Meat, phyllanthus emblica and cistanche deserticola tablet candy

Abstract

The invention belongs to the technical field of health-care food, and relates to an emblic leafflower fruit and cistanche tabletting candy capable of enriching yin and nourishing kidney. Comprising the following components in parts by weight: 20-50 parts of phyllanthus emblica, 20-50 parts of a cistanche extract, 10-40 parts of at least one yin-nourishing medicinal material extract selected from a prepared rehmannia root extract, a Chinese wolfberry fruit extract and a dogwood extract, 30-60 parts of a filler, 2-8 parts of a disintegrating agent and 1-2 parts of a lubricant. According to the emblic leafflower fruit and cistanche tabletting candy capable of enriching yin and nourishing kidney, the effects of enriching yin and nourishing kidney are ensured through scientific compatibility and a specific extraction process, meanwhile, the problems of moisture absorption and sticking are effectively solved, tabletting is smooth, and the rate of finished products is high.

Description

Technical Field

[0001] This invention belongs to the field of health food technology and relates to a compressed candy made from Phyllanthus emblica and Cistanche deserticola. Background Technology

[0002] Traditional Chinese medicine recognizes kidney yin deficiency and commonly uses tonifying herbs such as Cistanche deserticola, Rehmannia glutinosa, and Lycium barbarum. Traditional applications and modern research on Cistanche deserticola mainly include its effects of tonifying kidney yang, nourishing essence and blood, and moistening the intestines to relieve constipation. Its main active ingredients are phenylethanoid glycosides such as echinacoside and verbascoside. Currently, the following problems exist with Cistanche deserticola-based kidney-tonifying health products / foods (including compressed candies): 1. Its effects are singular, focusing on tonifying kidney yang, and it is insufficient or not very effective for kidney yin deficiency.

[0003] 2. The raw materials are mostly coarse powder or simple water extracts, with low content of active ingredients, poor stability, and low bioavailability. The formulation lacks scientific basis and synergistic effect research.

[0004] 3. During the tableting process, Cistanche deserticola extract is prone to absorbing moisture and sticking, which leads to difficulties in tableting, long disintegration time, poor taste, and poor release of active ingredients. Summary of the Invention

[0005] The purpose of this invention is to solve the above problems and provide a compressed candy containing Phyllanthus emblica and Cistanche deserticola.

[0006] To achieve the above objectives, the present invention provides a compressed candy containing Phyllanthus emblica and Cistanche deserticola, comprising the following components by weight: 20-50 parts Phyllanthus emblica, 20-50 parts Cistanche deserticola extract, 10-40 parts of at least one yin-nourishing herbal extract selected from Rehmannia glutinosa extract, Lycium barbarum extract, and Cornus officinalis extract, 30-60 parts of filler, 2-8 parts of disintegrant, and 1-2 parts of lubricant.

[0007] Furthermore, the Cistanche deserticola extract is prepared by reflux extraction of the fleshy stem of Cistanche deserticola, followed by vacuum concentration and drying using 50-70% (v / v) ethanol aqueous solution, wherein the total content of echinacoside and verbascoside is not less than 15%.

[0008] Furthermore, the weight ratio of the Cistanche deserticola extract to the Yin-nourishing herbal extract is (1:0.5) - (1:1).

[0009] Furthermore, the filler comprises microcrystalline cellulose and mannitol, and the weight ratio of microcrystalline cellulose to mannitol is (2:1) - (4:1).

[0010] Furthermore, the disintegrant is croscarmellose sodium or croscarmellose, and 50-70% is an internal disintegrant and 30-50% is an external disintegrant.

[0011] Furthermore, the lubricant includes magnesium stearate and micronized silica gel, with the amount of magnesium stearate being 0.8-1.5 parts and the amount of micronized silica gel being 0.1-0.5 parts.

[0012] This invention also provides a preparation process for the above-mentioned Phyllanthus emblica and Cistanche deserticola compressed candy, comprising: (1) Preparation of Cistanche deserticola extract: Crush the fleshy stems of Cistanche deserticola and extract them by reflux with 50-70% (v / v) ethanol aqueous solution at 70-85℃ for 1-3 times, each time for 1-3 hours. Combine the extracts, concentrate under reduced pressure to a relative density of 1.10-1.25 (60℃), spray dry or freeze dry under vacuum to obtain an extract powder with a total content of echinacoside and verbascoside ≥15%; (2) Preparation of extracts from yin-nourishing medicinal materials; (3) Mixing: Mix the Cistanche deserticola extract obtained in step (1), the Yin-nourishing herb extract obtained in step (2), the microcrystalline cellulose in the filler and the disintegrant in the internal part evenly, then add the mannitol in the filler and mix evenly, and finally add the lubricant and the remaining external disintegrant and mix evenly to obtain the mixture. (4) Tableting: The mixture is pressed into tablet cores under conditions where the relative humidity is below 40%. (5) Optional coating: a thin film coating layer is wrapped around the core.

[0013] Furthermore, in step (3), the mixing is carried out in a three-dimensional motion mixer, with a total mixing time of 15-30 minutes, of which the mixing time after adding lubricant and external disintegrant is 2-5 minutes.

[0014] Furthermore, the tableting pressure in step (4) is 8-15 kN.

[0015] The beneficial effects of this invention are as follows: The compressed tablets of Phyllanthus emblica and Cistanche deserticola of this invention, through scientific formulation and specific extraction processes, ensure the effects of nourishing Yin and tonifying the kidneys. The combination of specific extracts and excipients effectively solves the problems of moisture absorption and sticking, ensuring smooth tableting and a high yield. Specific extraction processes and coating technologies improve the stability of the active ingredient (phenylethanol glycosides) and extend shelf life. The application of specific disintegrants ensures rapid release of the active ingredient and improves bioavailability. Detailed Implementation

[0016] The present invention will now be described in detail with reference to specific embodiments. The embodiments cannot be described in detail here, but the embodiments of the present invention are not limited to the following embodiments.

[0017] This invention provides a compressed candy containing Phyllanthus emblica and Cistanche deserticola, comprising the following components by weight: 20-50 parts Phyllanthus emblica, 20-50 parts Cistanche deserticola extract, 10-40 parts of at least one yin-nourishing herb extract selected from Rehmannia glutinosa extract, Lycium barbarum extract, and Cornus officinalis extract, 30-60 parts filler, 2-8 parts disintegrant, and 1-2 parts lubricant.

[0018] According to one embodiment of the present invention, the Cistanche deserticola extract is obtained by reflux extraction of the fleshy stem of Cistanche deserticola, followed by vacuum concentration and drying, using 50-70% (v / v) ethanol aqueous solution as raw material. The total content of echinacoside and verbascoside is not less than 15%. The weight ratio of the Cistanche deserticola extract to the extract of the yin-nourishing medicinal material is (1:0.5) - (1:1).

[0019] In this embodiment, the filler comprises microcrystalline cellulose and mannitol, and the weight ratio of microcrystalline cellulose to mannitol is (2:1) - (4:1).

[0020] In this embodiment, the disintegrant is croscarmellose sodium or croscarmellose, and 50-70% is an internally added disintegrant and 30-50% is an externally added disintegrant.

[0021] In this embodiment, the lubricant includes magnesium stearate and micronized silica gel, and the amount of magnesium stearate is 0.8-1.5 parts, and the amount of micronized silica gel is 0.1-0.5 parts.

[0022] The present invention also provides a preparation process for the above-mentioned Cistanche deserticola compressed candy, comprising: (1) Preparation of Cistanche deserticola extract: Crush the fleshy stems of Cistanche deserticola and extract them by reflux with 50-70% (v / v) ethanol aqueous solution at 70-85℃ for 1-3 times, each time for 1-3 hours. Combine the extracts, concentrate under reduced pressure to a relative density of 1.10-1.25 (60℃), spray dry or freeze dry under vacuum to obtain an extract powder with a total content of echinacoside and verbascoside ≥15%; (2) Preparation of extracts from yin-nourishing medicinal materials; (3) Mixing: Mix the Cistanche deserticola extract obtained in step (1), the Yin-nourishing herb extract obtained in step (2), the microcrystalline cellulose in the filler and the disintegrant in the internal part evenly, then add the mannitol in the filler and mix evenly, and finally add the lubricant and the remaining external disintegrant and mix evenly to obtain a mixture; the mixing is carried out in a three-dimensional motion mixer, and the total mixing time is 15-30 minutes, of which the mixing time after adding the lubricant and external disintegrant is 2-5 minutes.

[0023] (4) Tableting: Under the condition that the relative humidity of the environment is less than 40%, the mixture is pressed into tablet cores, and the tableting pressure is 8-15kN.

[0024] (5) Optional coating: a thin film coating layer is wrapped around the core.

[0025] The following specific embodiments illustrate the Yin-nourishing and kidney-tonifying Cistanche deserticola compressed candy of the present invention: Components Example 1 Example 2 Example 3 Comparative Example 1 Comparative Example 2 Phyllanthus emblica 20 35 50 35 35 Cistanche deserticola extract (echinacoside + verbascoside ≥15%) 20 35 50 35 35 Rehmannia glutinosa extract 10 15 20 - 15 wolfberry extract 10 10 10 - - microcrystalline cellulose 30 25 20 40 25 Mannitol 15 12.5 10 20 12.5 Cross-linked carboxymethyl cellulose sodium (added internally) 1.4 1.8 2.1 2.4 1.8 Cross-linked sodium carboxymethyl cellulose (added externally) 0.6 0.9 1.0 1.6 0.9 magnesium stearate 1.0 1.2 1.5 1.5 1.2 Micronized silica 0.3 0.3 0.4 - - Preparation of extracts in examples and comparative examples: Cistanche deserticola extract: fleshy stems of Cistanche deserticola, refluxed twice at 75°C with 65% ethanol (2h each time) → concentrated to density 1.20 (60°C) → spray dried (inlet air 160°C, outlet air 80°C), echinacoside + verbascoside = 18.2%.

[0026] Rehmannia glutinosa / Lycium barbarum extract: water extraction and alcohol precipitation method, conforming to the standards of the Chinese Pharmacopoeia.

[0027] mix: Cistanche deserticola extract + Yin-nourishing herb extract + microcrystalline cellulose + internal disintegrant → Mix in a 3D mixer for 15 minutes. Add mannitol → Mix for 10 minutes. Add magnesium stearate + micronized silica gel + external disintegrant → Mix for 3 minutes.

[0028] Tableting: Ambient humidity ≤35%, tableting pressure 10kN, tablet weight 0.8g / tablet.

[0029] Coating: HPMC film coating (3% weight gain).

[0030] Comparison of tableting process performance: index Example 1 Example 2 Example 3 Comparative Example 1 Comparative Example 2 Sticking and punching rate 0% 0% 0% 15% 8% Tablet hardness (N) 65±3 68±2 70±4 52±5 60±3 Friability(%) 0.12 0.10 0.08 0.35 0.25 Disintegration timeout (min) 4.5±0.5 4.2±0.3 3.8±0.4 8.2±1.0 6.5±0.7 Conclusion: A specific combination of excipients (microcrystalline cellulose: mannitol = 3:1 + micronized silica gel) and internal and external disintegration processes significantly solved the sticking and punching problem, and improved hardness and disintegration speed (comparative example 2 without micronized silica gel resulted in an increased sticking and punching rate).

[0031] Dissolution and stability (key active ingredient: echinacoside) condition Example 2 (Dissolution rate over 30 min) Comparative Example 1 (Dissolution rate at 30 min) Initial dissolution 95.2%±1.5% 78.3%±2.1% After accelerated testing 93.5%±1.8% 70.1%±3.0% in conclusion: Synergistic components (Rehmannia glutinosa + Lycium barbarum) and specific excipients improve dissolution efficiency and protect the stability of active ingredients (Comparative Example 1: No synergistic components resulted in decreased dissolution).

[0032] This invention relates to a compressed candy containing Phyllanthus emblica and Cistanche deserticola. Through scientific formulation and a specific extraction process, it ensures the effects of nourishing Yin and tonifying the kidneys. The combination of specific extracts and excipients effectively solves the problems of moisture absorption and sticking, ensuring smooth tableting and a high yield. Specific extraction processes and coating technologies improve the stability of the active ingredient (phenylethanol glycosides) and extend shelf life. The application of specific disintegrants ensures rapid release of the active ingredient and improves bioavailability.

[0033] The above description is merely one embodiment of the present invention and is not intended to limit the invention. Those skilled in the art will recognize that the present invention can be modified and varied in various ways. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A type of compressed candy containing Phyllanthus emblica and Cistanche deserticola, characterized in that, By weight, it includes the following components: 20-50 parts of Phyllanthus emblica, 20-50 parts of Cistanche deserticola extract, 10-40 parts of at least one yin-nourishing herb extract selected from Rehmannia glutinosa extract, Lycium barbarum extract, Cornus officinalis extract, 30-60 parts of filler, 2-8 parts of disintegrant, and 1-2 parts of lubricant.

2. The compressed candy containing Phyllanthus emblica and Cistanche deserticola according to claim 1, characterized in that, The Cistanche deserticola extract is prepared by reflux extraction of the fleshy stems of Cistanche deserticola, followed by vacuum concentration and drying using 50-70% (v / v) ethanol aqueous solution. The total content of echinacoside and verbascoside is not less than 15%.

3. The compressed candy containing Phyllanthus emblica and Cistanche deserticola according to claim 2, characterized in that, The weight ratio of the Cistanche deserticola extract to the Yin-nourishing herbal extract is (1:0.5) - (1:1).

4. The compressed candy containing Phyllanthus emblica and Cistanche deserticola according to claim 3, characterized in that, The filler contains microcrystalline cellulose and mannitol, and the weight ratio of microcrystalline cellulose to mannitol is (2:1) - (4:1).

5. The compressed candy containing Phyllanthus emblica and Cistanche deserticola according to claim 4, characterized in that, The disintegrant is croscarmellose sodium or croscarmellose, with 50-70% being an internal disintegrant and 30-50% being an external disintegrant.

6. The compressed candy containing Phyllanthus emblica and Cistanche deserticola according to claim 5, characterized in that, The lubricant includes magnesium stearate and micronized silica gel, with magnesium stearate used in an amount of 0.8-1.5 parts and micronized silica gel used in an amount of 0.1-0.5 parts.

7. The compressed candy containing Phyllanthus emblica and Cistanche deserticola according to claim 6, characterized in that, The preparation process includes: (1) Preparation of Cistanche deserticola extract: Crush the fleshy stems of Cistanche deserticola and extract them by reflux with 50-70% (v / v) ethanol aqueous solution at 70-85℃ for 1-3 times, each time for 1-3 hours. Combine the extracts, concentrate under reduced pressure to a relative density of 1.10-1.25 (60℃), spray dry or freeze dry under vacuum to obtain an extract powder with a total content of echinacoside and verbascoside ≥15%; (2) Preparation of extracts from yin-nourishing medicinal materials; (3) Mixing: Mix the Cistanche deserticola extract obtained in step (1), the Yin-nourishing herb extract obtained in step (2), the microcrystalline cellulose in the filler and the disintegrant in the internal part evenly, then add the mannitol in the filler and mix evenly, and finally add the lubricant and the remaining external disintegrant and mix evenly to obtain the mixture. (4) Tableting: The mixture is pressed into tablet cores under conditions where the relative humidity is below 40%. (5) Optional coating: a thin film coating layer is wrapped around the core.

8. The compressed candy containing Phyllanthus emblica and Cistanche deserticola according to claim 7, characterized in that, In step (3), the mixing is carried out in a three-dimensional motion mixer, with a total mixing time of 15-30 minutes, of which the mixing time after adding lubricant and external disintegrant is 2-5 minutes.

9. The compressed candy containing Phyllanthus emblica and Cistanche deserticola according to claim 8, characterized in that, In step (4), the tablet compression pressure is 8-15 kN.