CN116492436A - Preparation method of Pingxiao preparation - Google Patents

Preparation method of Pingxiao preparation Download PDF

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Publication number
CN116492436A
CN116492436A CN202310188965.7A CN202310188965A CN116492436A CN 116492436 A CN116492436 A CN 116492436A CN 202310188965 A CN202310188965 A CN 202310188965A CN 116492436 A CN116492436 A CN 116492436A
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preparation
dregs
volatile oil
extracting
fructus aurantii
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宋鹏远
杨继华
李秋平
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JINAN CENTER HOSPITAL
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JINAN CENTER HOSPITAL
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Abstract

The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a preparation method of a Pingxiao preparation. The Pingxiao preparation is prepared from radix Curcumae, herba Agrimoniae, oletum Trogopterori, alumen, sal Nitri, resina Toxicodendri, fructus Aurantii, semen Strychni Pulveratum, and can be granule, tablet, capsule, etc. The Pingxiao capsule prepared by the preparation method has obvious inhibition effect on tumor growth, and can activate immune function to achieve the anti-tumor effect.

Description

Preparation method of Pingxiao preparation
Technical Field
The invention relates to a preparation method of Pingxiao preparation, belonging to the technical field of traditional Chinese medicines.
Background
The Pingxiao capsule has the effects of promoting blood circulation, removing blood stasis, relieving pain, resolving hard mass, clearing heat, detoxicating, strengthening vital qi and eliminating pathogenic factors. Has the functions of relieving symptoms, reducing tumor body, inhibiting tumor growth, improving immunity, and prolonging life of patients. The Pingxiao capsule comprises radix Curcumae, herba et Gemma Agrimoniae, oletum Trogopterori, alumen, sal Nitri, resina Toxicodendri (preparata), fructus Aurantii (parched with bran), and semen Strychni Pulveratum.
Chinese patent CN200910203497.6 discloses a method for preparing a Chinese patent drug "Pingxiao" preparation, which comprises the following steps: extracting radix Curcumae volatile oil, radix Curcumae residue and fructus Aurantii, percolating with ethanol, mixing the residues with herba et Gemma Agrimoniae, decocting with water, mixing the decoction and percolate, concentrating under reduced pressure to obtain soft extract, drying at low temperature, pulverizing into fine powder, adding semen Strychni powder, dry lacquer, oletum Trogopterori, alumen, sal Nitri fine powder and appropriate amount of adjuvants, mixing, percolating, granulating, drying at low temperature, adding volatile oil, mixing, and making into various dosage forms.
Chinese patent CN201210265111.6 discloses an anti-tumor traditional Chinese medicine composition and preparation method thereof, the preparation method comprises the following steps: pulverizing radix Curcumae, parched fructus Aurantii with bran, and radix rehmanniae Preparata, percolating with ethanol, and concentrating the extractive solution under reduced pressure to obtain extract A; decocting herba et Gemma Agrimoniae, alumen, sal Nitri, oletum Trogopterori and the above residues with water, filtering the decoction, concentrating the filtrate, and drying to obtain powder B; mixing above extract A, powder B and semen Strychni powder.
Disclosure of Invention
The invention aims at providing a preparation method of a Pingxiao preparation, which is prepared from radix curcumae, hairyvein agrimony, trogopterus dung, alum, niter, resina Toxicodendri, fructus aurantii and nux vomica powder; wherein the fructus Aurantii is stir-fried with bran, and the lacquer is prepared lacquer;
the preparation method comprises the following steps:
step A, extracting volatile oil from radix curcumae, fructus aurantii and nux vomica powder by adding water and distilling, wherein the volatile oil and distilled dregs are reserved;
b, adding water into the distilled radix curcumae dregs, the bran-fried fructus aurantii and the hairyvein agrimony, adjusting the pH, adding enzyme, carrying out enzymolysis, and keeping the enzymolysis liquid and the dregs for later use;
c, stir-frying the bitter orange dregs obtained in the step B with bran, and reflux-extracting the nux vomica powder dregs and the dried lacquer in the step A with ethanol to obtain an extracting solution for later use;
step D, trogopterus dung, alum and niter are added with water for decoction for standby;
and E, mixing the enzymolysis liquid obtained in the step B, the extracting liquid obtained in the step C and the decoction liquid obtained in the step D, concentrating, adding the volatile oil obtained in the step A, uniformly mixing, and preparing into a clinically common preparation according to a conventional process.
In the above method, the specific operation of the step a is as follows: extracting volatile oil from radix Curcumae, fructus Aurantii and semen Strychni powder by water distillation, adding dextrin into the volatile oil, and making clathrate.
The amount of enzyme added per 100g of medicinal materials in the step B is 1-3g; further, the amount of enzyme added per 100g of the medicinal material in the step B is 1.5-2.5g.
The enzyme in the step B is one or more of cellulase, pectase and hemicellulase; further, in the step B, the enzyme is a mixture of cellulase and pectase, and the use ratio of the cellulase to the pectase is 3-8:1-5.
And (C) adjusting the pH value to 4-7 in the step B.
And B, performing enzymolysis for 1-3 hours.
Specifically, the preparation method comprises the following steps:
step A, extracting volatile oil from radix curcumae, fructus aurantii and nux vomica powder by water distillation, adding dextrin into the volatile oil to prepare an inclusion compound for standby, and keeping distilled dregs for standby;
b, adding water into the distilled radix curcumae dregs, the bran-fried fructus aurantii and the hairyvein agrimony, adjusting the pH, adding enzyme, carrying out enzymolysis, and keeping the enzymolysis liquid and the dregs for later use;
c, stir-frying the medicinal residues of the fructus aurantii with bran, wherein the medicinal residues of the semen strychni powder and the dried lacquer are extracted by reflux with 50-80% ethanol in the step A for later use;
step D, trogopterus dung, alum and niter are added with water for decoction for standby;
and E, mixing the enzymolysis liquid obtained in the step B, the extracting liquid obtained in the step C and the decoction liquid obtained in the step D, concentrating, adding the volatile oil obtained in the step A, uniformly mixing, and preparing into a clinically common preparation according to a conventional process.
The Pingxiao preparation can be an oral solid preparation or a liquid preparation; oral solid formulations are preferred.
The oral solid preparation comprises, but is not limited to, granule, tablet, capsule, pill and other preparation types.
Compared with the prior art, the invention has the remarkable technical effects that:
the Pingxiao capsule prepared by the preparation method has obvious inhibition effect on tumor growth, the tumor inhibition rate can reach more than 66%, the effect is obviously better than that of the Pingxiao capsule prepared by the traditional method, the contents of VEGF, IL-2 and IL-10 in serum can be effectively improved, and the immune function can be activated to achieve the anti-tumor effect.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
The present invention is further illustrated below with reference to specific examples, which are to be construed as merely illustrative of the invention and not limiting of its scope, as various equivalents thereof will suggest themselves to those skilled in the art upon reading the present invention, as defined in the appended claims.
EXAMPLE 1 preparation of Pingxiao Capsule
The formula comprises the following components: 54g of radix curcumae, 54g of hairyvein agrimony, 45g of trogopterus dung, 54g of alum, 54g of niter, 18g of prepared dry paint, 90g of bran-fried bitter orange and 36g of nux vomica powder;
the preparation method comprises the following steps:
step A, extracting volatile oil from radix curcumae, bran-fried fructus aurantii and nux vomica powder by water distillation, and adding beta-cyclodextrin into the volatile oil for inclusion after the distillation of the residue for later use;
b, adding 10 times of water into distilled radix curcumae dregs, bran-fried fructus aurantii and hairyvein agrimony, adjusting the pH to 5, adding 3.6g of compound enzyme (cellulase: pectase=7:2), heating at the constant temperature of 45 ℃ for enzymolysis for 2 hours, boiling for sterilization, cooling to room temperature, filtering, and reserving the enzymolysis liquid and the dregs;
c, stir-frying the bitter orange dregs obtained in the step B with bran, and reflux-extracting the nux vomica powder dregs and the dried lacquer with 65% ethanol in the step A, wherein the extracting solution is filtered for later use;
step D, trogopterus dung, alum and niter are added with water for 2 times, each time is 1 hour, and the decoction is combined;
and E, mixing the enzymolysis liquid obtained in the step B, the extracting liquid obtained in the step C and the decoction liquid obtained in the step D, concentrating under reduced pressure to obtain thick paste, adding the volatile oil inclusion compound obtained in the step A, uniformly mixing, granulating, drying, and encapsulating to obtain 1000 capsules.
EXAMPLE 2 preparation of Pingxiao Capsule
The formula comprises the following components: 54g of radix curcumae, 54g of hairyvein agrimony, 45g of trogopterus dung, 54g of alum, 54g of niter, 18g of prepared dry paint, 90g of bran-fried bitter orange and 36g of nux vomica powder;
the preparation method comprises the following steps:
step A, extracting volatile oil from radix curcumae, bran-fried fructus aurantii and nux vomica powder by water distillation, and adding beta-cyclodextrin into the volatile oil for inclusion after the distillation of the residue for later use;
b, adding 10 times of water into distilled radix curcumae dregs, bran-fried fructus aurantii and hairyvein agrimony, adjusting the pH to 5, adding 3.6g of compound enzyme (cellulase: pectase=5:4), heating at the constant temperature of 45 ℃ for enzymolysis for 2 hours, boiling for sterilization, cooling to room temperature, filtering, and reserving the enzymolysis liquid and the dregs;
c, stir-frying the bitter orange dregs obtained in the step B with bran, and reflux-extracting the nux vomica powder dregs and the dried lacquer with 65% ethanol in the step A, wherein the extracting solution is filtered for later use;
step D, trogopterus dung, alum and niter are added with water for 2 times, each time is 1 hour, and the decoction is combined;
and E, mixing the enzymolysis liquid obtained in the step B, the extracting liquid obtained in the step C and the decoction liquid obtained in the step D, concentrating under reduced pressure to obtain thick paste, adding the volatile oil inclusion compound obtained in the step A, uniformly mixing, granulating, drying, and encapsulating to obtain 1000 capsules.
EXAMPLE 3 preparation of Pingxiao Capsule
The formula comprises the following components: 54g of radix curcumae, 54g of hairyvein agrimony, 45g of trogopterus dung, 54g of alum, 54g of niter, 18g of prepared dry paint, 90g of bran-fried bitter orange and 36g of nux vomica powder;
the preparation method comprises the following steps:
step A, extracting volatile oil from radix curcumae, bran-fried fructus aurantii and nux vomica powder by water distillation, and adding beta-cyclodextrin into the volatile oil for inclusion after the distillation of the residue for later use;
b, adding 10 times of water into distilled radix curcumae dregs, bran-fried fructus aurantii and hairyvein agrimony, adjusting the pH to 5, adding 5.4g of compound enzyme (cellulase: pectase=7:2), heating at the constant temperature of 45 ℃ for enzymolysis for 2 hours, boiling for sterilization, cooling to room temperature, filtering, and reserving the enzymolysis liquid and the dregs;
c, stir-frying the bitter orange dregs obtained in the step B with bran, and reflux-extracting the nux vomica powder dregs and the dried lacquer with 65% ethanol in the step A, wherein the extracting solution is filtered for later use;
step D, trogopterus dung, alum and niter are added with water for 2 times, each time is 1 hour, and the decoction is combined;
and E, mixing the enzymolysis liquid obtained in the step B, the extracting liquid obtained in the step C and the decoction liquid obtained in the step D, concentrating under reduced pressure to obtain thick paste, adding the volatile oil inclusion compound obtained in the step A, uniformly mixing, granulating, drying, and encapsulating to obtain 1000 capsules.
EXAMPLE 4 preparation of Pingxiao Capsule
The formula comprises the following components: 54g of radix curcumae, 54g of hairyvein agrimony, 45g of trogopterus dung, 54g of alum, 54g of niter, 18g of prepared dry paint, 90g of bran-fried bitter orange and 36g of nux vomica powder;
the preparation method comprises the following steps:
step A, extracting volatile oil from radix curcumae, bran-fried fructus aurantii and nux vomica powder by water distillation, and adding beta-cyclodextrin into the volatile oil for inclusion after the distillation of the residue for later use;
b, adding 10 times of water into distilled radix curcumae dregs, bran-fried fructus aurantii and hairyvein agrimony, adjusting the pH to 5, adding 3.6g of cellulase, heating at the constant temperature of 45 ℃ for enzymolysis for 2 hours, boiling for sterilization, cooling to room temperature, filtering, and reserving enzymolysis liquid and dregs;
c, stir-frying the bitter orange dregs obtained in the step B with bran, and reflux-extracting the nux vomica powder dregs and the dried lacquer with 65% ethanol in the step A, wherein the extracting solution is filtered for later use;
step D, trogopterus dung, alum and niter are added with water for 2 times, each time is 1 hour, and the decoction is combined;
and E, mixing the enzymolysis liquid obtained in the step B, the extracting liquid obtained in the step C and the decoction liquid obtained in the step D, concentrating under reduced pressure to obtain thick paste, adding the volatile oil inclusion compound obtained in the step A, uniformly mixing, granulating, drying, and encapsulating to obtain 1000 capsules.
EXAMPLE 5 preparation of Pingxiao Capsule
The formula comprises the following components: 54g of radix curcumae, 54g of hairyvein agrimony, 45g of trogopterus dung, 54g of alum, 54g of niter, 18g of prepared dry paint, 90g of bran-fried bitter orange and 36g of nux vomica powder;
the preparation method comprises the following steps:
step A, radix curcumae, hairyvein agrimony and fructus aurantii, adding 10 times of water, adjusting the pH to 5, adding 3.6g of compound enzyme (cellulase: pectase=7:2), heating at a constant temperature of 45 ℃, carrying out enzymolysis for 2 hours, boiling, sterilizing, cooling to room temperature, filtering, and reserving enzymolysis liquid and dregs;
b, performing reflux extraction on the hairyvein agrimony obtained in the step B, the bitter orange dregs obtained by stir-frying with bran, nux vomica powder and dried lacquer, and 65% ethanol, and filtering the extracting solution for later use;
step C, trogopterus dung, alum and niter are added with water for 2 times, each time is 1 hour, and the decoction is combined;
and D, combining the enzymolysis liquid obtained in the step A, the extracting liquid obtained in the step B and the decoction liquid obtained in the step C, concentrating under reduced pressure to obtain thick paste, granulating, drying, and encapsulating to obtain 1000 capsules.
EXAMPLE 6 preparation of Pingxiao Capsule
The formula comprises the following components: 54g of radix curcumae, 54g of hairyvein agrimony, 45g of trogopterus dung, 54g of alum, 54g of niter, 18g of prepared dry paint, 90g of bran-fried bitter orange and 36g of nux vomica powder;
the preparation method comprises the following steps:
step A, extracting volatile oil from radix curcumae, bran-fried fructus aurantii and nux vomica powder by water distillation, and adding beta-cyclodextrin into the volatile oil for inclusion after the distillation of the residue for later use;
b, reflux-extracting herba et Gemma Agrimoniae, distilled bran-fried fructus Aurantii dregs, semen Strychni powder dregs and dried lacquer with 65% ethanol, and filtering the extractive solution for later use; the dregs are reserved;
step C, decocting the distilled radix curcumae dregs, the bran-fried fructus aurantii dregs, trogopterus dung, alum and niter in water for 2 times, each time for 1 hour, and combining the decoctions;
and D, combining the extracting solution obtained in the step B and the decoction obtained in the step C, concentrating under reduced pressure to obtain thick paste, adding the volatile oil inclusion compound obtained in the step A, uniformly mixing, granulating, drying, and encapsulating to obtain 1000 capsules.
Comparative example 1 preparation of Pingxiao Capsule
The formula comprises the following components: 54g of radix curcumae, 54g of hairyvein agrimony, 45g of trogopterus dung, 54g of alum, 54g of niter, 18g of prepared dry paint, 90g of bran-fried bitter orange and 36g of nux vomica powder;
the preparation method comprises the following steps: pulverizing resina Toxicodendri, oletum Trogopterori, alumen, and Sal Nitri into fine powder; pulverizing radix Curcumae and bran-parched fructus Aurantii into coarse powder, percolating with 70% ethanol as solvent, and collecting percolate 600ml; decocting the residue and herba et Gemma Agrimoniae in water twice, filtering, and mixing filtrates; recovering ethanol from the percolate, mixing with the above filtrate, concentrating under reduced pressure to obtain soft extract, drying, pulverizing into fine powder, adding semen Strychni powder, the above fine powder and adjuvant, mixing, granulating, drying, encapsulating, and making into 1000 capsules.
Comparative example 2 preparation of Pingxiao Capsule
The formula comprises the following components: 54g of radix curcumae, 54g of hairyvein agrimony, 45g of trogopterus dung, 54g of alum, 54g of niter, 18g of prepared dry paint, 90g of bran-fried bitter orange and 36g of nux vomica powder;
the preparation method comprises the following steps: pulverizing radix Curcumae, parched fructus Aurantii with bran, and radix rehmanniae Preparata, percolating with 70% ethanol, collecting percolate, and recovering ethanol under reduced pressure to obtain extract A; decocting herba et Gemma Agrimoniae, alumen, sal Nitri, oletum Trogopterori and the above residues with water for 2 times each for 1 hr, filtering, mixing decoctions, adjusting ethanol concentration of the filtrate to 80% with 95% ethanol, standing for 24 hr, filtering, concentrating the filtrate, and drying to obtain powder B; mixing above extract A, powder B and semen Strychni powder, granulating, drying, and making into capsule of 1000 granules.
Comparative example 3 preparation of Pingxiao Capsule
The formula comprises the following components: 54g of radix curcumae, 54g of hairyvein agrimony, 45g of trogopterus dung, 54g of alum, 54g of niter, 18g of prepared dry paint, 90g of bran-fried bitter orange and 36g of nux vomica powder;
the preparation method comprises the following steps: pulverizing radix Curcumae into coarse powder, extracting volatile oil by steam distillation, and storing the volatile oil in another container; mixing radix Curcumae residue and fructus Aurantii coarse powder, adding 70% ethanol, percolating, and collecting primary percolate and secondary percolate; decocting the percolated residues and herba et Gemma Agrimoniae in water twice, and mixing decoctions; recovering ethanol from the percolate, mixing with the decoction, concentrating to obtain soft extract, drying, pulverizing into fine powder, adding semen Strychni powder, resina Toxicodendri, oletum Trogopterori, alumen, sal Nitri fine powder and conventional adjuvants, mixing, granulating with the percolate as binder, drying, spraying radix Curcumae volatile oil, mixing, and making into capsule of 1000 granule.
2. Pharmacological experiments
In order to verify the application of the Pingxiao preparation in treating tumors, the inventor selects a representative formula and a preparation method thereof to obtain medicines, and develops related pharmacodynamic test researches.
The inventors have noted that the following experimental studies were conducted by referring to the prior art, and were conducted on the basis of the acute toxicity test and the long-term toxicity test, which prove the safety of the drug, and the administration doses in the experimental studies were within the safe dose range.
1 Material
1.1 animals:
BALB/c mice, SPF grade, 18-22g, laboratory animal license number: SCXK 2019 0003, supplied by Jinan Pengyue laboratory animal Breeding Co., ltd, was adapted for one week prior to the experiment.
1.2 drugs, agents
1.2.1 medicaments
Pingxiao capsules obtained in examples 1-6 and Pingxiao capsules obtained in comparative examples 1-3 of the present invention
1.2.3 doses of the drug
0.72g/kg
2. Modeling, grouping and administration
Modeling was performed by injecting CT26-WT colon cancer cell suspension (1 ml cell suspension containing 5X 10) 6 Individual cells) 0.2ml. After inoculation, the breeding is continued for 5 days until the tumor grows to be not less than 0.5cThe size of m.times.0.5 cm was considered as successful in molding. 100 mice were randomly divided into a model group, examples 1 to 6 groups, and comparative examples 1 to 3 groups, 10 groups each, and 10 groups each.
Each administration group was given the corresponding drug by gavage, and the model group was given the same amount of physiological saline by gavage. The administration was continued for 30 days.
3 observation index
3.1 observation of mouse status: mouse activity, response, mental, coat condition, etc.
3.2 tumor volume changes in mice.
3.3 after 24h of last administration, mice were sacrificed, hearts were bled, tumors and organs were peeled off, the tumor weights were measured, and the rate of tumor overflow was calculated.
Tumor suppression rate (%) = (average tumor weight of model group mice-average tumor weight of administration group mice)/average tumor weight of model group mice×100%
3.4 detection of Vascular Endothelial Growth Factor (VEGF), interleukin-2 (IL-2), interleukin-10 (IL-10) content in serum
3.5 statistical treatments
Statistical analysis of the obtained data using SPSS 22.0 software for metering the dataExpressed as P<A difference of 0.05 is statistically significant.
4. Results and conclusions
4.1 mouse State
At the initial stage of administration, tumors of each group of mice normally grow, and from the 10 th day of self-administration, tumors of the model group of mice grow faster than those of other groups, and the mice have slow movement and no luster of hair; the mice in example 1 group had the slowest tumor growth, but the mice were in a worse state and had reduced activity; the mice in the other groups, the mice in examples 2 and 3, had slower tumor growth and better mobility than the mice in the other groups.
4.2 tumor weight and tumor inhibition Rate
The tumor weight of the mice was significantly reduced (P < 0.05 or P < 0.01) in each of the dosing groups compared to the model group, with the most significant reduction in mice in example 1, followed by the mice in example 2, example 3, example 4, example 5, example 6, comparative example 1, comparative example 2, comparative example 3, with minimal reduction in tumor weight but superior to the model group.
Table 1 comparison of tumor weight and tumor inhibition ratio of mice in each groupn=10)
Note that: in contrast to the set of models, @ P<0.05,*P<0.01。
4.3 comparison of VEGF, IL-2 and IL-10 content in serum
The IL-2 and IL-10 content of mice in each of the administration groups was significantly increased compared to the model group, with the increase being most pronounced in the example 1 group.
TABLE 2 comparison of VEGF, IL-2 and IL-10 in groups of micen=10)
Group of VEGF(μg/ml) IL-2(pg/ml) IL-10(pg/ml)
Model group 6.98±0.92 38.12±8.69 31.25±5.36
Example 1 group 4.25±1.03* 65.98±11.56* 63.85±6.01
Example 2 group 4.53±0.83* 60.25±8.32* 60.35±7.36
Example 3 group 4.73±0.99* 57.12±9.02* 55.01±6.01
Example 4 group 4.79±1.01* 56.98±9.87* 53.67±5.01
Example 5 group 5.26±1.07* 56.24±10.03* 50.26±4.98
Example 6 group 5.32±0.88 @ 55.38±8.97* 46.38±6.94
Comparative example 1 group 5.41±0.79 @ 52.67±9.41 @ 41.82±6.01
Comparative example group 2 5.38±1.02 @ 53.16±7.15 @ 42.65±6.54
Comparative example 3 group 5.36±0.86 @ 50.36±6.58 @ 40.25±2.98
Note that: in contrast to the set of models, @ P<0.05,*P<0.01。

Claims (10)

1. a preparation method of a Pingxiao preparation is characterized in that the Pingxiao preparation is prepared from radix curcumae, hairyvein agrimonia herb and bud, trogopterus dung, alum, sal Nitri, resina Toxicodendri, fructus aurantii and nux vomica powder; the preparation method comprises the following steps:
step A, extracting volatile oil from radix curcumae, fructus aurantii and nux vomica powder by adding water and distilling, wherein the volatile oil and distilled dregs are reserved; b, adding water into the distilled radix curcumae dregs, the bran-fried fructus aurantii and the hairyvein agrimony, adjusting the pH, adding enzyme, carrying out enzymolysis, and keeping the enzymolysis liquid and the dregs for later use;
c, stir-frying the bitter orange dregs obtained in the step B with bran, and reflux-extracting the nux vomica powder dregs and the dried lacquer in the step A with ethanol to obtain an extracting solution for later use;
step D, trogopterus dung, alum and niter are added with water for decoction for standby;
and E, mixing the enzymolysis liquid obtained in the step B, the extracting liquid obtained in the step C and the decoction liquid obtained in the step D, concentrating, adding the volatile oil obtained in the step A, uniformly mixing, and preparing into a clinically common preparation according to a conventional process.
2. The preparation method according to claim 1, wherein the specific operation of step a is as follows: extracting volatile oil from radix Curcumae, fructus Aurantii and semen Strychni powder by water distillation, adding dextrin into the volatile oil, and making clathrate.
3. The method of claim 1, wherein the amount of enzyme added per 100g of the medicinal material in step B is 1-3g.
4. The method of claim 3, wherein the amount of enzyme added per 100g of the medicinal material in step B is 1.5-2.5g.
5. The method of claim 1, wherein the enzyme in step B is one or more of cellulase, pectase, and hemicellulase.
6. The method according to claim 5, wherein the enzyme in the step B is a mixture of cellulase and pectase.
7. The method of claim 6, wherein the cellulase and pectase are used in a ratio of 3-8:1-5.
8. The method of claim 1, wherein the pH is adjusted to 4-7 in step B.
9. The method of claim 1, wherein the enzymatic hydrolysis time in step B is 1-3 hours.
10. The preparation method according to any one of claims 1 to 9, wherein the preparation method comprises the steps of:
step A, extracting volatile oil from radix curcumae, fructus aurantii and nux vomica powder by water distillation, adding dextrin into the volatile oil to prepare an inclusion compound for standby, and keeping distilled dregs for standby;
b, adding water into the distilled radix curcumae dregs, the bran-fried fructus aurantii and the hairyvein agrimony, adjusting the pH, adding enzyme, carrying out enzymolysis, and keeping the enzymolysis liquid and the dregs for later use;
step C, stir-frying the medicinal residues of the fructus aurantii with bran, wherein the medicinal residues of the nux vomica powder and the dried lacquer are obtained in the step B, and the ratio of the medicinal residues to the dried lacquer is 50-80 percent
Reflux-extracting with ethanol, and collecting extractive solution;
step D, trogopterus dung, alum and niter are added with water for decoction for standby;
step E, mixing the enzymolysis liquid obtained in the step B, the extracting liquid obtained in the step C and the decoction liquid obtained in the step D, concentrating,
adding the volatile oil obtained in the step A, uniformly mixing, and preparing into a clinically common preparation according to a conventional process.
CN202310188965.7A 2023-03-02 2023-03-02 Preparation method of Pingxiao preparation Pending CN116492436A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101284120A (en) * 2008-05-29 2008-10-15 宁夏金太阳药业有限公司 Process for preparing Pingxiao preparation
CN101612357A (en) * 2009-02-13 2009-12-30 西安正大制药有限公司 A kind of Chinese medicine composition for the treatment of tumor and preparation method thereof
CN106039210A (en) * 2016-06-29 2016-10-26 宁夏金太阳药业有限公司 Traditional Chinese medicinal composition for treating hyperplasia of mammary glands as well as preparation method and application thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101284120A (en) * 2008-05-29 2008-10-15 宁夏金太阳药业有限公司 Process for preparing Pingxiao preparation
CN101612357A (en) * 2009-02-13 2009-12-30 西安正大制药有限公司 A kind of Chinese medicine composition for the treatment of tumor and preparation method thereof
CN106039210A (en) * 2016-06-29 2016-10-26 宁夏金太阳药业有限公司 Traditional Chinese medicinal composition for treating hyperplasia of mammary glands as well as preparation method and application thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
贾晓波;陈东圣;林冲;于清峰;濮存海;: "RP-HPLC法同时测定平消片中3种成分", 中成药, no. 12, pages 2685 - 2688 *

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