remarkable therapeutic effect appears, and the total effective rate is 94.1. %.
From the experimental results, it was confirmed that the effects of improvement of subjective symptoms, anti-inflammatory analgesia, cough, etc. were found by using Example 1 (Sendan leaf throat) generally in 3-5 days. The throat lozenge of Example 1 is an oral tablet for sudden and chronic pharyngitis because of its fast anti-inflammatory analgesic effect, no side effects, and ease of use. In addition, the results show that it is effective suddenly, chronic tonsillitis, stomatitis, etc.

[Influenza virus inactivation test]
In order to examine the effect of this example on the prevention and treatment of influenza, the influenza virus inactivation test of Example 1 was requested to the Japan Food Analysis Center and conducted as follows (Japan Food Analysis Center No. 209040684). -001).

(1) Specimen: A sample obtained by dissolving the throat cake of Example 1 in purified water.
(2) Test outline:
A virus suspension of influenza virus was added to and mixed with the sample (liquid in Example 1) to obtain a working solution. The solution was allowed to act at room temperature, and the virus infection titer of the working solution was measured after 30 and 60 minutes.
(3) Test method:
3-1. Test virus: Influenza virus type A (H1N1)
3-2. Cells used: MDCK (NBL-2) cells ATCC-34 strain (Dainippon Pharmaceutical Co., Ltd.)
3-3. Medium used
(a) Cell growth medium: Eagle's MEM medium “Nissui” (Nippon Pharmaceutical Co., Ltd.) supplemented with 10% fetal calf serum was used.
(b) Cell maintenance medium: The following medium was used.
Eagle MEM medium "Nissui" ... 1,000 ml
10% NaHCO ₃ ... 14 ml
L-glutamine (30 g / l) ・ ・ ・ 9.8 ml
100 × MEM vitamin solution ・ ・ ・ 30 ml
10% albumin ・ ・ ・ 20 ml
0.25% trypsin ・ ・ ・ 20 ml

3-4. Preparation of virus suspension
(a) Cell culture: Using a cell growth medium, the used cells were cultured in a monolayer in a tissue culture flask.
(b) Inoculation of virus: After monolayer culture, the cell growth medium was removed from the flask, the test virus was inoculated, and then a cell maintenance medium was added, followed by a carbon dioxide incubator (CO ₂ concentration: 5 at 37 ° C. ± 1 ° C.). %) For 1-5 days.
(c) Preparation of virus suspension: After culturing, the morphology was observed using an inverted phase-contrast microscope, and it was confirmed that morphological change (cell metamorphic effect) occurred in the cells. Next, the culture solution was centrifuged (3,000 r / min, 10 minutes), and the resulting supernatant was used as a virus suspension.
3-5. Test procedure: 0.1 ml of a virus suspension was added to and mixed with 1 ml of a sample to obtain a working solution, which was allowed to act at room temperature and diluted 1,000-fold with a cell maintenance medium after 30 and 60 minutes. In addition, purified water was tested in the same manner as a control, and measurement was also performed at the start.
3-6. Measurement of virus infectivity titer: Using cell growth medium, the used cells were cultured in a monolayer in a tissue culture microplate (96 wells), then the cell growth medium was removed and 0.1 ml of cell maintenance medium was added. Next, 0.1 ml of the diluted solution of the working solution was inoculated every 4 wells and cultured in a carbon dioxide incubate (CO ₂ concentration: 5%) at 37 ° C. ± 1 ° C. for 4 to 7 days. After culturing, observe the presence or absence of morphological change (cell metamorphic effect) in the cells using an inverted phase contrast microscope, calculate the 50% cell culture infectious dose (TCID ₅₀ ) by the Reed-Muench method, and virus per ml of working fluid. Converted to infectious titer.

(4) Test results:
The test results obtained by the above test method are shown in [Table 3]. In addition, it was confirmed by a preliminary test that the virus infection titer can be measured without being affected by the specimen by diluting the working solution 1,000 times with the cell maintenance medium.

(5) Conclusion
As is clear from [Table 3], the logarithmic value of TCID ₅₀ of the infection amount between the sample of Example 1 and the purified water control at the start was 7.3.
In other words, logTCID _{50 /} ml 7.3 is the virus count at the start of the test,
10 ^7.3 = 19952623.1.
However, after 30 minutes in Example 1, the logarithmic value of TCID ₅₀ is 5.5, and the virus count is 10 ^5.5 = 316227.766,
Inactivation rate is 10 ^5.5 ÷ 10 ^7.3 = 0.0158
It is 100−0.0158≈98.42%, which is drastically reduced.
Also, after 60 minutes, the logarithmic value of TCID ₅₀ is 4.3,
The number of viruses is 10 ^4.3 = 19952.6231,
Deactivation rate is 10 ^4.3 ÷ 10 ^7.3 = 0.001
100−0.001≈99.9%, which is a drastic decrease.
Therefore, it can be seen that the inactivation rate of the throat flu virus (H1N1) of Example 1 is very high. On the other hand, the logarithmic value of 7.3 of TCID ₅₀ of the control purified water is not changed, and the virus count at the start of the test is 10 ^7.3 = 19952623.1.
From the above test results, it is determined that the throat cake of Example 1 of the present invention is effective for influenza prevention / treatment.

  Of course, as long as the characteristics of the present invention are not impaired, the present invention is not limited to the throat cake of the above-described embodiments. You may make it insert in a mask.

  Since the influenza virus is drastically reduced in the throat bowl of the embodiment of the present invention, it can be used as a spray sprayed on soap or clothes.

Claims (2)

Sendai leaf extract and ganoderma extract extracted with hot water under pressure, dried extract powder, and ganoderma extract powder, and ganoderma black baked powder obtained by steaming ganoderma As a base material, it contains syrup, brown sugar and granulated sugar, the Sendan leaf extract powder is 0.15 wt% or more and 2.50 wt% or less, and Ganoderma extract powder is 1.40 wt% or more. 1. An orally administered composition for pharyngitis and influenza prevention / treatment, characterized by not more than 1.57% by weight and the amount of Reishi Kuroyaki powder not less than 0.25% by weight and not more than 0.4% by weight.   The composition for oral administration for pharyngitis and prevention / treatment of influenza according to claim 1, wherein the fragrance is selected from cinnamon, rahan fruit, theanine, licorice and bellflower.