CN114712323A - Human placenta tablet and preparation method thereof - Google Patents

Abstract

The invention discloses a human placenta tablet, which is characterized in that: the tablet comprises the following components in percentage by mass: 70-78% of human placenta powder, 10-17% of cane sugar, 8-13% of cane sugar powder, 0.07-0.1% of sodium carboxymethyl cellulose, 0.04-0.08% of sodium benzoate and 0.3-0.7% of talcum powder. Because the human placenta powder is dark brown, has special smell and has hygroscopicity or hygroscopicity, the invention can isolate the active ingredients of the placenta powder from external contact by introducing a special tablet process so as to avoid the stability reduction caused by water absorption, the degradation of the active ingredients and the like, solve the hygroscopicity or hygroscopicity of the human placenta powder, cover bad smell and improve the compliance of patients when the human placenta powder is taken.

Description

Human placenta tablet and preparation method thereof

Technical Field

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a solid oral preparation, in particular to a tablet containing oral human placenta powder and a preparation method thereof.

Background

Placenta hominis is loaded in Ben Cao Shi Yi (supplement to materia Medica), named as "human cell", which is called "human placenta". Warm kidney, replenish essence, tonify qi and nourish blood. Can be used for treating asthenia, marasmus, hectic fever, night sweat, cough, asthma, anorexia, short breath, sexual impotence, spermatorrhea, infertility, and hypogalactia. Recorded in modern practical Chinese medicine, it is used for neurasthenia, impotence and infertility, and is also a pain-promoting and milk secretion-promoting agent. After virus screening and qualification, the placenta of a healthy donor is processed in a series of processes to obtain human placenta powder which is brown powder and contains active polypeptide, a small amount of steroid hormone such as progesterone, estrogen, nucleoside, nucleotide, basic group and the like, various immune globulin such as IgG, IgM and the like, and various amino acids, vitamins, trace elements and the like which are necessary for a human body. The contained estrogen can promote the secretion of gonadal hormone by regulating pituitary through hypothalamus, and simultaneously, the hormone can induce the synthesis of messenger RNA of a characteristic protein, and the induction can lead to the rapid synthesis of RNA, protein and phospholipid, thereby having the effects of reducing blood cholesterol and preventing atherosclerosis of hyperlipidemic animals. Steroid hormone can promote the deposition of bone calcium and prevent fracture. The contained various immunoglobulins can enhance the pharmacological actions of the immunity of the organism and the like. Therefore, the traditional Chinese medicine composition is clinically used for treating uterine dysplasia, infertility and neurasthenia and enhancing the immunity of organisms.

The human placenta powder is used as a medicine in traditional Chinese medicine, or is prepared into capsules. The human placenta powder is rich in polypeptide, hormone, nucleotide, various immune globulin, etc., has hygroscopicity and hygroscopicity, and is easy to absorb water and deteriorate at normal temperature. As the basic knowledge of pharmaceutical industry, the stability of the drug is greatly influenced by the high or low moisture content in the preparation, especially the polypeptide, nucleotide and various immune globulin in the preparation are easily influenced by moisture to generate degradation reaction, and if the moisture content is increased in the long-term storage process, the stability of the product is influenced. Therefore, the moisture content of the finished preparation during transportation and storage can be controlled, and the stability of the placenta can be improved.

Because the human placenta powder is dark brown, has special smell and has hygroscopicity or hygroscopicity, the problem that the stability of the product is possibly affected and the unpleasant smell of the human placenta powder is covered due to the hygroscopicity is solved in order to avoid the stability reduction and the degradation of effective components caused by the hygroscopicity.

Disclosure of Invention

The purpose of the invention is: provides a tablet of human placenta powder with simple process and stable quality.

The technical scheme of the invention is as follows: the human placenta tablet comprises the following components in percentage by mass: 70-78% of human placenta powder, 10-17% of cane sugar, 8-13% of cane sugar powder, 0.07-0.1% of sodium carboxymethyl cellulose, 0.04-0.08% of sodium benzoate and 0.3-0.7% of talcum powder.

Preferably, the tablet comprises the following components in percentage by mass: 74% of human placenta powder, 13.4% of cane sugar, 11.9% of cane sugar powder, 0.09% of sodium carboxymethyl cellulose, 0.06% of sodium benzoate and 0.55% of talcum powder.

The preparation method of the human placenta tablet comprises the following steps: (1) detecting the qualification of human placenta powder and other auxiliary materials; (2) pulverizing placenta hominis powder, and sieving; (3) adding sucrose into boiling purified water, stirring to dissolve completely, making syrup, and sieving with 120 mesh sieve; (4) adding human placenta powder and sucrose powder into a mixing machine according to the prescription amount, slowly adding the prepared syrup into the mixing machine from a hopper, preparing a soft material, continuously stirring after the addition is finished, and recovering the soft material for the next operation; (5) granulating the prepared soft material on a granulator by using a screen meeting the specified mesh number, uniformly paving the prepared granules in a stainless steel drying disc, and drying; (6) the drying temperature is controlled to be 65-75 ℃, the drying time is about 4-6h, and the moisture of the particles is controlled to be within 6%; (7) finishing the dried particles on a granulator by using a screen with the specified mesh number, after finishing; (8) and (3) totally mixing the sodium carboxymethylcellulose, the sodium benzoate and the talcum powder with the granules on a mixer according to the prescription amount to obtain the human placenta tablet granules.

The preparation method of the human placenta tablet further comprises the following steps: (1) directly tabletting the granules obtained by total mixing to obtain a plain sheet of the placenta hominis sheet; (2) coating; (3) airing the slices: taking the slices out of the pan, spreading the slices in a stainless steel plate, placing the stainless steel plate in a room at the temperature of 18-26 ℃ and the relative humidity of 45-65% for about 12-15 hours, then filling the dried coated slices into a PE-lined plastic bag, and waiting for the human placenta slices to be packaged.

The coating is as follows: (1) preparing syrup:

preparing simple syrup: adding sucrose into a heating jacketed kettle, heating and decocting, boiling, and filtering the syrup with a 120-mesh stainless steel screen;

preparing gelatin syrup for capsules: adding purified water, heating to boil, adding gelatin for capsule, stirring to dissolve, adding prepared simple syrup, heating to boil, filtering with 120 mesh stainless steel screen, and keeping the temperature;

preparing color syrup: adding a proper amount of boiling purified water into a specified amount of composite red pigment, and stirring until the composite red pigment is completely dissolved for later use; pouring the mixture into a jacketed kettle when color syrup needs to be prepared, adding the prepared simple syrup, continuously heating to boil, and finally filtering with a 120-mesh stainless steel screen for heat preservation for later use;

(2) coating operation

Coating an isolation layer: adding gelatin slurry for capsules, uniformly stirring, and drying by hot air for 40-50 minutes;

wrapping a gelatin layer: adding the rest capsule with gelatin slurry and pulvis Talci for 3 times, and hot air drying for 40-50 min each time;

coating a powder coating layer: alternately coating with simple syrup and pulvis Talci, coating the edge of tablet core, leveling the surface of tablet, and hot air drying for 20-30 min each time;

coating a sugar coating layer: adding simple syrup into a pot, stirring to make the simple syrup uniformly adhere to the surface of the tablet, blow-drying with cold air after each addition, drying for 15-20 minutes each time, and allowing the tablet surface to be smooth, fine and firm;

coating a colored sugar coating layer: adding the prepared color syrup into the coated tablet, repeating the steps for a plurality of times until the color of the coated tablet is consistent, drying the coated tablet by cold air, and entering the next working procedure;

polishing: adding insect white wax into the tablets coated with the colored sugar coating layer, covering the pot cover, polishing, taking out of the pot, and finishing coating.

The invention has the beneficial effects that: because the human placenta powder is dark brown, has special smell and has hygroscopicity or hygroscopicity, the invention can isolate the active ingredients of the placenta powder from contact with the outside by introducing a special tablet process in order to avoid the reduction of the stability caused by water absorption, the degradation of the active ingredients and the like, solve the hygroscopicity or hygroscopicity of the human placenta powder, cover bad smell and improve the compliance of patients when in use.

Drawings

FIG. 1 is an HPLC standard assay profile of adenosine;

FIG. 2 is a placental disc assay map;

FIG. 3 is a picture of the appearance of the product of the present invention.

Detailed Description

The preparation process and the implementation effect of the present invention will be further described by the following examples, but the scope of the present invention is not limited to the following examples:

the first embodiment is as follows:

prescription:

the preparation method comprises the following steps:

1. preparation of the granules (granulation)

(1) Checking that the placenta powder and other auxiliary materials are qualified, and can be used as a feed.

(2) Pulverizing sucrose and human placenta powder respectively, sieving for use,

(3) adding sucrose into boiling purified water according to a certain proportion, stirring until completely dissolving, making syrup, and sieving with 120 mesh sieve;

(4) adding human placenta powder and sucrose powder into a mixing machine according to the prescription amount, stirring and mixing for 15min, slowly adding the prepared syrup into the mixing machine from a hopper to prepare a soft material, continuously stirring for 15min after the addition is finished, and recovering the soft material to perform the next operation;

(5) granulating the prepared soft material on a granulator by using a screen with the specified mesh number, uniformly paving the prepared granules in a stainless steel drying disc to obtain granules with the thickness of about 2cm, and drying;

(6) the drying temperature is controlled at 70 ℃, the drying time is about 4-6h (the time is started when the temperature reaches 70 ℃), and the moisture of the granules is controlled within 6%.

(7) And (3) granulating the dried particles on a granulator by using a screen with the specified mesh number, after finishing granulation, attaching a material circulation label, weighing the weight of the particles, and mixing.

(8) The sodium carboxymethyl cellulose, the sodium benzoate and the talcum powder are mixed with the granules on a mixer according to the prescription amount. Obtaining the human placenta tablet particles.

2. Tabletting

Directly tabletting the granules obtained by total mixing to obtain plain tablets of the placenta hominis tablets, and sampling and detecting the properties, weight difference, friability and disintegration time limit to reach the requirements of related standards.

3. Coating film

(1) Preparing syrup:

preparing simple syrup: adding sucrose into a heating jacketed kettle at a certain ratio (7: 3), heating and decocting, boiling for 5min, and filtering the syrup with 120 mesh stainless steel screen;

preparing gelatin syrup for capsules: adding purified water, heating to boil, adding gelatin for capsule, stirring to dissolve, adding simple syrup, heating to boil, filtering with 120 mesh stainless steel screen, and keeping the temperature.

Preparing color syrup: adding a proper amount of boiling purified water into a specified amount of composite red pigment, and stirring until the composite red pigment is completely dissolved for later use; when the color syrup needs to be prepared, pouring the color syrup into a jacketed pan, adding a certain volume of prepared simple syrup, continuously heating until the color syrup is boiled, and finally filtering by using a 120-mesh stainless steel screen mesh for heat preservation for later use.

(2) Coating operation

Coating an isolation layer: adding gelatin slurry for capsule, stirring, and hot air drying for 40-50 min.

Wrapping a gelatin layer: adding the rest capsule with gelatin slurry and pulvis Talci for 3 times, and hot air drying for 40-50 min each time.

Coating a powder coating layer: alternately coating with simple syrup and pulvis Talci, coating the edge of tablet core, leveling the surface of tablet, and hot air drying for 20-30 min each time.

Coating a sugar coating layer: adding a certain amount of simple syrup into a pan, stirring to make the simple syrup uniformly adhere to the surface of the sheet, blow-drying with cold air after each addition, and drying for 15-20 minutes each time. The tablet is prepared after the surface of the tablet is smooth, flat, fine and solid.

Coating a colored sugar coating layer: adding the prepared color syrup into the coated tablet, repeating the steps for a plurality of times until the color of the coated tablet is consistent, drying by using cold air, and entering the next procedure.

Polishing: adding insect white wax into the tablets coated with the colored sugar coating layer, covering the pot cover, polishing, taking out of the pot, and finishing coating.

4. Airing piece

Taking the slices out of the pan, spreading the slices in a stainless steel plate, placing the stainless steel plate in a room at the temperature of 18-26 ℃ and the relative humidity of 45-65% for about 12-15 hours, then filling the dried coated slices into a PE plastic bag, and waiting for the human placenta slices to be packaged. The appearance of the finished product is shown in figure 3, and the appearance of the product is smooth and flat.

Example 2 quality testing of placental disks

1. The characteristics are as follows: the product is sugar-coated or film-coated tablet, and has brown color and fishy smell after removing color coat.

2. Identification: taking the powder of the test sample under the content measurement, and testing according to the following method:

(1) taking a proper amount of powder (about 0.25g of human placenta powder), placing the powder in a test tube with a plug, adding 10ml of ethanol, shaking for 10 minutes, filtering, taking 5ml of subsequent filtrate, evaporating the subsequent filtrate on a water bath, adding 5ml of glacial acetic acid to dissolve residues, adding 0.5ml of acetic anhydride, then dropwise adding 1 drop of sulfuric acid along the tube wall, wherein the solution is reddish brown, and then gradually turns into dark green.

(2) Taking a proper amount of powder ((about equivalent to 0.25g of human placenta powder), adding 10ml of water, shaking up, heating in a water bath for 30 minutes, cooling to room temperature, filtering, taking 2ml of subsequent filtrate, adding 1ml of ninhydrin test solution, and heating to show bluish purple.

(3) The clear filtrate obtained in the above (2) was added with an equal volume of 10% sulfosalicylic acid solution to produce a white turbidity.

(4) Taking appropriate amount of powder (equivalent to 0.5g of human placenta powder), adding 50% ethanol solution 15ml, ultrasonic dissolving for 30min, filtering, collecting filtrate 5ml, and concentrating to 1ml to obtain sample solution; an aqueous solution containing 0.5mg of hypoxanthine per 1ml was taken as a control solution. Performing thin-layer chromatography (general rules of four parts 0502 of 2020 version of Chinese pharmacopoeia), sucking 20 μ l of test solution and 4 μ l of control solution, respectively dropping on the same silica gel GF254 high-efficiency thin-layer plate, spreading with ethyl acetate-isopropanol-water-concentrated ammonia solution (5: 5: 0.5:0.25) as developing agent, air drying, and viewing under ultraviolet lamp (254nm) to show the same dark spots on the corresponding positions of the control solution.

3. Examination of

(1) Drying to lose weight, taking about 0.5g of the product, placing in a reduced pressure drier, drying at room temperature under reduced pressure to constant weight with phosphorus pentoxide as desiccant, wherein the weight loss can not exceed 8.0% (0831, the fourth general rule of the China pharmacopoeia 2020 edition).

(2) Adenosine is measured by high performance liquid chromatography (China pharmacopoeia 2020 edition four-part general regulation 0512)

Octadecylsilane chemically bonded silica is used as a filling agent in chromatographic condition and system applicability tests; gradient elution is carried out by taking 0.02mol/L potassium dihydrogen phosphate solution (solution A) and 0.06mol/L potassium dihydrogen phosphate solution-methanol-tetrahydrofuran (89: 10: 0.9) (solution B) as mobile phases; 0-10 min, 100% of A liquid and 1.5ml/min of flow rate; 10-15 min, 100% of liquid B, and the flow rate of 1.0 ml/min; 25-30 min, 100% of the A liquid and 1.5ml/min of flow rate; the detection wavelength is 260nm, and the theoretical plate number is not less than 4000 according to adenosine.

Measurement method 8mg of adenosine control was weighed precisely and diluted with water to about 0.8. mu.g per 1ml as a control solution. Measuring 50 mul, injecting into a liquid chromatograph, and recording a chromatogram; another appropriate amount of powder (about 0.25g of human placenta powder) under the content determination item is precisely weighed, placed in a 50ml conical flask, 10ml of water is added, ultrasonic dissolution is carried out for 20min, centrifugation is carried out for 5min at 3500rpm, the supernatant is transferred to a 50ml volumetric flask, the conical flask is washed by water, washing solutions are combined and centrifuged, the supernatant is completely transferred to the measuring flask, 3ml of 10% trichloroacetic acid solution is added, water is used for diluting to the scale, shaking is carried out uniformly, filtration is carried out by a 0.45 mu m filter membrane, 50 mu l of subsequent filtrate is taken and injected into a liquid chromatograph, the chromatogram is recorded, and the peak area is calculated according to an external standard method. The adenosine content of 1g should not be less than 0.10 mg.

(3) The limit of microorganisms should be determined according to the law (four general rules 1105, 1106 in the Chinese pharmacopoeia 2020 edition).

(4) Taking the product when disintegrating, and checking according to law (0921 in the four general guidelines of the 2020 version of Chinese pharmacopoeia).

4. Determination of content

(1) Measuring 20 tablets containing nitrogen, removing sugar coating, grinding, precisely weighing appropriate amount of powder (about equivalent to human placenta powder 0.1g), and performing nitrogen determination (China pharmacopoeia 2020 edition four-part general rule 0704)

Table 1 shows the results of mass measurement of each example

As can be seen from the test results in Table 1, the indexes of the prepared placenta hominis sheet meet the standards after the accelerated test.

Claims (5)

1. A human placenta tablet, comprising: the tablet comprises the following components in percentage by mass: 70-78% of human placenta powder, 10-17% of cane sugar, 8-13% of cane sugar powder, 0.07-0.1% of sodium carboxymethyl cellulose, 0.04-0.08% of sodium benzoate and 0.3-0.7% of talcum powder.

2. A human placental tablet according to claim 1, wherein: 74% of human placenta powder, 13.4% of cane sugar, 11.9% of cane sugar powder, 0.09% of sodium carboxymethyl cellulose, 0.06% of sodium benzoate and 0.55% of talcum powder.

3. A method of preparing a human placental tablet according to claim 1, wherein: comprises the following steps: (1) detecting the qualification of human placenta powder and other auxiliary materials; (2) pulverizing placenta hominis powder, and sieving; (3) adding sucrose into boiling purified water, stirring to dissolve completely, making syrup, and sieving with 120 mesh sieve; (4) adding human placenta powder and sucrose powder into a mixing machine according to the prescription amount, slowly adding the prepared syrup into the mixing machine from a hopper, preparing a soft material, continuously stirring after the addition is finished, and recovering the soft material for the next operation; (5) granulating the prepared soft material on a granulator by using a screen with the specified mesh number, uniformly paving the prepared granules in a stainless steel drying disc, and drying; (6) the drying temperature is controlled to be 65-75 ℃, the drying time is about 4-6h, and the moisture of the particles is controlled to be within 6%; (7) the dried particles are sized on a sizing machine by using a screen with the specified mesh number, after finishing sizing, a material circulation label is attached, the weight of the particles is weighed, and total mixing is carried out; (8) and (3) totally mixing the sodium carboxymethylcellulose, the sodium benzoate and the talcum powder with the granules on a mixer according to the prescription amount to obtain the human placenta tablet granules.

4. The method of claim 3, wherein said human placental tablet is prepared by: also comprises the following steps: (1) directly tabletting the granules obtained by total mixing to obtain a plain sheet of the placenta hominis sheet; (2) coating; (3) airing the slices: taking the slices out of the pan, spreading the slices in a stainless steel plate, placing the stainless steel plate in a room at the temperature of 18-26 ℃ and the relative humidity of 45-65% for about 12-15 hours, then filling the dried coated slices into a PE-lined plastic bag, and waiting for the human placenta slices to be packaged.

5. The method of claim 4, wherein said human placental tablet is prepared by: the coating is as follows: (1) preparing syrup:

preparing simple syrup: adding sucrose into a heating jacketed kettle, heating and decocting, boiling, and filtering syrup with 120 mesh stainless steel screen;

preparing gelatin syrup for capsules: adding purified water, heating to boil, adding gelatin for capsule, stirring to dissolve, adding prepared simple syrup, heating to boil, filtering with 120 mesh stainless steel screen, and keeping the temperature;

preparing color syrup: adding a proper amount of boiling purified water into a specified amount of composite red pigment, and stirring until the composite red pigment is completely dissolved for later use; pouring the mixture into a jacketed kettle when color syrup needs to be prepared, adding the prepared simple syrup, continuously heating to boil, and finally filtering with a 120-mesh stainless steel screen mesh for heat preservation for later use;

(2) coating operation

Coating an isolation layer: adding gelatin slurry for capsules, uniformly stirring, and drying by hot air for 40-50 minutes;

wrapping a gelatin layer: adding the rest capsule with gelatin slurry and pulvis Talci for 3 times, and hot air drying for 40-50 min each time;

coating a powder coating layer: alternately coating with simple syrup and pulvis Talci, coating the edge of tablet core, leveling the surface of tablet, and hot air drying for 20-30 min each time;

coating a sugar coating layer: adding simple syrup into a pot, stirring to make the simple syrup uniformly adhere to the surface of the tablet, blow-drying with cold air after each addition, drying for 15-20 minutes each time, and allowing the tablet surface to be smooth, fine and firm;

coating a colored sugar coating layer: adding the prepared color syrup into the coated tablet, repeating the steps for a plurality of times until the color of the coated tablet is consistent, drying the coated tablet by cold air, and entering the next working procedure;

polishing: adding insect white wax into the tablets coated with the colored sugar coating layer, covering the pot cover, polishing, taking out of the pot, and finishing coating.

Images