Rice bran sterol sugar-coated tablet

Abstract

The present invention discloses a rice bran sterol sugar-coated tablet comprising rice bran sterol, a filler and a coating agent, wherein a mass ratio of the rice bran sterol, the filler and the coating agent is 1:3.9-4.5:1.30-1.35. The filler is composed of starch, dextrin, talcum powder, calcium carbonate, microcrystalline cellulose, starch slurry, carboxymethyl starch sodium, magnesium stearate and silicon dioxide in a mass ratio of 1.29-1.5:0.5-0.71:1:1:0.24-0.25:1.86-2.25:0.16-0.18:0.028-0.03:0.14-0.17, and the coating agent is composed of white sugar, gum, gelatin, pigment and Chinese insect wax in a mass ratio of 201-249:5.56-8:1:0.06-0.07:1. The rice bran sterol sugar-coated tablet may be used for treating periodontitis and acute pharyngolaryngitis and has obvious treatment effects on peniculus system inflammations, and is harmless to the human body.

Claims

1. A rice bran sterol sugar-coated tablet, comprising: a host material comprising rice bran sterol having a chemical formula below ##STR00006## wherein R is one of ##STR00007## and an auxiliary material comprising: a filler comprising starch, dextrin, talcum powder, calcium carbonate, microcrystalline cellulose, starch slurry with a mass concentration of 5-10%, carboxymethyl starch sodium, magnesium stearate and silicon dioxide mixed in a mass ratio of 1.29-1.5:0.5-0.71:1:1:0.24-0.25:1.86-2.25:0.16-0.18:0.028-0.03:0.14-0.17; and a coating agent comprising white sugar, gum, gelatin, pigment and cera chinensis mixed in a mass ratio of 201-249:5.56-8:1:0.06-0.07:1, and wherein a mass ratio of the host material, the filler and the coating agent is 1:3.9-4.5:1.30-1.35.

2. The rice bran sterol sugar-coated tablet of claim 1, wherein the mass ratio of the host material, the filler and the coating agent is 1:4.0-4.3:1.32-1.34.

3. The rice bran sterol sugar-coated tablet of claim 1, wherein the filler comprises the starch, the dextrin, the talcum powder, the calcium carbonate, the microcrystalline cellulose, the starch slurry, the carboxymethyl starch sodium, the magnesium stearate and the silicon dioxide mixed in a mass ratio of 1.33-1.45:0.55-0.67:1:1:0.243-0.249:1.90-2.22:0.163-0.178:0.0285-0.0297:0.145-0.166.

4. The rice bran sterol sugar-coated tablet of claim 1, wherein the coating agent comprises the white sugar, the gum, the gelatin, the pigment and the cera chinensis mixed in a mass ratio of 208-240:5.61-7.8:1:0.062-0.068:1.

5. The rice bran sterol sugar-coated tablet of claim 1, wherein the rice bran sterol sugar-coated tablet is prepared by the following steps: (S1) respectively grinding the starch, the dextrin, the talcum powder, the calcium carbonate and the microcrystalline cellulose, and then thoroughly mixing the starch, the dextrin, the talcum powder, the calcium carbonate and the microcrystalline cellulose to form a first mixture; (S2) grinding the host material, and then thoroughly mixing the host material with the first mixture to form a second mixture; (S3) adding starch slurry to the second mixture, and then mixing the starch slurry and the second mixture to form a soft material; (S4) making wet granules by the soft material, and then drying the wet granules at 60-90 C. to obtain dried granules; (S5) evenly mixing carboxymethyl starch sodium, magnesium stearate and silicon dioxide to form a third mixture; (S6) mixing the third mixture and the dried granules to form a fourth mixture; (S7) punching the fourth mixture into plain tablets; (S8) thoroughly mixing the white sugar, the gum, the gelatin, the pigment and the cera chinensis to form a coating agent, wherein the white sugar, the gum, the gelatin, the pigment and the cera chinensis mixed in the mass ratio of 201-249:5.56-8:1:0.06-0.07:1; and (S9) placing the plain tablets into the coating agent, and then thoroughly mixing the plain tablets and the coating agent to obtain a final product, wherein the starch, the dextrin, the talcum powder, the calcium carbonate, the microcrystalline cellulose, the starch slurry, the carboxymethyl starch sodium, the magnesium stearate and the silicon dioxide mixed in the mass ratio of 1.29-1.5:0.5-0.71:1:1:0.24-0.25:1.86-2.25:0.16-0.18:0.028-0.03:0.14-0.17, wherein the mass ratio of the host material, the filler and the coating agent is 1:3.9-4.5:1.30-1.35.

6. A pharmaceutical composition comprising the rice bran sterol sugar-coated tablet of claim 1 combined with an oryzanol tablet for treating symptoms of periodontitis, acute pharyngolaryngitis, common cold induced throat drying, throat itching, throat swelling and throat aching, scapulohumeral periarthritis, cervical pain, neuralgia comprising trigeminal neuralgia, sciatica, and intercostal neuralgia, and allergic dermatitis.

7. A pharmaceutical composition comprising the rice bran sterol sugar-coated tablet of claim 2 combined with an oryzanol tablet for treating symptoms of periodontitis, acute pharyngolaryngitis, common cold induced throat drying, throat itching, throat swelling and throat aching, scapulohumeral periarthritis, cervical pain, neuralgia comprising trigeminal neuralgia, sciatica, and intercostal neuralgia, and allergic dermatitis.

8. A pharmaceutical composition comprising the rice bran sterol sugar-coated tablet of claim 3 combined with an oryzanol tablet for treating symptoms of periodontitis, acute pharyngolaryngitis, common cold induced throat drying, throat itching, throat swelling and throat aching, scapulohumeral periarthritis, cervical pain, neuralgia comprising trigeminal neuralgia, sciatica, and intercostal neuralgia, and allergic dermatitis.

9. A pharmaceutical composition comprising the rice bran sterol sugar-coated tablet of claim 4 combined with an oryzanol tablet for treating symptoms of periodontitis, acute pharyngolaryngitis, common cold induced throat drying, throat itching, throat swelling and throat aching, scapulohumeral periarthritis, cervical pain, neuralgia comprising trigeminal neuralgia, sciatica, and intercostal neuralgia, and allergic dermatitis.

10. A pharmaceutical composition comprising the rice bran sterol sugar-coated tablet of claim 5 combined with an oryzanol tablet for treating symptoms of periodontitis, acute pharyngolaryngitis, common cold induced throat drying, throat itching, throat swelling and throat aching, scapulohumeral periarthritis, cervical pain, neuralgia comprising trigeminal neuralgia, sciatica, and intercostal neuralgia, and allergic dermatitis.

Description

DESCRIPTION OF THE EMBODIMENTS

(1) The present invention is described below in detail in combination with embodiments.

Embodiment 1

(2) A rice bran sterol sugar-coated tablet was provided, which was prepared through the following steps:

(3) S1. respectively grinding starch, dextrin, talcum powder, calcium carbonate and microcrystalline cellulose with a 40-mesh grinder, and then thoroughly mixing them to form a first mixture;

(4) S2. grinding rice bran sterol technical materials with the 40-mesh grinder, and then thoroughly mixing them with the first mixture obtained in the S1 to form a second mixture;

(5) S3. placing the second mixture obtained in the S2 into a wet-type granulator, and then adding starch slurry with a mass concentration of 8% to make them into a soft material;

(6) S4. placing the soft material obtained in the S3 into an oscillating granulator to be made into wet granules, drying the wet granules at 60-90 C., and then screening them with a 10-16 mesh sieve to obtain dried granules;

(7) S5. placing carboxymethyl starch sodium, magnesium stearate and silicon dioxide into a main mixer to be evenly mixed so as to form a third mixture;

(8) S6. achieving thorough mixing of the third mixture obtained in the S5 with the dried granules obtained in the S4 in the main mixer so as to form a fourth mixture;

(9) S7. punching, via a puncher with 9 mm punch marks, the fourth mixture obtained in the S6 into plain tablets, wherein each of the plain tablets has a weight of 170 mg;

(10) S8. placing white sugar, gum, gelatin, pigment and Chinese insect wax into a coating pan, and then thoroughly mixing them to form a coating agent;

(11) S9. placing the plain tablets obtained in the S7 into the coating agent obtained in the S8, and then thoroughly mixing them to obtain a final product.

(12) Here, the components and corresponding masses thereof are shown in Table 1 (in 10,000 tablets).

(13) The structural formula of the rice bran sterol technical materials is follows:

(14) ##STR00004##
and R is

(15) ##STR00005##

Embodiment 2

(16) A rice bran sterol sugar-coated tablet was provided, which differed from that of Embodiment 1 in that the fourth mixture obtained in the S6 was punched into plain tablets via a puncher with 8.5 mm punch marks, wherein each of the plain tablets had a weight of 170 mg. The components and corresponding masses thereof are shown in Table 1.

Embodiment 3

(17) A rice bran sterol sugar-coated tablet was provided, which differed from that of Embodiment 1 in that the fourth mixture obtained in the S6 was punched into plain tablets via a puncher with 8 mm punch marks, wherein each of the plain tablets had a weight of 170 mg. The components and corresponding masses thereof are shown in Table 1.

Embodiment 4

(18) A rice bran sterol sugar-coated tablet was provided, which differed from that of Embodiment 2 lies in the components and the corresponding masses. The components and corresponding masses thereof are shown in Table 1.

Embodiment 5

(19) A rice bran sterol sugar-coated tablet was provided, which differed from those of Embodiment 2 and Embodiment 1 lies in the components and the corresponding masses. The components and corresponding masses thereof are shown in Table 1.

Embodiment 6

(20) A rice bran sterol sugar-coated tablet was provided, which differed from that of Embodiment 2 in that the rice bran sterol sugar-coated tablet did not contain carboxymethyl starch.

Embodiment 7

(21) A rice bran sterol sugar-coated tablet was provided, which differed from that of Embodiment 2 in that the content of carboxymethyl starch was 25 g (in 10,000 tablets).

Embodiment 8

(22) A rice bran sterol sugar-coated tablet was provided, which differed from that of Embodiment 2 in that the contents of carboxymethyl starch, starch slurry and microcrystalline cellulose were respectively 20 g, 400 g and 25 g (in 10,000 tablets).

Embodiment 9

(23) A rice bran sterol sugar-coated tablet was provided, which differed from that of Embodiment 8 in that the content of rice bran sterol technical materials was 200 g (in 10,000 tablets).

Embodiment 10

(24) A rice bran sterol sugar-coated tablet was provided, which differed from that of Embodiment 8 in that the content of rice bran sterol technical materials was 200 g, and the content of magnesium stearate was 3 g (in 10,000 tablets).

(25) TABLE-US-00001 TABLE 1 Various Components in Embodiments 1-5 and Corresponding Masses Thereof Embodiment Num. 1 2 3 4 5 Components Masses (g) Rice Bran Sterol Technical Material 350 400 500 450 420 Starch 300 390 450 350 410 Dextrin 100 120 250 200 170 Talcum Powder 200 270 350 240 300 Calcium Carbonate 200 300 350 250 300 Microcrystalline Cellulose 50 75 85 65 70 Starch Slurry 450 575 650 520 600 Carboxymethyl Starch Sodium 35.5 47.5 55.5 50.5 40.5 Magnesium Stearate 5 9 10 7 8 Silicon Dioxide 35 39 50 45 43 White Sugar 450 525 650 550 500 Gum 14.5 17.5 18 15.5 16.5 Gelatin 1.8 2.5 3.2 2.8 3 Pigment 0.1 0.2 0.2 0.1 0.15 Chinese Insect Wax 1.8 2.5 3.2 2.8 3

Experiment 1

(26) Experiment Samples: Drugs prepared in Embodiments 1-10 were taken as Experiment Samples 1-10.

(27) Experiment Method: 1,000 patients of similar age, who had similar physical conditions and whose throats were afflicted by similar symptoms of drying, itching and swelling and aching induced by periodontitis, acute pharyngolaryngitis and common cold, were selected from the same area, and divided equally into 10 groups marked respectively as 1-10. Groups 1-10 were treated using Experiment Samples 1-10 respectively, and the patient's recovery conditions were observed and recorded for a week.

(28) Experiment Results: The recovery conditions of the patients taking Experiment Samples 1-10 for a week are as shown in Table 2.

(29) TABLE-US-00002 TABLE 2 Recovery Conditions of the Patients Taking Experiment Samples 1-10 for a Week Symptom Throat Acute Swelling Perio- Pharyngo- Throat Throat and Experiment dontitis laryngitis Drying Itching Aching Sample Recovery Number of People (Person) 1 100 99 96 97 99 2 100 100 99 98 100 3 100 100 98 98 99 4 100 100 97 97 100 5 100 99 96 99 99 6 63 59 61 57 58 7 68 62 65 62 63 8 72 66 71 68 73 9 55 32 17 24 28 10 50 49 41 43 42

(30) As can be known from Table 2, for patients treated with Experiment Samples 1-5, the healing rate of drying, itching and swelling and aching afflicting their throats due to periodontitis, acute pharyngolaryngitis and common cold is high, and they are almost completely healed. During taking, the drugs can be swallowed down easily, and are not prone to get stuck in the esophagus. Moreover, no dizziness, vomiting, stomachache and the like are reported from the patients during treatment. However, for patients treated with Experiment Samples 6-10, the recovery conditions of drying, itching and swelling and aching afflicting their throats due to periodontitis, acute pharyngolaryngitis and common cold are poor, and what's worse is that different levels of dizziness and vomiting are reported from the patients. This indicates that rice bran sterol technical materials, carboxymethyl starch sodium, starch slurry and microcrystalline cellulose may interact with one another to improve the healing rate of periodontitis and treat such symptoms as drying, itching, swelling and aching and the like afflicting the throat due to acute pharyngolaryngitis and common cold, and their treatment effects on pharyngeal membrane system inflammations are also remarkable.

Experiment 2

(31) Experiment Samples: Drugs prepared in Embodiments 1-10 were taken as Experiment Samples 1-10.

(32) Experiment Method: 500 adult patients and 500 child patients (ages ranging from 4 to 12), who were of similar age and had similar physical conditions and identical cold symptoms, were selected from the same area. They were divided equally into 10 groups marked respectively as 1-10, and each group was composed of 50 adult patients and 50 child patients. Groups 1-10 were treated using Experiment Samples 1-10 respectively, wherein the patients in Group 1 only took Experiment Sample 1 orally; the patients in Groups 2-5 orally took oryzanol tablets in addition to Experiment Samples 2-5; the patients in Groups 6-10 only took Samples 6-10 orally.

(33) Here, the dosage of Experiment Sample 1 orally taken by each adult patient in Group 1 was 340 mg on a four-times-a-day basis, while that of Experiment Sample 1 orally taken by each child patient was 200 mg on a three-times-a-day basis.

(34) The dosages of Experiment Sample 2 and oryzanol tablets orally taken by each adult patient in Group 2 were respectively 320 mg and 40 mg on a four-times-a-day basis, while those of Experiment Sample 2 and oryzanol tablets orally taken by each child patient were respectively 200 mg and 20 mg on a three-times-a-day basis.

(35) The dosages of Experiment Sample 3 and oryzanol tablets orally taken by each adult patient in Group 3 were respectively 400 mg and 50 mg on a four-times-a-day basis, while those of Experiment Sample 3 and oryzanol tablets orally taken by each child patient were respectively 200 mg and 20 mg on a three-times-a-day basis.

(36) The dosages of Experiment Sample 4 and oryzanol tablets orally taken by each adult patient in Group 4 were respectively 340 mg and 43 mg on a four-times-a-day basis, while those of Experiment Sample 4 and oryzanol tablets orally taken by each child patient were respectively 200 mg and 20 mg on a three-times-a-day basis.

(37) The dosages of Experiment Sample 5 and oryzanol tablets orally taken by each adult patient in Group 5 were respectively 380 mg and 46 mg on a four-times-a-day basis, while those of Experiment Sample 5 and oryzanol tablets orally taken by each child patient were respectively 200 mg and 20 mg on a three-times-a-day basis.

(38) The dosage of Experiment Sample 6 orally taken by each adult patient in Group 6 was 340 mg on a four-times-a-day basis, while that of Experiment Sample 6 orally taken by each child patient was 200 mg on a three-times-a-day basis.

(39) The dosage of Experiment Sample 7 orally taken by each adult patient in Group 7 was 380 mg on a four-times-a-day basis, while that of Experiment Sample 7 orally taken by each child patient was 200 mg on a three-times-a-day basis.

(40) The dosage of Experiment Sample 8 orally taken by each adult patient in Group 8 was 320 mg on a four-times-a-day basis, while that of Experiment Sample 8 orally taken by each child patient was 200 mg on a three-times-a-day basis.

(41) The dosage of Experiment Sample 9 orally taken by each adult patient in Group 9 was 400 mg on a four-times-a-day basis, while that of Experiment Sample 9 orally taken by each child patient was 200 mg on a three-times-a-day basis.

(42) The dosage of Experiment Sample 10 orally taken by each adult patient in Group 10 was 360 mg on a four-times-a-day basis, while that of Experiment Sample 10 orally taken by each child patient was 200 mg on a three-times-a-day basis.

(43) Rehabilitation conditions of the patients were observed and recorded.

(44) Experiment Results: For Group 1, 92% of the adult patients and 80% of the child patients fully recovered from their cold in the fifth day; for Group 2, 94% of the adult patients and 90% of the child patients fully recovered from their cold in the fourth day; for Group 3, 100% of the adult patients and 88% of the child patients fully recovered from their cold in the fourth day; for Group 4, 96% of the adult patients and 88% of the child patients fully recovered from their cold in the fourth day; for Group 5, 96% of the adult patients and 88% of the child patients fully recovered from their cold in the fourth day; for Group 6, 90% of the adult patients and 86% of the child patients fully recovered from their cold in the eighth day; for Group 7, 94% of the adult patients and 88% of the child patients fully recovered from their cold in the eighth day; for Group 8, 92% of the adult patients and 88% of the child patients fully recovered from their cold in the eighth day; for Group 9, 90% of the adult patients and 86% of the child patients fully recovered from their cold in the ninth day; for Group 10, 92% of the adult patients and 88% of the child patients fully recovered from their cold in the eighth day. No side effects were reported from the child patients during treatment.

Experiment 3

(45) Experiment Samples: drugs prepared in Embodiments 1-10 were taken as Experiment Samples 1-10.

(46) Experiment Method: 1,000 patients of similar age, who had similar physical conditions and similar symptoms induced by scapulohumeral periarthritis, cervical pain and all types of neuralgia (including trigeminal neuralgia, sciatica, intercostal neuralgia and the like), were selected from the same area, and divided equally into 10 groups marked respectively as 1-10. Groups 1-10 were treated using Experiment Samples 1-10 respectively, and the patient's recovery conditions were observed and recorded for three weeks.

(47) Experiment Results: the recovery conditions of the patients taking Experiment Samples 1-10 for three weeks are as shown in Table 3.

(48) TABLE-US-00003 TABLE 3 Recovery Conditions of the Patients Taking Experiment Samples 1-10 for Three Weeks Symptom Scapulohumeral Cervical All Types of Experiment Periarthritis Pain Neuralgia Sample Recovery Number of People (Person) 1 99 100 98 2 100 99 99 3 99 99 97 4 100 99 98 5 99 100 99 6 66 62 63 7 69 63 65 8 75 70 72 9 62 58 50 10 65 53 52

(49) As can be known from Table 3, Experiment Samples 1-5 have relatively good curing effects on scapulohumeral periarthritis, cervical pain and all types of neuralgia, wherein there are 99-100 people recovering from scapulohumeral periarthritis and cervical pain, and there are 97-99 people recovering from all types of neuralgia, but Experiment Samples 6-10 have poor curing effects on scapulohumeral periarthritis, cervical pain and all types of neuralgia, and these curing effects are greatly different from those of Experiment Samples 1-5 as there are 62-75 people recovering from scapulohumeral periarthritis, there are 62-70 people recovering from cervical pain, and there are 50-72 people recovering from all types of neuralgia.

Experiment 4

(50) Experiment Samples: drugs prepared in Embodiments 1-10 were taken as Experiment Samples 1-10.

(51) Experiment Method: 1,000 patients of similar age, who had similar physical conditions and similar symptoms induced by allergic dermatitis, were selected from the same area, and divided equally into 10 groups marked respectively as 1-10. Groups 1-10 were treated in a skin surface coating way using Experiment Samples 1-10 respectively according to an affected part coating amount calculated based on 0.2 ml/cm.sup.2, and the patient's recovery conditions were observed and recorded for a week.

(52) Experiment Results: the recovery conditions of the patients taking Experiment Samples 1-10 for a week are as shown in Table 4.

(53) TABLE-US-00004 TABLE 4 Recovery Conditions of the Patients Taking Experiment Samples 1-10 for a Week symptom Allergic Dermatitis Experiment Sample Recovery Number of People (Person) 1 100 2 100 3 100 4 100 5 100 6 65 7 68 8 71 9 53 10 50

(54) As can be known from Table 4, for patients treated with Experiment Samples 1-5, the recovery rate of allergic dermatitis is the highest, all members in the groups are cured, and no side effects are caused during treatment, but for patients treated with Experiment Samples 6-10, only 50-71% of patients recover from allergic dermatitis.

(55) What have been described above are merely preferred embodiments of the present invention, but the scope of protection of the present invention should not be so limited. All technical solutions that fall within the spirit of the present invention shall be covered by the scope of protection of the present invention. It should be noted that for those of ordinary skill in the art, various improvements and modifications that are made without departing from the principles of the present invention shall also be regarded as being covered by the scope of protection of the present invention.